There is no excuse for not issuing Leronlimab an EUA with a phase 4 to confirm the data. How could it hurt? Who could it hurt? Well that, my friends is the billion dollar question. And there is only one answer, Big pharma.
As has been pointed out, the evidence against Remdesivir was plentiful and strong, yet it was ignored and continues to be ignored by our FDA. Other studies confirmed poor results and futility. In fact, data has shown that the mortality is actually higher among Remdesivir patients. Fauci claimed the emergency justified approval even though they were just trending towards positivity. Special allowances were made for it's approval. Subgroups of data were used to reach that conclusion, but we ignored all of this because a pandemic was raging worldwide. Of course, exceptions had to be made during such a horrible emergency!
We assumed the FDA was just trying their best to find something, anything that they could call helpful, and then Leronlimab started showing spectacular results at Montefiore and UCLA through the EIND program. We expected immediate support and guidance from the FDA, and why not, Remdesivir got it for much less, and people were dying by the thousands every day. Safety was not an issue!! What did they have to lose? So we waited, holding our collective breath, thinking that of course the FDA would do something, that Fauci would talk about this drug showing so much promise. The one drug that was actually taking death off the table. But nothing, radio silence. Government and media blackout. Then we blamed the Trump administration, surely once that changed we would start to see some progress? Nope, nada, zip.
Unlike others here, I don't blame Nader or Kelly or anyone at Cytodyn for being optimistic, for feeling sure that emergency use, recognition, some sort of acknowledgement was on the way. How could it not when the FDA had already set the bar so low with Remdesivir? How could Cytodyn not expect great things when people were literally getting up off their death beds within 14 days?!
At that time I was literally scouring the internet and the clinical trial sites, researching every possible drug in trials. I often wondered why given the emergency, an FDA taskforce was not assembled to review the data for every Covid trial in real time, to speed up assistance, and manufacturing for promising drugs. Imagine if Fauci and the NIH supported the Leronlimab trial effort with a larger trial or funding, imagine how many people could have been saved if they really wanted to help people? But it hasn't been about that in this country, it's about big pharma profits, and Fauci is complicit. What a shame he was carried over to the new administration.
Are you aware that Remdesivir has had over 96 trials related to Covid-19? 96!!! By the way, Fauci did the same thing with AZT during the aids crisis. Trialed it over and over and over again, ignoring other promising treatments (including our Pro-140).
Remdesivir given 96 trials, and yet many are upset with management because Leronlimab wasn't able to hit it out of the park with one very small trial (phase 2/3 combined!), designed early on in the pandemic when little was known about the drug or the disease? Phase 2 is where you figure out dosing and most effective endpoints and Cytodyn didn't get the benefit of that research. Their trial was combined into one "all or nothing" blinded phase 2b/3. Given the major headwinds this company has faced and the stranglehold that Gilead has on our FDA, shouldn't we wait until after at least trial 3 or 4 before making judgements about management?
So, needless to say, I support management and I'm very happy that Cytodyn has pivoted overseas, working to save lives where the need is greatest. Remdesivir is now falling out of favor in both the Philippines and in India. The Israel Albert Einstein hospital in Brazil is a respected institution with much experience in clinical trials. Macleod's in India an extremely strong company with worldwide reach. Yes, this race is definitely taken longer than I expected, and the sprint turned into a marathon, but I have no doubt Leronlimab will get over the finish line if given a chance to run.
As has been pointed out, the evidence against Remdesivir was plentiful and strong, yet it was ignored and continues to be ignored by our FDA. Other studies confirmed poor results and futility. In fact, data has shown that the mortality is actually higher among Remdesivir patients. Fauci claimed the emergency justified approval even though they were just trending towards positivity. Special allowances were made for it's approval. Subgroups of data were used to reach that conclusion, but we ignored all of this because a pandemic was raging worldwide. Of course, exceptions had to be made during such a horrible emergency!
We assumed the FDA was just trying their best to find something, anything that they could call helpful, and then Leronlimab started showing spectacular results at Montefiore and UCLA through the EIND program. We expected immediate support and guidance from the FDA, and why not, Remdesivir got it for much less, and people were dying by the thousands every day. Safety was not an issue!! What did they have to lose? So we waited, holding our collective breath, thinking that of course the FDA would do something, that Fauci would talk about this drug showing so much promise. The one drug that was actually taking death off the table. But nothing, radio silence. Government and media blackout. Then we blamed the Trump administration, surely once that changed we would start to see some progress? Nope, nada, zip.
Unlike others here, I don't blame Nader or Kelly or anyone at Cytodyn for being optimistic, for feeling sure that emergency use, recognition, some sort of acknowledgement was on the way. How could it not when the FDA had already set the bar so low with Remdesivir? How could Cytodyn not expect great things when people were literally getting up off their death beds within 14 days?!
At that time I was literally scouring the internet and the clinical trial sites, researching every possible drug in trials. I often wondered why given the emergency, an FDA taskforce was not assembled to review the data for every Covid trial in real time, to speed up assistance, and manufacturing for promising drugs. Imagine if Fauci and the NIH supported the Leronlimab trial effort with a larger trial or funding, imagine how many people could have been saved if they really wanted to help people? But it hasn't been about that in this country, it's about big pharma profits, and Fauci is complicit. What a shame he was carried over to the new administration.
Are you aware that Remdesivir has had over 96 trials related to Covid-19? 96!!! By the way, Fauci did the same thing with AZT during the aids crisis. Trialed it over and over and over again, ignoring other promising treatments (including our Pro-140).
Remdesivir given 96 trials, and yet many are upset with management because Leronlimab wasn't able to hit it out of the park with one very small trial (phase 2/3 combined!), designed early on in the pandemic when little was known about the drug or the disease? Phase 2 is where you figure out dosing and most effective endpoints and Cytodyn didn't get the benefit of that research. Their trial was combined into one "all or nothing" blinded phase 2b/3. Given the major headwinds this company has faced and the stranglehold that Gilead has on our FDA, shouldn't we wait until after at least trial 3 or 4 before making judgements about management?
So, needless to say, I support management and I'm very happy that Cytodyn has pivoted overseas, working to save lives where the need is greatest. Remdesivir is now falling out of favor in both the Philippines and in India. The Israel Albert Einstein hospital in Brazil is a respected institution with much experience in clinical trials. Macleod's in India an extremely strong company with worldwide reach. Yes, this race is definitely taken longer than I expected, and the sprint turned into a marathon, but I have no doubt Leronlimab will get over the finish line if given a chance to run.
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