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New ELTP Job Posting:
Production Operator
About the Job
Operator/R&D Technician
JOB PURPOSE:
Lead Operator for Pharmaceutical Manufacturer of R&D and commercial products. Reports to Manager of Operations and/or Manager of R&D.
DUTIES:
Ensure the proper set-up and operation of standard pharmaceutical process equipment including tablet presses, tablet coaters, granulators, encapsulators, and fluid bed coaters.
Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols.
Ensure completion of equipment logs and/or lab notebooks.
Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).
Ensures accuracy of Standard Operating Procedures (SOP’s).
Weighs out material and components for production batches.
Works in GMP environment and ensures regulatory compliance.
Interface and consult with Analytical R&D and Quality Assurance.
Ensure proper training is completed for all operators.
QUALIFICATIONS:
Minimum of 5 -10 years experience in the pharmaceutical industry in solid oral operations or development groups;
High School degree or equivalent. College degree a plus;
Enthusiastic and self motivated;
Proven leadership abilities;
Experience supervising junior level operators;
Able to communicate effectively with operators and management;
Training experience a plus.
Located in northern New Jersey.
Elite Pharmaceuticals offers a competitive salary and benefits package and is an equal opportunity employer.
Please forward resumes to:
Via E-mail: hr@elitepharma.com
Via Facsimile: (201) 750-2755
Via US Mail:
Elite Pharmaceuticals, Inc.
ATTN: Human Resources
165 Ludlow Ave.
Northvale, NJ 07647
Actually their market caps are very similar.
Elite just has a lot more outstanding shares.
On just 20,000 shares. Might be just a shake out.
Why does that matter?
Is Elite "behind"? Who cares?
Is Elite "Better" Who knows?
All I know is if Elite captures just 2% of the 2.7 billion Oxy market the PPS can very easily reach $1/share. And that does not include the many other ART products that can be made with their tech. Nor does it include the many other generic drugs.
I say more power to Pfizer and Purdue.
Of course buying their stock (in the case of Pfizer) won't give me 1000% returns either.
I have.
This is my explanation. I'll type as slowly as I can.
There was just one sale by Epic Investments on 1/17 of 805,538 shares. These are reported as "directly held".
The shares reported as sold by Epic Pharma, Narine and Nigalaye are the same shares.
These shares are indirectly owned through Epic Investments.
The amounts they are reporting are the pro-rata number of shares they own through Epic Investments.
It's so simple....even a seasoned trader can understand it.
Oh, and here is the exact reply I received from Diane...
You are correct.
The forms explain that – especially if one reads the footnotes.
Epic Investments (EI”) is the direct holder.
Epic Pharma (“EP”), Ashok and Jai are indirect owners of EI.
Anytime EI has a filing event, EP, Ashok and Jai all must file as an indirect owner of EI.
Therefore, for each triggering event of EI, there are three additional filings for the indirect owners for the same event.
As for the total ownership in Box 5 of the form 4’s, the total ownership being reported for Jai and Ashok is only the percentage of ownership each has personally of EI and EP.
I agree and my understanding that has been made a higher priority.
Not a higher priority than say, developing multi-billion dollar drugs of course.
Fortunately for all of us our DD went well beyond window dressing.
That is not a fact but a question.
Thanks for confirming you are putting forth opinions rather than facts.
Nothing random about it. It has tripled since September. What is hard to understand about that?
I certainly remember April 2011. And yes it did fall quickly because they lost their sole source of income. They now have multiple streams of income and have pretty much kicked ass since.
So what is your point?
Why has the stock price increased three fold?
What does this number mean?
69,733,099
It's Epics remaining shares owned.
Why do you think they sold those 800,000 or so shares?
They are feeding the lamb to fatten it up.
If I have 10 lbs of food in my pocket but no lamb will I not eventually starve?
If I have a healthy lamb and I feed it does that mean I don't believe in the lamb?
If I plump up the lamb with feedings does that not benefit me?
