[b]I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.[/b]
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.
Maybe because this stock is listed on the OTCbb? It is not under NYSE or NASDAQ?
I agree with your post mrwrn. Bingo.
At first, when Elite filed this ANDA I thought only $40 million for the market? What is NH doing? There is a method as to why he filed specifically for this drug. He knows exactly what he's doing.
Total estimated revenue (conservative estimate) for Elite/SunGen pipeline..... from June/2017 CC
$6.5 billion
SunGen's platform can be used for any generic drug.
I will sell all of my Elite shares when NH decides that he is satisfied with his tapestry and sells his shares of...….. ELITE PHARMACEUTICALS.
Teva, Mylan, and Epic have no OxyContin ANDAs pending to my knowledge.
Only Elite has an OxyContin ANDA submitted. They will be the first and ONLY generic OxyContin.
It was oxycodone. And it was the last one granted approval without an ARF/ADF designation.
My bet is that Elite will be the first TRUE ADF opioid approval by the FDA.
OxyContin is just an ARF (Abuse resistant formulation). Big difference between ARF and ADF. As we all know OxyContin can be compromised rather easily.
Resistant means it can be compromised. Deterrent means it is much more difficult to almost impossible to abuse. Water resistant (does not mean water proof).
My take on it.
Thank you YJ4LIFE.
Yes I did say that Epic had nothing to do with Elite's submission of the OxyContin ANDA, but I see where you make your case. Epic along with other
pharmaceuticals won their case...… Purdue lost the appeal, but this was old news.
So we are good?
Epic was old news. Years old.
And? What of it? That was years ago before the FDA stated that they WANTED other pharmaceuticals to make this formulation.
Do you think NH submitted this ANDA without knowing what you are posting me? He knew the history... but submitted anyway.
Now my questions to you...….. WHY DO YOU THINK HE SUBMITTED THIS ANDA?
WHY DID HE SPEND MONEY ON THE ANDA IF HE THOUGHT THERE WAS NO CHANCE? THINK MAN! THINK!!!!
WHY DID HE SPEND MONEY ON BE TESTING IF HE THOUGHT THERE WAS NO CHANCE? THE FDA MORE OR LESS SAID THEY WANT COMPETITION FOR PURDUE'S FORMULATION!
GENERIC COMPETITION!
NH knows exactly what he is doing. People bashed him for the Mikah portfolio of generics he brought Elite. He was paid $10 million for that portfolio, right? PD results come in positive for isradipine….. guess what?
More $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ and that is just one drug, I trust what he is doing. There is a method to his madness.
If Elite's ANDA gets approval from the FDA there is likely to be another day in court.
With lawsuits mounting for Purdue and the FACT that Purdue is making a go of it in other countries under another pharmaceutical company the likelihood of them surviving in the US is dismal at best. Purdue sees the handwriting on the wall Ama. Just a matter of time before the lawsuits catch up to Purdue and they go BK.
Don't care what Epic had or has. This about Elite's ANDA not Epic's.
Ama follow the ball..... Epic now manufactures oxycodone which ELite gets a percentage of the revenue since it was Elite who helped Epic with their oxycodone.
OxyContin is Elites ANDA for which Elite did BE testing against the comparator and results were excellent. This will be Elite's version or generic for the parent drug. Purdue's baby.
FDA wants other pharmaceuticals to manufacture generic OxyContin.
Purdue has a monopoly. To my knowledge Elite is the first and may be the only pharmaceutical to submit their generic ANDA for OxyContin.
They will surely be the first to have a generic should the FDA approve the ANDA.
Agree here. OxyContin will be a lengthy & legal battle
Elite's generic OxyContin.
Gman, I also believe this is a win win for Elite. should the FDA decide an ADF version of APAPs is needed Elite has the answer. No other pharmaceutical has what Elite has, an effective ADF version. DrugDoctor should know what he is talking about and I trust his judgement on this totally.
Elite's ADF version will give healthcare professionals much more flexibility in prescribing opioids for pain management without the worry of abuse. Elite's ADF will be like rat poison to addicts. They will steer clear of it and possibly have to move to heroin to get their fix. Heroin is the government's problem.
but should have learned plenty from the Perc filing as to how to respond
Elite already getting a percentage of the oxycodone revenue from Epic.
There is something forgotten in all of the responses. All APAPs are being abused, the reason healthcare professionals were told to cut back on prescribing them. The FDA has said acetaminophen is enough of a deterrent to prevent abuse which is totally false. Aceto does not do didley to stop abuse of Percocet, or Norco for that matter.
Enter Elite, which has already submitted their ADF version of Percocet to the FDA. Studies passed with flying colors. Elite's version there would be much less to worry about with regard to abuse. Cannot crush it to snort it, liquify it, smoke it and so on..... Healthcare professionals could feel much better about prescribing without the possible consequences of abuse of their prescriptions
The FDA has a choice here. It isn't like they have no other option.
Now the fact that the FDA came out and said that APAPs already had an abuse deterrent built in tells me that they either didn't bother to do their due diligence with healthcare professionals or that they were told to look the other way. Big Pharma has that type of influence no doubt about it. Something to ponder.
Cutting prescriptions for those that have a true pain management need is the band aide approach to dealing with the problem at hand. Denying those who need opioids for a better quality of life is taking a short cut at the expense of their quality of life.
Granted there is a point to be made with Conix post and companies like Purdue have taken advantage by putting money over people. Doctors that over prescribe just to push product.
Still, with all that, Elite is going to be okay. Late to the party? Maybe in one sense they are, but the fact that there are still legitimate patients out there that need pain relief for chronic pain cannot be refuted. It was never intended that Elite would make a killing off of Percocet or Norco. They still stand to make enough though.
