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Re: TheBigTicket post# 178777

Friday, 08/13/2021 8:08:43 AM

Friday, August 13, 2021 8:08:43 AM

Post# of 233147
Important statement

CMC and Non-Clinical Sections Will Be Fully Resubmitted as Early as September 2021



The fact that Cytodyn added this to this short PR emphasizes their confidence that the BLA process is moving properly, and informs us further that the FDA guidance will indeed be appropriately addressed.

Add: may be this has nothing to do with FDA guidance and comments, but it is rather encouraging that they added this note that indicates they are not letting the timelines get away.
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