Epic is feeding the lamb. They will soon feast.
Think.
Couldn't tell you.Long term it's going up, otherwise I wouldn't be holding so many shares.
I traded some of my shares in the past but really not inclined to do so now.
I don't pay much attention to RSI but I'm sure one of the many more technically oriented traders here can help with that.
Here is more detail on this.
Definitely opens the door to tamper resistant Oxy....
know anybody in that business?
Law360, Los Angeles (January 14, 2014, 6:32 PM ET) -- A New York federal judge on Tuesday found that Teva Pharmaceuticals USA Inc. did not infringe any valid Purdue Pharma LP patent when it attempted to sell a generic version of narcotic pain medication OxyContin.
U.S. District Judge Sidney H. Stein concluded that Purdue had failed to prove Teva had infringed U.S. Patent Number 7,776,314 when it sought approval from the U.S. Food and Drug Administration to sell bioequivalents of OxyContin, and that the asserted claims in the remaining four patents-in-suit — U.S. Patent Numbers 7,674,799, 7,647,800, 7,683,072 and 8,114,383 — are invalid.
“The court concludes that Teva has not infringed any valid patent asserted by plaintiffs. Plaintiffs have not carried their burden of proving infringement of the ‘314 patent,” Judge Stein wrote in the findings documents. “Although plaintiffs have proved by a preponderance of the evidence that Teva’s proposed products infringe the ‘799, ‘800, ‘072, and ‘383 Patents, Teva has proved by clear and convincing evidence that the asserted claims of those patents are invalid.”
The judge’s decision follows a 20-day bench trial and comes more than a month after Impax Laboratories Inc. settled a similar suit that was also rolled into antitrust multidistrict litigation in New York federal court.
The judge denied Purdue's requests for relief and issued a number of declaratory judgments in favor of Teva, finding certain claims of the patents-in-suit to be invalid.
Teva previously had argued that its version of a tamper-resistant type of OxyContin, known generically as oxycodone, does not infringe patents that Purdue licensed from a university. Teva also said the patents are invalid, according to court documents.
Although Purdue’s patents on straightforward formulations of OxyContin, a potent painkiller, have expired, it says it retains the rights to make versions that are designed to prevent the recreational abuse of the drug. The oxycodone formulation at issue is designed to make it hard for users to crush tablets and inject them, a technique that has earned the extended-release drug the moniker “hillbilly heroin."
The Purdue patents cover techniques through which drug components are mixed as a molten liquid and squeezed out of a machine, a technique that distributes the active painkiller through a difficult to break nonactive chemical.
Philip C. Strassburger, Purdue’s vice president and general counsel, said the company plans to challenge the court's decision.
“We are confident in the strength and validity of our patents and are disappointed in the court’s decision,” Strassburger told Law360 on Tuesday. “We intend to appeal.”
A representative for Teva declined to comment Tuesday.
Plaintiffs are represented by Robert J. Goldman, Sona De and Pablo D. Hendler of Ropes & Gray LLP.
Teva is represented by Todd S. Werner and David M. Hashmall of Goodwin Procter LLP and by Mark D. Schuman, Todd S. Werner and Jennell C. Bilek of Carlson Caspers Vandenburgh Lindquist & Schuman.
The patents-in-suit are U.S. Patent Numbers 7,674,799, 7,647,800, 7,683,072, 7,776,314 and 8,114,383.
The cases are Purdue Pharma LP et al. v. Teva Pharmaceuticals USA Inc., case numbers 1:11-cv-02037 and 1:12-cv-05083, in the United States District Court for the Southern District of New York.
The MDL is In re: Oxycontin Antitrust Litigation, case number 1:04-md-01603, in the same court.
--Additional reporting by Richard Vanderford and Michael Lipkin. Editing by Richard McVay.
