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CytoDyn Inc CYDY
(Total Views: 377)
Posted On: 03/18/2021 11:55:18 AM
Post# of 153886
Posted By: mtruong34
Re: SAF #83444
I agree with your statement as well. The linchpin for probability of approval is sitting on whether NP got the FDA's blessing or if he is being bold and filing regardless of the FDA's opinion. Based on history, NP has been very reluctant to even offer the slightest hint of criticism or willingness to publicly pressure the FDA so this would lead me to believe he got their blessing.
But in the Dr. Been video and in some parts of the CC, it seemed that NP was sure that CD12 results did not meet the FDA's criteria for EUA. My best guess is that CYDY has decided to file for EUA (and did file per the PR) and that the FDA has taken a neutral tone in their discussions (i.e., did not flat out say don't bother as they did with CD10).













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