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I suspect the invitro is already complete, maybe resubmission next quarter. It's a fed study, not a clinical trial... they just completed one for the generic oxy that only took a couple of months....
Maybe a little , but not a HUGE one, I plan on buying more if there is a dip. Stock is still undervalued for its current pipeline.
Most likely they have to adjust the polymer coating on the beads or something along those lines.... the tech is fine.... we already knew there was gonna be a fed study that needs to be done as well as a resubmission this year because Nasrat told us that in December. There is no REAL news here, just moving forward towards approval. Now the top line data from those studies is the news we're waiting on....
Hmmm, if the meeting wasn't a good one why would they extend the trademark? More evidence that the news is GOOD!!!
I would assume the same, maybe tomorrow or Tuesday. What's great is we have the quarterly update and CC coming up in a few weeks as well... that will hopefully cover all the questions we have going forward. Last CC I doubled my position, if this one is as good I might do the same lol
They're not gonna post the transcripts, if you want them you have to file a FOIA request. They will release them back to elite, who will then update us.
About 200k shares were purchased in the last hour and a half of trading on Friday, and they were purchased around the HOD price.... all the way up to closing. I wont be surprised if we get news in the morning. Anyone who is gonna buy $35k-$40k worth of shares right before the close on a Friday isn't gambling. If they have that kind of dough to lay down in a "penny OTC" stock then they know something.
Here you go
NORTHVALE, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (ELTP) today announced the Company met with the U.S. Food and Drug Administration (the “FDA”) on December 21, 2016 for an end-of-review meeting to discuss steps that Elite can take to obtain approval of SequestOx™. Based on the FDA response, the Company believes there is a clear path forward to address the issues cited in the July 14th Complete Response Letter (“CRL”). The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time.
SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride) is Elite’s investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The proposed plan submitted by the Company addresses items cited in the CRL dated July 14, 2016 for the New Drug Application (the “NDA”) for SequestOx™.
“We are extremely pleased that there is a path forward to seek FDA approval of SequestOx™,” said Nasrat Hakim, President and CEO of Elite. “Based on the guidance received from the agency, Elite will begin to execute the proposed plan immediately.”
They met on the 22nd of December, the FDA has 30 days to release the minutes back to Elite, who informed us that they will update us by the end of January. They didn't say they will post the minutes for us to read.
Yes, they will. My answers to you will be as informed as yours are.
Yeah ok
Bravo WeeZuhl, a tip of the hat to you friend... I'm not even gonna attempt to comment on this in fear of soiling it. Five star deduction....
Furthermore, there is such a thing as precedent, abuse deterrent labeling and abuse is a topic at this AdCom... what is decided there will have a direct impact on Elite and others
Proof??? Link ???
While the narcotic itself is different ( I know oxycodone and oxymorphone are different) the technology behind Elite is relevant, the discussion is opioid abuse and the information divulged in that meeting will have an affect on elite and all narcotic producing manufacturers.
How does discussions of ER and IR abused generic narcotics not involve elite?
"The committees will also discuss abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products."
Read further down, it's not just about endo pharma
A few days before the AdCom we will be able to review the docket as well as comments, this link is preloaded directly to the docket number:
https://www.regulations.gov/searchResults?rpp=25&po=0&s=FDA-2017-N-0067&fp=true&ns=true
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm536620.htm
Elite will be discussed here.... no doubt about it, approval is eminent.
3rd week of March is gonna be a good one..... planning on doubling position to 20% before then...
Where's the terrible news after the close on Friday????? The terrible news that comes out when nobody is paying attention because of the inauguration????Guess that means there isn't any because it's GREAT NEWS WERE EXPECTING .......
Wow, who bought the 200k just before the close?
Granted I know the drug itself is not new but the technology definitely is, so for all the naysayers 25% of that valuation is still $1.25....
Here's something to think about, The average cost to develop A new pharmaceutical drug is $2.5 billion..... and that's not even counting the revenues from sale of the new drugs into valuation.... once sequestox is approved, and it being the only IR approved, the sheer value of its technology alone at the very minimum is $2.5 billion, add that to other factors like time to develop and it's easily worth $5 billion... of course this is just my opinion but here's a link
https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
Depends on how much is being diluted.... I have a alert set at 4.85.... I hope it's not that bad but hard to pass on that price
Dilution for sure
Uhhh we've closed green everyday this week and are up +20% over the last 30 days....
http://www.nasdaq.com/symbol/eltp/historical
Ahhh the mikah deal.... it's definitely worth the dough
Only if you bought up top.... this is the bottom.....
Hakim clearly stated the meeting was successful......, during the conference call he said
"They FDA is studying our proposal, and they will give us feedback soon. They have given us a date to meet us in the third week of December. We believe that our proposal will address the FDA Tmax concern, and if they agree with our proposal and we will know that next month, Elite will complete additional work and a fed BE study and target resubmission in 2017. We will know more after we meet with the FDA."
So he knew what they wanted and addressed it, being that the meeting was successful one can infer that the FDA accepted the proposal and is waiting for the fed BE study results....
That is our next PR plus other goodies in a nutshell
It could be..... also might be part of the non-opioid family of drugs they've launched like Phendimetrazine, Isradipine and Hydroxyzine.... who knows it's all more ammo for bigger revenues lol
Not sure, they are ANDAs awaiting application and/or development....
I wonder what the undisclosed generic that is pending FDA approval is?? Undisclosed.....hmmm, makes you wonder if they are saving it for a blockbuster PR????
He wouldn't, he knows he can get to NASDAQ on his own.....something like 140 million shares? Worth ~~$15 million now???? Clearly he wants to build an EMPIRE and this is change to him, he probably doesn't even check the stock price because he knows the numbers right now are irrelevant.
The guys over at elite are professionals, not pink sheet scammers, they have a profitable company with MASSIVE Billion dollar market changing technology and they KNOW it...they're not gonna waste time with fluff and BS....it will all reflect in the balance sheets.... there was a reason for the poison pill
They're trading it sideways pending PR/CC.....even the MMs think the news is gonna be good.....
Successful = $$$$$
Something about this statement says BUY!!!
"“Following our recent announcement regarding a successful FDA meeting for our immediate release Oxycodone HCl product SequestOx™, I am now very pleased to announce these positive topline study results for an abuse-deterrent twice-daily Oxycodone,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “We intend to file an ANDA for this product later this year.”
Quote:
"That's not what the RS will be used for, it will used to wipe out current shareholders and give nasRAT about another 950 million shares to sell."
Says John-Langston, a username on a free website....
Come on John, I don't mean to fire shots but of course the CEO is gonna have faith in his company...