Even- My take on this is that one claim was dismissed but one was not. In particular the court agreed that it would not dismiss claims in regards to Rexista NDA content. In my opinion, that is spot on. We were misled and they acted like they submitted a complete and thorough NDA but never ran the oral and nasal HAP tests. Also in my opinion, there was a precedent with Collegium who filed an NDA for a similar abuse resistant opioid. All that info was public and Collegium ran ALL HAP TESTS prior to submitting NDA. If IPCI was only going for IV abuse resistant properties they should have specified. I really think IPCI intended to submit all HAP data but for whatever reason they did not get the studies done. They were under a lot of pressure to submit, so they did. I think they intended to run the oral and nasal studies right after submission and then get them added to the submission. But they did not. Thus, in my opinion they came up with some lam brain idea that they were now only going for IV abuse resistance. The level of mismanagement, incompetence and now shadiness of this company is now at levels that rae rarely seen.
Shanawaz v. Intellipharmaceutics International Inc. et al, No. 1:2017cv05761 - Document 35 (S.D.N.Y. 2018)
Court Description: OPINION AND ORDER: re: 29 MOTION to Dismiss Amended Complaint filed by Intellipharmaceutics International Inc., Domenic Della Penna, Isa Odidi. For the foregoing reasons, Defendants' motion to dismiss is GRANTED IN PART and DENIED IN PART. D efendants' motion to dismiss is granted with respect to Lead Plaintiffs' Section 10(b) and 20(a) claims to the extent they are based on Defendants' statements describing Rexista's abuse-deterrent features and its bioequivalence to OxyContin. Defendants' motion to dismiss is denied with respect to Lead Plaintiffs' Section 10(b) and 20(a) claims based on Defendants' statements describing the contents of the Rexista NDA as filed with the FDA. Defendants shall file answers to the remaining claims within 21 days of the date of this Order. The Clerk of Court is directed to close the motion at Docket Number 29. SO ORDERED. (Signed by Judge J. Paul Oetken on 12/17/2018) (ama)
