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So what do we think of the new Form 4? https://www.sec.gov/Archives/edgar/data/0001053369/000158374220000002/xslF345X03/primary_doc.xml
Haven't been paying attention to AMBS for a few years, what exactly is our relationship with Todos? Does AMBS own a stake in Todos? Any info appreciated. Thanks
On February 20, 2020, the Company executed an agreement with Nostrum Laboratories Inc. (“Nostrum”) pursuant to which the Company will sell to Nostrum all of its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its generic Dolophine® (methadone hydrochloride tablets, 5 mg and 10 mg) and generic Bontril PDM® (phendimetrazine tartrate tablet, 35 mg) for $600,000 in cash. The sale has been consummated.
Just out (I believe)
http://archive.fast-edgar.com//20191010/A322W22CLM22G262222J2CX2FTBA222242B2/
Dear Fellow Shareholders,
As a substantial shareholder and steward of our Company, I begin this letter with a sense of pride about Elite Pharmaceuticals. Having faced a number of hurdles and changes in the industry, we have been agile and able to make necessary adjustments needed to execute our business plan. Now, in 2019, we are truly beginning to see quantifiable results of this work through drug approvals and increases in revenues, which have us on a pathway for financial independence. Our primary focus is the development of products that are difficult to formulate or have barriers to entry supported by our R&D activities and subsequent FDA approvals. I expect the growth of generics to continue. Our development and license agreement with SunGen Pharma, LLC, has produced an approval for a generic immediate-release Adderall® which was launched earlier this year and has already made a significant impact on Elite’s business. Elite and SunGen have an extended-release CNS Stimulant which hopefully will be approved soon and is expected to bring the Company to profitability. Our focus on opioid and abuse-deterrent technology products has changed, short term, due to the opioid crisis and accompanying lawsuits. We have dramatically improved our marketing reach with giants like Lannett Company, Inc. and Glenmark Pharmaceuticals, Inc. as reflected in our recent sales. In just a few years, we have dramatically improved the Company’s infrastructure; developed, filed, and received several product approvals; created co-development projects; and added significant marketing partners for our products.
To continue to execute on our initiatives and grow our business, it is imperative that shareholders approve Proposal No. 2- an increase in our authorized shares of common stock. While we anticipate possible profitability from our extended-release CNS Stimulant with SunGen if and when this product is approved, Elite still needs to raise funds and a primary and necessary fund-raising tool is the sale of our securities. At present, we have very few shares available.
Working capital is needed for current projects for expensive API, raw material and operating expenses long before reimbursement from our distributors. Also, Elite must pay annual generic drug FDA fees (GDUFA fees) as the government now charges pharmaceutical companies increased yearly facility registration and program fees which cost Elite nearly $1 million, in addition to any new product (ANDA) filing fees.
We also need funding for future projects: for research and development, materials and expensive clinical trials which must be paid for today to create approved future products. These future products should add value to our stock and benefit our shareholders. Even though Elite is approaching profitability, we still cannot afford the above initiatives today.
We also are asking for an increase in authorized shares to allow the conversion of outstanding Series J preferred stock into common stock. Failure to convert these shares will eventually result in a 20% interest penalty.
If this proposal is not adopted, management believes we will be severely limited in our ability to raise capital to grow or even sustain our business. We are beginning to see the results from all the seeds that have been planted over the last few years and need the ability to continue to execute on our plans. It is critical that you vote YES on Proposal No. 2.
Please remember that as a shareholder, your vote is extremely important to the Company, no matter how many shares you own. For certain very important resolutions, failure to vote or specifically direct your broker to vote would be considered the same as a “NO” vote. Please take a few moments to vote whether or not you plan to attend the Annual Meeting. You can vote by completing, signing, dating and promptly returning the enclosed proxy card. Alternatively, you may vote through the Internet or by telephone as directed on your proxy card. If you receive more than one proxy card because you own shares that are registered differently, please vote all of the shares shown on all of your proxy cards.
If you have any questions or need assistance voting your shares, please call our proxy solicitor, Morrow Sodali toll-free at 800-662-5200 or Dianne Will, Investor Relations for Elite Pharmaceuticals at 518-398-6222.
As the largest shareholder of Elite Pharmaceuticals, my interests could not be more aligned with yours. We are executing the plan we’ve laid out to create value for you, our shareholders. Thank you for your confidence and trust.
If I am not mistaken, PDUFA dates are specific dates, not a month. What is the exact PDUFA date? I can't find it.
ELTP just filed a Form 12b-25 Notification of Late Filiing?????
Wow, exactly the same as me, E1 AB-E7 MSgt, O1 2dLt-O4 Major, USAF 1974-2000
for undisclosed immediate-release antibiotic generic product being co-developed with SunGen Pharma
News out. positive topline results from pivotal bioequialence studies
News out, received approval of ANDA for generic Percocet
NORTHVALE, N.J., Feb. 09, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, announced results for the third quarter of fiscal year 2018 ended December 31, 2017 (“Third Quarter”).
