Replies to post #22385 on Intellipharmaceutics International Inc. (IPCI)

[Despicable_Z]

"FDA will not grant a 6 month Priority Review for any drug that cannot receive Full Approval for another 19 months. But I do agree with you that it does not matter, since Rexista as it is currently formulated, will never make it out of AdComm."


1) Why not?

2) Then why are you here?

[numbersarefun]

WeeZuhl, Oxycontin's exclusivity code is NPP, not PED. NPP means "New Patient Population". Pediatric Exclusivity code is "PED".

I am pretty sure you are wrong about Pediatric. Abuse-deterrent Oxycontin approved in April 2013. FDA probably gave 3 years marketing exclusivity, which would end in April 2016. Pediatric would only extend that 6 months.

FDA probably gave 3 years New Patient Population exclusivity in 2015, which only applies to that population. So it is not full marketing exclusivity and does not matter.

WeeZuhl wrote: "Better do some more reading tonight on Pediatric Exclusivity."