Intellipharmaceutics International Inc. (IPCI)

[fred198484]

Has anyone wondered why the FDA accepted the Rexista NDA if it failed to live up to the protocols established by the FDA? We investors had no idea they accepted the NDA even though it was technically not complete. That is why we were all blindsided yesterday. The committee could not get past the idea that the category 2 and 3 tests were not completed and, as a result, just disregarded all other evidence that supported the fact that Rexista would have been the best product on the market. Also, they basically said who cares if it was the best product as all the opioid ADF products are ineffective since abuses just move on to other drugs and they see no reason in approving the best option since none of them solve the problem.

What a mess of an ADCOM - they complete lost perspective and there was no one to shout at them and point that out. They just effectively shot down the best option. If Rexista helped prevent 1 death, it was worth approving. While there were no studies supporting the ADF claims, there was a lot of common sense supporting them. But, the committee members were more concerned about the stigma of the blue dye or the possibility it might be a badge of honor to teens or that the kid's parents might get upset with their kid for abusing drugs - all of which was total speculation on their part as well.

I have to believe the FDA understands the benefits of Rexista and that approving it is the most sensible thing to do. But they will need some political cover so the company has to perform some of the tests. The question is how long will it take and how much will it cost. Related to the cost question is how will the company get the required cash and how much will that dilution hurt current shareholders. We know the company is pursuing the tests but we were not informed about timing or cost.

I bet Rexista gets approved and commercialized on a time frame that ends up not being all that different than if the ADCOM had been a success since we would have had to wait for a settlement with Purdue anyway. The FDA has to find a way to get it to approval since it is the best drug available. They also probably feel a bit guilty for putting IPCI in a bad spot by accepting the NDA without the normally required tests.