Replies to post #12398 on Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

In the past I would totally agree that IPCI should prepare for the FDA to comeback after IPCI submits bioequivalence and inform them that they still have to do phase III trials.

But given all the recent push within congress and the FDA to speed up drug approvals...the 2 recent FDA decisions pertaining to IPCI's Rexista progress make all the more sense ie: FDA granting IPCI a fast track designation and the FDA advising IPCI that they're so impressed with IPCI's phase 1 trial results that they can skip phase III entirely.

2 paragraphs from earlier this month which totally fit into the FDA's 2 recent decisions on IPCI's Rexista pathway to approval>>>

The legislation contains numerous ways for FDA regulators to accelerate clinical trials of products, including allowing the use of data from case studies, patients' experiences, other countries and medical journals

Other provisions would speed how many drugs and devices reach consumers, such as letting regulators approve some medical equipment with shorter studies using fewer people. New uses of existing drugs could be based partly on case studies and other processes that are less rigorous than traditional clinical trials.

[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.