Anybody see this yesterday?
http://www.bloomberg.com/news/2014-01-14/purdue-pharma-loses-oxycontin-patent-trial-against-teva.html?cmpid=yhoo
Purdue Pharma Loses OxyContin Patent Trial Against Teva
By Patricia Hurtado Jan 14, 2014 6:52 PM ET - Comments Email Print
Teva Pharmaceutical Industries Ltd. (TEVA), the world’s biggest generic drugmaker, didn’t infringe any of Purdue Pharma LP’s valid patents related to the painkiller OxyContin, a federal judge ruled after a nonjury trial.
U.S. District Judge Sidney Stein in Manhattan today also invalidated some of the six Purdue patents covering the drug that were involved in the case. Purdue argued that Teva, which manufactures generic pharmaceutical products, infringed its patents by seeking approval from the U.S. Food and Drug Administration to sell an equivalent of OxyContin.
Stein said in his ruling that while Teva infringed at least three of Purdue’s patents, it escaped liability for the infringement because it demonstrated that the patents were “obvious” and therefore invalid.
“The court concludes that Teva has not infringed on any valid patents asserted by plaintiffs,” Stein ruled. “Although plaintiffs have proved by a preponderance of the evidence that Teva’s proposed products infringe” upon four patents, “Teva has proved by clear and convincing evidence that the asserted claims of those patents are invalid,” Stein said.
OxyContin sales made up about $2.81 billion of the $9.38 billion U.S. market for prescription painkillers in 2012, according to IMS Health Inc., a health-care data provider based in Danbury, Connecticut.
American depositary receipts of Teva, which is Israel’s biggest company, rose as much as 4.4 percent after the ruling. Teva rose 6.7 percent to $44.21 at the close in New York, the highest price since May 8, 2012.
Appeal Planned
James Heins, a spokesman for Stamford, Connecticut-based Purdue, said the company intends to appeal.
“We are confident in the strength and validity of our patents and are disappointed in the court’s decision,” Heins said.
Denise Bradley, a spokesman for Teva, declined to comment on the ruling.
In April, Purdue settled a patent-infringement lawsuit against Actavis Inc. over OxyContin, a narcotic used to treat pain from cancer and other conditions that can also be abused by addicts.
Purdue granted Actavis (ACT) a license to sell “defined quantities” of a generic version of the drug as early as this year, the companies said in a statement at the time. Actavis, based in Morristown, New Jersey, would acknowledge that its formulations infringed the Purdue patents, according to the statement.
Prescription painkillers were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, according to the Centers for Disease Control and Prevention. Drugmakers including Purdue and Endo Health Solutions Inc. (ENDP) are attempting to make tamper-resistant formulations that deter tablet crushing that gives addicts a greater high.
The case is In Re OxyContin Antitrust Litigation, 04-md-01603, U.S. District Court, Southern District of New York (Manhattan).
To contact the reporter on this story: Patricia Hurtado in Federal Court in Manhattan a
I know you pride yourself on your DD. Perhaps you overlooked NH's extensive regulatory experience? Actually, no perhaps about it....
• Twenty six years of pharmaceutical and medical industry experience in Quality Assurance, Quality Control, AR&D and Regulatory Compliance.
• Educational discipline in Law (JD/LLM), Business, Regulatory Affairs (RAC) and Chemistry/Bio-Chemistry (MS).
• Proven management experience establishing new departments, building cross-functional teams, creating sustainable GxP-compliant programs and preparing domestic and international sites for successful FDA/regulatory inspections.
• Extensive quality experience designing and implementing Corporate Quality Systems impacting multiple sites, and managing internal and external compliance oversight and risk assessment.
• In-depth technical knowledge of quality and manufacturing systems and technologies including immediate and extended release formulations used in solid dosage, transdermals, (Medical Device) insert and implant finished products.
• Solid regulatory command of GMP’s, national and International regulations. Ability to research, analyze and implement systems to comply with global regulations in support of timely and successful new product applications.
• Successful change agent via creation and implementation of global compliance program and remediation of existing programs and systems across multiple sites.
If this is a pump and dump stock show me some more!
I'll take a 68% return any day!
