Down syndrome treatments – Nova Scotia Down Syndrome Society http://www.novascotiadownsyndromesociety.com/ Wed, 11 Aug 2021 04:24:55 +0000 en-US hourly 1 https://wordpress.org/?v=5.8 https://www.novascotiadownsyndromesociety.com/wp-content/uploads/2021/07/icon-2021-07-30T230350.091.png Down syndrome treatments – Nova Scotia Down Syndrome Society http://www.novascotiadownsyndromesociety.com/ 32 32 Apply Online for a Loan With Bad Credit. -Internet Loans for Bad Credit: Get Cash Now https://www.novascotiadownsyndromesociety.com/small-payday-loan-lenders/ Wed, 11 Aug 2021 04:22:26 +0000 https://www.novascotiadownsyndromesociety.com/?p=3094 Internet loans for poor credit: Get short-term cash now If two or three years earlier, most Ukrainians had not heard of such a service, today almost everyone knows about the opportunity to internet loan for bad credit, so just click here to visit GreenDayOnline for free. Every day, technology is making our lives easier. This should not […]]]>

Internet loans for poor credit: Get short-term cash now

If two or three years earlier, most Ukrainians had not heard of such a service, today almost everyone knows about the opportunity to internet loan for bad credit, so just click here to visit GreenDayOnline for free. Every day, technology is making our lives easier. This should not be overlooked in the financial boom. It should not be considered a panacea. However, a short-term loan may prove to be useful in certain circumstances.

You must have been in a situation where you were too busy with the holidays and your wallet was empty. This was a situation that put us in an awkward place before. Loans from friends and requests for financial help from parents – not once repaid debt destroyed many human relationships. We now have an alternative to dealing with financial problems. The downside was that the new features also came with the pain of choice: is it better to apply online for a loan?

Microfinance firms that offer fast internet loans are growing like mushrooms since the last rain. This is a good thing because potential customers have many options. However, it can also confuse experienced borrowers. Credit companies can have many different business models, despite the common line of business. This isn’t about the location or design of the main office. It’s about the terms of the loan.

Online loans are available in many ways. You can click on any advertisement or banner on the Internet and trust the blind event. Our helpful tips can help you.

  • Avoid contextual advertising

These are the first lines of Google’s dropped results. These are often empty promises of lucrative lending with no justification.

  • Compare different companies

Use calculators from different microfinance websites to choose the same loan amount and term. This will give you an estimate of the interest overpayment. The only thing left is to choose the smallest.

  • Use “comparison sites”

Today, there are many such resources. As a rule, they have a long list of credit services, which indicate the maximum amounts and terms of loans, daily interest rate and valid shares. There are often comments from users.

  • ELine offers a loan

You don’t have to look at all the lending websites if you don’t have the time or desire to. We are currently the only company that offers a Ukrainian loan online at a low interest rate. This means that you will repay less than what you owe when you repay the loan.

No matter what you do, monetary matters must be handled with care. It is worth taking the time to apply for your first hit business – it will help you get better terms.

How do you find a trustworthy company without getting into bondage?

Let’s get back to the topic of responsibility. Be familiar with the reputation of the company in the marketplace before you sign a loan agreement.

You can read through customer reviews and search Google for unpleasant, loud scandals.

Once you have established trust in the company’s reliability, evaluate your financial resources. Don’t borrow money unless you absolutely need it. Also, be aware of the penalties that may apply in the event of delay.

Borrowers often find themselves in a financial hole when it comes time to pay their bills. Do not rely on luck to win the lottery. Only stable income sources are acceptable. Remember that both the parties are responsible for creating a mutually beneficial financial partnership.

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How to get a Covid vaccine if you’re 16 or 17 https://www.novascotiadownsyndromesociety.com/how-to-get-a-covid-vaccine-if-youre-16-or-17/ Fri, 06 Aug 2021 11:12:03 +0000 https://www.novascotiadownsyndromesociety.com/how-to-get-a-covid-vaccine-if-youre-16-or-17/ More than one million children and young people can now receive the Covid vaccine in the final stage of the NHS vaccination program. The NHS has worked to quickly expand the program to 16 and 17 year olds, the country’s most vulnerable children and those living with vulnerable adults following changes to the Joint Committee’s […]]]>

More than one million children and young people can now receive the Covid vaccine in the final stage of the NHS vaccination program.

The NHS has worked to quickly expand the program to 16 and 17 year olds, the country’s most vulnerable children and those living with vulnerable adults following changes to the Joint Committee’s guidelines on immunization and vaccination (JCVI).

All 16 and 17 year olds will be offered a jab dose of the vaccine, according to new guidelines released by the JCVI earlier this week.

As a first step, they must wait to be contacted by their GP to arrange an appointment, although walk-in services will soon be available for anyone aged 16 and over.

While children and young people can contract the coronavirus, there are fewer cases compared to adults and the symptoms are usually mild.

Dr Nikki Kanani, NHS Medical Director for Primary Care and Assistant ORS for Immunization Program, said: ‘NHS staff have delivered 70 million Covid-19 vaccines across England in just over seven months, providing protection against the coronavirus to more than 39 million people and saving thousands of lives.

‘The NHS has also been working hard to implement the JCVI guidelines as quickly as possible and I am happy to say that a million children and young people will now be able to get vaccinated, protecting themselves and their family and friends .

“The Covid-19 vaccine is safe and effective and I urge any eligible person of any age to come forward and accept the offer. ”

Children between the ages of 12 and 15 who are clinically vulnerable to Covid, or who live with adults who are at increased risk of serious illness from the virus, will also be contacted by the NHS and asked for their vaccine in the coming weeks.

Eligible individuals include people with Down syndrome or who are undergoing multiple cancer treatments, who have had an organ or bone marrow transplant, or who are on the Learning Disabilities Registry.

The Covid-19 vaccine will also be offered to children 12 years and older who live with an immunocompromised person, such as those who are receiving chemotherapy or who have had a transplant.

Children and youth now eligible will be offered the Pfizer Covid-19 vaccine.

More than 70 million vaccines have been issued since the NHS in England made history when Margaret Keenan received the first vaccine outside of a clinical trial in Coventry in December 2020.

Anyone aged 18 or over is eligible for a Covid-19 jab via nhs.uk or by visiting the nearest walk-in center, which in Cornwall includes Stithians Showground and the Royal Cornwall Showground near Wadebridge.

Second doses are available for people who received their first dose eight weeks ago, as directed by JCVI.

Anyone who cannot connect can call the service on 119 to reserve their jab.


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He is the chiropractor of the Olympic athletics stars https://www.novascotiadownsyndromesociety.com/he-is-the-chiropractor-of-the-olympic-athletics-stars/ Tue, 03 Aug 2021 10:44:22 +0000 https://www.novascotiadownsyndromesociety.com/he-is-the-chiropractor-of-the-olympic-athletics-stars/ For his part, Ball doesn’t seem to have much trouble keeping a step back. “It’s always funny to me because they tell me ‘Ugh, my Achilles hurts’,” Ball said. “OK, well, they cut off part of my eye last week. Everyone has their problems. Gravity is the enemy Ball grew up in Davenport, Iowa, where […]]]>

For his part, Ball doesn’t seem to have much trouble keeping a step back.

“It’s always funny to me because they tell me ‘Ugh, my Achilles hurts’,” Ball said. “OK, well, they cut off part of my eye last week. Everyone has their problems.

Ball grew up in Davenport, Iowa, where his father was a football coach and his mother, Jan, was a chiropractor. Tim O’Neill, one of his closest friends, recalled that Ball was smart and athletic – the fastest kid in the neighborhood. Ball thought he would play college basketball, until his 3-point shot evaporated when he was in high school.

“I couldn’t see the hoop,” he said.

Diagnosed with keratoconus, gradual thinning and bulging of the cornea, Ball gave up his wayward jump shot to arizona state race track, where he learned the hard way what it’s like to run with nagging injuries. Before his final year, he left school due to a family emergency and ended up studying for his chiropractic degree in his hometown.

“I wanted to be really good at something,” Ball said, “and when I found out about that I probably got a little bit obsessive.”

He returned to Arizona and opened his own practice, seeing ordinary people with regular problems. His favorite patient, he said, was an elderly woman with carpal tunnel syndrome who knitted a blanket for her.

His career changed as the 2004 Olympics approached, when he met Patrick Nduwimana, an NCAA champion within half a mile while at the University of Arizona. Nduwimana, who was recovering from ankle surgery, said a friend recommended Ball as a practitioner of “active release therapy,” a form of manual chiropractic treatment. For about an hour, Ball applied pressure using his hands on Nduwimana’s ankle to release the tension.


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Gilead Sciences (GILD) Q2 2021 Earnings Call Transcript https://www.novascotiadownsyndromesociety.com/gilead-sciences-gild-q2-2021-earnings-call-transcript/ Fri, 30 Jul 2021 15:22:08 +0000 https://www.novascotiadownsyndromesociety.com/?p=2975 Image source: The Motley Fool. Gilead Sciences (NASDAQ:GILD)Q2 2021 Earnings CallJul 29, 2021, 4:30 p.m. ET Contents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: Operator Good day, and thank you for standing by. Welcome to the Gilead Sciences second-quarter 2021 earnings conference call. [Operator instructions] Please be advised that today’s conference is being recorded. [Operator […]]]>

Image source: The Motley Fool.

Gilead Sciences (NASDAQ:GILD)
Q2 2021 Earnings Call
Jul 29, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, and thank you for standing by. Welcome to the Gilead Sciences second-quarter 2021 earnings conference call. [Operator instructions] Please be advised that today’s conference is being recorded. [Operator instructions] I would now like to hand the conference over to your speaker today, Jacquie Ross, VP, investor relations.

