Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

O SequestOx, Where Art Thou?


Let’s first recognize the fact that Nasrat doesn’t need the FDA to tell him how to run a pivotal BE study. He’s done at least half a dozen since he’s been here, and he hasn’t gotten prior instructions from FDA on any of them. He can go ahead and do the study as he normally would, and worst case would be adding a few more subjects at the end if they want a bigger study. I don’t think this is true, but it is possible that the pivotal BE is already started and either ongoing now or already finished. It doesn’t sound that way to me when Nasrat discusses it, but he is awfully good at being coy when he wants to be. He usually only PR’s a pivotal topline result, not when the study begins. When he hears from FDA and he knows he has sufficient number of subjects, then he can drop the PR that pivotal BE is complete and resubmit the application (assuming nothing else is required). Again, I doubt this scenario, but I do think if the pivotal BE is not yet substantially complete, then there is a reason, and that reason definitely is not because we’re still waiting to hear back from FDA.


My best guess is that Nasrat is pumping the brakes on SequestOx. Quietly slowing it down but not publicly saying so. Essentially he is pushing back the need for the $1+ million expenditure until revenue and/or share price increases. “Just taking a little breather” is what I think, and the FDA makes for an easy target to blame for the delay. I also consider the possibility it is a hard brake on SequestOx. It could be an indication of the transition away from naltrexone ADF’s and towards the new, less expensive, patent-pending ADF tech. He already shelved the naltrexone versions of Percocet and Norco, and ELI-216 is seemingly permanently blocked by Troxyca’s failure to launch. One must ask: is this the end of the 2 bead antagonist ADF? I doubt it, but it might be. Another point to consider: of the ten drugs FDA-approved with an ADF label, five have never hit the market: Troxyca, Ventrela, Morphabond, Roxybond, and Targiniq. There is a problem in the ADF opioid market, especially for extended-release opioids not called OxyContin. As we see Elite filing ANDA’s for non-ADF opioids, CNS stimulants, antibiotics, beta blockers, etc., it is clear that ADF’s will be a less significant part of Elite’s future than previously thought.


So after all that, I admit I don’t know what the hell is going on with SequestOx, but I do know for sure there is more to it than just waiting for the FDA to tell us how to run a pivotal BE study.