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N2K, you say you predict a buyout within 18 months. Do you also predict a price? If so, please name it or at least a range. Thank you.
This is an R&D company. They might not have revenue for a long time, if ever, and they don't really need to. What they need to have is patents on their special biosynthesis technique(s) and later their meds, and then a buy-out! imo..
But the generics won't bring in an immediate $$$$7.5million from Epic...wish it were otherwise.
What matters most is whatever a potential buyer of the company would care about the most. That would be the pipeline and approvals imo.
Yes he was CEO of Purdue. Numerous major lawsuits against Purdue for lying to docs and the public about the allegedly low chance of addiction. So he's not exactly an honest dude but perhaps he is trying to redeem his soul with what he's creating here. In any case, he certainly has the right connections within the industry and FDA....
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SequestOx is not intended for druggies because they are already addicted. SequestOx is intended to prevent addiction from starting in the first place.
Anyone think there's a realistic chance of going above $0.06 like a few years ago?
Does this company actually still exist? No word about anything since Oct 2016.
I asked Schwab if ELTP is being shorted. They said that shorting ELTP is allowed but they don’t have info as to whether or not it is, in fact, being shorted.
pps didn't rise because of manipulation, obviously. As to it never will get to a dollar with R/S that is not necessarily true at all. First, there could be a buyout at any time and that would do it.
All we need is formal removal of warning letter and things will start cooking. Approval of SequestOx is coming, followed by the whole line of IR AD meds. and get to Nasdaq.
You will see!
The P3 was a success with all foods, non-fatty AND fatty. Patients were allowed to eat whatever they wanted.
'NASDAQ2020' --do you know if our intrepid CEO has registered ELTPto present at this Abuse-Deterrent Formulations Critical Update Forum, taking place December 7th in Philadelphia, PA.
A buyout by BP and/or approvals in China and problems solved. It could happen pretty easily imo.
jour_trader: I have never left a message for Dianne to return a call but several different times she has answered the phone and answered all my questions. She even stayed on the phone about 20 minutes. So, i suggest keep trying to reach her in person.
Mazeppa, There is one more possibility for ELTP to generate real money for investors much sooner than you suggest—but only after the warning letter is resolved/removed: namely, a buy-out. Hopefully, for at least 0.30. Doesn’t this seem reasonably possible to you? If not, why not?
Mazeppa,
I hope you will send to Dianne what you just posted here. Please let us know. I would be happy to do it myself. Perhaps all should send it to her.
As to the ANDAs filed, even if an irresponsible strategy as to affordability, wouldn't they at least make the company more attractive to a partner/buyout (assuming the warning letter gets removed)?
Well, ELITE is in NJ too. So Christie should be at least as excited about ELITE, with its huge pipeline, as he is about Advaxis. Maybe our team should be making sure that our relationship with Christie is top-notch!!!
To jour-trader and others: What should Naz have done differently in the past and/or be doing differently now, in your opinion, to play ball with the FDA and/or to get in their good graces? If you were Naz’s advisor, what would you advise him to do that he has not done and/or is not doing now? i’ll wait.
Overdosing on the Job: Opioid Crisis Spills Into the Workplace
http://www.newsmax.com/t/finance/article/814619?ns_mail_uid=27607924&ns_mail_job=1754438_09202017&s=al&dkt_nbr=010124dbbt8m§ion=Economy&keywords=opioids-drugs-job-employers&year=2017&month=09&date=20&id=814619&aliaspath=%2FFinance%2FArticle%2FFinance-ArticleTemplate&oref=news.newsmax.com
I asked Diane recently why they haven’t filed in China and she said they would have to do expensive clinical trials there, they couldn’t just use the data from US trials. If this is the case with China, it probably would also be the same in Europe and Canada.
Maybe the best solution is to partner with BP and let them deal with the FDA. Or sell the company. But maybe we couldn’t get enough $ selling right now with the pps being so low. ???
Naz knows that approval of Sequest-Ox has to be via labelling. (Approval with appropriate labelling should gave been granted long ago and was recommended by FA director before Calif). Therefore, he stopped trials because Tmax is what it is so there's no point spending any more time and $ pursuing the Tmax path).
Sequest-Ox works great (and T-max is fine) when used properly!
T-max problem is ONLY IN RELATION TO HIGH FAT MEAL!!!
Get that straight and stop with the lies like saying Nasrat throws in the towel and declares results are garbage, etc etc
Yes he said results were disappointing but what results was he referring to??? He was referring ONLY to T-Max after a high fat meal. He WAS NOT referring to effectiveness and safety of Sequest-Ox when taken as it should be taken (i.e. one hour before or two hours after a fatty meal)!!!
All that's needed is a simple instructional label like a gazillion other approved drugs of all kinds have. PERIOD!!!
There are many other and better (non-addictive) ways to control chronic pain than opioids but there are NOT better ways to deal with Acute pain. It is as an IR ADT pain med (not as an ER drug) that Sequester-Ox is urgently needed right now.
Hopefully, Gottlieb will be reasonable and approve ELTP's desperately needed IR ADT med, Sequest-Ox, with appropriate labeling! But if he doesn't (due to being bribed by BP), then most likely China will.
