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Posted On: 02/23/2021 1:03:56 PM
Post# of 148903
exactly right! I do like that everyone is working hard to fine bad news possibilities in this PR. We should all feel confident that the worst case possibility has less support than the most obvious. I also want to bring up the 2-3 week timeline. In my opinion (even with a Nader timeline correction) is that this is not enough time needed to alter the primary endpoint or look at 14 day vs 42 day data. It is enough time to ask/answer questions about labeling/manufacturing and distribution. I think we are fine, this PR clearly shows the ball is in the regulators court and not in Cytodyn's court. We are not modifying protocals to get a more compelling data set, we are answering questions about good data results and how to get this drug out there.
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