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Re: Atom0aks post# 208887

Wednesday, 08/14/2019 4:16:50 PM

Wednesday, August 14, 2019 4:16:50 PM

Post# of 426697
Atom,

You can believe those as facts ALL that you want to BUT, it is very obvious that the FDA has NOT followed the PDUFA guidelines to this point. If they had, the adcom would have been announced at Mid-cycle review and it was not. In fact I believe, by timeline, that it was announced after the Late Cycle review. See pages 10-14 in the PDUFA guidelines.

It doesn't matter at this point if that DB is cutting and pasting PDUFA guidelines on twitter or not. The FACT is the FDA has not followed their own guidelines.
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