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rafunrafun

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rafunrafun

Re: None

Thursday, 07/11/2019 7:42:50 AM

Thursday, July 11, 2019 7:42:50 AM

Post# of 424150
AdCom

105 days passed since sNDA acceptance

79 days remaining (or less) until PDUFA

IMO the time for an AdCom has expired because:

July & 1st week of August = not enough heads-up

August, after 1st week = historically there haven't been any AdComs

September = too close to PDUFA

https://www.fda.gov/advisory-committees/advisory-committee-calendar
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