Please go ahead.

Jacquie RossVice President, Investor Relations

Thank you, Joelle, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the second quarter of 2021. The press release, slides and supplementary data are available on the Investors section of our website at gilead.com. The speakers on today’s call will be our chairman and chief executive officer, Daniel O’Day, our chief commercial officer, Johanna Mercier; our chief medical officer, Merdad Parsey; and our chief financial officer, Andrew Dickinson.

After that, we’ll open up the call to Q&A, where the team will be joined by Christi Shaw, the chief executive officer of Kite. Before we get started, let me remind you that we will be making forward-looking statements, including those related to the impact of the COVID-19 pandemic on Gilead’s business; financial condition and results of operations; plans and expectations with respect to products; product candidates; corporate strategy; financial projections and the use of capital; and 2021 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Non-GAAP financial measures will be used to help you understand the company’s underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release, in our supplementary data sheet, as well as on the Gilead website. I will now turn the call over to Dan.

Daniel O’DayChairman and Chief Executive Officer

Thank you, Jacquie, and good afternoon, everyone. Thanks for taking the time to join us here today. We’re pleased to provide you with an update on our second quarter, where we delivered solid financial performance and significant progress on our increasingly diverse pipeline. 2021 is an important year for our pipeline, and we’re very encouraged by the milestones we’ve achieved for therapies that are potentially transformative for Gilead and for patients.

All of this reinforces our confidence in our strategic direction. I want to take this opportunity to thank our global community of Gilead and Kite employees, who consistently go above and beyond to drive progress with resilience and dedication. Different parts of the world are riding the ebb and flow of COVID-19 cases at various times. And while the vaccines give us hope and optimism, we are still very much living with the pandemic.

Remdesivir continues to play an important role in fighting the virus and has now been used to treat an estimated seven million hospitalized patients worldwide. Turning to the main highlights of the quarter on Slide 4, the second quarter was a solid quarter overall. Veklury sales of $829 million were once again higher than anticipated, offsetting the lingering impact of the pandemic, particularly on HIV treatment. In light of this pandemic impact, Biktarvy’s performance is quite encouraging, revenue for the quarter was USD 2 billion, up 24% or $390 million from the same quarter last year.

This more than offset the $322 million headwind associated with the impact of the Truvada and Atripla LOEs. Much of that headwind is now, of course, behind us. Overall, our share of the HIV treatment market held steady quarter over quarter, and our PrEP share remains steady even with generic entries. These dynamics give us confidence that the underlying demand for our HIV products remains strong and positions us well for growth as the overall HIV market recovery gains momentum.

Moving to our clinical pipeline, 2021 is a catalyst-heavy year for Gilead, and we’ve delivered all of our key first-half pipeline commitments. Among other milestones, we shared top-line data from the highly anticipated ZUMA-7 trial, where Yescarta improved event-free survival for second-line large B-cell lymphoma or LBCL patients by 60% compared to the standard of care. This is truly a landmark trial, the first and largest reported Phase 3 trial readout that demonstrates the efficacy and safety of cell therapy, and we are excited by the opportunity to bring the potential benefits of cell therapy to patients in earlier lines. We shared positive Phase 3 data from MYR301, which will help support our anticipated BLA filing for Hepcludex for HDV in the U.S.

later this year, and we submitted our NDA for use of lenacapavir in the heavily treatment-experienced population with multidrug resistance. This filing was based on data from the Phase 1/2 CAPELLA study presented earlier this month. We also shared strong lenacapavir data from the Phase 2 CALIBRATE study in HIV treatment, which will be used to inform our broader lenacapavir efforts. Our partner, Arcus provided an interim update from ARC-7 that supports the continuation of both ARC-7 and ARC-10 trials for their anti-TIGIT candidate, domvanalimab.

Lastly, on Slide 4, we’re beginning to see the positive impact of our strategy, which we introduced early last year. The business is diversified across indications and therapies. In particular, we are seeing Cell Therapy and Trodelvy contribute to growth and expect they will be key growth drivers for Gilead. While we build out the oncology business, we remain focused and committed on ensuring the long-term competitive positioning of our virology portfolio.

Next, on Slide 5, we highlighted our pipeline execution so far this year. And I’d like to thank all those who helped us to deliver on this ambitious agenda, including our employees, the people who participated in the studies, our partners and the study investigators. As we look ahead to the rest of the year, our target milestones include a progression-free survival or PFS readout in our event-driven Phase 3 TROPiCS-02 study evaluating Trodelvy in hormone receptor HER2-negative metastatic breast cancer. A Phase Ib readout for magrolimab and myelodysplastic syndrome or MDS.

Depending on the data, timing and results, this could result in a BLA submission for accelerated approval and initiation of the potential Phase 3 lenacapavir and islatravir long-acting oral combination. As you know, this is in collaboration with Merck and the development and formulation work remains on track. We look forward to updating you next quarter about the additional milestone progress. We understand the continued strong and consistent pipeline execution is critical to the extending the virology business and expanding further into oncology.

We believe our current and pipeline therapies can address significant unmet medical needs. We are very encouraged by the progress Gilead and Kite are making. We are well on our way in our journey to expand and diversify into new therapeutic areas and we are already seeing the evolution of both our pipeline and commercial portfolio. With that, I’ll hand over to Johanna, who will share an update on our commercial performance for the second quarter.

Johanna MercierChief Commercial Officer

Thanks, Dan, and good afternoon, everyone. Starting on Slide 7, total product sales of $6.2 billion were up 21% year over year, primarily reflecting Veklury, which was not a contributor to revenue in the second quarter of 2020. On Slide 8, Veklury second-quarter revenues of $829 million declined sequentially, reflecting the impact of higher vaccination rates and lower infection and hospitalization in many regions. While hospitalizations trended lower in the second quarter, Veklury remains the therapy of choice in three out of five patients hospitalized with COVID-19.

We estimate that since the launch in May 2020, roughly 7 million patients globally have been treated with remdesivir. It’s truly remarkable and encouraging to see how remdesivir continues to play such a key role in fighting this global pandemic. Excluding Veklury, total product sales of $5.3 billion were up 5% year over year. We saw growth in Cell Therapy and HCV in addition to new revenue contributions from Trodelvy and more modestly Hepcludex for HDV.

Additionally, other product revenues of $291 million grew 20% year over year, driven by increased demand for AmBisome outside of the U.S. to treat mucormycosis, which has seen a rise in incidents in patients hospitalized with COVID-19. Sequentially, we saw 9% growth for total product sales, excluding Veklury, primarily driven by growth in Biktarvy. Moving to Slide 9, HIV product sales were $3.9 billion, up 8% sequentially and down 2% year over year.

Compared to the second quarter of 2020, total HIV revenue reflected strong Biktarvy growth that more than offset the $322 million lower revenue from Truvada and Atripla following their loss of exclusivity. Compared to last quarter, HIV grew $288 million, reflecting customary seasonal inventory dynamics and growing demand for treatment. Biktarvy revenue of $2 billion was up 24% year over year and 9% sequentially, with quarter-over-quarter growth, primarily driven by increased demand. Biktarvy remains the #1 prescribed therapy in the U.S.

across naive, switch and continuing patients and remains #1 in naive across all EU5 countries. Approximately 70% of switches from both Gilead and non-Gilead regimens, result in incremental revenue. Overall, and despite the ongoing impact of the pandemic, Biktarvy continues to gain market share with 1% share growth versus last quarter in both the U.S., as well as the EU5. Descovy revenues of $435 million grew 21% sequentially due to a modest improvement in the demand for prep and more favorable inventory and pricing dynamics that we typically see in the second quarter relative to the first.

As we highlighted in prior quarters, we’ve been working with payers to ensure patients’ community to have access to Descovy in light of entry of generic alternatives for Truvada. We’re really pleased to see the strong sequential growth in Descovy, and we continue to maintain mid-40% share despite generic impacts. Year over year, Descovy grew 4%, largely due to higher demand for PrEP. And overall, PrEP demand is showing signs of recovery and is expected to continue to improve as pandemic restrictions phase out.

Earlier this month, federal FAQs for the U.S. Preventative Services Task Force were released. It provided greater clarity as to the importance of PrEP in ending the epidemic, and we’re really encouraged by this recent development. We hope it will help to minimize the barriers of PrEP use going forward.

Before I transition to other products, I just wanted to take a moment to share some perspective on the HIV treatment market, given the longer-than-expected pandemic impact. In regions outside of the U.S., such as Europe, we’re beginning to see signs of recovery in the dynamic market with second-quarter trends generally in line with our expectations. In the U.S., however, the pace of the pandemic recovery was slower than we expected in this last quarter. And while we’re seeing signs of recovery in PrEP and some sequential growth in the treatment market, it’s clear that it will take several quarters for treatment to return to pre-pandemic levels.

In treatment, there are really two pandemic-related headwinds that we observed. First, lower HIV screening and diagnosis resulting in lower treatment initiation; and second, due to the limited support services available during the pandemic, we’ve seen a higher number of patients discontinue their HIV treatments. Taken together, these two factors have reduced the number of active patients on HIV therapy entering 2021, thereby reducing the overall volume of new and refill prescriptions we would expect to see in 2021. We did, however, see growth resume from this lower base in the second quarter.

After prior quarter-over-quarter decline, second-quarter U.S. HIV treatment prescriptions grew 2% and we expect the market to grow at historical rates once screening and diagnosis rates return to pre-pandemic levels. To continue our efforts to advance progress against the HIV epidemic, we are partnering with healthcare professionals, advocacy groups and policymakers to raise awareness of the unique challenges COVID-19 poses to HIV screening, diagnosis and adherence . Our goal is to help healthcare providers ensure that patients continue to be diagnosed and treated.

