This is what happened to the EUA request for mild/moderate
This is what happened to the EUA request for mild/moderate from the FDA in my opinion.
Pourhassen went to the FDA and told them he was going to make the request. The FDA said he was not going to get an EUA for M/M. Why? BECAUSE OF SUPPLY!
The FDA spoke clearly - the sickest come first! There were two reasons - their goal is to take dying off the table as quick as possible so the economy can begin to open up again; second, the limited supply of Leronlimab was not to be used up on patients who were not that sick.
This is, reading between the lines, great news - the FDA believes Leronlimab could be the therapy that takes death off the table and that such a valuable resource can not be sqandered on those who are less sick.
It is evident to me that supply is still Cytodyn and Leronlimab's biggest stumbling block. It was one of the first things asked about by the UK. They, to their credit, said they would help with funds for manufacture. However, no one can supply us with extra time to make the quantities needed if approved!
How much Leronlimab is available? You can't sell and supply what you DON'T HAVE! Some people here have said, "Well, we wouldn't have severe/critical cases if mild/moderates were given Leronlimab." They really don't get it!
The maximum Leronlimab available now is unknown but small. The max by the end of the year is 1.3 million vials maybe. At a minimum of 4 vials per treatment an now prescribed, that allows us to treat a little over 300,000 patients. That might cover severe/critical by the end of the year in the US but what about the UK and the rest of the world?
Supply and visibility are still Cytodyn's biggest problems, assuming with visibility comes funds and the political power to "jump the line" at limited production facilities.
This is how I see things. Cytodyn, being so small and all thing considered, has done a pretty good job in evolving emergency times of the pandemic and is not neglecting the promise of efficacy for other indications. They have my respect!
17
CytoDyn Inc (CYDY) Stock Research Links
Scroll down for more posts ▼
Top 10 Most Recent News Articles
Wuliangye Takes Center Stage at Global Event Everyone's chasing that global branding magic, but here's Wuliangye strutting its stuff at the Global Panda Partners Conference. Held in Sichuan Province from November 2 to 4, this is not just another show; it's a bold move from the Chinese baijiu maker to push the 'harmony and coexistence' mantra on the world stage. Not just...
Continue Reading
Antengene's AnTenGager-D2 Offers Fresh Hope Alright, let's dig into the latest buzz from the 2026 Society for Immunotherapy of Cancer conference about Antengene's AnTenGager-D2 platform. If you're not into biotech lingo, buckle up, because this is a ride into the future of cancer treatments—where science fiction might soon become science fact. A Novel Approach to Tumor...
Continue Reading
Securities Fraud Allegations Hit AST SpaceMobile Days like this remind me why we keep our eyes peeled in the stock game—AST SpaceMobile (NASDAQ: ASTS) is tangled in a web of legal drama, and it's something you can't brush off with a shrug. Class action lawsuits for securities fraud? That's like finding out the foundation's shaky beneath a skyscraper. If you've got skin...
Continue Reading
Semaglutide, a name on the lips of many investors looking for breakthroughs, is making waves again. This time, the stir comes from recent findings in the MASH field, and it's got folks in white coats quite excited. Revolutionary Results from Novo Novo Nordisk has announced promising results from their phase 3 ESSENCE trial that looks into semaglutide's effects on a...
Continue Reading
Innovent's Latest Breakthrough with SINTBILO® One moment you're sipping coffee, the next you're staring at a clinical milestone. Innovent Biologics has shouted from the rooftops that their drug, SINTBILO® (tafolecimab injection), has wrapped up its Phase 3 CREDIT-5 study, snagging the primary endpoint with both hands. This isn't just any drug; it's marked as the first...
Continue Reading
A Looming Legal Storm for D-Wave Investors Call it another day, another legal tangle in the investing world. This time, it's D-Wave Quantum Inc. (NASDAQ: QBTS) on the receiving end of a securities fraud class action lawsuit. Yeah, those fancy quantum computers they're pushing didn't predict this one coming. The legal arena is getting ready for a bout, and if you've got...
Continue Reading
Transforming the Motorcycle Communication Landscape Motorcycling ain't just about the roaring engines and the rubber on the road. In the world of helmets and handlebars, some bright minds are weaving tech magic at the EICMA 2026 in Milan. ASMAX has rolled out its shiny new RoamX intercom gadget, leaving folks buzzing at Hall 6. What RoamX Brings to the Table This ain't...
Continue Reading
The Clock is Ticking for Webull Investors If anyone's got a Webull stake, listen up! You’ve got a deadline that's staring you in the face: December 7, 2026. This is when you need to throw your hat in the ring to be a lead plaintiff in the Webull Corporation class action. We're talking securities fraud, folks, with allegations flying that would make your head spin....
Continue Reading
Data Breach Fallout: Amplifon Under Fire When a big player like Amplifon gets hit with a data breach, it's like a wake-up call across the board. This one’s no small spill—over 1.3 million folks left wondering whether their personal information is fluttering around cyberspace for all who dare to peek. If you’ve missed the memo, Edelson Lechtzin LLP, the savvy cats in...
Continue Reading
Breaking Barriers with U6G-Capable Technology Sneaking into the industry's spotlight at MWC Doha 2026, Fibocom flaunts a robust lineup of next-gen 5G solutions. It's as if they're shuffling every card they’ve got to win over the broadband world. With breakthroughs like the FG390, FG370, and FG670 modules, alongside PCBA-level innovations, Fibocom is not just throwing...
Continue Reading
Top 5 Most Recently Viewed Articles
HeyGears Set to Launch the New UltraCraft Reflex Series 3D Printer HeyGears, a well-known name in the 3D printing world, is about to introduce its newest creation, the UltraCraft Reflex series 3D printer. This innovative product is designed to deliver outstanding speed and precision, catering to the varied needs of engineers, designers, and 3D printing fans. Join Us for...
Continue Reading
A Legendary Achievement in Wine Tasting What does it take to stand out in a sea of thousands in the wine industry? Well, Willamette Valley Vineyards seems to have cracked the code, clenching the USA TODAY’s #1 Best Wine Tasting Room accolade for a record three years in a row. Now, that’s one juicy tidbit to savor for a moment. A Devotion to Excellence Found in the...
Continue Reading
UTR Sports Unveils Innovative College Team Rankings UTR Sports continues its mission to elevate the world of college tennis with the launch of its groundbreaking College Team Rankings. This new ranking system highlights the top college teams across various divisions, including Division I, Division II, Division III, and NAIA, setting a new standard in collegiate athletics....
Continue Reading
Understanding KKR's Impressive Stock Performance Over the past 15 years, KKR (NYSE: KKR) has consistently outperformed the broader market, achieving an annualized return of 16.02%, exceeding market averages by 4.06%. This level of performance is a testament to KKR's strong business model and investment strategies, which have been pivotal in growing investor wealth. The...
Continue Reading
Banco Santander Chile's Strong Performance in 2024 Banco Santander Chile recently shared its financial results for the third quarter of 2024, demonstrating a remarkable improvement in profitability and operational metrics. As of September 30, 2024, the bank reported a significant rise in net income, showcasing solid operational efficiency and customer satisfaction amidst...
Continue Reading
