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sharinky

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sharinky

Re: Biobillionair post# 198332

Tuesday, 06/25/2019 7:38:14 AM

Tuesday, June 25, 2019 7:38:14 AM

Post# of 425621
Good question. From what I have seen in the past, it is not part of the normal process for the FDA to let the company know this early that there would be no ADCOM. I have never seen a company PR that they will not be having a ADCOM. The FDA and the company hold the possibility open in case something comes up during the review of the application. If something does come up during the review, the FDA informs the company of the ADCOM. If the timing is later in the cycle, they just delay the PDUFA date so the company still has proper time to prepare for the ADCOM.
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