Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

If it means SOx is dead, and to be replaced

I don't think it means that. I believe Nasrat when he says SequestOx is a priority. I think the new physio-chemical ADF will target a different segment of the market than the antagonist ADF. Nasrat has mentioned it in several calls now- naltrexone ain't cheap. SequestOx will be at a cost disadvantage with any physio-chem ADF that has no naltrexone. (Is this maybe the holdup with Pfizer's Troxyca?) But you get good bang for the buck. We know what the snorting data looks like, and it is hotter than a $130,000 porn star. I haven't ever seen the SequestOx chewing HAL studies, but I believe when they are revealed, they will be good enough to qualify SequestOx for the chewing label. I do not have similar confidence that this new formula Nasrat is working up will get the chewing label, and I doubt any physio-chem ADF will get a chewing label (Roxybond did not). SequestOx could stand alone among all other oxyIR's as the only one with IV, snorting, AND chewing ADF labels. As a result, it may be preferred on some insurance formularies and therefore command a higher price. Sadly, these days most brand preference decisions are based more on cost containment than rational science. Either way, we have it covered. If cost is the driving issue, and the decision maker is okay with less aggressive ADF features, then we have this other option which is less expensive but still touts a few ADF labels.



To illustrate my point, take a look at this old post from April. Look at the snorting study for Roxybond, which was overwhelmingly recommended to get the snorting label at AdComm. Compare dark blue line (crushed Roxybond) to the red line (crushed oxy). The ADF cuts out about half the fun. Okay, guess I gotta snort two. Now look at the SequestOx (dark blue line) snorting study. Never goes above placebo. Even starts out in the negative, which is awesome. SequestOx was liked less than a son-in-law without security clearance. That's where you're spending your money with our premium model, friend, we call it the naltrexone effect. Zero plus zero is still zero, sucka. You get what you pay for.



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they would also lose the deal with Epic, and with it, the milestone that was said to be necessary else may put us back as a "going concern."

I assume that deal with PuraCap (nee Epic) is already dead. I doubt the two parties even know for sure at this point. Wouldn't be surprised either way, might be bad might be good. No biggie either way, and sure as hell not a "going concern" issue. Co breaks even without R&D, has access to $40 million through LPC, has multiple pending ANDA's. All NJ bonds remain current (which was not the case when co carried going concern language). The $7.5 million from Epic would be a pleasant surprise, but not make or break by a long shot.

Another Priority Review? I'd agree, possible but uncertain-

So far every ADF opioid NDA has been Priority Review.

Just seeing the path forward is now a lot more murky than a simple coating fix for the T-max issue.

The tmax issue appears fixed, pending verification with a pivotal study. Nasrat wants the FDA on the record about what is needed from here. He was previously told since the naltrexone bead was unchanged, the HAL studies will stand and the Phase 3 safety study would not need to be repeated. He wants that part on the record now, and he wants to know the number of participants they expect for the pivotal BE. As long as those things are still true, and as long as he really does meet with FDA soon, there is no reason why the re-application can't happen this year before the deadline and with Priority Review in 6 months. To me, Maz, it all seems a lot less murky since we heard about the pilot study success.