Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Boom. Appreciate your presence here!
I would. Lol
You think?
Must’ve missed SequestOx and the multiple large generics, both approved and pending approval, in multi-billion dollar markets.
I didn’t record it happening. But that doesn’t mean it didn’t happen. lol.
Why would I or anyone else randomly make that up??
Wrong, the homepage has been seen to go down or otherwise act oddly on occasion before PRs are announced and posted to the site.
I believe you’re referring to the process of getting Isradipine “on label” for Parkinson’s. MD’s can prescribe it to their PD patients off-label if they so choose while the drug makes its way through the normal approval process (assuming positive results from this study).
https://www.fda.gov/forpatients/other/offlabel/default.htm
Probably this. I guess it is a ton of data to compile and analyze. 3 years long?
Gracias ama.
Do we know the expiration date of the current agreement?
Wouldn’t be undeserved. Problem is that we’re on a timetable with the FDA waiver/extension of the filing fee.
Lol. I’m not worried about it. Won’t be a big deal at all to continue funding Sox development when they’re making 50M/yr, 100M/yr, and more from the generic side of the house.
The blow up with Opana causing infections and such was only less than 2 years ago. I’m with Nasrat.. not even sure how you test that - have a bunch of patients come in willing to shoot up your drug intravenously? Gotta be a highly monitored situation there.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm
I thought HAL trials were having patients come in and crush/snort Sox. I know they also did laboratory testing with chemical solvents and such but that might’ve been before HAL. Injecting it IV is pretty hardcore, which is probably why Nasrat was surprised by that requirement and how to even go about it (again, I think the Opana debacle screwed us here).
You think? I’d be interested to see what we’d fetch in a buyout that early on in Elite’s turnaround.
We did from Epic on Sox, right?
Would be great press to be mentioned as partnering with a household name big Pharma company, IMO.
Bigger partner than Glenmark, which does over a billion a year in sales.
Wonder which launch we see first. The two pain meds have been approved the longest but are controlled substances. Looks like Adderall IR is as well.
Should be looking at another SunGen approval this quarter as well unless the shutdown delayed the timeline.
Thanks.
Surely we get 1 or more launches by then. I’m pretty forgiving but even I’m wondering about the launch delays since approvals. Let’s get it rolling.
Remind me when next earnings call is?
Last I saw, Norco was the most prescribed opioid pain medication of them all. Could’ve changed in the last year or two with the addiction landscape though.
New around here? Welcome!
Memorable “calls” for Elite Pharma:
-Elite will go bankrupt
-Elite will never get ANDA approvals
-Elite will never launch ANDAs
-Elite won’t pass P3 trial
-Elite won’t pass HAL trials
Show the proof that this has been the regulatory requirement all along then.
The IV abuse study the FDA is now requiring is based on the recent and colossal failure of Opana, IMO. No fault of Elite’s.
Good thing we have billion+ market generics (plural) coming with ~5-7 competitors then!
Really? I thought he had launched that one awhile back.
How is a 1.8 BILLION dollar drug a puny generic??????????????? With only like 5-7 competitors too?????
Website updated, Adderall moved from pipeline to products section.
https://www.elitepharma.com/products/
Correct.
I looked around a little... saw 1.3 and 1.4 billion in some headlines.
Mylan launched their Concerta generic in late December, 2016. They reported $1.56 billion in IMS sales as of October 2016.
The market size is growing.
http://newsroom.mylan.com/2016-12-29-Mylan-Launches-Generic-Concerta-Tablets
Interesting, thanks!
How much does a PR cost?
Haha sure. That explains the excellent patient retention rate..... oh wait, it actually doesn’t. LOL.
Thanks for your data. My 8 interns have also arrived at the same conclusion. They will be publishing the top line results soon.
Nvm, about 3 months to the day.
Whew! Mad money on that one. Hopefully they have it launched ASAP.
How long did it take us to go from Methadone approval to launch?
The previous set of generics were indeed breadcrumbs when discussing their market potentials. I don’t think anyone seriously disputes this. A generic with brand/generic market with total sales of 40M and less is not a huge deal. However, a drug with a 400M, 700M, 1.6B market? Yeah, that’s big. Elite has multiple approvals like these now. Comparing the “old” generics to the majority of the approvals and filings of the recent 2 years or so is apples and oranges.
For SequestOx, there have been missteps on Elite’s part as well as goalpost-moving guidance from the FDA.
Isradipine is an extra, gravy, icing on the cake. Maybe it turns into a surprise double/triple, maybe not. What is most certainly happening is the approval and launch of generics with massive markets.
A company/stock “valued to have potential” and actually having potential are not always the same thing. You will see Elite demonstrate this in a positive way going forward.