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Re: Biobillionair post# 208438

Tuesday, 08/13/2019 10:50:03 AM

Tuesday, August 13, 2019 10:50:03 AM

Post# of 425888
I just wanted to provide my input since there seems to be a lot of speculation regarding PDUFA and the Federal Register. I think it would be to our benefit to take Thero's word that there will be an AdCom, it will most likely occur in November (at the earliest), and the PDUFA action date will be extended to December. The fact that the FDA has not filed a notification with the Federal Register means nothing. A brief look at the FDA's past notifications shows that they file notifications as late as a month prior to the meeting. An agenda is filed 48 hours prior to the meeting. All the other rumor-mongering going around will only cause more harm than good in the face of recent revelations.
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