Total BS! Sequest-Ox DID NOT FAIL!!! It works perfectly as an ADT IR pain med. THE ONLY ISSUE is T-Max after a high fat meal, easily dealt with by labelling “take one hour before or two hours after a fatty meal”, just as many other opioid AND other meds have been doing for decades.
Testing has been “paused” (or even stopped) for T-Max after fatty meals, but all previous trials for effectiveness and safety (and “liking”) of Sequest-Ox passed with flying colors!!!
Hopefully, FDA chief Gottlieb will be reasonable and will approve Sequest-Ox in its existing formulation (original or revised) in order to get a really good ADT IR opiate pain med out there asap that this country desperately needs RIGHT NOW!
So stop with the BS false info you are sending out!
Sequest-Ox kicks in immediately EXCEPT after fatty meal. It's an IR, abuse-resistant pain med that has been demonstrated to work perfectly as designed, so long as it's taken an hour before or two hours after a fatty meal. Which can be stated on the label (like many other opioid meds are) and would have been approved just as it is by FDA before previous director. SEQUEST-OX works perfectly, get that straight!!!
Nothing has changed about the effectiveness of the drug both as an IR pain med and in its abuse deterrence in all forms. Hopefully it will be approved soon as an IR ADT!!!
Wrong. Sequest-Ox works just fine as previous studies have shown!!! The ONLY issue is T-Max after high fat meal, and that can be addressed with simple label as many other IR oxy drugs have done. this drug is needed out there right now and hopefully will be approved very soon.
Of course Nas knows the technology works. Otherwise, why would he have patented it in Canada recently???
btw, PharmaSleuth, what did Novel sell for?
Lasers, my understanding is that Camargo is the one who handles the study. Or does the FDA determine all the criteria--including qualifications--and then Camargo runs the study accordingly?
Assuming BE results are in and positive, what reasonable explanation(s) for no PR yet?
Will this ever, ever, ever reach $.05 or above again????????
Lasers--What calendar date is 1HCY2017 ?
thanks
An alternative to generic was discussed here long ago. I forget the name. Something like 502B ??? It requires showing equivalency to the drug that’s already there. Gets around the exclusivity problem. Wonder why isn’t Elite going that way?
I don’t think Elite missed anything at all. I think the whole thing comes down to fact that a new director of FDA was put in place just before we crossed the finish line and he had a personal agenda that blind-sided us. But we will prevail. Very soon, i hope.
This is wrong on all counts. A fatty meal does not at all cancel out the proprietary technology. It merely slows down when the pain relief kicks in, as is the case with all opioid meds, whether they are formulated to be abuse deterrent or not.
Taking a second pill soon after the first should not be done for health reasons, again just like with any other opioid drug. However, it does not render the technology useless. The technology is not affected in such a case.
As to addiction, nothing can stop a person from ingesting multiple pills, as is the case across the board. The technology provides a deterrence against becoming addicted in the first place.. Nothing can stop people from killing themselves if they are determined to do so.
Couch—you said the FDA will most likely suggest something that Naz will then do a quick study on. (I don’t have your exact words). But i thought the FDA had already told Naz what was needed and that he immediately started the process of doing it, as per his comments in most recent CC following meeting with FDA on the CRL. Please explain why you think we are waiting on some additional suggestion from the FDA for testing. And if so, when would that be? (my one post for the day).
Nasrat also said (not in these exact words) that if the FDA continues to screw Elite, he will pursue approval in China for SequestOx.
Letter to be sent to editors, etc. I have updated the letter posted by goodh2o1 to be sent to editors and/or elected representatives, and others in government. If anyone can improve on my version, please do so and post it. Here is my updated version:
Dear Editor….
I have been following a company called Elite Pharma (ELTP) which has a patent on an opioid medication called “Sequest-Ox” that reduces the possibility of abusing opioids. Elite accomplishes this goal by coating the opioids with Narcan.
Taken properly, the Narcan passes through and has no effect. However, if the pill is crushed to snort or inject, you get only the Narcan.
Elite went to the FDA in 2014, stated the tests they had run successfully and asked if anything further was needed. They were told that no further tests were needed. ELTP then received a waiver of NDA application fee as well as priority review, yet their application was not approved in July of this year.
The reason cited is that there is a chance for someone to overdose if they take the medication with a fatty meal, because the pain-relieving effect is delayed and the person might therefore take an additional dose. However, all currently approved immediate release opioids (none of which are abuse deterrent) have the exact same "fatty meal” problem. Simple labelling directions to take the medication either one hour before a meal or two hours afterwards were deemed sufficient for those other opioids to be approved and should likewise be sufficient for approval of Elite’s "Sequest-Ox”.
Elite’s cutting edge technology is applicable to 17 different opioids and needs to go forward! As is well-known, there is an epidemic of deaths by opioid abuse in this country and Elite’s technology would provide a powerful new way to significantly mitigate this enormous problem. Politics of any kind should not be allowed to hold back "Sequest-Ox”!
How to access ELTP's FB page? Please post link.
We all should do whatever we can to get the word out that ELTP has a great product ready to launch (as of July) that was stalled by FDA in favor of BP products that were repeatedly rejected by previous FDA director. New director Califf was known by Congress, prior to his appointment as FDA director, to be a lobbyist for BP.
Approval in China still a strong possibility! Then Canada. FDA will eventually come around, if not to Elite then to the BP that buys out Elite.