Replies to post #388356 on Elite Pharmaceuticals Inc (ELTP)

[Pharma Sleuth]

Dude. Deep breath. They filed in August to get the clock started. They had insufflation study or whatever else most likely ongoing. They did this because they knew the FDA would require it but got their place in line.

The $5.1b BE trial drug pending application submission is a different drug. Then there's a third one. And a bunch of other stuff.

[meshcan]

Hope all is well Weezhul! I agree this has been on Nasrat radar for a while and have filed and then went to hold due to lawsuits etc. My only surprise was the market size of Oxycontin used to be 2.3B in 2017 (I think?) when initially this was filed and now is $720M, does this make sense? Also, with all aging nation etc that we are moving into then is that sharp drop make sense too? or maybe doctors and hospitals switched their patients to other opiate in last couple days. Any thoughts?

[kayak_wench]

CCs are not reliable but stock message boards are!?....Er...ok.....wouldn't want you responsible for any important decisions in my life....

1. Elite said in the 3rd quarter 2022 CC in Feb 15 (months ago!!!) that they were working on a generic opioid extended release that involved an insufflation study.
2. In 4th quarter CC (Jun 30) we learn that the company submitted a partial ANDA for pain management for review by FDA and tells us that submission is generic Oxy. The partial application contains the recently conducted insufflation study. Elite tell us that they intends to provide the FDA with the remaining data in the 3rd quarter of the calendar year 2023 to complete the filing. They explain they submitted the partial application to quote "get the PDUFA date going". Nasrat also tells us that he learned that three other companies that are doing the same insufflation study for Oxy and they did not want to alert those companies that we were close to filing, so they decided not to PR either the positive study results or the submission of the partial filing. So both those events were behind us as of the Jun 30th CC. In that CC Nasrat said he expected the full application should be filed by August 1st and hopefully the FDA would accept it 40 to 65 days later and that Elite would release a PR when the application was submitted.
3. Aug 1comes and goes with no news
4. Q1 2024 CC on August 15 we learn that the FDA asked for more information after getting the insufflation study and that Elite expected to get that information to the FDA by the end of the week. Nasrat also explains this pain product requiring the insufflation study is one of the 3 big revenue products that Elite is pursing in the near-term (we all know its the Oxy generic because in the previous CC he said that is what the insufflation study is for)
5. Today we get a PR that Elite "filed an Abbreviated New Drug Application (ANDA) on August 17, 2023," (that would have been the end of the week of the Q1 2023 CC just as Nasrat said would happen) and that the FDA has " accepted that submission review by the US Food and Drug Administration (FDA) on September 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics".

So todays' PR is a completion of a story started back in Feb, so yes we have been hearing about this products progress for at least 7 months.

[The ELTP King]

Holy sh*t you're phuckin' DUMB.

I'm not even going to address ANY of this.

Just pathetic that you don't even have the SLIGHTEST clue what's going on with Elite. (No wonder you said you sold recently)

First, no of course not, I have a day job. I've said this before. I do not find calls to be a reliable source of information. I read them eventually. I've also been clear that Elite's secrecy is usually more for the benefit of Nasrat Hakim individually than the company generally. When I see odd verbiage like today's PR then it causes me to think. That's called intellectual curiosity. Do you have that anymore? In 2017 they set a world record for number of mentions of OxyContin in one paragraph, and now they don't even refer to it as "extended release"? What about the increase in annual sales? Last we heard OxyContin is in the 5's, and suddenly today it's $720M? Sure, maybe, lots happening, but that's a decent jump for a drug that has been in a sharp decline for multiple years. It also happens to be pretty damn close to annual sales of Norco equivalents.

Second, what does today's PR have to do with a Spring PDUFA date or what they have been telling us for months? It's about an application in August that was accepted in September. What are you even talking about?