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Re: Venture_Cap post# 108270

Wednesday, 08/19/2020 8:25:34 PM

Wednesday, August 19, 2020 8:25:34 PM

Post# of 232961
Dr. BP was asked about viral load not being submitted to FDA and he said FDA was not interested in a lot of data including viral load. Just safety and effectiveness. NOW, I do not know how viral load would not be something important, as the studies point to viral load. But, FDA appears to not be interested at this time according to him along with much of the data Cytodyn could give the FDA. Results, no matter the other data points and safety with statistical significance is what FDA is concerned with seeing for approval.
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