Given the strength of the demand fundamentals for Biktarvy, Descovy for PrEP and other Gilead HIV products, we remain confident in our competitive positioning now that many communities aren’t using social distancing requirements. In the meantime, we continue to see strength in underlying treatment demand with no material changes in the competitive landscape, with our total Gilead treatment market share holding steady at 75% in the U.S. and just under 50% in Europe despite competition and the entry of new generics. Next, on Slide 10, HCV product sales in the second quarter were $549 million, up 23% compared to last year, but patient starts remain well below pre-pandemic levels.

The growth reflects a modest sequential recovery in HCV patient starts in the U.S. in Q2 ’21, in addition to an artificially low Q2 of ’20 that was impacted by unfavorable government rebate adjustments. We’ll be watching for further signs of recovery in the third quarter. Both U.S.

and EU Gilead market shares remain steady at around 60% and 50%, respectively. Moving to Slide 11, HBV and HDV product sales were $237 million, up 8% year over year with improving patient starts on Vemlidy, particularly in ex U.S. markets. In its first full quarter as part of Gilead Hepcludex contributed $7 million and is currently available in France, Germany and Austria.

We’re excited to be working with the various reimbursement authorities to increase patient access and expect to secure full reimbursement in the major European markets in 2022. Moving to Trodelvy on Slide 12, product sales in the second quarter were $89 million, up 24% quarter over quarter, driven by demand for the two new indications approved in April, namely second-line plus metastatic triple-negative breast cancer and urothelial cancer. We continue to be encouraged by the positive feedback from physicians on the Phase 3 ASCENT data, which demonstrated a one-year medium overall survival benefit for second-line metastatic TNBC patients treated with Trodelvy. To build on this growing interest, we’re increasing community awareness, especially the expanded indication to second line in TNBC.

And we expect to see growing demand as breast cancer screening ramps back up to pre-pandemic levels. IQVIA data suggests that breast cancer screening volumes were about 20% lower in the U.S. in 2020 compared to 2019. This suggests as many as 41,500 breast cancer patients have not been diagnosed during the pandemic.

On behalf of Christi and the Kite team, I’m pleased to share a Cell Therapy commercial update on Slide 13. Total cell therapy product sales totaled $219 million in the second quarter, representing 39% growth year over year, driven by both Yescarta and Tecartus. Yescarta growth was driven by strong demand in Europe, as well as successful follicular lymphoma launch in the U.S. Increased competition, particularly in third-line LBCL, continues to raise the profile of cell therapy and is positive to Kite overall.

We remain confident in Yescarta’s competitive profile and positioning, and are particularly proud of Kite’s industry-leading manufacturing turnaround time and reliability. Our results also reflected strong momentum from the Tecartus mantle cell lymphoma launch, highlighting the unmet medical need for MCL patients. We continue to add new indications and geographies for our cell therapy products. For example, the Fosun-Kite joint venture recently received approval in China for Yescarta as the first cell therapy to treat third-line LBCL.

And we’re excited to see the top-line data for ZUMA-7, getting us a step closer to second-line LBCL cell therapy. Even as we prepare for discussions with regulatory agencies later this year, commercial and manufacturing preparations are ramping up to ensure sufficient capacity and support for second-line LBCL demand in both the U.S. and in Europe. Christi is here with the team to take your questions on cell therapy later in the call.

But for now, I’ll hand it over to Merdad to walk us through the pipeline updates.

Merdad ParseyChief Medical Officer

Thank you, Johanna. As Dan mentioned, it’s been a gratifying year so far, delivering on all our key pipeline commitments, supporting Gilead’s ambitions to extend our leadership in HIV and creating a broader portfolio spanning virology and oncology and building our portfolio in inflammation. I’ll spend our time today on the highlights of the quarter and pointed to the appendix of the earnings presentation for a more complete view of our pipeline activities. First, in HIV, as you can see on Slide 15, programs for our investigational lenacapavir agent continued to progress.

At the recent International Aid Society Meeting, we shared data from the Phase 1/2 CAPELLA study that evaluated heavily treatment experienced individuals who’ve already developed resistance to multiple antiretroviral drugs. CAPELLA demonstrated lenacapavir’s potency in this difficult-to-treat population. Despite significant prior resistance, antiviral activity was observed starting at day 15. By week 26, 81% of individuals had viral suppression when lenacapavir was combined with an optimized background regimen.

Based on these data, we filed a new drug application. If approved, this would become the first six-month long-acting subcutaneous injection regimen available and deliver a welcome new option for people living with HIV, who have developed multidrug resistance to other antiretrovirals. Also with IAS, we presented strong interim results from the Phase 2 CALIBRATE study, evaluating lenacapavir in a treatment-naive population. In CALIBRATE, participants receive lenacapavir either as a subcutaneous injection or as a daily oral pill in combination with Descovy.

At week 28, 94% of subjects achieved HIV-1 RNA loads of less than 50 copies per ml. These findings will be used to help inform our broader efforts establishing lenacapavir as a foundational agent for our long-acting franchise. Late last month, we screened the first patient for the Phase 3 PURPOSE-II trial, studying lenacapavir for HIV prevention in cisgender men, transgender women, transgender men and gender nonbinary people who have sex with men and are at risk of HIV infection. We expect to initiate the Phase 3 PURPOSE-I study of lenacapavir for HIV prevention in adolescent girls and young women later this year.

Finally, we’re actively working on the co-formulation for the long-acting investigational oral and injectable combination of lenacapavir and islatravir and expect to initiate the oral Phase 2 trial by the end of the year. Moving on to HDV on Slide 16. Last month at the International Liver Congress, we presented data from the MYR301 and MYR204 programs. MYR301 is a Phase 3 registrational study evaluating bulevirtide as monotherapy for the treatment of HDV.

Interim results demonstrated that bulevirtide was well tolerated in both cirrhotic and noncirrhotic patients, with compensated chronic HDV infections. At week 24, bulevirtide treatment was associated with significantly greater HDV RNA declines and improvements in biochemical measures of disease activity compared to no treatment. Moreover, there were no treatment-related serious adverse events leading to discontinuation. These results continue to support the effectiveness of the two-milligram dose, which has received conditional approval from the EMA and will form the basis of the BLA filing plan for later this year in the U.S.

As part of our HDV cure efforts, we also presented interim data from the MYR204 Phase IIb study, investigating finite regimens of bulevirtide, both as monotherapy and in combination with PEG interferon alpha. Both monotherapy and combination treatments of bulevirtide were found to be generally well tolerated and more effective than PEG interferon alone through 24 weeks of therapy. The primary endpoint analysis occurs at 24 weeks after completion of therapy and includes virologic and biochemical response data. We look forward to sharing those data when available.

Moving to Slide 17 and on behalf of Christi and the Kite team, as you know, we shared earlier the strong positive top-line data from ZUMA-7, the landmark 359-patient Phase 3 study evaluating Yescarta in second-line LBCL. The study met the primary endpoint for event-free survival with a hazard ratio of 0.398, representing a 60% improvement in event-free survival compared to standard-of-care stem cell transplant. Yescarta had a safety profile comparable to or better than what we have seen in the third-line setting. This is a clinically and statistically meaningful improvement in outcomes that, if approved in the U.S., could extend Yescarta’s reach to a total unique population of 14,000 patients annually in the second and third-line LBCL setting.

ZUMA-7 also met the key secondary endpoint of objective response rate. As expected, data for overall survival is immature at this time, but the interim analysis suggests a favorable trend in this critical milestone. In summary, we’re very excited about the potential benefit to patients demonstrated in ZUMA-7 and look forward to beginning discussions with regulatory agencies later this year as we work toward potential SBLA and MAA filings for Yescarta in second-line LBCL. And separately, we’re on track for the Phase 2 readout for our first-line LBCL study before the end of the year.

Beyond LBCL, we’ve completed filing Yescarta with the EMA for patients with follicular lymphoma after three or more lines of systemic therapy. We also have a PDUFA date of October 1 under accelerated review with the FDA for Yescarta’s MALL. And of course, while our internal focus remains on ontologist cell therapies, we continue our engagement in alternative approaches. Most recently partnering with Shoreline Biosciences to develop novel off the shelf allogeneic cell therapies based on natural killer targets for hematologic cancers.

Slide 18 is a recap of our pipeline execution so far this year. In addition to the items we have discussed already, our partner Arcus has provided an early interim update of their Phase 2 ARC-7 trial in late June, demonstrating clinical activity in the anti-TIGIT domvanalimab-based doublet and triplet combinations. Zimberelimab, our anti-PD-1 antibody, saw similar levels of activity in the monotherapy arm compared to marketed anti-PD-1s. Based on the interim analysis, we’re pleased that ARC-7 and the confirmatory Phase 3 ARC-10 trial will continue to enroll as planned.

We look forward to seeing how the data mature with additional patients and duration of follow-up to inform our opt-in decision. Separately, our partner, Galapagos, also shared data readouts from their Toledo SIK2/3 programs across psoriasis, ulcerative colitis and rheumatoid arthritis and the plaque psoriasis data from their TYK2 program. Both studies were early and had small samples, and we look forward to additional data. We also remain focused on the following upcoming milestones.

For Trodelvy, we continue to target a TROPiCS-02 PFS readout this year. The study is an event-driven Phase 3 trial in patients with hormone receptor positive HER2-negative metastatic breast cancer. Pending data, we will evaluate and then determine the appropriate regulatory next steps. We estimate there are roughly 17,000 patients in the U.S.

who could benefit from Trodelvy in this setting. We continue to expect the Phase 3 non-small cell lung cancer for Trodelvy to initiate in the second half of this year. We plan to share an update from the TROPiCS-03 basket study on lung cancer later this year and will separately provide updates on head and neck squamous cell carcinoma and endometrial cancer as those data mature. We anticipate a Phase Ib readout from magrolimab in MDS later this year, and pending data will engage with regulators as we explore potential BLA filing for accelerated approval.

