Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

This assumes facts not in evidence.

IPCI was anticipating Priority Review of 6-months. IPCI is probably disappointed with the 10-month review time. I am disappointed. Most of the abuse-deterrent drugs got Priority Review. I guess IPCI did not convince FDA why Rexista should get Priority Review in their filing. FDA does not have to give a reason why Priority Review was not granted.

Where has any representative of the company ever said they expect Priority Review for Rexista? In fact, where has any representative of the company even said they ASKED for Priority Review for Rexista?


Dr. Odidi understands that OxyContin has FDA marketing exclusivity until August 2018, and that Rexista will never get Full Approval prior to expiration of marketing exclusivity. He knew there would be no Priority Review for this reason. Dr. Odidi HOPES that Purdue will sue, since a successful Paragraph IV patent challenge in court is the only legal bypass to OxyContin's FDA marketing exclusivity.


By the way, companies do not release good news at 5pm, and for proponents of a "No RLD" application, please know that the FDA decides what the RLD will be for an IND and not the sponsor.