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rafunrafun

06/27/19 1:27 PM

#198766 RE: Biobillionair #198761

BB & Vet

BB - please show me any mention of 55 days from FDA's website / policy.

Vet - I don't know.
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SocialBoom

06/27/19 1:29 PM

#198767 RE: Biobillionair #198761

I think the Adcom window is closed with the exception of FDA moving the PDUFA date, which they could always do. I suspect JT gets word from them of no Adcom very soon and I think it's time to begin a debate about how far in advance of Sept 28th FDA might go ahead and approve the expanded label.
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marzan

06/27/19 1:45 PM

#198775 RE: Biobillionair #198761

BB, FDA could shorten the PR review time from 6 months to less than 6 months bot not lengthen it, imo, then it is not Priority Review in my mind. No precedence in the later case, imo.