There will be no EUA on Tuesday, imo. It would be
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(Total Views: 743)
Posted On: 10/16/2020 5:13:30 PM
There will be no EUA on Tuesday, imo. It would be stupid to issue an EUA while the trial goes to completion because NO ONE WILL ENROLL IN THE TRIAL!
If Seethamraju's comment that the FDA was reviewing is correct, then the FDA has instructed CYDY to releas some topline data in the hopes of acclerating the patient recruitment.
Probably there is something like 20 or 30 percent mortality reduction, and the FDA doesnt want to issue an approval on that. AT 20 to 30 percent mortality reduction the FDA wants the trial to run out to the end so ther are better statistics to show that its not just random chance that LL was better.
If the FDA is forced to make a public statement as to their decision on LL, they can say "its promising but we need more data to make sure it works."
But probably the FDA will make no statement whatsoever on LL.
Probably the FDA has told CYDY to make the statement that "Mortality is reduced by 25%. If that holds after 390 patients, covid approval is highly likely. It can't be approved yet because we need more data.But we have terrific results at 25% mortality reduction so that should accelerate the trial enrollment."
My guess is the FDA would have approved if greater than 50% mortality reduction.
If Seethamraju's comment that the FDA was reviewing is correct, then the FDA has instructed CYDY to releas some topline data in the hopes of acclerating the patient recruitment.
Probably there is something like 20 or 30 percent mortality reduction, and the FDA doesnt want to issue an approval on that. AT 20 to 30 percent mortality reduction the FDA wants the trial to run out to the end so ther are better statistics to show that its not just random chance that LL was better.
If the FDA is forced to make a public statement as to their decision on LL, they can say "its promising but we need more data to make sure it works."
But probably the FDA will make no statement whatsoever on LL.
Probably the FDA has told CYDY to make the statement that "Mortality is reduced by 25%. If that holds after 390 patients, covid approval is highly likely. It can't be approved yet because we need more data.But we have terrific results at 25% mortality reduction so that should accelerate the trial enrollment."
My guess is the FDA would have approved if greater than 50% mortality reduction.
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