I was told the same thing. Yet I made money on the stock since then.
Go figure.
Elite home page updated with direct link to R&R PowerPoint presentation.
http://www.elitepharma.com/ELTP%20Rodman%202013.pdf
...it certainly has been done.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2997309/
In seven BE studies the pharmaceutical products had two active ingredients and in one study three (isoniazid, pyrazinamide and rifampicin). In these cases all active substance were analyzed independently for BE purposes.
Are you referring to this?
http://www.elitepharma.com/investor_relations.asp?goto=288
SA Article out:
http://seekingalpha.com/article/1903051-strong-demand-for-resistance-technology-bodes-well-for-intellipharmaceutics?source=email_rt_article_readmore_button&app=1
I just picked up 7000 @ $3.29 and $3.30
I took a flier @ 3.37
Effexor up next within 60 days my guess.
Thanks Lasers. Everyone have a great weekend!
Some perspective:
Posts from doubters on JAZZ...when it was about .76/share
Now its over $114/share.
SOUTHFORK Thursday, 11/20/08 08:46:42 PM
Re: mlkrborn post# 24
Post # of 188
This will be a dime soon, best to run while you can.
Oscar Grouch Wednesday, 04/22/09 04:25:42 PM
Re: None
Post # of 188
And the collapse continues…sad
Novel Vaccine Dramatically Boosts Survival in Glioblastoma
Roxanne Nelson
December 05, 2013
A novel therapy has extended survival in glioblastoma patients far beyond the current median. After undergoing surgical resection and standard treatment, half the patients treated with the experimental vaccine in a small phase 1 study survived more than 5 years.
The usual median survival in such patients is around 15 months, but in this study, 7 of the 16 participants are still alive, with survival ranging from 60.7 to 82.7 months after diagnosis.
The findings were published earlier this year (Cancer Immunol Immunother. 2013;62:125-135) and were presented last month at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology in San Francisco.
It is striking that this many patients are still alive, said study author Keith Black, MD, chair of the Department of Neurosurgery and director of the Neurosurgical Institute at Cedars-Sinai Medical Center in Los Angeles. "Some patients are approaching 7 years, and 4 are alive without any sign of recurrence and living normal lives," he told Medscape Medical News. "Another patient has some signs of recurrence but is stable."
"I am not aware of any other trial that has had such dramatic results for glioblastoma multiforme," Dr. Black said. However, a question remains: "Is this just a statistical fluke, or is the mechanism of action of this vaccine really providing such a robust increase in survival?"
I am not aware of any other trial that has had such dramatic results. Dr. Keith Black
The experimental therapy, known as ICT-107, is an autologous vaccine that consists of a patient's dendritic cells pulsed with 6 peptides from tumor-associated antigens: AIM-2, TRP-2, HER2/neu, IL-13Ra2, gp100, and MAGE1. The vaccine is being developed by ImmunoCellular Therapeutics.
"One of the speculations is that the antigens are also targeting cancer stem cells, which may actually be part of the mechanism for the robustness of these results," Dr. Black explained. "We have also initiated 2 other vaccine trials at Cedars-Sinai targeting these cancer stem cells."
Survival Beyond 5 Years
The primary objective of the study was to determine the benefit of the ICT-107 vaccine in patients newly diagnosed with glioblastoma multiforme and to identify patients who survived longer than 5 years or who were disease free more than 5 years after receiving the vaccine.
The 16 study patients had undergone surgical resection and standard follow-up therapy with concurrent temozolomide and radiation. Only 4 patients did not undergo complete resection.
Patients were human leukocyte antigen serotype A1 or A2, and had at least 1 of the vaccine antigens present in their tumor. The vaccine was administered intradermally 3 times at 2-week intervals.
Median progression-free survival in the cohort was 16.9 months, and the 5-year rate of progression-free survival was 37.5%. Median overall survival was 38.4 months, and the 5-year rate of overall survival was 50%.
