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Re: Biobillionair post# 213441

Tuesday, 09/10/2019 12:41:16 PM

Tuesday, September 10, 2019 12:41:16 PM

Post# of 424150
FDA would have gone over solicited data much earlier than 8/8 to tentatively schedule an ADCOM.

Since JT was surprised by the ADCOM I’m assuming they sent their response a while back, and having not heard from the FDA nearing the PDUFA date, thought an ADCOM unlikely.

Though we won’t know officially if the FDA solicited data until the official “possible” PDUFA delay letter.
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