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CytoDyn Inc CYDY
(Total Views: 858)
Posted On: 12/22/2020 6:27:36 PM
Post# of 154930
Posted By: ohm20
Re: Shopcop7 #69312
Quote:
I’m actually surprised they didn't mention the BLA, you know the one which was supposed to be filed about 10 times, then was filed, but had to be refilled,



You mean the one that should have been filed at 525mg but the FDA screwed Cytodyn on that. Maybe the one that the FDA insisted on 700mg for but then insisted on additional safety data. Possibly the one that should have been filed once we had the additional safety data but then the FDA insisted on all the data from the monotherapy trial which would do nothing but muddle up the entire BLA. Was it the final one where the FDA decided that they wanted the additional data from the mono trial from January until June when the trial was finished and rejected the occupancy data that wasn't even in the trial protocol.













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