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Regeneron CEO Dr. Leonard Schleifer On Distribution Of Covid-19 Antibody Cocktail

CNBC Transcript: Regeneron Chairman and CEO Dr. Leonard Schleifer speaks With CNBC’s Meg Tirrell on “Squawk Box” today on the distribution of Covid-19 antibody cocktail. Q3 2020 hedge fund letters, conferences and more   Regeneron CEO Dr. Leonard…

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Regeneron CEO Dr. Leonard Schleifer

CNBC Transcript: Regeneron Chairman and CEO Dr. Leonard Schleifer speaks With CNBC’s Meg Tirrell on “Squawk Box” today on the distribution of Covid-19 antibody cocktail.

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Q3 2020 hedge fund letters, conferences and more

 

Regeneron CEO Dr. Leonard Schleifer On Distribution Of Covid-19 Antibody Cocktail

 

Brian Sullivan: yeah, certainly starting to become a trend, Andrew thank you very much. But of course all the talk about vaccines, remember, folks, it’s not just about preventing the virus, it’s about treating the virus as well, and we’ve got breaking news out of Regeneron as they get good news out of their COVID-19 treatment. Meg Tirrell had 10 minutes to revamp, joining us with the CEO of Regeneron everything is very fast moving, meg, we appreciate it.

Meg Tirrell: thank you, Brian. Dr Leonard Schleifer, thank you for being with us this morning you got the news that you have emergency authorization use for your anti body cocktail for covid-19, and speaking of face moving the pace of development was astounding tell us how you’re looking at how this drug will be used to help in this pandemic.

Dr Leonard Schleifer: we’re very excited the FDA has granted the emergency use authorization. It’s intended to be used for mild to moderate patients who have definite COVID-19, who are not on oxygen and are at high risk, and that’s a large group of patients, and it has to be given by an infusion so people have to get to a place where you can get an intravenous drug. It takes about an hour to get it, and you have to be watched for about an hour. I suspect it will be deployed our first doses were contracted by the federal government. 300,000 doses, and they will be allocating it to the various state in proportion to the need and the amount of COVID-19 in each state, and the state health departments will dispense it to our distributors to places of administration so it’s a bit of a complicated process. But I think it will be worth it because the data are encouraging.

Tirrell: so let’s talk through how patients actually get this drug, as you were just saying, it’s an iv infusion. You have to go to a place where you can get the infusion, and you’re supposed to get it as soon as possible after your diagnosis. So if you are a high risk patient, if you’re over 65 if you have a BMI over 35 or if you have one of the conditions you laid out here in the authorization, what is that going to be like for patients and what have you observed in the process for Eli Lilly whose antibody got emergency use authorization a couple of weeks ago.

Dr Leonard Schleifer: the way we expect it’s going to work is if you get a diagnosis, you will ask your doctor how can I get let’s say the Regeneron cocktail infusion, the two antibodies, which, by the way, must be given together. We think a cocktail is very important for reasons related to potential resistance, and you will ask your doctor where can I get this cocktail, and he or she will prescribe this cocktail for you if you’re a patient who meets the criteria, and you’ll go to one of your local infusion centers where this will be administered I suspect it will be different, meg, in each state, where, depending upon the logistics from each state, but the easiest thing is the doctor will be able to contact their health department or web site that the health department puts up and say where can I send my patient. I think it will get going pretty streamlined once some of the difficulties are ironed out.

Becky quick: hey, Len, it’s Becky quick that’s for being with us today. There were some questions raised in the past about this and similar treatment, just in terms of where it has happen if you have to go to a hospital to have this happen, there hasn’t been home use that’s been described but Dr. Scott Gottlieb said it would be great if you could have home use prescribed to have a nurse come to you, rather than bringing more COVID-19 patients into the hospital at a time when they’re going to be tightly stretched anyway, is that in the works down the road, do you think?

Dr Leonard Schleifer: I do, Becky it’s a great question, and I think the government and others are exploring different ways I think CVS, for example, is trying to figure out whether they can do this with their clinics in their stores, whether or not home infusion is appropriate. I think all of these things have to be figured out, and I think as we get more experience, we’ll have a more efficient administration supply chain.

Quick: I’d love to see it more easy for patients to get access to this the idea of bringing a bunch of COVID-19 patients into a CVS where people are shopping for toilet paper and tissue right around the corner.

