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Re: WojD40 post# 402943

Monday, 09/20/2021 10:43:23 AM

Monday, September 20, 2021 10:43:23 AM

Post# of 716862

Can anyone shed any light on whether a peer reviewed paper is part of the official BLA application?



A peer reviewed paper is not part of the BLA application and has no bearing at all on FDA approval. Many journal articles publishing full trial results come out after FDA approval.











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