Eight of the 16 patients survived more than 5 years, and 7 are still alive (at 60.7, 65.1, 67.5, 67.4, 69.4, 77.9, and 82.7 months).
In 6 patients, progression-free survival has been more than 5 years. Four of the 6 continue to be disease-free at 65.1, 67.4, 77.9, and 82.7 months. One patient died of leukemia at 61 months, but the leukemia was not related to the therapy, Dr. Black explained. Another patient, who developed tumor progression at 62 months and underwent surgery and active treatment with temozolomide, is currently stable and doing well, he reported.
All of the long-term survivors had tumors with at least 5 antigens, and 75% percent had tumors with all 6 antigens. In addition, 100% expressed at least 4 cancer stem cell antigens (AIM2, TRP-2, HER2/neu, IL-13Ra2).
The secondary outcome of interferon-gamma response was significantly higher in those who survived at least 5 years than in those who did not (P = .0499).
Phase 2 Trial Underway
On the basis of this single-institution phase 1 trial, a phase 2 trial was initiated. "It is being conducted at 25 medical centers, and is randomized, placebo-controlled, and blinded," Dr. Black reported.
About 125 patients are now enrolled, and preliminary results will be released after 64 events, he explained.
"If the results are as good as the phase 1 trial, where we saw a very robust response, and if there is a greater than 9-month median survival increase, there will be a lot of interest in talking with the FDA about accelerated approval," Dr. Black said. "But if it is an intermediate increase, such as 3 to 4 months, we will be looking at a larger phase 3 trial."
Dr. Black reports owning stock in ImmunoCellular Therapeutics. Several members of the research team report ties to the company.
4th Quadrennial Meeting of the World Federation of Neuro-Oncology. Presented November 23, 2013.
Medscape Medical News © 2013 WebMD, LLC
Send comments and news tips to news@medscape.net.
Cite this article: Novel Vaccine Dramatically Boosts Survival in Glioblastoma. Medscape. Dec 05, 2013.
He sold 8000 shares, He holds over 6,000,000 shares.
And that causes you to panic?
Dude take a Xanax!
"Doctor" any serious investor, knowing that PK studies lead to efficacy studies would be excited.
What is your issue with PK studies "Doctor"?
The study is in the public domain "Doctor".
Not sure why anyone would find it difficult to find.
I thought the statement of expecting to get to a pace of one ANDA a quarter/ four per year was notable.
Think about that.
Don't just value it on the "current" pipeline. Value it on a pipeline that could be twice as big in 3 years.
So you agree he owns 11 million shares purchased on the open market.
Thanks doc.
Actually it was.
The quote from Nasrat on the conference call was:
"Nasrat Hakim: I have purchased more than 11 million shares including 2 million in my 401K and they are all locked and not for sale anytime soon. "
How else do we suppose he acquired these shares? Osmosis? Divine gift? They fell out of a piñata?
Jerry Puts His Money Where His Mouth Is.
Nice.
Mr. Treppel stated that "Elite is now in the best financial, operational, and product development position in its history. Elite is only days away from the beginning of its first human clinical trial on its twice daily oxycodone/naltrexone product. I welcome the opportunity to substantially increase my equity position in the company.”
I did and I stated my conclusion.
I made a quick spreadsheet and uploaded to Google Docs to track pipeline and perhaps put dates and values on it.
Obviously I took a very conservative route with the numbers.
I know this is far from perfect but would appreciate input to make this better.
https://drive.google.com/file/d/0BwI9WYgqHk9mOFdMS3VIQ3ZmOW8/edit?usp=sharing
It wasn't "promoted" by these companies. There is no "pump" in it other than regurgitating what was in the official PR.
These guys just put out articles on stocks that are in play to get people to sign up for their newsletters or whatever.
Thanks all. I did read the SA article and the presentation. Was wondering if anyone mapped out best case/ worse case revenue projections on a time line etc.
Guess I'll have to take a stab myself!
Has anyone done a serious revenue projection for this stock?