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Posted On: 08/25/2020 5:28:34 PM
Post# of 148984
Re: chazzledazzle #52194
My guess is that there is a back-and-forth going on right now with the FDA, and that the FDA will need time to confirm the results.
Given the massive amount of data generated by the trial and the expedience in which is was delivered to the FDA, I doubt the initial submission was comprehensive enough to satisfy the FDA's wants.
I don't think there is any way the FDA just looks at the p values and grants an EUA. Not to an outsider pharma. I think they will want to analyze the raw data in some form to confirm that what Cytodyn is claiming is real, and that's going to take time.
Given the massive amount of data generated by the trial and the expedience in which is was delivered to the FDA, I doubt the initial submission was comprehensive enough to satisfy the FDA's wants.
I don't think there is any way the FDA just looks at the p values and grants an EUA. Not to an outsider pharma. I think they will want to analyze the raw data in some form to confirm that what Cytodyn is claiming is real, and that's going to take time.
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