HOLDING STRONG!
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ELITE PHARMACEUTICALS had an increase of 92.22% in short interest
October 14, 2017
snup, could ANDA approval and warning letter removal news come at the same time??
Based on the latest 8K and Nas's comments during CC it appears that many issues are about to be resolved. Good inspections, minor deficiencies, and it appears ongoing cooperation which all could lead to a lot of good news coming soon.
Elite's Percocet generic ANDA approval SOON!!!!!!!!
It has been 7 days since the deficiencies classified as MINOR in the 8K so the “MINOR AMENDMENT” to address the deficiencies would be submitted by now!
How many days until we see FDA approval??
30 days,60 days, or sooner??
Agree rocioyogi, Elite is developing their relationship with Dr. Jim Huang, CEO of SunGen. Do the research on Dr. Huang and see his connections to the pharma industry and companies in China.
More opportunity with SunGen I believe.
Copy and paste error only - used same from last years announcement- see below
So, now we have 9 products in the agreements. First 4 have a current market of $3 billion and this new 5 have a current market of 2.5 billion. Even a tiny % of market give Elite major $$$$
August 29, 2016 - Elite announces development and license agreement with Sungen Pharma LLC
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, and Valeant Pharmaceuticals International. 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. Elite’s lead pipeline products include abuse-deterrent opioids which utilize the Company’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.
July 12, 2017 - Elite Announces New Development and License Agreement with SunGen Pharma LLC
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, and Valeant Pharmaceuticals International. 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. Elite’s lead pipeline products include abuse-deterrent opioids which utilize the Company’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.
oxycodone pharmacokinetic parameters
see the link and go down to about page 5 and look at Table 1 Mean oxycodone pharmacokinetic parameters and look at the Tmax info.
Intersting ranges on the high end from 4 to 10 hours.
https://oup.silverchair-cdn.com/oup/backfile/Content_public/Journal/painmedicine/16/11/10.1111_pme.12834/2/16-11-2142.pdf?Expires=1499886675&Signature=aUeYd50M-6OEK6bNtjVPdCH9CPxXmU-gSjeTrI9e9xBPA3SdqN~eGFSbXFFC5YZ3nMJxFaZITnYn5UQRmGUgQFmQGaqt6W~lJthXKvJk6Cj8XRXA0u5prNaanZwSqHHomMYpA1lW1yVUQO8ih2jmuxjbt0zbDcs1Fn1-yUmNHqkv33P7pcHVBY8hxAzM0IVt0RjAKVKFQ0uQTxdu~lMEG0OttQHJ3FrSJdJOOcwcfS1fC3ON1ODfblftmM4-KahzrubVag6EHUwDjMMZQ8nsa~6r961tZyExPTNs06QnqjyeSbzPvhu~laZxkrWVEXfgtHUvii1LPvSQwXy1ZhWkug__&Key-Pair-Id=APKAIUCZBIA4LVPAVW3Q
Tmax 3 to 4 hours-Oxycodone from Purdue's TARGINIQ ER tablets was rapidly absorbed with the median Tmax 3 to 4 hours following a single oral administration over a range of doses from 10 mg/5 mg to 80 mg/40 mg.
I know this is a extended release but is there any tmax relative info to SequestOx?
TARGINIQ ER it is a combination product which contains an extendedrelease opioid analgesic (oxycodone ER) and an opioid antagonist (naloxone) that was approved by the FDA in 2014.
This is a the combination Elite uses but the technology is different.
So is there anything interesting from Targuiniq we can use.
Send an email to each of the congress men/women that signed this letter.
http://katherineclark.house.gov/_cache/files/a577bd3c-29ec-4bb9-bdba-1ca71c784113/mundipharma-letter-signatures.pdf
We need them to know about Elite's ADT technology!!!!
We have to get the right people asking the FDA questions about SequestOx! There is no reason for us to sit on the sidelines!
We must take action to support Elite and their mission to put ADT products out there to save lives!
Senators and Representatives - Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Claire McCaskill (Missouri), Chris Murphy and Richard Blumenthal (Connecticut), Susan Collins (Maine), John Barrasso (Wyoming, Katherine Clark (Massachusetts), Hal Rogers (Kentucky) and many others.
Is there any reason that we cannot reach out to these Senators and Representatives to inform them of abuse deterrent efforts of a little company called Elite Pharmaceuticals????
