Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

In March of this year this is what IPCI claimed the FDA informed them>>>

The FDA has informed the Company that it considers the resubmission a complete response to the September 22, 2017 action letter it issued in respect of the NDA. The FDA has also assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2019.

And way back in September 2017 this is what IPCI claimed the FDA's CRL required IPCI to do>>>

Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration.

So why there's been no AdCom scheduled yet for the upcoming August PDUFA date is beyond me. And the even bigger mystery is why IPCI never bothered publishing their CAT 2 & 3 studies which they now claim the FDA considers a complete response to the Sept 2017 CRL the FDA issued IPCI.

And considering how long Remoxy's been at it(a full decade) and the 4 rejections Remoxy's received so far(as numbers laid out)...I definitely agree that the percentage for potential success is ultra-slim here considering what a train wreck this stock/company has been lol.