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Posted On: 03/05/2021 9:12:04 PM
Post# of 151003
“The FDA sees the data and it is encouraging. Need more data and time to look at any number of endpoints to decide how to proceed.”
Exactly. It appears from the PR that the FDA may have already given some feedback to CYDY and CYDY is moving forward:
“Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the Company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions.”
The FDA may have provided this initial guidance and more is to follow. The major problem is the small number of critical patients, only 62, and that a trial of 62 patients is likely not powered to FDA standards.
Exactly. It appears from the PR that the FDA may have already given some feedback to CYDY and CYDY is moving forward:
“Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the Company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions.”
The FDA may have provided this initial guidance and more is to follow. The major problem is the small number of critical patients, only 62, and that a trial of 62 patients is likely not powered to FDA standards.
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