Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

N2KA, Rexista with PODRAS will require Phase 3

All published bio-equivalence data (and FDA comments about not needing Phase 3) thus far has been for the old formulation WITHOUT PODRAS. That was simply a mechanical-barrier ADF. There is no substantiated bio-equivalence as of yet for Rexista with PODRAS, nor has the FDA ever said that Rexista with PODRAS will not require Phase 3. Addition of PODRAS makes all prior studies moot. I guarantee there will be a Phase 3 requirement, assuming it even passes Phase 1 bio-equivalence, which as of yet, it has not. You need to think of the addition of PODRAS, which is what qualifies for Fast Track, as an entirely new drug which needs to start over from the beginning. I'd give you my opinion on the likelihood of successful Phase 1 for Rexista with PODRAS, but there has been no disclosure or description of PODRAS mechanism, making it impossible.