If approved, magrolimab will be the first-in-class checkpoint inhibitor targeting CD47 and Gilead’s first frontline oncology indication. There’s a significant unmet need for MDS, with no new treatments approved in 14 years despite 15,000 new patients being diagnosed each year in the U.S. alone. We continue our development efforts in AML and have enrolled our first patient in the Phase 3 frontline AML magrolimab study.

Before I wrap up the pipeline discussion, I wanted to share an update on remdesivir. We’ve decided not to move forward with an inhaled formulation of remdesivir based on the results of our initial proof-of-concept study, suggesting suboptimal lung deposition. To address patient needs in the evolving pandemic, we are continuing our efforts on advancing multiple novel antivirals. We expect to submit IND filings later this year or early next year for these agents.

We remain committed to supporting patients through this pandemic and continuing our legacy of developing antiviral therapeutics for the treatment of emerging diseases. Finally, on Slide 19, I want to recognize the teams at Gilead and Kite. Compared to just two years ago, our pipeline has grown from 30 clinical stage programs to over 50 today, and resulted in a considerably more diverse set of assets that can be transformative, not only for patients but for Gilead. The Gilead and Kite teams have worked tirelessly to deliver on our pipeline programs during this time of dramatic growth despite the pandemic.

It’s a thrilling time to be part of the team, with tireless dedication and commitment to helping patients. I look forward to updating you on our progress in the quarters ahead. With that, I’ll hand the call over to Andy to walk us through the financial results of the quarter.

Andrew DickinsonChief Financial Officer

Thank you, Merdad, and good afternoon, everyone. Moving to Slide 21, our financial results in the second quarter were solid overall, with total product sales up 21% year over year, given the important role Veklury continues to play in this pandemic. Excluding Veklury, total product sales grew 5% year over year, with strong Biktarvy growth more than offsetting lower Truvada and Atripla revenues. In addition to impressive growth in cell therapy and, of course, the new revenue contribution associated with Trodelvy, which was not part of our portfolio in the second quarter of last year.

Moving down the P&L, non-GAAP product gross margin was 86.4% in the second quarter, 210 basis points higher year over year and primarily associated with a lower royalty expense. Non-GAAP R&D was $1.1 billion, down 9% year over year with lower remdesivir-related investments as compared to the same period last year, partly offset by higher investments across our pipeline, notably Trodelvy and magrolimab. Non-GAAP SG&A expense was $1.1 billion, down 4% year over year, primarily due to lower legal expenses, offset in part by continued commercial investment in Trodelvy and Veklury outside the United States. Moving to tax, we realized a lower effective tax rate of 19.6% for the quarter or down 320 basis points year over year due to a shift in geographic earnings mix.

Overall, our non-GAAP diluted earnings per share was $1.87 per share in the second quarter of 2021, compared to $1.11 for the same period last year. The year-over-year improvement primarily reflects higher product sales due to Veklury, higher gross margin, as well as lower operating expenses and a lower effective tax rate, offset by lower interest income. Overall, we’re encouraged by our first-half results shown on Slide 22. Moving to Slide 23, you can see that we are updating our guidance for 2021.

As always, the duration and magnitude of the COVID-19 pandemic continue to be uncertain and the rate and degree of these pandemic impacts, as well as the corresponding recovery from the pandemic may vary across our business. With that said, we now expect full-year total product sales in the range of $24.4 billion to $25 billion, compared to our previous range of $23.7 billion to $25.1 billion. The new range increases the midpoint from $24.4 billion to $24.7 billion, and reflects our solid results year to date, as well as our updated expectations for the second half of the year. With first-half Veklury revenue of $2.3 billion, we now expect full-year Veklury revenue in the range of $2.7 billion to $3.1 billion, compared to our previous $2 billion to $3 billion range.

Our updated range reflects the ongoing role of Veklury in this pandemic and assumes we’ll continue to see regional outbreaks. The situation continues to be dynamic, and we’ll likely update our thinking again when we report our earnings after the third quarter. Back to our guidance, we now expect total product sales, excluding Veklury, for the year to be in the range of USD 21.7 billion to $21.9 billion, compared to our previous range of $21.7 billion to $22.1 billion. This tightening of the range reflects the longer-than-expected pandemic impact on our business, including the latest increase in COVID-19 cases.

As Johanna discussed, the pandemic has most notably impacted our HIV treatment business, where we saw substantially fewer treatment initiations and a greater number of discontinuations than expected in 2020. It’s taking longer than we expected for treated patient volumes to ramp back up to more normal levels, particularly in the United States. That said, we saw encouraging signs of recovery in the HIV market in the second quarter, and our guidance assumes recovery will continue through the remainder of the year. Based on market share dynamics, we remain very confident in our competitive positioning, and we believe we’re well-positioned as the recovery continues.

Looking at the rest of our P&L. We now expect non-GAAP product gross margin in the range of 86% to 87%, reflecting the lower mix of HIV revenue. We now expect non-GAAP R&D to decline low to mid-single-digit percentage compared to 2020 levels. This primarily reflects the timing of investments, and we remind you that the expenses in both R&D and SG&A are back-end loaded this year, increasing sequentially from Q2 into Q3 and then even more from Q3 into Q4.

Our non-GAAP SG&A guidance remains unchanged at flat to low single-digit percentage decline over 2020. In R&D, we’ll be ramping up additional studies with magrolimab, Trodelvy, long-acting combination work with lenacapavir for the treatment of HIV and other pipeline activities. And in SG&A, we will be ramping up marketing activities to support our growing portfolio of indications, such as with Trodelvy and Tecartus. Finally, reflecting the updates to our revenue, gross margin and operating expense guidance, we now project non-GAAP diluted EPS between $6.90 per share and $7.25 per share for the year, and GAAP diluted EPS between $4.70 and $5.05.

Additionally, our capital allocation priorities have not changed, and we remain committed to our dividend. Year to date, we’ve paid down $1 billion — $1.25 billion in debt, and we’re on track to repay at least $4 billion in debt by the end of the year. With that, I’ll invite the operator to begin the question-and-answer session.

Questions & Answers:

Operator

[Operator instructions] Our first question comes from Cory Kasimov with J.P. Morgan. Your line is now open.

Gavin ScottJ.P. Morgan — Analyst

Hi. this is Gavin on for Cory. Just wanted to go back to the U.S. HIV business.

Can you provide additional color, particularly in the context of why this is so much different from the ex U.S. markets? And what is the most important factor you’ll be watching for to have confidence in the U.S. market normalizing? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Yeah. Thanks a lot, Gavin, for joining. I’m obviously going to turn that over to Johanna. I’d just point out that we continue to do really well in our share and certainly, Biktarvy growth and are well-positioned as the market rebounds.

And with that, I’ll turn it over to Johanna for some specifics.

Johanna MercierChief Commercial Officer

Thanks. Gavin, thanks for your question. I think from a market dynamic standpoint, what we’re seeing is we saw a little bit last year in Q2, most of the industry was actually slowing down pretty quickly in Q2. HIV took a little bit longer, and it’s kind of that playing out in ’21.

It’s taking a little bit longer to come back and bounce back. One of the major reasons for that has to do with your dynamic market being much smaller in this market. You have a very large pool of patients that are just continuing patients. And you’re really playing in the dynamic market with your naive patients coming in and your switches and your restarts, really around 5% or so.

And so that’s why it’s taking a little bit longer as we’re going through this. From a different standpoint between U.S. and Europe, I think it has more to do with the fact that in Europe, there’s diversity across some of the different countries as to the pandemics and the timing of kind of the recoveries or even some of the surges that happened. So it’s a little bit more blended than what we’ve seen in the U.S.

thus far. And so I think that’s just what’s playing out here. Obviously, the bigger impact being in the U.S. because that’s where most of our business lies in HIV.

And just to close out on that, the — that’s from a market standpoint, and it’s very different than kind of the fundamentals of our HIV business. I think what we’ve seen with Biktarvy, we’re really quite pleased with in light of the fact that not only it’s grown quarter over quarter by 1 point, both in the U.S., as well as in the EU5. But also, if you think about it over the last 12 months, it’s grown 6-point share over a very strong base. We’re just under 40%, we’re at 39% share at this point in time.

So we’re very pleased with the continued growth of Biktarvy, and you can appreciate that because it’s such a larger base, that’s going to get more challenging as we move forward. And that’s why I think we’re excited about the market coming back a little bit. We’ve seen it come back in Q2. Where the market goes, obviously, our HIV business goes because we own 75% of the market.

And so therefore, we’re watching that very closely, but we would expect that recovery to continue, although at a slower pace than we had originally expected.

Daniel O’DayChairman and Chief Executive Officer

That’s great, Johanna. Anything on the indicators. I think you’ve mentioned but anything more on the indicators that you’ll be looking for.

Johanna MercierChief Commercial Officer

Yes. So we’ve been looking, of course, at the HIV screening and the diagnosis and how that’s playing out. And we’re still under by about 13% to — below pre-COVID levels. So I think once those come back up, I think that would be something that we’re watching very closely and also the drop-off rates.

We talked a little bit in — earlier about the adherence piece of the puzzle, because you have less patient support groups around, you have less surround sound around those HIV patients. You have a lot of those case managers and physicians that have moved over to treat COVID-19 and so for impacting HIV, a little bit disproportionately. And so we’re also looking at those drop-offs. And we’ve seen those drop-offs come back to normal to pre-COVID levels just most recently.

And so that’s another positive sign to that recovery of the market.

