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Re: sharinky post# 212309

Tuesday, 09/03/2019 2:50:21 PM

Tuesday, September 03, 2019 2:50:21 PM

Post# of 425621
Look up reasons the FDA would do a three month delay in PDUFA date. The FDA only cites two reasons that I can find. Either there would need to be a manufacturing issue causing a delay or a major amendments.

Neither of those may apply in this case. It appears that it may just be that the FDA failed to schedule the AdCom when they should have. If that is the case the FDA will not move the PDUFA date. They will hold the Adcom and then work to finish the approval process.
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