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Re: Biobillionair post# 198761

Thursday, 06/27/2019 1:29:13 PM

Thursday, June 27, 2019 1:29:13 PM

Post# of 447187
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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