Daniel O’DayChairman and Chief Executive Officer

And Gavin, obviously, just from a patient perspective, we have been and will continue to be dedicated to helping patients, particularly in underserved communities get back into the care system. I think that’s something that Gilead prides itself on. And it’s exceptionally important as a leader in HIV medicines to make sure we are always on the side of the patients as we emerge from this pandemic. So thanks for the question, Gavin.

Operator

Thank you. Our next question comes from Terence Flynn with Goldman Sachs. Your line is now open.

Terence FlynnGoldman Sachs — Analyst

Great. Thanks so much for taking the question. Maybe a two-part for me. First for Johanna, just wondering if you can provide any more insight on the Trodelvy launch, specifically the split of sales by either setting or indication.

And then for Merdad, can you remind us of the size of the lung cancer cohort in TROPiCS-03 and then how are you thinking about the potential risk of ILD in that population? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Terence. Yes, go ahead, Johanna.

Johanna MercierChief Commercial Officer

Sure. Thanks for the question. So yes, so we’re really pleased with the Trodelvy sales. I had 24% growth quarter over quarter.

I think, is a very strong quarter, and I think that really has to do with the approval, the second line plus approval that we got in metastatic triple negative breast cancer early April. It’s also related to the fact that because now we have the full approval, we have the opportunity to promote the incredible overall survival data that we have with the ASCENT data. And so that’s been a big piece of the puzzle. If you’re asking me to split the sales per line of therapy, that’s very challenging in light of the claims data that we have.

But what I would say if it’s more about bladder cancer versus triple-negative breast cancer, I would say most of that is triple-negative breast cancer, probably about a 90-10 ratio as our bladder cancer is much smaller. Although we’ve done some nice inroads there already and are looking at about just under 10% share in bladder right now with Trodelvy. So we’re excited about that as well. Merdad?

Merdad ParseyChief Medical Officer

And then with TROPiCS-03, it’s a basket study. So the ends per arm are not hard and fast. We’ll probably be looking at data once we get to the 20, 30 range in there. But it’s not predetermined.

So I wouldn’t want to overstate it. Regarding ILD, we are definitely very sensitive to and watching for it, as you can imagine. To date, we haven’t had any reports of that, but we’re ever vigilant. So…

Daniel O’DayChairman and Chief Executive Officer

Great. Thank you both. Thanks Terence. We’ll get the next question now, please.

Operator

Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is now open.

Brian AbrahamsRBC Capital Markets — Analyst

Hey, good afternoon. Thanks for taking my question. A question regarding HIV life cycle. You recently reported data for subcu lenacapavir-based combo with treatment-naive HIV.

I’m curious, how do the learnings there with respect to the resistance profile you’re observing, shape how you think about the future development steps vis-a-vis potentially exploring higher doses, more frequently — more frequent than every six-month injections and/or combining with agents that might have a higher intrinsic barrier resistance versus F/TAF. And then, I guess, along the lines of HIV life cycle, I’m also curious your level of confidence as to the potential of F/TAF to have exclusivity beyond 2025? Thanks. 

Daniel O’DayChairman and Chief Executive Officer

Great. Why don’t we have you start, Merdad, and perhaps Andy can comment a little bit on the second piece, too.

Merdad ParseyChief Medical Officer

Yeah, thanks. It’s a very good question. And I think if you think about the patients in that trial, these are highly treatment-experienced patients who often develop resistance because of noncompliance. And when these subjects are getting a subcu injection of lenacapavir, remember that these patients are going to potentially continue to go off and on their oral regimens.

As we think about the future, as you know, we are — for treatment going outside the highly treatment-experienced population, we’re really thinking about how we’re going to combine lenacapavir with other long-acting agents like islatravir. And as we do so, I think the concerns about patients potentially having effective monotherapy with lenacapavir go away in some regards, right, ensuring that patients are taking multiple agents at the same time is going to be really important for us.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Merdad. And perhaps, Andy, you want to comment on the exclusivity question for Brian?

Andrew DickinsonChief Financial Officer

Sure. I’d be happy to. Brian, thanks for the question. As you know, there’s litigation that’s underway.

There are some recent developments that the number of analysts wrote about. Our base case continues to be that there will be generics arriving in 2025 and 2026 in the U.S. and EU respectively, but we think we have a strong case and that there — we look forward to continuing to prosecute the case and we’ll see where it plays out. We should have an additional update later this year.

So that’s really where it stands.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Andy. Can we have the next question, please?

Operator

Thank you. [Operator instructions] Our next question comes from Geoffrey Porges with SVB Leerink. Your line is now open.

Geoffrey PorgesSVB Leerink — Analyst

Thanks very much for taking my question. So just a couple of parts in my question. Could you clarify a couple of your partnerships? There’s been some news from Galapagos, you’ve invested over $5 billion there. Are you going to take on any of those drugs from the Toledo portfolio that the company recently highlighted? And then related to that, your Arcus partnership.

Does your guidance include the mild upfront cost of opting in for any of those programs? And what’s the trigger and the window for when you can opt in to any of those three programs? Because they sort of appear on your pipeline slide, but it’s not completely clear whether they’re in or out. So could you clarify where you’re going with those two partnerships?

Daniel O’DayChairman and Chief Executive Officer

Sure, Geoff. Thank you very much for the question. And I’ll start a little bit and then ask Merdad and Andy, if he wants to add anything as well. So I think, first and foremost, I think we’re — we believe deeply in partnerships.

We have a robust internal portfolio. And we also, as you know, have designed these opt-ins as a way to expand our portfolio in, different therapeutic areas. Starting with Galapagos, as you know, which was predominantly focused on inflammation. At this stage, we don’t have any opt-in milestones right now with Galapagos.

We’re working closely with them on their science and their discovery platform and some of their preclinical to clinical molecules to support them in their efforts. But at this stage, we don’t have anything more to report other than like Galapagos has reported on the, for instance, Geoff, to your question on the Toledo program. But rest assured that as those programs evolve and mature and develop, we’ll keep you informed. Perhaps, Merdad, if you want to say anything else in Galapagos and bridge to Arcus?

Merdad ParseyChief Medical Officer

Yes. I think the stories are similar. We like to keep you apprised of what could potentially come into our portfolio, and we have the opt-in rights too for Arcus. I mean I think Dan laid out Galapagos well.

For Arcus, we continue to wait for data to mature. And once the data get to a level of maturity where we can really make the call, that’s when we’ll have our opt-in. We have not included, and Andy will confirm for me, but we have not included the financials of a potential opt-in in our guidance at this point.

Daniel O’DayChairman and Chief Executive Officer

Andy, you want to [inaudible]

Andrew DickinsonChief Financial Officer

That’s correct. Yes. No, I’m happy to follow up here, Geoff, good question. And nothing has changed from the guidance at the beginning of the year.

So our R&D spend and all of our expense guidance does not include the opt-ins on any of the programs that we have options to, including the three programs that you mentioned at Arcus. You also asked about the opt-in windows. The opt-in window for the first TIGIT antibody should be coming most likely at the end of this year. It could be early next year, but it’s most likely at the end of this year, we’ll have enough patient data to trigger the opt-in or our desire to opt in potentially early.

On the other two programs, the adenosine programs at Arcus, that’s most likely next year. And again, there may be additional data that comes this year that if it looks really strong. We want to move as quickly as we can, and we can opt in early, Geoff, on those programs. And then on Toledo, it’s relatively simple.

And all of the Galapagos programs that opt-in comes after Phase 2 enabling studies. So the Toledo programs are a long ways away from a potential opt-in decision.

Merdad ParseyChief Medical Officer

Phase 3 enabling.

Andrew DickinsonChief Financial Officer

Yes, I’m sorry, Phase 3 enabling. Thank you.

Daniel O’DayChairman and Chief Executive Officer

Geoff, and I’d just kind of round out to your question. I mean, there’s obviously many other partnerships we have that we’re working closely with at different phases, but those are the specific ones you asked about. Thank you very much for the question. Can we have the next question please?

Operator

Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is now open.

Geoff MeachamBank of America Merrill Lynch — Analyst

Great. Afternoon, guys. Thanks for taking my question. A question for Dan or Merdad on COVID.

There’s a high expectation that vaccines are here for a while now that the Delta variant has really changed the dynamic. The question is, has the strategic value of Veklury change for you guys as new cases have ticked up? I know you decided not to pursue inhale, but is there a life cycle here worth investing in over the long term? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Geoff. I’ll start, and then Merdad will either correct me or add important information to it. But I think — I mean, just to emphasize, the importance of Gilead’s legacy in antivirals and frankly, our strength in that too, to us as well. So being, of course, the first company to have — and the only company to have an approved antiviral for COVID is no accident.

Obviously, it’s decades of experience, decades of investments in a variety of emerging viruses, including COVID, and we haven’t stopped. So to your point, Geoff, I think we’re all learning about this pandemic as it rolls out. And it’s certainly going through different phases, and we think will continue to go through different phases. And therefore, we are, if you like, kind of doubling down on an ability to think about antivirals outside the hospital setting, where remdesivir plays such an important role.

And maybe with that, I’ll hand it over to Merdad, as a clinician, how you might also see the future [inaudible] and also our role in it.

Merdad ParseyChief Medical Officer

Yes, thanks. I think we have, I think, been pretty consistently of the mindset that the vaccines will make a tremendous impact in the case numbers and those sorts of things. Even though I think even when we get to some sort of equilibrium, unfortunately, they’ll continue to be, we believe, infections. People will continue to get infected and some proportion of those patients will end up in the hospital.

