“I think the chances of EUA within a couple of d
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Posted On: 01/02/2021 1:07:19 AM
Re: onestepahead #70829
“I think the chances of EUA within a couple of days from unblinking happening 10x more likely than it taking a month.”
Highly unlikely to occur within a few days. None of the previous EUA processes, for therapeutics or vaccines, happened that quickly. The Pfizer vaccine received EUA about 21 days after the application was submitted, which I think has been the fastest approval so far. The primary endpoint for the vaccine is as easy to review as mortality: X patients in vaccine arm contracted the infection vs X patients in the placebo arm (and a review of side effects). CYDY will need to complete the application process, which itself could take a day or two once the data has been fully analyzed. If the data is great and the analysis is ready for submission, I could see 14-21 days for approval from submission base on Pfizer’s timeline.
“If DSMC may have enough evidence that as soon at 28th day hits...”
As others have pointed out (thanks Jlang), the DSMC is no longer part of the trial process as the trial has concluded.
“I imagine the FDA will be looking at data the minute it comes in through the day on Jan 12th.”
Unlikely. The FDA does not play a role in analyzing the data as the onus is on the company to complete the trial process and apply for approval as needed. Amarex will compile the final data on or around the 12th and complete it’s analysis sometime after that.
Highly unlikely to occur within a few days. None of the previous EUA processes, for therapeutics or vaccines, happened that quickly. The Pfizer vaccine received EUA about 21 days after the application was submitted, which I think has been the fastest approval so far. The primary endpoint for the vaccine is as easy to review as mortality: X patients in vaccine arm contracted the infection vs X patients in the placebo arm (and a review of side effects). CYDY will need to complete the application process, which itself could take a day or two once the data has been fully analyzed. If the data is great and the analysis is ready for submission, I could see 14-21 days for approval from submission base on Pfizer’s timeline.
“If DSMC may have enough evidence that as soon at 28th day hits...”
As others have pointed out (thanks Jlang), the DSMC is no longer part of the trial process as the trial has concluded.
“I imagine the FDA will be looking at data the minute it comes in through the day on Jan 12th.”
Unlikely. The FDA does not play a role in analyzing the data as the onus is on the company to complete the trial process and apply for approval as needed. Amarex will compile the final data on or around the 12th and complete it’s analysis sometime after that.
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