Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

Intellipharmaceutics' PDUFA 2 months away end of August. Company reapplied and got a 6 month PDUFA date. Company should have reapplied earlier. Second PDUFA is about 2 years after the 1st one. Hopefully, no 2nd CRL for IPCIF. Amazingly, Remoxy got rejected 4 times and is still not approved. Remoxy's first filed back in 2008 and has been working on the drug for over a decade.

It seems Oxycodone ER is basically a generic of Oxycontin. I am guessing FDA will not hold another Advisor Committee meeting since is it so close to being a generic. All IPCIF has to do is show Oxycodone ER is equally as abuse-resistant as Oxycontin to get approved. IPCIF claims Oxycodone ER is bioequivalent with or without food so the drug meets the requirement to be generic AB-rated.