So we do believe that Veklury in the hospitalized setting is going to be — continue to be really important for treating those patients. And as Dan alluded to, we continue to believe and are committed to treatments — making treatments available in the outpatient setting. So I wouldn’t — the inhaled nebulized approach didn’t give us the results we were hoping for, the consistency we were looking for. But because we have other agents in our pipeline based on our virology expertise, we will be bringing those forward and really focusing on the outpatient setting there.

So we continue to believe that having a treatment available for people, whether they’re vaccinated or not, is going to be important for the foreseeable future.

Daniel O’DayChairman and Chief Executive Officer

And Geoff, what I might add is that our preclinical folks continue to study remdesivir against a variety of variants. In fact, all four major variants of concerns, so the Alpha from the U.K., the Beta from South Africa, the Gamma from Brazil and the Delta from India, and all are fully sensitive against — or remdesivir is as sensitive against all those strains. Which would make sense because we’re not seeing any mutations in the polymerase remdesivir binding site. And so I think it’s important as we think about next-generation products to also think about medicines that will be effective against these ongoing variants like remdesivir.

It’s an important bar for us as we move forward. Thanks, Geoff, for the question.

Operator

Thank you. Our next question comes from Umer Raffat with Evercore. Your line is now open.

Umer RaffatEvercore ISI — Analyst

Hi, guys. Thank you for taking my question. I had two quick ones as well. First, have you had an interim PFS on the HR positive study of Trodelvy? And secondly, congrats on Bill Grossman’s hire from Arcus.

And I was wondering to what extent was the decision of Bill bring onboard driven exclusively by Bill’s familiarity with Arcus programs? Thank you very much.

Daniel O’DayChairman and Chief Executive Officer

Yeah. Why don’t you start, Merdad?

Merdad ParseyChief Medical Officer

Yeah. Thanks, Umer. Great questions. Yes, we have not done the interim PFS analysis as we’ve talked about, that will happen certainly before the end of the year, we hope.

And we’re — that’s still what we’re tracking to. But we have not done the analysis yet. So we remain blinded to those data. And then in terms of Bill, I think I wouldn’t necessarily tie it as you’re suggesting to Arcus, it’s certainly an advantage for us that should we opt into Arcus programs, Bill will bring familiarity.

But for us, Bill’s experience and leadership and his excitement about being here and overseeing the overall portfolio were the drivers for Bill coming onboard.

Daniel O’DayChairman and Chief Executive Officer

Yeah. And I would just add, Umer, I mean, look, many of us know Bill, you know him as well. Our relationship with Arcus is extremely important and continues to be. And this was an example of Bill seeing a career opportunity and seeing an evolution for his career that made sense for him.

We certainly want to make sure that Arcus continues to have the skill set that it needs to be successful. We have the skill set that we need to be successful. I think it’s just a good example of how partners collaborate at times. And so I just wanted to emphasize, our relationship with Arcus is unchanged and as strong as ever.

Umer RaffatEvercore ISI — Analyst

Thank you.

Operator

Thank you. Our next question comes from Michael Yee with Jefferies. Your line is now open.

Michael YeeJefferies — Analyst

Hey, thanks for the question. Appreciate it. maybe a question for Merdad on Trodelvy a couple of parts. In the TROPiCS-02 study, you had the smart decision to take a look at that, enlarge it, powered for PFS, etc.

Did you have any information that could help give you confidence around the powering? And any information that would help you give confidence in the overall study, such as the number of events that have passed or anything like that? Or even knowing that it had passed a futility, if you could even comment on that. And then on the lung data that’s coming up, can you just comment around your belief in the profile versus the competitor? Is it similar efficacy, better safety? Or how should we interpret that data when it comes later this year? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Nice to hear your voice, Michael. Over to you, Merdad.

Merdad ParseyChief Medical Officer

Yeah. Thanks, Michael. On the TROPiCS-02 study, we have not done a futility analysis. We are — we continue to look to those data maturing and getting the number of events that we need for the PFS analysis that we have planned.

We’re pretty confident in our powering. And in particular, since we expanded the sample size to make sure that we are able to hit the PFS endpoint. Of course, the relevant issue is more the duration of PFS that we get. But from a powering standpoint, we’re comfortable.

And it’s just a matter of seeing those data. From an ongoing event standpoint, I think we are where we thought we would be at this point, and it’s really around just letting the events come in, make sure they get adjudicated, we clean the data in time to do the analysis properly. So that’s where we are with that. And then in terms of the lung data on efficacy, yes, I mean, I think — as I think we’ve said before, we’re really proceeding somewhat at risk and pretty aggressively, partly based on our belief in the drug, partly because of what we’ve seen with other agents in lung and partly based on our early data that you’re familiar with in lung that we’ve seen.

Of course, we want to make those data more robust while we go into the Phase 3 world. So we are going to augment our existing data to make sure that we are mitigating our risk somewhat. But thus far, I think what we are hoping for is efficacy that certainly is comparable to what the benchmark might be, even though I think it’s too early to say what that benchmark is with the direct competitor. But we are, again, I think, confident about our ability to bring safety profile that hopefully, will be better for patients.

Daniel O’DayChairman and Chief Executive Officer

Excellent. Thank you, Michael. Can we have the next question, please?

Operator

Thank you. Our next question comes from Alethia Young with Cantor. Your line is now open.

Alethia YoungCantor Fitzgerald — Analyst

Hey, guys. Thanks for taking my questions. I’m just curious about, again, going back to the Arcus collaboration with ARC-7. How do you think about what the hurdle is for a triple? Do you think that it has to be more than like some of the competitors like Roche happen in doublets do you think?

Daniel O’DayChairman and Chief Executive Officer

Thanks, Alethia. Merdad?

Merdad ParseyChief Medical Officer

I think we have the luxury of being able to look at a singlet, a doublet and a triple here. We would be, of course, excited if the triplet differentiates from the doublet and provides better efficacy. I think that’s what we’d be looking for. And so as the data mature, looking for some signals, some — a reason to believe that the triplet is performing more robustly than the doublet is probably going to be our focus.

We’d be very excited if that plays out. It gives us, I think, a pretty unique position.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Alethia. So I think we have time for one more question, and thanks, everybody, for your involvement. Can I have the last question, please?

Operator

Thank you. And the last question comes from Ronny Gal with Bernstein. Your line is now open.

Ronny GalSanford C. Bernstein — Analyst

Hi, everybody, and thanks for squeezing me in. Question about the projections for HIV for the next couple of years. Part one, I guess, is you changed your reimbursement policy on 340B clinics next year. How big essentially is that difference in terms of what it creates for you? And where on P&L will it appear on revenue on SG&A? And the second one, you already mentioned the PrEP barriers are dropping with preventative treatment designation for PrEP.

I can’t figure if this is good or bad for you from the perspective of branded drug adoption, given that they don’t have to cover branded drugs.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Ronny. So over to you, Johanna.

Johanna MercierChief Commercial Officer

Sure. Ronny, I’m assuming you’re talking about the patient assistance program changes?

Ronny GalSanford C. Bernstein — Analyst

Correct. Yeah.

Johanna MercierChief Commercial Officer

OK. So I want to differentiate that. Those aren’t 340B changes. That’s actually a program that’s really in line with our commitment to help end the HIV epidemic.

To date, the program has actually provided free drug to more than 250,000 individuals. And really, that’s what it is. It’s a free program that was always intended and will continue to provide free Gilead medication to eligible individuals to treat and prevent HIV. Unfortunately, it was not intended to be a source of funding for organizations to deliver services, and that’s what we’re trying to reset a little bit.

So the changes to our program model will protect our ability to be able to do this in the longer term and make it a sustainable program for us and more importantly, for patients. So that’s the patient assistance program on that front. The question you’re asking me about PrEP, we’re actually quite encouraged with the FAQs that came out from the U.S. PSTF.

The — and here’s why. In the FAQ, they provide a lot more clarity than they had in the past, right? This isn’t new. The recommendation actually came out, the Affordable Care Act recommendation came out two years ago. But what this provided was actually more details to it and clarity on the importance of PrEP in ending the epidemic and minimizing the barriers of use.

And there’s a couple of things in the FAQ that pop out for me. One is it truly supports physician and patient choice. And that’s the piece where generics or nongenerics, right? So Truvada generics or Descovy would then need to be really — the physicians and the patients get to decide together what is the right medicine for which patient. And of course, with the bone and renal safety benefits that Descovy brings, I think this is a great addition to the FAQs.

In addition to that, there’s also some guidance around timely management of the request for this by payers, so to turn it around within 24 hours, which is quite different. than what’s happening today. And then the last piece is $0 of out-of-pocket costs. So I think for patients, this is great news.

And I also think for patient choice and physician choice, this is quite promising as well.

Daniel O’DayChairman and Chief Executive Officer

Ronny, I wanted to make sure we covered your question. Did we understand you correctly? I assume so, Ronny. Great. Well, thank you all very much.

Jacquie RossVice President, Investor Relations

So thank you all for joining us today. We appreciate your continued interest in Gilead and look forward to updating you on our progress.

Operator

[Operator signoff]

Duration: 63 minutes

Call participants:

Jacquie RossVice President, Investor Relations

Daniel O’DayChairman and Chief Executive Officer

Johanna MercierChief Commercial Officer

Merdad ParseyChief Medical Officer

Andrew DickinsonChief Financial Officer

Gavin ScottJ.P. Morgan — Analyst

Terence FlynnGoldman Sachs — Analyst

Brian AbrahamsRBC Capital Markets — Analyst

Geoffrey PorgesSVB Leerink — Analyst

Geoff MeachamBank of America Merrill Lynch — Analyst

Umer RaffatEvercore ISI — Analyst

Michael YeeJefferies — Analyst

Alethia YoungCantor Fitzgerald — Analyst

Ronny GalSanford C. Bernstein — Analyst

More GILD analysis

All earnings call transcripts

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis — even one of our own — helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.