Why can't we inform them about SequestOx and that when this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
Why can't we get them asking the FDA why they are not doing more to help this company that could provide a major ally for the battle against the opioid crisis in their state????
Send an email to these Senators/Representatives today!
Send an email to your Senators/Representatives today!
Senators and Representatives - Rob Portman (Ohio), Shelley Moore Capito (W.Va.), Claire McCaskill (Missouri), Chris Murphy and Richard Blumenthal (Connecticut), Susan Collins (Maine), John Barrasso (Wyoming, Katherine Clark (Massachusetts), Hal Rogers (Kentucky) and many others.
Is there any reason that we cannot reach out to these Senators and Representatives to inform them of abuse deterrent efforts of a little company called Elite Pharmaceuticals????
Why can't we inform them about SequestOx and that when this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
Why can't we get them asking the FDA why they are not doing more to help this company that could provide a major ally for the battle against the opioid crisis in their state????
Send an email to these or your Senators/Representatives!
Elite has more things working!
SquestOX may be PAUSED for now but Elite still has-
10 August 2016 - Elite submitted ANDA for a generic formulation of Percocet - Percocet and its generic equivalents annual sales of approximately $700 million
21 December 2016 - Elite submitted ANDA for aGeneric Hydrocodone, Acetaminophen Combination - combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million
4 April 2017 - Elite submitted ANDA for a synthetic narcotic analgesic - annual sales of approximately $40 million
Should see something on generic Percocet soon!
Then there are these that are working for the future -
29 August 2016 Elite Development and License Agreement with SunGen Pharma - Two of the products are classified as CNS stimulants and two of the products are classified as beta blockers. For the twelve months ending June 30, 2016, the four products and their generic equivalents had total U.S. sales of more than $3 billion.
Elite/SunGen are moving quickly as seen by this progress - 30 May 2017 Elite 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.
Elite as a company is NOT stopped by this pause for SequestOX!
Elite ELTP BUY signals coming back!
American Bulls is saying BUY again!
Barcharts is trending BUY again! 8% Monday and now shows 24% BUY indicators. The weak hands shake out from last week is building into another step UP on the charts.
ELTP held up nicely today!
The whole market tanked today or did you notice??
Considering the run we have maintained over the past couple of weeks and the minor down day of $0.007 today tells me that no one is selling and everyone is holding.... I say ELTP did GREAT!
Still got my shares!
Proof with link - ELTP is 96% BUY (up from 88% BUY). The Barchart Technical Opinion rating is a 96% Buy with a Strengthening short term outlook on maintaining the current direction.
Longer term, the trend strength is Maximum. Long term indicators fully support a continuation of the trend.
https://www.barchart.com/stocks/quotes/ELTP/overview
Worth a repeat - ELTP is 96% BUY (up from 88% BUY). The Barchart Technical Opinion rating is a 96% Buy with a Strengthening short term outlook on maintaining the current direction.
Longer term, the trend strength is Maximum. Long term indicators fully support a continuation of the trend.
Got that, the continuation of the trend UP! UP! UP!
ELTP is 96% BUY (up from 88% BUY). The Barchart Technical Opinion rating is a 96% Buy with a Strengthening short term outlook on maintaining the current direction.
Longer term, the trend strength is Maximum. Long term indicators fully support a continuation of the trend.
Got that, the continuation of the trend UP! UP! UP!
mjohn, very true! ELITE (ELTP) believes Lincoln Park is very smart with shares. That is why Elite Pharmaceuticals trust them and uses them for operating cash when needed.
The S-3 also talks about a $0.22 share price and if Elite sold the shares for the $800,000 to Lincoln at $0.22 then they are not going to dump tomorrow and drive the pps down so they lose big money.... LOL.... that is ridiculous....they buy from Elite at $0.22 and then sell for less, that ain't happening!
I expect that the pps will continue to increase and maybe even more then many of us are thinking because Lincoln Park is going to want to make money!!!!
READ THE FILING Date of First Sale: 2017-05-01
That was Monday May 1, 2017
There have been 8 trading days since the Date of First Sale: 2017-05-01 and we are still moving UP! UP! UP!
That is less than 5 mil shares so NO BIG DEAL considering they are using the money to complete SEQUESTOX trials for resubmission or for the next ANDA or for their other abuse deterrent pipeline drugs!
STRONG BUY! Barchart Technical Opinion rating is a 88% Buy with a Strongest short term outlook on maintaining the current direction.
Longer term, the trend strength is Maximum. Long term indicators mostly agree with the trend.