Dr Leonard Schleifer: I’m not sure it will be bring to the CVS, but a home infusion company, where it will be done whether in a tent, in a parking lot, these things have to be figured out. You’re right we don’t want to comingle with somebody who’s infected but we want to treat these people you can reduce the risk of hospitalizations we’re very sensitive to doing the right thing for patients, and the first thing we wanted to do, we thought, was bringing a cocktail together. The second thing is we thought that, you know, sometimes it’s hard for even experts to know which things are actually working and which things aren’t working. You hear about one treatment is approved in one jurisdiction, and another jurisdiction says don’t use it we wanted to bring forth really strong data, the best data we could, and we felt the first point to make was you had to be able to reduce the viral load. If you’re going to affect this virus, you have to be able to do that, and I think our cocktail is the first drug of any kind that has convincely, statistically robustly significantly, prospectively and repetitively shown that you can reduce the viral load that’s not enough but now we can have this as a foundation where we also show you can reduce these medical related visits such as hospitalizations, E.R. Visits, et cetera.

Andrew Ross Sorkin: first, congratulations, we are all rooting for you, the whole world is rooting for you and the success you’re having with this. We want you to be able to make as many doses of this as humanly possible as you look out over the next six months, and I know we showed what your expectations were for doses, how do you really want it to be distributed? I know you said if you get COVID-19, you should ask your doctor, if you can get access to it, but there’s going to be a big debate about who’s supposed to get it, and who’s supposed to get it first given the number of cases that we’re seeing, and given that you want to take it early, actually.

Dr Leonard Schleifer: yeah.

Sorkin: so you don’t really frankly want to take it on the late side there was a big debate even over the weekend, Ben Carson, god bless him, is now better, but, you know, he came out and said he was given experimental cocktails, and people said, look, he’s now going to be considered a special case, if somebody’s wealthy, and they can somehow get access to this what’s your prescription for how this should work

Dr Leonard Schleifer: I think this is a very important moment, and we’ve got to do it right let’s start with facts let’s start with what’s our supply situation the governor initially contracted for 300,000 doses. We’ve got about 80,000 on hand ready to go, and we’ll have that full 300,000 by sometime in early January, we expect thereafter, we expect to be able to deliver about 100,000 doses every month. Now, we’re also looking at cutting the dose in half those experiments are actually ongoing, and that would double, if we were successful at that, and that would get to 200,000 a month, plus, we have a great partnership with Roche and they have already been doing the technology transfer from Regeneron to Roche, they know how to make this stuff, they’re very sophisticated, they’ll be making this ready for use in the first quarter. We hope to have millions of doses available. Still, that might not be enough. Look, I’m hopeful, we have seen nice vaccine data from three different vaccine makers now, and I’m hopeful that will really bring down the number of cases and that those people that still get it because they didn’t either respond to the vaccine or they didn’t access the vaccine or didn’t want the vaccine that there will be this monoclonal cocktail available for treatment. We have to make sure this is done in a fair way I can tell you even before approval, we had a compassionate use program, and it had nothing to do with who you were in society, so to speak, or whether you’re rich or what have you, we did it on a principled basis, and I think that’s how it has to be done, on a principled basis, and I think there are sophisticated people, and medical experts in health departments who can direct it to the people who need it the most and who will benefit them the most we can’t have a black market for rich people or something like that. This has got to go to where it needs to go to people who best benefit from it.

Sullivan: you know, doctor, you’re not just a doctor and a ceo. You’re probably a dad, you’re a friend when your friends say to you, when are we going to be out of this, and we all know what I mean, how do you answer them when

Dr Leonard Schleifer: yeah, so I get that question a lot. I also get the question of whether or not they can get on the list, to which I frequently say to my golfing friends, if they get that putt, maybe they can get on the list, but I really think that we’re all frustrated we all want to get out of this my belief is that and I’m not the world’s expert on vaccines but when I look at all the data, and I look at what’s going on, and I see the amazing things, call them miracles from vaccines to therapeutics to monoclonals call them miracles that our industry has brought forth, I think we get out of this and back to normal, certainly late next year, and I’m hoping sooner than that as we roll out the vaccine program.