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Equity BCDC unveils a new identity and positions itself to be the bank of choice in the DRC https://www.novascotiadownsyndromesociety.com/equity-bcdc-unveils-a-new-identity-and-positions-itself-to-be-the-bank-of-choice-in-the-drc/ Thu, 11 Mar 2021 08:02:36 +0000 https://www.novascotiadownsyndromesociety.com/equity-bcdc-unveils-a-new-identity-and-positions-itself-to-be-the-bank-of-choice-in-the-drc/ After a successful merger of Equity Bank Congo (EBC) and Banque Commerciale du Congo (BCDC), to form Equity BCDC, the bank unveiled a new identity. The identity of the new bank, he said, reflects the coming together of the oldest and most established bank in the DRC and the most dynamic and dynamic bank in […]]]>

After a successful merger of Equity Bank Congo (EBC) and Banque Commerciale du Congo (BCDC), to form Equity BCDC, the bank unveiled a new identity.

The identity of the new bank, he said, reflects the coming together of the oldest and most established bank in the DRC and the most dynamic and dynamic bank in Africa to shape a future where the people of the DRC will experience the freedom of modern banking.

“Today marks a historic event in our country, when two legendary banks with varying strengths came together to form a bigger and stronger bank for the Congolese people.

The new bank has the capacity, the talent pool, the experience and the vision to make banking services affordable and accessible to all households in the Democratic Republic of the Congo. With our large footprint of 74 branches and 3,055 agents, we invite all citizens to visit a BCDC Equity branch and they will be able to open a bank account there. A bank account is the start of a journey to empowerment. With a bank account, every Congolese will be able to save any amount of money as little as 1,000 CDF and will be able to carry out transactions as needed. The bank will be able to provide small loans to enable young people and small traders to develop their businesses and their dreams, thus becoming key players in our economy. Celestine added.

Mr. Muntuabu also said that, “For the majority of Congolese who have to work every day to earn a living, they won’t have to worry about taking the time to go to the bank to open a bank account. EquityBCDC has rolled out digital banking, including mobile banking, making banking something you can do anywhere, anytime.

At the same time, Equity BCDC, with a balance sheet of $ 2.7 billion, has the capacity, skills and financial capacity to lend up to $ 40 million to a single client. Combined with a rich history of more than 112 years in the service of corporate clients, the bank has unparalleled expertise and experience in the field of corporate banking. To deepen the relationship with our corporate clients and offer them an enhanced banking experience, Equity BCDC will extend the banking ecosystem to our corporate clients, providing them with an end-to-end management system for their finances and those of their ecosystem value chains. , thus bringing transparent and optimized operations to their businesses. This unique banking innovation for the DRC market will “eliminate the challenges of cash and liquidity management, and we will relieve our corporate clients of the burden of financing their suppliers, leaving corporate clients the freedom to focus on conduct of their respective activities. Celestin said.

He added: “EquityBCDC promises to dominate the market as the first fully digital bank. All of our customers will benefit from our market leading position in card payments (both credit and debit), industry-leading mobile banking applications, real-time internet banking access that offers banking services at any time, and the full integration of their bank accounts with the main mobile wallets available in the country and abroad. Based on Equity Group’s balance sheet, the size of the loan facility on a single debtor can be set at $ 350 million, which allows us to make a real contribution to structuring projects and to the economy. of the DRC. We want to be identified as a catalyst for socio-economic transformation by partnering with our employees at all income levels and offering them products and services that meet their financial needs and being the preferred financial service provider by being relevant to all people of the DRC.

“This merger created a platform for the Bank to evolve its offerings and capabilities, thus becoming a financial institution endowed with strength, expertise, innovation, a solid capital base and regional and global in scope to support the economic growth aspirations of the DRC, ”said Mr. Muntuabu. “We now have the legacy, size and nationwide infrastructure that can bring our experiences and capacities to meaningfully contribute to transforming lives and livelihoods in DRC, while boosting the economic transformation of the country through the allocation of resources. “

Mr. Yves Cuypers, former CEO of BCDC, said: “The merger transition has gone very smoothly, from the transaction agreement in August to the migration to Equity’s central banking system, and today hui, we unveil the new identity ”. The process went smoothly thanks to the support of the government ”.

Mr. Cuypers thanked Central Bank of Congo, other regulators and the government through the Ministry of Portfolio for facilitating and approving the merger of the two entities.

Equity Group Holdings Plc CEO Dr James Mwangi said: “The new identity reflects the prosperous future we envision for the DRC and its people. One that communicates our global capacity, our strong heritage, our innovative culture and our agile business model to serve as a vehicle of social and economic transformation for the people of the DRC.

Given the bold leadership, strong operational capacity and significant financial resources of Equity Group and the business synergies stemming from its membership in a pan-African financial services group operating in 7 countries, Equity BCDC will leverage its rich heritage in pioneering financial democratization to support the DRC to develop its economy for all of its population.

“We are proud of Equity’s example and the role it has played and continues to play in the growth and prosperity of Africa’s people. But we also know that our work in Africa is not yet finished. We will continue to grow our brand to build the bank of the future for all of our clients across the continent, as we help fulfill our own mission of supporting a more equitable and prosperous DRC and an even stronger and more inclusive financial services provider with our innovative value proposition to everyone we serve, ”added Dr. Mwangi.

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IPDC Ogroj: Dr. Atiur Rahman’s discusses his journey to excellence in academics and governance https://www.novascotiadownsyndromesociety.com/ipdc-ogroj-dr-atiur-rahmans-discusses-his-journey-to-excellence-in-academics-and-governance/ Thu, 11 Mar 2021 08:02:36 +0000 https://www.novascotiadownsyndromesociety.com/ipdc-ogroj-dr-atiur-rahmans-discusses-his-journey-to-excellence-in-academics-and-governance/ Dr Atiur Rahman was the guest of honor on the 14th episode of IPDC Ogroj. He spoke about his life growing up, his journey to obtaining higher education, his dedication to digitizing and revolutionizing our country’s banking process from a central role. The session was moderated by revered banker Anis A. Khan. Dr Atiur Rahman […]]]>

Dr Atiur Rahman was the guest of honor on the 14th episode of IPDC Ogroj. He spoke about his life growing up, his journey to obtaining higher education, his dedication to digitizing and revolutionizing our country’s banking process from a central role. The session was moderated by revered banker Anis A. Khan.

Dr Atiur Rahman was on 10e Governor of the Bank of Bangladesh. He is a world renowned economist with several publications and articles attached to his name. He has been involved in various national and international projects that have helped people eradicate poverty, especially women in rural communities. He has publications that cover multiple topics, from war and economics to society and social development. He also received the “Central Bank of the Year 2015” award from the Asia-Pacific region, in recognition of his achievements in supporting lending to farmers and small and medium-sized enterprises (SMEs) without compromising growth and stability. macroeconomics, by the London- based on Financial Times-owned magazine The Banker.

Born on December 13, 1953, this iconic figure is currently a professor in the Department of Development Studies at Dhaka University. He was named “Bangabandhu Chair” by the Dhaka University Union on November 1st.st, 2019.

He spoke of his small beginnings, of a guy from a small village entering Dhaka University through hard work and sheer determination.

“I had never even been to a real city before, let alone live there. When I entered Mirzapur Cadet College in Mymanshingh, I was a little stunned at first, as it was a completely different scenario than this. what I was used to. He was a melting pot of different cultures, origins and people. Nevertheless, with the help of my teachers there, who were the guiding lights of my path, I was able to persevere at university with outstanding results and I was fortunate enough to study at Dhaka University. They are the ones who taught me to face challenges head-on. “

He spoke briefly about his father, how he inspired and supported him in his quest for always better. His mother, his uncle, a local high school teacher, who taught him English and especially his wife, who is the pillar of his life. He explained that he had learned so much from his wife, Professor Shahana Rahman, vice-chancellor of Bangabandhu Medical University and professor of pediatrics, and how brave and principled she was. He also spoke about his three wonderful daughters and how they helped him become a better person every day and how their names were inspired by the writings of Rabindranath Tagore.

He also spoke about his journey throughout university life. How his love for writing and research started there while writing for various local newspapers and also working as an editorial assistant at a newspaper called Daily People. After graduating, he started working as a planning officer at the Tourism Corporation to support his family and complete his master’s degree.

“I would go out with a tie in my pocket, I would put this tie on my way to work, I would work until 2:30 p.m. and then I would take the scheduled classes in the evening. I would collect notes from my friends from morning classes that I couldn’t attend. By the grace of the Almighty I finished my masters and went abroad on a scholarship to continue my studies. “

After making notable stints in several national banks and various social organizations, he was named 10e Governor of the Bank of Bangladesh. As soon as he got to the line of work, he knew it was time to completely change the structure of the banking system and began to modernize and digitize it. He also took the initiative to move to online banking, which made transactions even smoother and more efficient, and established the Bangladesh Automated Clearing House. The foreign exchange reserve hit a record $ 32 billion at the end of his term in 2016. He also prompted banks to focus heavily on CSR activities, green banking, providing small loans to women. entrepreneurs and climate change. Due to its regulation, banks invest heavily in CSR activities, which in turn help society in general.

When asked about his hobby, he said that his favorite thing to pass the time is writing, and that it is also obligatory to read a lot if one is to write correctly. He also watches historical shows to enrich his knowledge and participate in more conversations and research with his beloved students.

The segment ended with him, imploring the youth of our nation to love their nation and focus on us to bring us further on the global pedestal.

