Cytodyn Inc (CYDY): Wrong - BLAs are submitted once all data...

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Cytodyn Inc (CYDY)

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Re: pearsby09 post# 12298

Tuesday, 03/14/2017 10:01:35 AM

Tuesday, March 14, 2017 10:01:35 AM

Wrong - BLAs are submitted once all data is complete and the drug is proven efficacious in Phase 3. If the data are not good, companies can choose to not submit the BLA. Happens all the time when drugs fail to show efficacy in Phase 3. The FDA would not even accept a BLA submission without all the endpoints being complete, as per your clinical protocol. Your ignorance around the drug approval process is not shocking considering all of your incoherent ramblings on this board.

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