Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

I totally hear ya on all counts Tek...but let's face it...the FDA themselves set todays Rexista AdCom agenda and couldn't have been any clearer that the panel was supposed to be voting solely on the intravenous abuse deterrence...and whether or not the data from the briefing doc supported an IV abuse deterrent label.

The panel however had an entirely differing perspective as we all heard...hence their landslide no vote.

So Dr Odidi and IPCI are back to the drawing board as I highly doubt the FDA is going to grant tentative approval on just the IV abuse deterrent label that todays adcom was supposedly about.

So Dr Odidi has 2 choices now...partner Rexista and give the partner a sweet deal in order for the partner to pay the probable $25M to $30M in all the category 2 and 3 studies that will be required for nasal and oral and to prove the blue dye is safe...or put out a big dilution offering that will result in IPCI's 30M O/S bloating to 60 or 80M shares and paying for all the category 2 and 3 studies themselves.

It would take a miracle at this point in time for the FDA to over-rule the panels no vote...but that possibility definitely exists...since the FDA themselves were the ones who made todays IV adcom agenda which the adcom panel members chose to ignore and instead hone in on all the other potential abuse deterrent properties and novel use of the blue dye.

Is IPCI to blame for todays AdCom failure definitely...but the FDA themselves are also to blame for telling IPCI no phase III studies were required and setting up todays AdCom agenda to supposedly just be a vote on whether or not the panel would recommend that Rexista did in fact deserve an abuse deterrence label.