Tirrell: len, it’s meg tirrell again before we let you go, we have to ask, you’re testing this drug as a prevention, which is a lower dose among people who live with somebody diagnosed with covid. When are you expecting we’ll get to see those results

Dr Leonard Schleifer: we’re accumulating that data now, and as soon as we have enough information perhaps this year, we’ll be able to take a look at this data. What you’re referring to is we’re trying to treat people who aren’t infected, give them a substitute immune response remember, if your brother, mother, sister, whatever, is affected and you’re at risk to get it because you live them, a vaccine won’t help you if you haven’t been vaccinated because the vaccine is going to take weeks if not months to be effective. Our drug could be instantaneously effective, if you will, to protect you, and that’s what we’re testing and we hope to get the data in the not too distant future, which could be not only good for people at high risk, think of a nursing home, doctors, people living with people, but it also could prevent the ongoing spread, the downstream spread through contact tracing, and aggressive treatment of people who are at risk to get it, and then spread it

Tirrell: well, we really look forward to seeing those data, and for now, you know, big news this morning with the emergency use authorization, len, thanks for being with us.

Dr Leonard Schleifer: good to be here thank you, Meg.

The post Regeneron CEO Dr. Leonard Schleifer On Distribution Of Covid-19 Antibody Cocktail appeared first on ValueWalk.

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Are Voters Recoiling Against Disorder?

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super…

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Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super Tuesday primaries have got it right. Barring cataclysmic changes, Donald Trump and Joe Biden will be the Republican and Democratic nominees for president in 2024.

(Left) President Joe Biden delivers remarks on canceling student debt at Culver City Julian Dixon Library in Culver City, Calif., on Feb. 21, 2024. (Right) Republican presidential candidate and former U.S. President Donald Trump stands on stage during a campaign event at Big League Dreams Las Vegas in Las Vegas, Nev., on Jan. 27, 2024. (Mario Tama/Getty Images; David Becker/Getty Images)

With Nikki Haley’s withdrawal, there will be no more significantly contested primaries or caucuses—the earliest both parties’ races have been over since something like the current primary-dominated system was put in place in 1972.

The primary results have spotlighted some of both nominees’ weaknesses.

Donald Trump lost high-income, high-educated constituencies, including the entire metro area—aka the Swamp. Many but by no means all Haley votes there were cast by Biden Democrats. Mr. Trump can’t afford to lose too many of the others in target states like Pennsylvania and Michigan.

Majorities and large minorities of voters in overwhelmingly Latino counties in Texas’s Rio Grande Valley and some in Houston voted against Joe Biden, and even more against Senate nominee Rep. Colin Allred (D-Texas).

Returns from Hispanic precincts in New Hampshire and Massachusetts show the same thing. Mr. Biden can’t afford to lose too many Latino votes in target states like Arizona and Georgia.

When Mr. Trump rode down that escalator in 2015, commentators assumed he’d repel Latinos. Instead, Latino voters nationally, and especially the closest eyewitnesses of Biden’s open-border policy, have been trending heavily Republican.

High-income liberal Democrats may sport lawn signs proclaiming, “In this house, we believe ... no human is illegal.” The logical consequence of that belief is an open border. But modest-income folks in border counties know that flows of illegal immigrants result in disorder, disease, and crime.

There is plenty of impatience with increased disorder in election returns below the presidential level. Consider Los Angeles County, America’s largest county, with nearly 10 million people, more people than 40 of the 50 states. It voted 71 percent for Mr. Biden in 2020.

Current returns show county District Attorney George Gascon winning only 21 percent of the vote in the nonpartisan primary. He’ll apparently face Republican Nathan Hochman, a critic of his liberal policies, in November.

Gascon, elected after the May 2020 death of counterfeit-passing suspect George Floyd in Minneapolis, is one of many county prosecutors supported by billionaire George Soros. His policies include not charging juveniles as adults, not seeking higher penalties for gang membership or use of firearms, and bringing fewer misdemeanor cases.

The predictable result has been increased car thefts, burglaries, and personal robberies. Some 120 assistant district attorneys have left the office, and there’s a backlog of 10,000 unprosecuted cases.

More than a dozen other Soros-backed and similarly liberal prosecutors have faced strong opposition or have left office.

St. Louis prosecutor Kim Gardner resigned last May amid lawsuits seeking her removal, Milwaukee’s John Chisholm retired in January, and Baltimore’s Marilyn Mosby was defeated in July 2022 and convicted of perjury in September 2023. Last November, Loudoun County, Virginia, voters (62 percent Biden) ousted liberal Buta Biberaj, who declined to prosecute a transgender student for assault, and in June 2022 voters in San Francisco (85 percent Biden) recalled famed radical Chesa Boudin.

Similarly, this Tuesday, voters in San Francisco passed ballot measures strengthening police powers and requiring treatment of drug-addicted welfare recipients.

