Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Things I assume, things I know.


I know there were no Phase 1 / Phase 2 study deficiencies. These would have been identified and addressed before Phase 3. I assume that in the three Phase 3 studies, NH did everything he was asked to do. I know the FDA deemed the application complete and appropriate for Priority Review.

In retrospect, I have to assume the lack of an AdComm means SequestOx was going to get a CRL from the start. I assume if it was a close call, there would have been an AdComm. Best case scenario, there is a technical violation in a Phase 3 study. Improper methodology of some sort caused the FDA to invalidate the results of one of the three studies. Simple study redesign and do over, resubmit NDA. I doubt that.

I know that KemPharm KP201/APAP AdComm gave thumbs up for approval but thumbs down for ADF label, and they got a CRL. I assume this is what happened to SequestOx today. I assume the FDA’s letter probably says something about our HAL studies being insufficient to support the ADF label. I assume there will be no more FDA approvals of NDA’s that do not get the ADF label. No more Oxaydo’s. If you do not qualify for ADF label, you get a CRL.

Why wouldn’t HAL deficiencies be identified prior to submission? I assume things changed. FDA Leadership changed, with prescription opioid abuse the hottest issue of the Senate hearing. The biggest change, though, was the Pfizer ALO-02 AdComm. I was shocked by their HAL results. First, I don’t think we’ve done anything near the kind of extraction studies that were done for ALO-02, some of which identified issues with crushed pellets that could be relevant to ELTP technology.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123214162

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123133533

Also, the oral abuse data was poor for ALO-02, which was surprising for an antagonist ADF. I do not believe any oral abuse studies were even done for SequestOx, because it is immediate release. IV abuse HAL studies are usually simulated and not human studies, but I’m not sure if they were done, either. We’ve only ever seen nasal abuse data and been told that it passed extraction studies, without any specific information about what kind of extraction studies were done. Yes, it passed all the tests, but it only took the remedial tests.

My best bet is that our problem with SequestOx is insufficient HAL studies. The good news, if this is true, is that SequestOx did not fail these studies. They have not yet been done. Pass the additional HAL studies, get approval with ADF label. I don’t know how long that would take, but it would be months not years.

I want to make additional comments about today’s PR. First, the company had the CRL yesterday, and waiting until close the next day (Friday) to release it is chicken-shit antics. That PR should have come out Thursday night. For the unnecessary extra 24 hours of anxiety, screw you Nasrat. Second, it’s obnoxiously god-awful bad. It contains a whole rambling paragraph incorrectly describing what a CRL is and then gives no details about the specific CRL they received. It does not need to spell out every detail, but those of us who hold our shares next week will pay for the lack of specificity. I can take my lumps and handle bad news, but when it comes in a disrespectfully-tardy PR that could have been better written by an 8th grader, then it does not help me to maintain my confidence in the professionalism of the organization.

The FDA issues CRLs to indicate that the Agency considers the review cycle for an application is complete and whether the application is ready for approval in its present form. CRLs often include guidance that describes deficiencies that the FDA has identified in the application. When possible, the FDA recommends actions that the applicant may take to place the application in condition for approval. The CRL determined that the NDA was not ready for approval in its present form.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084143.htm

Complete response letters will only be issued for applications that are not approved.

If there is a way that Nasrat and Dianne could have handled this any worse, I cannot imagine how.