Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

The original evaluation was based upon the company being a major player in ADFs with SequestOx.

Although we don't know about the future prospects of SequestOx, we do know the company has all the components in place to become a major player in ADFs with generic OxyContin. Since the SequestOx fatty food failure in 2016, the progress on any opioid project has been painfully slow, but we are fortunate to know about some important advancements:

1. Oxycodone fatty food Tmax delay fixed
2. Hard-shell ADF (similar to OxyContin's) was developed and successfully tested for bioequivalence
3. Successful development of a time-release formulation (Adderall ER)
4. Money available to complete necessary abuse-deterrence testing

Everything is there. The approval process will be long and complicated, and there are multiple difficult steps where a stumble-prone company can muck it all up. And maybe a boring oxycodone ER ANDA might not be as sexy to the market as the SequestOx NDA once was, but I believe it will be just as impactful from a revenue standpoint, probably more. OxyContin is a drug that is over-ripe for multiple generic approvals, and it would be a big deal to be in the first handful of competitors. A product on the shelves is definitely a few years away, depending on trials getting done in a timely fashion, and by then, I would like for Elite to be able to market it without a distribution partner. If that is a real possibility, then now is the time to get started.

Good riddance Lannett. Now is the best time to rip off the band-aid and take the ouchie. They never did squat with ER, and one wonders how hard they really tried. Whether it's on our own or with a distributor, we can do better. Neither product will be starting over from scratch because Nasrat knows everything Lannett knows about the market pricing and the players involved. At least initially, Elite is in a much better spot than Lannett. We've got the FDA quota and we've got two proven products- they have neither. An effective team from Elite could easily grab that market share before Lannett can pull their head from their ass. Make sure all the current customers understand they'll get the same reliable product with a new label and NDC# and a new, better price. Given Lannett's recent performance, it is not a stretch to imagine keeping most of the current IR customers while building up the ER product more quickly than Lannett ever could. Then in a few years, with a little luck, when we get approval for generic OxyContin, our seasoned team will be ready to market it for 100% benefit of Elite and no one else.

Whatever the decision, I think it's most important to remember that the amphetamine quota from the FDA belongs to Elite, and Adderall is in shortage in multiple areas. We should be able to sell as much amphetamine as the FDA allows us to make, and sometimes it seemed as if Lannett hindered us more than helped us.


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