N2K or laser?? It say "J Preferred held by the holders are convertible as of the date of the Liquidation". Does this mean that the "J" shares cannot be converted until the company is sold??
lasers?? $0.80 with the stats from Fidelity! Should that put Elite (ELTP) pps in a trading range of $0.80 to $1.60??
Understood that current trading determines pps but based on stats and calculations ELTP should be much higher!
$0.80 would be just on stats without speculation of coming ANDA approvals and SequestOx approval!
SOURCE FinancialBuzz
NEW YORK, February 14, 2017 /PRNewswire/ --
According to a report by Grand View Research, Inc. the global biotechnology market size is expected to reach USD 604.40 billion by 2020. This is due to increasing demand for sophisticated biotech based diagnostic and therapeutic solutions. For example, recombinant technology, red biotechnology, DNA sequencing and many more are expected to serve as a high impact rendering driver during the forecasted period. An emphasis is put on the importance of the presence of government funded institutions such as the NBTB (National Biotechnology Board) and DBT (Department of Biotechnology) which are carrying out R&D and product development exercises pertaining to this field. Funding and scientific updates rendered by these institutions are likely to boost market growth over the forecast period. Mount Tam Biotechnologies, Inc. (OTC: MNTM), Elite Pharmaceuticals Inc. (OTC: ELTP), CytoDyn Inc. (OTC: CYDY), Arch Therapeutics Inc. (OTC: ARTH), Pharmacyte Biotech Inc. (OTC: PMCB)
Missed this one, it is from mid February but still any mention of Elite is good especially when associated with a $604 BILLION market!
Shark, great link, Elite - "this is a biotechnology company with all the reward of a development stage entity targeting a big indication, but only a fraction of the risk."
That is an excellent description of Elite!
It will not take years, review my previous posts on CRL Class 1 and 2 resubmittal review times.
SequestOX will be approved this year!
FDA has told Elite what they want and Elite is working hard to get everything done! Elite will resubmit later this year which means it could be in just a few months. FDA will have 6 months to review which will probably include an ADCOM. Approval with all ADT approval will follow and Elite will have the FIRST IR ADT Opioid - SEQUESTOX!
If the CRL is classified as a Class 1, CDER will complete the review and act on the application within 2 months of the receipt date.
A Class 1 classification includes
*Final printed labeling
*Draft labeling
*Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences, not previously reported with the product are presented in the resubmission)
*Stability updates to support provisional or final dating periods
*Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
*Assay validation data
*Final release testing on the last 1 to 2 lots used to support approval
*A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category)
*Other minor clarifying information (determined by CDER as fitting the Class 1 category)
If the CRL is classified as a Class 2, CDER will complete the review and act on the application within 6 months of the receipt date
A Class 2 resubmission includes any item not specified as a Class 1 item, including any item that would require a presentation to an advisory committee. A resubmission that requires a reinspection also would be a Class 2 resubmission.
FYI - SEQUESTOX resub review timeline for the FDA
FDA Center for Drug Evaluation and Research (CDER)
CDER will complete the review and act on Class 1 resubmissions within 2 months of the receipt date.
CDER will complete the review and act on Class 2 resubmissions within 6 months of the receipt date.
American Bulls on ELTP says Our system’s recommendation today is to STAY LONG.
The ELITE (ELTP) Barchart Technical Opinion for rating is a 80% Buy with a Strongest short term outlook on maintaining the current direction.
Longer term, the trend strength is Average. Long term indicators mostly agree with the trend.
stockboy, please explain it to us, please do that with exact evidence. Links, copy and paste, anything you could provide would be greatly appreciated....
You say rejected when everyone NOW knows for a fact that SEQUESTOX was NOT rejected.... get that.... not rejected and the FDA has provided a path forward to approval.... if it was rejected the FDA would not have given Elite that path so therefore SEQUESTOX was NEVER rejected.
stockboy, give us a link....
You say that the FDA already stated this in NOT A LABEL change so it should be easy for you to prove.... we will all wait for you link providing evidence....
ELTP = 0.20 in the next week and 0.40 to $1.00 the end of the month!
Really ties to FDA release of meeting mintues but I believe they are going to be GREAT news for Elite and SequestOx.
JMHO!
ELTP Barchart Technical Opinion rating is a 64% Buy with a Strengthening short term outlook on maintaining the current direction.