Consolidated revenues for the third quarter were $2.5 million, an increase of $0.2 million or approximately 9% from the comparable period in the prior year. The increase in revenue is primarily attributable to growth across Elite’s generic product lines. Elite continued to invest heavily in product developmentwhich resulted in the positive outcome in a pilot study conducted on SequestOX™ and, in February, the filing of an ANDA for the first product being co-developed with SunGen Pharma.
what story, did I miss something?
Are you being serious, or just trying to be funny?
NORTHVALE, N.J., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today reported positive topline results from a pilot study conducted for SequestOx™, Elite’s immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology. An objective of the study was to assess whether the reformulated SequestOx could achieve a Tmax (the mean or median time to the maximum drug concentration in subjects) comparable to the reference drug, Roxicodone, when dosed with the standard high fat meal specified by the FDA. As opposed to the earlier formulation, based on these pilot results, the modified SequestOx™ is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions. Elite intends to review with the FDA the study results and discuss the pharmacokinetic study requirements for a re-submission of the NDA.
Lasers???? Anyone know what happened to Lasers? He hasn't posted anywhere since Dec 15th, very unusual. Miss his informative post, hope all is well with him.
Wow, a rare Aqua siting, maybe this move is real Hope all is well.
give me about 3m-4m more shares traded and I'll start believing this move may be real.
Let's not get carried away here, 1m shares traded at .10 is only $100k, and probably half that at least is off this board. When news leaks we will see a lot more volume than this and sharper rise or fall. I am long and have been for more years than I care to admit and will keep the faith, but don't believe whatever is happening today is it, even though I do like the green on my screen.
This statement in the news release talks about "just" received the CRL for SequestOx??? Is this a new CRL? Did I miss something or are they talking about a previous CRL?
"Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and the NDA for SequestOx™, for which it just received the CRL from the FDA."
I don't understand your post on this. To me it clearly did give results for reformulated SequestOx.
NORTHVALE, N.J., May 30, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today reported positive topline results from pivotal bioequivalence studies conducted in April of this year for an undisclosed generic product in co-development with SunGen Pharma. The topline results indicate that the generic product is bioequivalent to the branded product in both fasted and fed studies.
The studies were single dose crossover comparative bioavailability studies in healthy male and female volunteers in both the fed and fasted states. IMS reported approximately $600 million in revenue for the generic market for this product in 2016.
“We are very pleased to announce this successful BE study for the first of four products under development in collaboration with our partner, SunGen,” said Nasrat Hakim, Chairman and CEO of Elite. “According to IMS Health Data, the four brand products and their generic equivalents had total U.S. sales of more than $3 billion for the twelve months ending June 30, 2016.”
“We are thrilled to have positive BE results for the first of the four products under co-development with Elite,” said Dr. Jim Huang, Co-CEO of SunGen. “We are very pleased with the collaboration between our two companies and the progress we have made so far with these very important products.”
About SunGen Pharma LLC
NEWS OUT
This board would be much more informative and enjoyable if we could get rid of about 5-6 people, both on the bullish and bearish side. They post multiple times a day and have nothing to add except cheerlead or try to talk the stock down. Of course then we would only have about 56,000 post instead of 256,000.
people getting scared out of their shares. not enough volume to me news related. should be back above .20 soon.
I think MMs saw some stop loss orders in and took it down quickly to pick up some cheap shares, think it will rebound in the morning.
For those who use to own aria, Brigatinib approved today. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm
halt was for a computer problem, nothing to do with eltp itself
News 8/5/2016 4:02 IntelGenx has sold its royalty on future sales of Forfivo XL to SWK Holdings Corp for $6 million. SWK will pay IntelGenx $6 million at closing. In return for 100% of any and all royalties or similar royalty amounts received on or after April 1 2016, 100% of the $2 million milestone payment upon Edgemont reaching annual net sales of $15 million, and 35% of all potential future milestone payments.
I don't believe we will hear anything from the company until after they talk to the FDA, which will not be any time soon unfortunately. Panic selling will happen Monday and we'll have to wait and see where it levels out at and then you need to make your decision to sell, hold, or average down (or up as the case may be). Don't ruin your weekend worrying to much about it, there is nothing we can do at this point until Monday morning.
I don't believe we will hear anything from the company until after they talk to the FDA, which will not be any time soon unfortunately. Panic selling will happen Monday and we'll have to wait and see where it levels out at and then you need to make your decision to sell, hold, or average down (or up as the case may be). Don't ruin your weekend worrying to much about it, there is nothing we can do at this point until Monday morning.
This is not tanking, if they post a bad PR, then you will see tanking.
Just for those looking for hope, if you noticed, one of the approvals from 7/13 was not posted until this morning, 7/15. So I guess it is still possible for an approval even if we don't see anything today. Bottom line, none of us know, we are all speculating, and we won't know until ELTP makes a public announcement. I do think ELTP already knows, just waiting to try and figure out how to break it to us. Good luck to all and have a good weekend.
which also means somebody just sold 156K, do they also know something? (retired Air Force)
The best place to watch for the outcome is the stock price and chart. You will see a sudden spike in volume and big move in price one way or the other. This will happen faster than you or I can check FDA website or news releases.