With regard to an EUA, this is what Drs. Lalezari
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Posted On: 07/22/2023 4:12:07 PM
With regard to an EUA, this is what Drs. Lalezari and Seethamraju wrote on 5/7/21:
There is new hope for severely ill patients with Covid-19. On March 30th, US company CytoDyn, released results from a randomized, double-blind study of a drug called leronlimab. The study revealed an unprecedented 82% reduction in the rate of death at Day 14 for patients on a ventilator who received 2 weekly doses of leronlimab compared to a placebo.
To confirm the finding, CytoDyn will need to perform another trial that will take months to complete. In the meantime, the company asked FDA to approve access to leronlimab for critically ill patients now, under an Emergency Use Authorization or EUA.
Unfortunately, the FDA rejected that request. The consequences of that decision, both here and abroad, where regulatory agencies generally follow the FDA’s lead, will likely be devastating as new strains of mutant virus sweep the globe.
If you want to read the entire article, here is the link:
https://www.counterpunch.org/2021/05/07/hope-...hin-reach/
With regard to the 2 vs. 4 dose fiasco, here is what Dr. L wrote in his 12/8/21 email to numerous folks including Dr. Woodcock at the FDA:
The CD12 study in 394 s/c patients was pivotal and, unfortunately, we made some mistakes (I use the word “we” because I was an advisor to CytoDyn for 6 months on Covid back in 2020).
First, we thought the results in critical patients would translate into benefit for hospitalized patients on oxygen but not yet intubated. Well such severe patients may indeed benefit from leronlimab, but it will require a larger study to prove it. There were also unforced errors like not stratifying for age > 65 which resulted in a significant randomization imbalance working against the drug.
The biggest mistake, however, was on dosing. The original CD12 protocol proposed to give s/c patients 4 weekly doses, in part because of data Bruce generated showing RANTES levels remained elevated in some ICU patients beyond day 14. Unfortunately, FDA saw Covid framed Covid as an acute viral illness and would only allow the same 2 week dose regimen as the m/m patients received. CytoDyn, fresh off clinical hold, wasn’t in a great position to push back and capitulated.
Craigakess said:
While that is probably true, the FDA had an opportunity to work with CYDY on the number of doses but they did not.
There is new hope for severely ill patients with Covid-19. On March 30th, US company CytoDyn, released results from a randomized, double-blind study of a drug called leronlimab. The study revealed an unprecedented 82% reduction in the rate of death at Day 14 for patients on a ventilator who received 2 weekly doses of leronlimab compared to a placebo.
To confirm the finding, CytoDyn will need to perform another trial that will take months to complete. In the meantime, the company asked FDA to approve access to leronlimab for critically ill patients now, under an Emergency Use Authorization or EUA.
Unfortunately, the FDA rejected that request. The consequences of that decision, both here and abroad, where regulatory agencies generally follow the FDA’s lead, will likely be devastating as new strains of mutant virus sweep the globe.
If you want to read the entire article, here is the link:
https://www.counterpunch.org/2021/05/07/hope-...hin-reach/
With regard to the 2 vs. 4 dose fiasco, here is what Dr. L wrote in his 12/8/21 email to numerous folks including Dr. Woodcock at the FDA:
The CD12 study in 394 s/c patients was pivotal and, unfortunately, we made some mistakes (I use the word “we” because I was an advisor to CytoDyn for 6 months on Covid back in 2020).
First, we thought the results in critical patients would translate into benefit for hospitalized patients on oxygen but not yet intubated. Well such severe patients may indeed benefit from leronlimab, but it will require a larger study to prove it. There were also unforced errors like not stratifying for age > 65 which resulted in a significant randomization imbalance working against the drug.
The biggest mistake, however, was on dosing. The original CD12 protocol proposed to give s/c patients 4 weekly doses, in part because of data Bruce generated showing RANTES levels remained elevated in some ICU patients beyond day 14. Unfortunately, FDA saw Covid framed Covid as an acute viral illness and would only allow the same 2 week dose regimen as the m/m patients received. CytoDyn, fresh off clinical hold, wasn’t in a great position to push back and capitulated.
Craigakess said:
Quote:
Understand the following: it still is not as if CYDY supplied with FDA with irrefutable evidence in the manner universally required by the FDA and the FDA then screwed CYDY. That just didn't happen. At least not yet.
While that is probably true, the FDA had an opportunity to work with CYDY on the number of doses but they did not.
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