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They did rise up from and overcome the apocalyptic devastation created by the Perc crl and got it approved. He predicted we would get an approval soon in the 3rd quarter and booooom got it on the first business day. Yeah, they know what theyve doing, contrary to all the shorts.
What about the CEO & CFO, do they know what theyve doing?
I agree. Perc will clearly give us additional revenue regardless of having a lot of competition. It is not hard to break into generic channels, and our company has plenty of experience. Furthermore, the approval overcomes some of the stigma with Elite and should increase confidence in getting more approvals.
Don't know how soon, but I fully expect us to be moving into the upper teens soon. Percocet anda has the strong potential to double our current revenue, which would theoretically double our market cap/pps. There should be some increased confidence going into the next conference call.
predict that we move up to a new level this coming week.
Our response to FDA for Perc was late October/early November bc it had already taken place at time of November 10th Conference Call:
We just filed our response to FDA’s complete response letter for OXY APAP
response to FDA took place sometime between Q3 (Oct-Dec)
I think we all pretty much agree the OxContin generic is going to get an automatic 30 month stay. We might can get that stay shortened or worked out prematurely, but I wouldn't expect that generic to be making money for a while.
OxyContin would take care of the Norco revenue issue con mucho gusto.
They certainly didn't say SequestOx doesn't work. Please support the claim with some evidence.
If it doesn't work, how could it pose a danger? Furthermore, you are referring to an outdated formulation.
We resolved that issue and our patent attorney, Dr. Smith determined that this is something patentable and we will be filing a patent sometime next week.
used as a story to suckers buying into the stock
I agree. That's a double negative which makes it a super positive.
Ludicrous nonsense
true, that is a link. It does not appear to contain the quote you offered or any reference to puny. Keep digging.
That's funny. There's no mention of Oxy Apap there. Also, there's no proof he actually said that. You got a link? Just like no link that he said anything remotely close to "puny".
Prove it. Don't just claim it.
"prove it"
The source predicted we would get an approval soon in this quarter, and THE SOURCE NAILED IT. BOOOOOOOOM. Great credibility.
but consider the source, nasrat , really
No. It's completely different. Both were part of the latest pilot study.
Is the "Unique Novel new ADF platform” what Sequest-ox new formulation is using?
We recently filed a patent for platform technology for ADF product that is not pharmacologically based.
. We resolve that issue and our patent attorney, Dr. Smith determined that this is something patentable and we will be filing a patent sometime next week.
True, it could be more than 2. It could be 5 or 10 or 100.
we look forward to additional product approvals in 2018
Yet that doesn't change the fact that the pr clearly says 2 more approvals this year. Period. Exclamation point. Question Mark. Hyphen. Comma.
Everyone agrees the recent PR from Elite did not state they would have 2 more approvals by years end.
He predicted we would get an approval this quarter. NAILED IT.
I believe that we'll start seeing approval soon in Q3 of this year.
except nasrat has never been right with a prediction
we look forward to additional product approvals in 2018.
everyone agrees the recent PR from Elite did not state they would have 2 more approvals by years end.
What's next on the approval list? NORCO....
The next approval I believe should be the undisclosed pain product licensed to Glenmark and we believe this ANDA could be approved within a couple of months.
Glenmark will have semi-exclusive marketing rights to the ANDA approved product, phendimetrazine 35 mg tablets and exclusive marketing rights to an undisclosed pain product, currently under review by the FDA with an expected approval date in the third quarter of this year
We've had two approvals in the past year.
The FDA won't approve anything for them.
75% of all drug applications that get a crl get approved on 2nd application. I know, I know, Seqestox is going to make the whole universe implode so nothing else matters.
That's absurd and completely wrong. Means absolutely nothing about Elite. It's just politicians doing what they do: Open up the coffers for corporate America so corporate America can open their coffers for politicians.
The bill is about providing money for opioid abusers. Go ahead and explain how that hurts Elite. Congress pretending to treat the symptom; Elite is going to prevent the symptom.
I would think so, except the context won't quite work since SunGen isn't the same juggernaut that Glenmark is. I haven't seen any mention of Glenmark being involved, but it could happen. That's not to poo poo the overall point though. Generics aren't that difficult to commercialize. A blind squirrel could see the profits coming.
Should it be SunGen ?
This seems out of place?
with the Glenmark partnership as the commercialization engine,
Glenmark certainly thinks Nasrat can keep things moving.
Yes, thanks for excellent math lesson that verifies low risk. But no, you couldn't lose $10,000. We have profit and assets. Companies with profit and assets don't just go to $0.
As I've stated many times, post both sides of the picture. There are many, many more positives than negatives. That chart is a good indication to invest in Elite. THANKS.
