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Re: tmeier post# 211342

Wednesday, 07/13/2016 1:38:06 AM

Wednesday, July 13, 2016 1:38:06 AM

Post# of 400671
Recently all abuse deterrent opiod formulations had adcoms before the pdufa date. The adcom is convened atleast month ahead of pdufa date. As elite doesnt have an adcom scheduled and we are just few days away from pdufa, three things can happen, fda can request more information by issuing a crl(more likely), or fda can move the pdufa date citing it needs more time(less likely) or it can approve the product without an adcom (very unlikely).
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