Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

BondsSF, thanks for a thoughtful response.

The bioequivalence required only has to do with Oxycontin so the PODRAS has NOTHING to be bioequivalent to.

I contacted the company asking them if a Phase 3 will be needed with the PODRAS added and will let you know what they respond.

Without knowing the PODRAS mechanism, it is most likely to somehow activate a pro-drug oxy molecule, or less likely to somehow deactivate a standard oxy molecule. So absolutely PODRAS will have a potential effect on oxy plasma concentration and bio-equivalence of the oxy will need to be re-established. Likewise, they'll need to show it works as described when multiple tabs are taken at once. This is very finicky, and many others have tried and failed. I'm not trying to say IPCI does not have it exactly right, just that they will, without any doubt, be required to prove it. That's all I'm saying. I would greatly appreciate hearing what they have to say when they get back to you.