Ramp up will not be overnight. It will take a few Qs to see the difference. Certainly won't be next Q, it's already in the books.
From chasing in regard to my thinking Norco would be soon. Since only the opioid API is different my thinking was that the FDA would cut some slack here..... but it's the FDA.
"probably not Norco since it hasn't been very long since we responded to the crl. Here's what Nasrat said during most recent CC. Of course, the Percocet generic occurred first, but we responded to the FDA regarding Percocet long before Norco."
Dec/Jan is a long time out Jour. Would have been nice to get Percocet then Norco, but given Elite has not addressed Norco yet.... I'd say it is at least that far out wouldn't you?
OxyContin would take care of the Norco revenue issue con mucho gusto..
Percocet just made them closer to CFP. Maybe it puts them over depending on how much market share they capture, but that will take quarters IMO.
Friend told me tonight that Percocet is not being given as it once was.
Can anyone else confirm this?
Elite still makes out though.
I was wrong with Norco, it will not be next or anytime soon IMO. Most here think the undisclosed ANDA that will couple to Glenmark.
I do think OxyContin ANDA approval will be this year after the undisclosed
ANDA.
Norco may be out of the mix for a while...maybe more. Too many other lucrative irons in the fire.
what happens when Elite gets approval of generic OxyContin?
KKKAAAAABBBBBOOOOOM! Upside Elite's stock price!
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
It's coming! OxyContin ANDA approval.
Not the only lawsuit against Purdue. But but but wasn't Purdue supposed to have THE abuse deterrent solution in OxyContin according to one who claims to have an upper degree who touted the merits of Purdue constantly? Say it ain't so Virginia~!
Looks like their pill mill days are almost over. AND when Elite gets their GENERIC version approved by the FDA market share will go to whom?
Purdue is so strapped with lawsuits right now I doubt they can really afford to go after other pharmaceutical companies even if they were able to try to defend this abused opioid in a court of law.
From the New Yorker article...…….
"Purdue executives won’t be able to settle every case against them, Moore believes. “There’s going to be a jury somewhere, someplace, that’s going to hit them with the largest judgment in the nation’s history,” he said. Paul Hanly noted that, in the face of a crippling judgment, Purdue may have to declare bankruptcy. “But I’m certainly not going to walk away if they do,” he said. “At that point, I would start looking closely at individual liability on the part of the Sacklers.”
I'm not Perry Mason though, Matlock, or Michael Cohen either so I could be wrong about Purdue having legal problems with OxyContin.... but busy bees at Purdue corporate law. Busy bees.
Only 1 drug manufacturer allowed per drug in China, JJ.
I expect approval on that OxyContin at any time too. More gold and emeralds
plus a diamond or two.
NASDAQ, just wondering when OxyContin Elite style will get approval.
Could be a few ANDAs approved and some of which are potentially huge money makers.
In the reality of it PR releases and times of release have little to do with stock price movement. In the overall scope of things it is not going to matter that Elite released the PR when they released it. To optimize instant gratification by time of PR release is silly.
Then again...…...
And how much is the Chinese market? Elite has a friend in China, and a big pharmaceutical friend at that in China, HumanWell.
Cobalt labs... never heard of them. No ticker. But let me guess.... second coming of Pfizer. Right?
Why does Elite even bother submitting this junk for approval?
Speaking about Europe why not shift to China. Since Epic (PuraCap) is the distributor for isradipine could Elite not get inquiries from HumanWell about use of this drug in China for PD? If this drug is already being marketed in China as a blood pressure med then FDA approval of clinical trials may be enough for Chinese acceptance of the FDA findings for PD. Elite may benefit from such a move. No?
Appropriate as elite is unlikely to get any benefit of isradipine for PD
I like that type of spending from Elite. Zero dollars. Call it luck of the draw or whatever. Elite may have a winner here in the near future without having spent a dime.
Nice to have a known face like Michael J Fox pushing for PD.
Thanks sharpie. A very happy fourth to you as well.
Keep those chart interpretations coming once this gets rolling. Elite not rolling yet, but volume shows renewed interest now that they got their first ANDA approved.
Any number of things can happen, including the undisclosed ANDA. Another, isradipine, could be as WeeZuhl posted, a dark horse. Since only Teva and Elite manufacture this generic it could bode very well for Elite.
With over 1 million in the US alone that have Parkinson's and only two current pharmas producing it, this could turn out to be a very nice money maker for Elite.
Thanks for that information Gman.
An excerpt from a June 29, 2016 Foxfeed article about isradipine.
"Isradipine is a calcium channel blocker currently prescribed to treat high blood pressure. It came to the attention of Parkinson’s researchers when data from large studies showed lower risk of Parkinson’s disease (PD) among people who took the drug for hypertension. Scientists believe isradipine works to prevent the death of dopamine-producing cells and therefore may slow the progression of PD. The Michael J. Fox Foundation (MJFF) funded pre-clinical work to make that connection, as well as the Phase II trial. In 2014, isradipine researchers received a $23 million grant from the National Institutes of Health to move the Safety, Tolerability and Efficacy Assessment of Dynacirc® for PD (STEADY-PD) study into Phase III efficacy testing. Dynacirc® is the commercial name of the isradipine hypertension drug."
Yep, you're right Chasing...… forgot completely about the Norco issue and got ahead of myself. Thanks for reminding me.
I stand corrected. Could the undisclosed ANDA be next? Methadone?
For now at least Percocet is a start. They may even decide to shelve Norco for good depending on what the future brings.
The ramp up for Percocet revenues will more than likely be slow.... but surprise me anyway and make me wrong.