Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

This is helpful information from CC.


http://seekingalpha.com/article/4045461-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q3-2017-results-earnings-call-transcript?part=single

And this is more from a stockholders given me advice on using roxycodone like Pfizer did, so we can overcome Pfizer's three year exclusivity that doesn’t happen, this is unrealistic, exclusivity will be given for company that makes a specific dosage for them and a specific type. So if you made the capsules, somebody else can make a tablet and it will be 505(b) 2 and you will get your own exclusivity. But Pfizer is making a capsule of roxycodone with Naltrexone, we cannot make another capsule and say let's waive their exclusivity because we used roxycodone as a reference's to drug, it doesn't work that way.

The gist of this is that NH does not believe using the 2nd bead for naltrexone sequestration will bypass the marketing exclusivity for Troxyca, which sequesters the naltrexone in the core. He is saying that FDA will not approve any 12 hour oxycodone/naltrexone combinations in capsule form until the Troxyca exclusivity expires in August 2019. This exclusivity can be extended by various measures, so it could be multiple years longer. This is a debatable interpretation of exclusivity, but he does not say who or what has informed his opinion. Besides the FDA's opinion, Nasrat's is the only one that matters, so it looks like there will be no ELI-201 NDA or ANDA approval until at least August 2019.