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Posted On: 03/08/2021 8:05:55 AM
Post# of 148902
Quote:
The BLA problem was a failure to acknowledge the skills required to do this work, thus delaying the approval from last Summer to perhaps this summer.
If one is looking at facts one does not push a false narrative. The FDA asked for data from the end of the monotherapy trial that Cytodyn didn't have when the BLA was filed since the monotherapy trial didn't end until June. How would the CEO know the FDA would ask for data that didn't even exist?
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