“No where in the PR did it say the FDA required
Post# of 155142
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Posted On: 03/06/2021 12:39:45 AM
“No where in the PR did it say the FDA required this protocol filing. In fact it satiated the exact opposite: "....the COMPANY has concurrently (meaning at the same time it submitted the data to the fda) filed an additional protocol with the FDA.”
The data was submitted to the FDA two weeks ago, not today.
CYDY stated in the PR two weeks ago that they were in discussions with 3 different FDAs and would release the data once those discussions concluded. Now that we have the data, and those preliminary discussions are complete, you want me to believe that the FDA gave no recommendations to CYDY? That’s very unlikely. CYDY reached out for feedback two weeks ago (EUA go or no-go) and the FDA appears to have responded and recommended the additional protocol, which could be as simple as enroll 50-100 more critical patients. And to be clear, it doesn’t matter if the FDA recommended the protocol or CYDY decided to file one because either way, more critical patients are needed to get the p<.05.
“(meaning at the same time it submitted the data to the fda)”
The unblinded data was submitted two weeks ago, per the PR two weeks ago. There was no mention of an additional protocol being submitted at that time, which means the need for the protocol was identified sometime between that PR and today.
The data was submitted to the FDA two weeks ago, not today.
CYDY stated in the PR two weeks ago that they were in discussions with 3 different FDAs and would release the data once those discussions concluded. Now that we have the data, and those preliminary discussions are complete, you want me to believe that the FDA gave no recommendations to CYDY? That’s very unlikely. CYDY reached out for feedback two weeks ago (EUA go or no-go) and the FDA appears to have responded and recommended the additional protocol, which could be as simple as enroll 50-100 more critical patients. And to be clear, it doesn’t matter if the FDA recommended the protocol or CYDY decided to file one because either way, more critical patients are needed to get the p<.05.
“(meaning at the same time it submitted the data to the fda)”
The unblinded data was submitted two weeks ago, per the PR two weeks ago. There was no mention of an additional protocol being submitted at that time, which means the need for the protocol was identified sometime between that PR and today.
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