Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

To come out in the public and say IPCI did not submit proof that Rexista is abuse deterrent is absurd.

The FDA document confirms the Reuter's reporting. IPCI did not submit any human studies to support the abuse deterrent label. All the ADF data was extraction studies. This might qualify for IV abuse ADF label but not a label for snorting or chewing. Go back and look at every drug that got the chewing and snorting labels. Every one submitted "Drug Liking" **human** studies. IPCI only submitted in vitro data, apparently due to "Philosophical differences with the FDA."


I bet Purdue's lawyers loved Della Penna's statement today. He basically said we use the exact same ADF tech as OxyContin, and therefore we expect to get an ADF label based on Purdue's HAL studies. Sorry, Dude, not how any of this works.


Best in class at what??? No human studies to support that. Like I said, maybe it is Best to Chew While In Class, but certainly not Best In Class.