Replies to post #278946 on Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Is this an accurate statement?
Quote:
Elite has ready-to-go antagonist ADF versions of Norco and Percocet

Is the sky blue? Does the Pope shit in the woods? Of course it is an accurate statement. The ELTP ANDA's for generic Percocet and Norco are nothing more than the agonist beads for their ADF versions, with the naltrexone beads removed. Generic Percocet is ELI-202 minus the naltrexone beads. I'm not sure which ELI number the Norco was designated. The FDA made it clear that no ADF label for snorting or IV abuse would be forthcoming because they consider the acetaminophen that is already in there as a deterrent. When that became obvious, Nasrat salvaged the projects by submitting ANDA's for non-ADF capsules (if you can't beat them, join them). Now, it turned out to be a very smart move. First, an ANDA costs a third of an NDA. Second, he probably didn't have to do any fed BE studies for the ANDA's, so no pesky tmax issues. Third, the FDA has just issued their Guidelines on how to convert generic opioids to ADF's, so once the ANDA's are approved, and when the FDA is ready to admit that every kid in America has been snorting Norco and Percocet for the last thirty years, then ELTP can run the necessary HAL studies with the naltrexone beads included. They'll have the only true ADF versions of Norco and Percocet with no new NDA required. In the meantime, they get a share of the generic market. Smart strategy.




https://seekingalpha.com/article/3885716-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q3-2016-results-earnings-call-transcript?part=single

Elite Pharmaceuticals, Inc. (OTCQB:ELTP) Q3 2016 Earnings Conference Call February 10, 2016 11:30 AM ET

Nasrat Hakim:

The second product that we were pursuing and we updated you on before is ELI-202. What we are doing with the ELI-202 is utilizing our Naltrexone sequester technology with an Oxy APAP combination. We moved to the clinical trials and the FDA notified us, Dr. Hertz pleaded that it is highly unlikely that we will give anybody the labelling for a product that has APAP and it is because they consider APAP to be the abuse deterrrent. As a matter of fact, the FDA guidelines that came out in 2015 did indicate that, that Oxy APAP and hydro APAP are products that are not used abuse nasally and via injection, that’s not the desired route. People take them orally, why, because the APAP is an irritant, it irritates your nose, so as I just noted. Therefore adding Naltrexone which is an expensive substance and it costs another $15 million, clinical trial does not give us any edge over just using APAP. We do intend to be competitive in this category but we also intend to be intelligent and not with our money on something that’s not going to get us a preferrable – preferred labeling.

Comprehensive Health Assessment for Teens (CHAT) is a computerized behavioral health assessment targeted to adolescents aged 18 years and younger: