[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.
FOX news? Fake news.... More like McKesson....
The "old tech" did not "fail". Now reformulated and conforms to comparator.
Let the FDA shoot this one down. Will not look good for the FDA to approve comparator and Elite is not good enough. Let them.....
Look for 2 cent bottom.
Sequest is history..
Agree with part of your post.
Grow the company with a combination of NDA’s and lucrative ANDA’s. File, file, file. Wait, wait, wait. Launch, launch, launch. Grow, grow, grow. Repeat, repeat, repeat. There is no way to speed up the process.
My take on the study.... NIH would not have continued this study to endpoint if they thought isradipine was a fluke. Apparently the NIH thinks there is value from a patient perspective, otherwise they would have pitched this study already.
I take this as a positive..... going to endpoint.
NASDAQ, I would think so too. Positive data submitted to the FDA from the pilot study would suggest that the FDA would want to review sooner than later.
Elite should hear from them soon. A meeting set up and particulars gone over with a fine tooth comb. NH is anxious to get started already.
That's my take on this. FDA is too damn slow. Time to join the 21st century FDA.
Makai63 good to see you posting. I imagine ADF prescription opioids are needed in Hawaii, eh?
What is it like throughout the islands?
Mahalo nui loa
Disagree with this premise that Elite is doing a BE without FDA guidance. Fool hardy at best to go it this way. Anyone in pharmaceuticals knows this.
Must wait for the FDA guidance.
And there is a reason for doing this. As Ama pointed out Elite has been through this 2 times already. Once when they were told by the FDA (when Tmax was brought to the FDAs attention by NH) that this was a mere labeling issue.
Okay, so Elite tried to reformulate and thought they had come up with a better formulation, did a full blown BE, but when results came in it was not much better than the original version. Data useless to submit.
Been there done that, already tried your way.
So now Elite has run a pilot study and it shows SequestOx latest reformulation very comparable to the comparator. They submit this data to the FDA and await a response from the FDA. NH said he wants the FDA to give specifics on how to proceed forward before committing the company's money to another full scale BE. This was during the June CC.
A short time has passed since that CC and NH says Elite has still not heard back from the FDA. Do I believe him? Yes. Why do I believe him? The FDA is god awful slow. This current administration isn't exactly prioritizing the opioid epidemic either. And Gottlieb? Where is he with regard to putting some teeth into this "epidemic"?
Nowhere. And if he speaks words alone do not do the deed. He's not done much except talk the talk.... if that.
So now NH is concocting and running a BE without FDA guidance in the hopes that it flies should the FDA give Elite an ear?
Doesn't work like that Doc. No way does NH jeopardize SequestOx without first getting specifics from the FDA. May as well trash SequestOx then. Not the way one does it. Period.
So? Now suddenly the sky is falling because Methadone contract is up?
Seriously?
They'll do better dealing with Glenmark than any contract ever would.
If folks look closely at what is happening many companies are going into
low revenue generic drugs simply because there is a need. Sodium Chloride injection for instance. How much money is made on this salt (drug)?
Not much but...……. there is a silver lining to this as well. It opens doors that might otherwise be closed.
BTW $110 million in total revenue is not chicken feed. Some APIs only make $25-50 million per year.
Cumulative revenue people...…...
Makai63, and some of those questions were redundant answered just minutes prior. NH is doing exactly the right thing. Give shareholders a taste but not the whole entrée. He is only allowed to say so much anyway, and must be careful in what he says. Don't think the competition is listening? Think again.....
They are.
Another ANDA to submit with topline results. All revenue no matter how large or small is cumulative. All of those smaller revenues add up.
$110 million in total is going to be good if Elite/SunGen can capture
even 3-5%.
Well for one thing, "other pharmas" like the one under constant lawsuit
pressure that will be forced out of the US eventually. (Good that they have Mundipharma to fall back on isn't it?)
If the "other pharma" were smart back in the day when Elite first posed this ADF technology to the public domain this entity would have snapped Elite's technology up.
But like most pharmas that make goo gobbs of money from what they have and refuse to think ahead, they were not that smart. Fortunate for Elite share holders like me.
There will be a price to be exacted when SequestOx gets approval.
Good for Elite.... bad for "other pharma".
Very good point NASDAQ. SequestOx will be much larger than people think IMO. There is no other IR ADF out there period. None.
There will be high demand for this formulation IMO.
Then there is also the possibility of licensing the ADF technology to other pharmas. Just the possibility. And just the possibility of that type of lucrative revenue power makes Elite even further attractive as a buyout target.
JMO
As NASDAQ has posted from time to time PuraCap aka Humanwell met with Elite
already wining and dining them. Dr. Fatima helped PuraCap acquire Epic.
