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Re: AngeloFoca post# 29492

Monday, 08/21/2017 1:01:29 PM

Monday, August 21, 2017 1:01:29 PM

Post# of 38634
Agreed with everything you just summed up. However with that said we need guidance from IPCI mgmt. on their CAT 3 HAP studies because someone stated earlier that if the FDA is no longer going to consider a tentative approval on next months Rexista PDUFA date...that the FDA will most certainly notify IPCI in writing in advance.

So all the while there's no further negative Rexista news released...the possibility regardless of how slim...still exists that the FDA may still grant tentative approval with an IV abuse deterrent label...which was ALL the FDA's Rexista AdCom was supposed to be going for anyways...exactly as the FDA's briefing docket stated.


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