Replies to post #28870 on Intellipharmaceutics International Inc. (IPCI)

[fabius]

Angelo, give them a call to illustrate it...I believe they really need some help

[doogdilinger]

Agreed Angelo

[Samsa]

Angelo.....I would agree, that would make sense. We can not afford to dilute at this point. besides, the lack of preparation going into adcomm clearly shows they need a big player on their side. I hope they are listening.

That or either start putting the screws to the FDA, which they didnt do last time with Focalin. while, IPCI has to accept blame for their lack of preparation. Clearly, IPCI can make a case for detrimental reliance in the event the FDA does not approve. However, with the recent PR stating they would just do the phase 3 its unlikely they would follow through with litigation.

Its 50/50 though as to that fiasco. someone had the responsibility to inform adcomm as to what the issues were and that the FDA granted the waiver and for what reasons. with it being IPCI's application I say they had the greater duty of care but clearly the FDA saw the thing was going south which is why they revised the question to vote on. which in turn just confused the panel more.

sad all the way around. lack of preparation all the way around. even the panelist seemed like they didnt read the packets given to them.

[fred198484]

If we really believe that the ADCOM was a joke and that Rexista is the best ADF Opioid available, then there is a good chance the FDA believes that and potential partners believe it as well. Common sense says we are right so the implication is that the company and the FDA will come up with some way to "address" some of the concerns of the ADCOM (leaving aside the truly wacky ones) and that a potential partner will also still be willing to pay a very nice amount.

On the other hand, if we are wrong in that assumption, the FDA is not going to approve and thus there will be no partner. There will be no partners willing to step in at half price, so to speak.

I think it is all or nothing. Well, maybe not all as the ADCOM had to take a piece of the economics away from IPCI. But if the drug is good, it will find its way to the market. Considering the delay the Purdue lawsuit would likely have caused anyway, the timing of when it gets to the market may not be much different from what it would have been anyway.