Overbought / Oversold – These terms have got to be the most over-used terms when talking about the markets. Overbought refers to the time in which the prices have risen to a level that seems as if they cannot go any higher. Oversold is the opposite, prices have dropped to a point it seems as they cannot go any lower. While this sounds simple enough, the term is usually based upon someone’s personal observation of price levels and not on sound analysis.
If I had to pick a concept in technical analysis that is so misunderstood, abused, and near worthless, it would be the concept of overbought and oversold. Let me try to explain. There are many types of conditions in the market where the pundits start hollering about overbought or oversold conditions. The condition can even be on a price chart after the price has moved so far in one direction that the expert thinks it has gone too far and must correct. The other misused of these terms is on technical indicators. There are two types of technical indicators: bounded, such as Stochastics and RSI, and unbounded, such as OBV, AD Line, Momentum, etc.
A bounded indicator such as a 14-day Stochastics %K, because of the calculation will remain between 0 and 100; it was mathematically designed to do that, somewhat like normalization. A generally accepted level for overbought is when it is over 80 and oversold is when it is below 20. So let’s work through an example. Chart A shows the US Dollar Index and a 21-day Stochastics in the lower panel. The period from early July, 2014 until mid-October, 2014; Stochastics remained above 50 and also above 80 for most of that time period. If you reacted in July as if Stochastics was overbought and took action to sell, place stops, etc. you would have been wrong for almost 4 months. That’s a really long time if you stop to think about it.
If you sold when it went below 50 in mid-October, you would have missed the next 6 months of up move in the issue. The red rectangle shows more of the same. The indicator remained essentially above 50 for almost 6 months. The point I’m trying to make is that relying on nebulous terms such as overbought and oversold, even when looking at price action can be quite costly. I stopped using the terms decades ago. And to make it even worse, using them on unbounded measures such as the AD Line, Momentum, etc. can be difficult at best.
Search it to look at chart example....
Search it....
Gman.... PuraCap is building an acquisition team.
Analyst, Business Development (M&A)
Serve as key member of an aggressive business development team focused on the acquisition of products and companies that complement PuraCap’s existing products and leverage its established commercial infrastructure.
Support the identification, evaluation and execution of acquisitions and other related business development transactions that enhance the value of PuraCap’s business.
This will include the creation of competitive and market analyses, development of commercial models and forecasts, and financial evaluations. Coordination of Due Diligence efforts will be part of the role.
Support of the development of Government business by identification of opportunities, supporting a financially sound bidding strategy and follow-through
With key stakeholders develop and execute an “opportunity landscape” in the generic space
There are no secrets! Elite has been one of the most honest companies I have seen with both bad and good news!
Elite has a clear path to approval for SEQUESTOX!
No lies, no deceit, no false info!
It is all in the SEC filings - FACT!
Fact - all your post is old news!
run to .97 was way before SequestOx was submitted and a spec run.
FACT - Fall since .39 was the CRL from FDA and NOW that has changed and SequextOx has a clear path to approval.
As with all stocks things happen and things change.... Elite's recent happenings are a sign of a great future - multiple ANDAs submitted and SequestOx clear path to approval!!!!!!!!
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 Complete Response Letter 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.”
FACT - Elites SequestOx has clear path forward!
Only believe the facts and not the speculation of others!
http://ir.elitepharma.com/profiles/investor/secDL.asp?c=1053369&ID=000114420416141038/0001144204-16-141038#LoadingArea
ELITE PHARMACEUTICALS INC /NV/ - 8-K (Filed: 22-12-2016)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
December 22, 2016 (December 21, 2016)
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Nevada
001-15697
22-3542636
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
165 Ludlow Avenue, Northvale, New Jersey 07647
(Address of principal executive offices)
(201) 750-2646
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01
Other Events.
Elite Pharmaceuticals, Inc. ("Elite" or 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 SequestOxTM. 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. The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time.
For more information on the SequestOx end-of-review meeting, please see the December 22, 2016 press release, a copy of which is furnished herewith as Exhibit 99.1.
The CT on ELTP SEC Filings is not a court order. It is an award of ORDER GRANTING CONFIDENTIAL TREATMENT (CT) UNDER THE SECURITIES EXCHANGE ACT OF 1934.
Read the 10-Q and you will see which one it applies to.... they have many CTs. Any pharma company will have numerous CTs.
That was for medical devices, not the process for FDA CBER meetings.
The link below is guidance for CRL and timeframes for actions that ELITE would have to take and the timeframe for FDA reviews after resubmission.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.110