Noticed 0 negatives listed in the history. Hard to list them when one can't find any.
Risk is pretty minimal when the stock is 9 cents, especially considering numerous drug applications, a quality facility, and partnerships.
price for minimizing my risk
the history of Nasrat and ELTP
IN the meantime, I can use my capital elsewhere. And I have done so.
some investors prefer to invest before everything becomes hindsight. The CEO said we would file an application per quarter, and basically we did. We have many applications filed and several more to come. We have a good facility. We have good partnerships. Should be as obvious as the sun that the company value is going to rise considerably. That's why the competition is clearly worried and working so hard against us. Quote is bookmarked for future reference, though.
I agree that once just one of these possible events is announced it will be time to buy.
Prove it. Absolute utter bs. Nasrat never said anything close to that. Nasrat specifically said we're going to grow the pps "organically". NO NEED TO REVERSE SPLIT SINCE WE ARE GOING TO DOLLARLAND IN LESS THAN 2 YEARS.
Would be best to read the trancripts. Link is stickied. Won't take long. Nasrat didn't specifically mention the Percocet generic as far as timeline update. Here are some quotes about his expectations on the applications:
I believe that we'll start seeing approval soon in Q3 of this year. It is possible for us to get two to three approvals this year. I would say on average, we should be getting at least an approval a quarter and a filing a quarter for the next four quarters. The next approval I believe should be the undisclosed pain product licensed to Glenmark and we believe this ANDA could be approved within a couple of months.
To summarize, Elite has six ANDA submitted to the FDA, we expect to start seeing the first approval soon and next quarter and start launching these products as we go along. We continue to move forward with SequestOx. For now, we await a response from FDA regarding the studies required. After that, we will diligently move forward for the submission, and we continue to develop other generics with our partners and by ourselves alone.
So for the rest of the ANDAs especially the two that we’ve filed recently, it is my expectation that they’ll be approved in under 12 months because I do think that we’ve spent a lot of time studying all of these and new things that FDA is coming with, and we can be 100%, but never the less we’re getting much closer to it than we were before.
Next set of question is on SunGen and update on the products from SunGen. I already covered that. I have this to say. We’ve five products with SunGen. Two we’ve already filed this year. Two more we may file by the end of this year maybe December, January, and one will be next year. We’ve so much work with SunGen really we need to slow down a bit and we still need to start shifting our focus from file-file-file to approve-and-launch-launch-launch. And that really is what we’re going to do over the next year.
I am hoping that next year will be the year of the launch. As promised you about the year and half ago, we’re going to start filing an ANDA every quarter and we’ve been doing it. Now, we’re going to shift and start launching ANDAs every quarter.
Long term disaster for our competition
75% of all drug applications that receive crl's are later approved.
l o l. freerealtime is legitimate. I mean it, really.
Wrong yet again. The drug technology behind the filings are considered assets. Assets have value. Things that have value are greater than squat. Many drugs that have been rejected have been sold after rejection.
the filings really don't mean squat.
We could have to through multiple hoops over multiple years while watching the landscape change drastically for these drugs.
proves your statement was just plain wrong. That's just one example. Maybe should read more on how to accurately calculate batting percentage.
FDA replies come in a lot more forms than what appears in public filings? Do you think we get a public filing every time the FDA calls with a question? You said "replied", not filing, not formal response, not written response.
Time to read up
This is old news.
First of all, you don't know what all the FDA replied to, unless you have insider knowledge.
Secondly, Elite Pharmaceuticals Announces FDA Approval of Phendimetrazine Tartrate Tablets USP
wrong. Complete bs and typical misinformation unless you have insider knowledge. Maybe you can post proof that all of Elite's applications have received CRLs.
Elite is batting 1000% here.
Wrong. We have a real facilty. Real applications that will get approved. We have real partnerships. The vast majority of what Nasrat has told us has come to pass. That's not theoretical. That's very real. More assets to come.
Everything is theoretical at this point.
They way management executed. 0.02 is just as likely as $20 like some here claimed.
Pure garbage that I wouldn’t call it theoretical.
Your statement is only theoretical bc we will never go to .02.
Here's a little more clarity on what Nasrat said regarding the SunGen products
Next set of question is on SunGen and update on the products from SunGen. I already covered that. I have this to say. We’ve five products with SunGen. Two we’ve already filed this year. Two more we may file by the end of this year maybe December, January, and one will be next year. We’ve so much work with SunGen really we need to slow down a bit and we still need to start shifting our focus from file-file-file to approve-and-launch-launch-launch. And that really is what we’re going to do over the next year.
Is that the next SunGen Filing?
Absolutely correct. There are 2 significant takeaways: Glenmark as a partner and Nasrat/Elite doing what he said we would do.
of more significance is getting Glenmark as a partner