In retrospect, it appears the Floyd video, appearing after three months of COVID-19 confinement, sparked a frenzied, even crazed reaction, especially among the highly educated and articulate. One fatal incident was seen as proof that America’s “systemic racism” was worse than ever and that police forces should be defunded and perhaps abolished.

2020 was “the year America went crazy,” I wrote in January 2021, a year in which police funding was actually cut by Democrats in New York, Los Angeles, San Francisco, Seattle, and Denver. A year in which young New York Times (NYT) staffers claimed they were endangered by the publication of Sen. Tom Cotton’s (R-Ark.) opinion article advocating calling in military forces if necessary to stop rioting, as had been done in Detroit in 1967 and Los Angeles in 1992. A craven NYT publisher even fired the editorial page editor for running the article.

Evidence of visible and tangible discontent with increasing violence and its consequences—barren and locked shelves in Manhattan chain drugstores, skyrocketing carjackings in Washington, D.C.—is as unmistakable in polls and election results as it is in daily life in large metropolitan areas. Maybe 2024 will turn out to be the year even liberal America stopped acting crazy.

Chaos and disorder work against incumbents, as they did in 1968 when Democrats saw their party’s popular vote fall from 61 percent to 43 percent.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Sat, 03/09/2024 - 23:20

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Department of Veterans Affairs (VA) reviewed no data when deciding in 2023 to keep its COVID-19 vaccine mandate in place.

Doses of a COVID-19 vaccine in Washington in a file image. (Jacquelyn Martin/Pool/AFP via Getty Images)

VA Secretary Denis McDonough said on May 1, 2023, that the end of many other federal mandates “will not impact current policies at the Department of Veterans Affairs.”

He said the mandate was remaining for VA health care personnel “to ensure the safety of veterans and our colleagues.”

Mr. McDonough did not cite any studies or other data. A VA spokesperson declined to provide any data that was reviewed when deciding not to rescind the mandate. The Epoch Times submitted a Freedom of Information Act for “all documents outlining which data was relied upon when establishing the mandate when deciding to keep the mandate in place.”

The agency searched for such data and did not find any.

The VA does not even attempt to justify its policies with science, because it can’t,” Leslie Manookian, president and founder of the Health Freedom Defense Fund, told The Epoch Times.

“The VA just trusts that the process and cost of challenging its unfounded policies is so onerous, most people are dissuaded from even trying,” she added.

The VA’s mandate remains in place to this day.

The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that estimate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.

There have also been increasing concerns among outside scientists about confirmed side effects like heart inflammation—the VA hid a safety signal it detected for the inflammation—and possible side effects such as tinnitus, which shift the benefit-risk calculus.

President Joe Biden imposed a slate of COVID-19 vaccine mandates in 2021. The VA was the first federal agency to implement a mandate.

President Biden rescinded the mandates in May 2023, citing a drop in COVID-19 cases and hospitalizations. His administration maintains the choice to require vaccines was the right one and saved lives.

“Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” the White House said.

Some experts said requiring vaccination meant many younger people were forced to get a vaccine despite the risks potentially outweighing the benefits, leaving fewer doses for older adults.

By mandating the vaccines to younger people and those with natural immunity from having had COVID, older people in the U.S. and other countries did not have access to them, and many people might have died because of that,” Martin Kulldorff, a professor of medicine on leave from Harvard Medical School, told The Epoch Times previously.

The VA was one of just a handful of agencies to keep its mandate in place following the removal of many federal mandates.

“At this time, the vaccine requirement will remain in effect for VA health care personnel, including VA psychologists, pharmacists, social workers, nursing assistants, physical therapists, respiratory therapists, peer specialists, medical support assistants, engineers, housekeepers, and other clinical, administrative, and infrastructure support employees,” Mr. McDonough wrote to VA employees at the time.

This also includes VA volunteers and contractors. Effectively, this means that any Veterans Health Administration (VHA) employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” he said. “We continue to monitor and discuss this requirement, and we will provide more information about the vaccination requirements for VA health care employees soon. As always, we will process requests for vaccination exceptions in accordance with applicable laws, regulations, and policies.”

The version of the shots cleared in the fall of 2022, and available through the fall of 2023, did not have any clinical trial data supporting them.

A new version was approved in the fall of 2023 because there were indications that the shots not only offered temporary protection but also that the level of protection was lower than what was observed during earlier stages of the pandemic.

Ms. Manookian, whose group has challenged several of the federal mandates, said that the mandate “illustrates the dangers of the administrative state and how these federal agencies have become a law unto themselves.”

Tyler Durden Sat, 03/09/2024 - 22:10

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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