“We do not belong to the country in which he was born. You have to know your country, its people, its culture and love every inch of it. You must come together as a nation, whatever your differences, and work to get our country to new heights. Studying properly is one of the greatest weapons in achieving success. Those of you who are becoming entrepreneurs, keep going. trying is what matters most. “

IPDC Finance Ltd presents Ogroj takes place from 8 p.m. to 9 p.m. every first and third Thursday of the month. Guests from previous episodes include former Finance Secretary Matiul Islam, CPD Founder-Chairman Prof. Rehman Sobhan, Adcomm Limited Chairman Geeteara Safiya Chowdhury, Former Finance Minister AMA Muhith, Former Governor from Bangladesh Bank, Dr Farashuddin Ahmed, Chairman of ACI Limited, Mr Anis Ud Dowla. , novelist Selina Hossain, former finance minister M Syeduzzaman, president of MediaWorld Limited Rokia Afzal Rahman, composer Shujeyo Shyam and playwright Ramendu Majumdar.


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Which emerging markets are the most financially threatened? https://www.novascotiadownsyndromesociety.com/which-emerging-markets-are-the-most-financially-threatened/ Thu, 11 Mar 2021 08:02:36 +0000 https://www.novascotiadownsyndromesociety.com/which-emerging-markets-are-the-most-financially-threatened/ Editor’s Note: The Economist makes some of its most significant coverage of the covid-19 pandemic available to readers of The economist today, our daily newsletter. To receive it, subscribe here. For our coronavirus tracker and more coverage, check out our hub WHAT TO WEAR? The question intrigued many people who had been taken out of […]]]>


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Which emerging markets are the most financially threatened? https://www.novascotiadownsyndromesociety.com/which-emerging-markets-are-the-most-financially-threatened-2/ Thu, 11 Mar 2021 08:02:36 +0000 https://www.novascotiadownsyndromesociety.com/which-emerging-markets-are-the-most-financially-threatened-2/ Editor’s Note: The Economist makes some of its most significant coverage of the covid-19 pandemic available to readers of The economist today, our daily newsletter. To receive it, subscribe here. For our coronavirus tracker and more coverage, check out our hub WHAT TO WEAR? The question intrigued many people who had been taken out of […]]]>


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DFAT accidentally reveals email addresses of stranded Australians https://www.novascotiadownsyndromesociety.com/dfat-accidentally-reveals-email-addresses-of-stranded-australians/ Thu, 11 Mar 2021 08:02:36 +0000 https://www.novascotiadownsyndromesociety.com/dfat-accidentally-reveals-email-addresses-of-stranded-australians/ The email addresses of more than 1,000 vulnerable Australians stranded abroad have been accidentally disclosed by the Department of Foreign Affairs and Trade. The email sent by the ministry on Wednesday contained information about a new loan program. Announced last month, the program allows “only the most vulnerable Australian citizens” stranded abroad to take out […]]]>

The email addresses of more than 1,000 vulnerable Australians stranded abroad have been accidentally disclosed by the Department of Foreign Affairs and Trade.

The email sent by the ministry on Wednesday contained information about a new loan program. Announced last month, the program allows “only the most vulnerable Australian citizens” stranded abroad to take out small loans to cover temporary accommodation, daily living expenses and tickets for commercial flights.

According to ABC News, 1021 email addresses were copied into the DFAT message, revealing the addresses to each recipient.

Realizing its mistake, the ministry contacted the recipients asking them to delete the original email “to protect the privacy of those affected”. He also posted a statement on Twitter.

“We apologize for unintentionally disclosing the email addresses of stranded Australians who we are trying to help return home. No other personal information was disclosed. We want to get you home and are working as hard as possible to do so, ”DFAT wrote.

More than 25,000 Australians are currently stranded abroad. During recent hearing of the Senate special committee, several people have shared their experiences trying to return to Australia from abroad during the pandemic.

One witness was Deanne Vowels, who has been stuck in the UK for six months and requested DFAT help during that time.

Vowels said her family were initially offered repatriation flights to return home in June at a cost of $ 10,000 each, for a total of $ 70,000 for the family. She described to the investigation how a DFAT consulate in the UK suggested that Vowels set up a GoFundMe page and ask friends and family for financial help to return home.

The family were also told they could wait for a flight in August, which would allow them to use the original tickets they had already purchased, but those flights were canceled. The family is currently due to return home in November.

Vowels has called on the government to lift the cap on international arrivals to Australia, which was recently increased from 4,000 to 6,000 per week.

“If you can get high paying actors and politicians, international cricketers and students and even lobsters inside and outside Australia, you can surely bring back some hard working Australians who work well, ”she said.


Read more: Over 80% of DFAT staff supported COVID-19 response effort


Another witness named Peta explained to the investigation that her husband and mother are stuck in Serbia. Peta’s stepfather died in May and her husband Luke was granted a humanitarian exemption to travel to help his mother return to Australia. They were due to return home on August 14, Peta said.

“Their fourth rescheduled flights, now landing in Brisbane, were changed again last Friday – not to one flight, but to two flights. They split my mother-in-law, who is now coming home on October 6, and my husband, who will follow nine days later – if they take these flights, ”she said.

“My mother-in-law is really shy. She is 79 years old, she struggles with the English language, she is vulnerable and she is in mourning. She is faced with navigating airports, transit, quarantine in hotels, taxis to come back to me alone in Melbourne. It’s total madness.

Peta said that although she had “spent hours and hours on the phone” trying to get help from the government, the Australian Embassy in Serbia offered Luke and his mother “no support. “. She expressed concern about the future security of her family’s home, as well as the health of her mother-in-law as European winter approaches, especially during COVID-19.

“My mother-in-law would not be living with the coronavirus. My husband will not have access to medical care because it will not be covered by his insurance policy for pandemics. They have to go home urgently, ”she said.

During questioning, DFAT Secretary Frances Adamson told the inquest that the hardship program and grant funding can be used to help families like Vowels’, “where there is a gap with the economic cost of the flight “. She said there was no limit on the funding DFAT can provide for these purposes.

“Whatever the need, we can help people bridge this gap. We’re also trying to help people get on the plane, but there is a limit to what we can do at this time until more quarantine places open up. But we are absolutely ready to take advantage of every place, if we can, ”she said.

DFAT chief financial officer Murali Venugopal told the investigation that a total of $ 470,847 in grants was paid to Australians stranded between September 2 and September 23. Between July 1 and September 23, the DFAT granted 220 loans with a total value of $ 330,516, Venugopal mentioned. Of these, 130 loans totaling $ 299,769 have been directly linked to COVID-19.

As of September 23, DFAT had received approximately 825 requests for emergency assistance under the hardship program.


Read more: “We did what we are here for”: Frances Adamson on APS crisis response



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Fed eases Main Street Lending loans for small businesses https://www.novascotiadownsyndromesociety.com/fed-eases-main-street-lending-loans-for-small-businesses/ Thu, 11 Mar 2021 08:02:36 +0000 https://www.novascotiadownsyndromesociety.com/fed-eases-main-street-lending-loans-for-small-businesses/ The Federal Reserve has sharply reduced the minimum loan amount in its Main Street lending program, potentially opening up emergency facilities to more US businesses at a time when Congress remains stuck on further aid. By lowering the minimum loan amount to $ 100,000 from $ 250,000 on Friday, the Fed was responding to widespread […]]]>

The Federal Reserve has sharply reduced the minimum loan amount in its Main Street lending program, potentially opening up emergency facilities to more US businesses at a time when Congress remains stuck on further aid.

By lowering the minimum loan amount to $ 100,000 from $ 250,000 on Friday, the Fed was responding to widespread calls to make the Main Street loan program easier to access for small businesses struggling to survive the pandemic. COVID-19. Fewer than 400 loans have been made since the program became operational in July for a total of $ 3.7 billion, a small fraction of the $ 600 billion potentially available.

The Fed has also changed the fee structure so that banks are better paid for facilitating loans under $ 250,000. Companies that have received less than $ 2 million in loans from the Paycheck Protection Program will now be eligible for the Fed’s program. All five members of the Board of Governors voted in favor of these changes.

The Fed’s announcement came near the end of a tumultuous week in markets and the global economy as virus cases increase in parts of the United States and Europe, clouding the outlook for the pace of recovery. Congress and the White House did not pass further stimulus measures before next week’s US presidential election, leaving US businesses and the unemployed without additional support as the country battles another wave of infections .

The adjustments to the Main Street loan program follow months of talks between Congress and the White House that ultimately failed to provide further fiscal stimulus. Lawmakers, business owners and industry groups have called for changes such as reduced minimum loan amounts and additional incentives for banks to provide support to small businesses.

Fed chief Jerome H. Powell has argued that businesses may need grants, not loans, to get through the long pandemic. But the PPP program, whose loans turn into grants if companies use a certain amount of funds for payroll retention, expired in August. The Fed is only legally allowed to lend money.

While program changes may come at a difficult time for businesses with few options now, demand for small loans has so far been limited. Only 14% of loans made on Main Street until the end of September were for loans under $ 1 million.

In a September hearing before the House Financial Services Committee, Powell pointed to the limited appetite for such small loans. He added that an entirely new program may be required for loans under $ 100,000, which often require personal guarantees.

To encourage banks to make loans below $ 250,000, the Fed has removed the 100 basis point transaction fee, which lenders will still pay the central bank for larger loans; increased loan origination fees that lenders charge borrowers; and increased the service fees the Fed pays to banks. The other provisions of the program, including banks’ withholding of 5% of every loan they sell to the Fed, remain unchanged.

Businesses can exclude PPP debt of less than $ 2 million, as long as it is expected to be written off under the Small Business Administration’s payroll provisions, from their eligibility calculations to apply for a loan on Main Street.

The Main Street program is scheduled to expire on December 31. It is backed by $ 75 billion in taxpayer money authorized by Congress in the Coronavirus Aid, Relief, and Economic Security Act.


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