Hummmmm
Then there is the recent partner Glenmark Pharmaceuticals. Hmmmmmmm
Just two of a few more no doubt on the table.
Should Elite get SequestOx to market I have no doubt the FDA/DEA will move to get non ADF opioids harder to come by. ADFs will become the norm.
Elite may even mull over licensing their ADF tech to those pharmas wanting to keep a reasonable market share in the pain med sector, which would be very lucrative for Elite. And they would not have to produce much themselves while reaping the benefit of the licensing agreements between themselves and Big pharmas…… No crime in being shrewd.
Yes, there will be lots of options for Elite. They do not have to settle for a buyout right away. They can play the field a little if they want to.
Just my opinion..... FWIW.
And the key operative word is OPTIONS.
From that I take it they already have suitors.
And the 2 cents coming is a real laugher too. LMMFAO~!
Where does ELTP stock price sit now? Hmmmmmm
$0.11s are almost done. Try two support levels at $0.11 with one at $0.10.
$0.12 not much resistance. Got the feeling more positive news is coming.
So Percocet and Methadone (coupled to Glenmark) was fluff? Okay whatever you say. LMMFAO~!
Could be Elite will get clear guidance from the FDA on SequestOx. That in and of itself would be very nice. Let the BE trial begin.
Good point toofun.
I bet he already has presented a plan....
Elite buyout at $38
Market to open at 9:30am. Is Elite's stock price supposed to react to this newest BoD member?
new board member, an unknown, with conflicting resumes -
If the Departmentbof Justice reduces the number of abused non-ADF opioids produced each year and increasing ADF opioid production .
DOJ could issue stricter limits on certain opioids (non-ADFs) if federal authorities believe they are being misused.
There are certain things I think NH wants in place before even starting to consider a buyout. One is SequestOx. The other could be the collaboration
pipeline of Elite/SunGen. A few approvals is all it will take. Meantime we wait for SequestOx. while other drugs get approvals like the Elite/SunGen basket.
Exciting times could be not that far off.
A move to Nasdaq organically.
Results likely to leak out before then.
If results of the NIH study show any kind of promise at all for PD Elite can call it a bonus round. All other PD drugs attempting to slow PD down
are not isradipine. There is a reason the NIH conducted this series of studies which cost in the millions. It may be considered amazing if it were beneficial for PD, but not totally unusual. Botox a cosmetic formulation has been proven effective for migraine headaches. Who'd a thought? So it is possible this CCB has some sort of property that can delay (slow down) the onset of PD while extending the lives of those that have PD.
In a short period of time the study results will begin to leak out.
If isradipine is found to be a dud with PD Elite still has bomb shell ANDAs waiting in the wings. There in lies the beauty of this drug. A bonus round for Elite still remains very possible.
I would say that the time to load up on more shares is now. Wish I had the cash because that is what I would be doing. Adding more to my Roth. $6500 more.
I agree.
Wish I had the means right now Drugdoctor. Have literally nothing to throw at this stock. Sometimes it just turns out like that.
Helping someone with her certification.
And yet that article says nothing about Isradapine causing Pancreatic cancer. WoW!
Am sure this D. James Surmeier, Ph.D., who is the Nathan Smith Davis Professor of Physiology at Northwestern Medicine in Chicago, IL, who led the study, and the findings which were published in the Journal of Clinical Investigation must know about "Doc's" finding. That Isradapine
causes pancreatic cancer. But but but he doesn't mention a single solitary thing about it. Wow! Just amazing! Guess all of these PD folks will be at risk.
Safe taken as directed by a real physician.
Was Vioxx used for PD too? N SAID no it was not for PD. No studies done for effect on PD.
Methadone should be a real winner for Elite. Not in the revenue sense, but it should a test for this new partnership between Elite and Glenmark.
Estimates IMO are most always low balled and conservative.
Dipping into a $1.6 billion market should do wonders for the share price
once that Elite/SunGen ANDA gets approval.
no it wont sorry
We were also told Elite would sink back below the 11s.
So much for who told is these things.
Methadone approved. Not a big revenue maker by any stretch, but it is all cumulative. This also sets the stage for Glenmark Pharmaceuticals, which in turn could set the stage for other drugs with Glenmark.
Percocet and now Methadone...…..
NEXT!
They declined this ADF because it isn't so ADF. Too many problems.
This is no head fake. You're right drugdoctor, exciting times indeed th be an Elite Pharma share holder.
IMO something is beginning to leak out. Could be earnings... or could be something else such as another approval.
Well for all of those that say it will not break $0.11 I say this:
Support now at two levels. $0.10 a support of 16 and since $0.11 was broken
it has formed a support of 14. Resistance is at $0.12 with a 4 (weak).
I think the run is ON~!