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Posted On: 10/07/2020 6:30:57 PM
Post# of 145875
I respectfully disagree with this. NP said at the CC they were advised not to take the penalty by amarex kazem kazempur(?) who used to be employed by the FDA. I don't know that the .05 or 005 is exact but may have been more of an example given by NP. I would take a former FDA employees advice. Also NP said they didn't completely file for EUA on the M/M because it didn't sound like the FDA was interested and Cytodyn didn't want that mark/flag of a rejection against them. So I don't know if the FDA treats you differently if your record has these marks, but without us knowing the exact penalty and how the FDA works, I don't know if it would be a very wise move as much as I would like to see the data myself, I'd rather see an approval.
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