Intellipharmaceutics International Inc. (IPCI)

[no2koolaid]

Let me preface my answer by saying that I am not a scientist, I am a strategist.

As a strategist, I would be concerned how a P-3 would impair the commercialization schedule and timing, but it would not be in my positional power to avoid the P-3; that is the role of the scientists/operational people.

With that, as a strategist, while hoping and planning for no P-3, it is only one scenario to plan for. The other is if a P-3 is required. For that scenario I would prepare/plan the costs, the administrative requirements/demands for such an endeavor, re-address commercialization, and I would make sure there would be a PR statement written that has words to the effect..."We do not view the FDA requiring a P-3 as a setback. Rather it was an anticipated, though separate step asked of us by the FDA that is taken to ensure that all ADFs are tested, measured and approved under the same auspices. So, we welcome the opportunity to show the quality of our product/tech. Our focus will be upon preparing for and executing a successful trial, followed by the effective commercialization of our world class product/tech."

This shows nothing had been taken for granted, there is a willingness to jump through all the hoops, there is confidence in the product/tech, and the company has a clear ability to adapt in the face of adversity.

With all of that, given their "scar tissue" from Embeda and Zohydro, I expect the FDA to ask for the P-3...