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Drug pipelines are absolutely crucial for pharma companies and Elite IS growing and developing theirs.
Almost 5%*
A 600 share sell to push it down almost 6%
l o l
Would be nice!
That doesn’t make sense to me. This change IMPROVES the formulation in multiple areas (TMax, AUC) as shown in the pilot. I don’t see why they couldn’t bridge that data with what they already have.
Boom, MAGA.
There were others who filed as well right? Was it Mylan and a handful of others who won the Purdue suit? Were they also required to complete HAL studies?
I wonder the same. I guess it all depends on how far along they are at the time. I’d personally be okay with $1-2/share but I imagine Nasrat wants more. What would your guess be?
Interesting that Nasrat and Jim Huang are working together, given both their prior experience with Actavis and now their own pharmas. I’m going to dig further, but based on Jim’s work with Abrika and it’s resulting acquisition, it looks like Nasrat may be trying to accomplish the same thing in the same way.
Doesn’t change what I said at all. SIRI had over 4 BILLION OS, several billion in debt and didn’t reverse split. They dropped all the way to .05 and are close to $6 a share currently. Took several years but it happened.
Elite has less than a billion OS and about 3-4 million in debt.
Facts.
Not necessarily. It isn’t mandatory at this level of OS. Look at SIRI. Think they had 4B+ OS and didn’t reverse split.
Agreed
Filings count for a lot actually. Look at Abrika Pharma.
Glad we agree the stock price has risen since Nasrat joined Elite. Thanks.
Actually completely on point but thanks for the opinion.
Nasrat wasn’t working at Elite 6 years ago and didn’t file the one that was approved. He also hasn’t started submitting ANDAs at Elite until late 2016. First approval will be soon and will obliterate another talking point.
My thoughts?
That’s all complete BS as the FDA just approved an Opana generic a few days ago.
Next.
Actually they are all excellent comparisons but Elite investors already recognize that.
“Simple mistake”, of course!
Generating some money is clearly better than generating none, yes. Most R&D companies make $0 and simply burn cash until they get approvals, acquired, or go under. Elite can offset some of its R&D costs with the generic side of the business which removes risk.
I don’t think anyone is here solely because of the small generic products they are currently selling.
They’ve had net losses for awhile. They are an R&D company and this is quite common.
Ask the FDA.
Actually his post was completely factual so.. LOL
400MM market sounds pretty valuable to me. I do agree that number of competitors and name of product would be desirable information.
BusinessWire, GlobeNewswire and PR Newswire News
Elite Pharmaceuticals Inc ELTP:OTCQB
Elite Pharmaceuticals and SunGen Pharma File ANDA
GlobeNewswire
11:32 AM ET
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of an immediate release CNS stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma, LLC ("SunGen") under the Development and License Agreement ("Agreement"). According to IMS Health data the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ending September 30, 2017.
Under the terms of the Agreement, the product will be owned jointly by Elite and SunGen. Elite shall have the e xclusive right to market and sell the product using Elite's label. Elite will also manufacture and package the product on a cost-plus basis.
"The filing of this ANDA represents the first of many products being developed under this Development and License Agreement with our partner, SunGen," said Nasrat Hakim, President and CEO of Elite. "In addition to our SequestOx(TM) NDA filing, Elite now has five ANDAs pending with the FDA."
"The strategic partnership with Elite is progressing exceedingly well," said Dr. Jim Huang, Co-CEO of SunGen. "And we are very pleased with the filing of this first ANDA with more t o follow."
About SunGen Pharma LLC
SunGen Pharma, LLC is a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products. SunGen specializes in the development of oral solid extended release and complex injectable products. SunGen has business partnerships with many US-based generic pharmaceutical companies to develop, manufacture, and sell several pharmaceutical products in the US.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma, Dr. Reddy's Laboratories and Valeant Pharmaceuticals International. Elite currently has nine commercial products being sold, five products filed with the FDA, additional approved products pending manufacturing site transfer and the NDA filing for SequestOx(TM). Elite's lead pipeline products include abuse-deterrent opioids which utilize the Co mpany's patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.). Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if a ny, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, Elite's ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of SequestOx(TM) by the FDA, and the actions the FDA require of Elite in order to obtain approval of the NDA. These forward-looking statements are not guarantees of future action or performance. These ri sks and other factors, including, without limitation, Elite's ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities and intellectual property protections and defenses, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
https://resource.globenewswire.com/Resource/Download/b985c263-7cb5-432b-96c5-c2c8fd94b9a5?size=1
Elite/SunGen ANDA filed per Elite’s Twitter just now.
Monday*
Not from me you haven’t
But I heard that since 2011 tho
Indeed. Multiple technical indicators point to this, not least of which is the uptrend in the BSHr% Index over recent weeks.
It was just announced maybe last week or two that Lasers has passed away. Dianne confirmed as much through Laser’s (Joe in real life) son. Very sad news.
I believe that is correct. More scripts for IR but more overall money in ER.
Because you fix what’s in the legal purview first. Opioids are legal, heroin is not. Government agencies will continue the fight against illicit drugs as they always have.
So addicts are the minority of opioid users. Glad we agree and that’s settled.
Right, because they’re the minority. LOL.
Post data that proves addicts are the majority of opioid users. We’ll wait.
Earnings and con call this week or next?
No technology protects against taking too many pills yet. This potential for overdose is applicable to nearly every substance known to man.
I do agree that Elite needs to get in the game sooner than later.
More fake news.
Fake news.