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DW: "However, I don’t doubt for a second that we won’t have a six month review."
. . . So, I am to take it that we won't have a six month review!
So much like everything else here these days.
Close GREEN today with flippers getting back in.
GLTA longs
"Due to the foregoing, demand for securities that are traded through the OTCBB may"
Found under the heading, "Risks Related to Our Common Stock", the
above fragment has me wondering why such a synopsis of the workings
of the OTCBB market is contained therein. In any case, I think we
may experience a significant rise in the PPS- an increase of a magnitude more commonly found on the OTCBB.
Another Friday afternoon announcement would seem appropriate.
-ELTP. . . I haven't heard from them in so long I thought
they borrowed my lawnmower!
ELTP Trades like Smith from 'The Matrix" is the MM in charge!
The lulls, the double-digit trades, the "draining". . . again
and again, this stock more than any other I have owned trades
to take advantage of negative human emotion
So. . . "Don't worry! Be Happy!" You've got ELTP!
Will we see LPC buying today?
I concur.
Although, that we 'should' close green today, might
be enough for us not to given recent actions. -Check out
the chart for SPIR- up we go on choppy seas.
That was the bottom. (54) JMHO
Obviously, these thugs can speculate about anything. . .
On the bright side, "Volume precedes price." Soon, these high-
volume days will be green and growing. We got a tease. Spring will soon arrive in ELTP-land. "Turn up the volume!". Sooner, rather than later we will be roaring past a dollar.
Let's have a 1.2 million share BUY this morning!
Sorry MODS, very crazy 24 hrs. here. Actually, I am a "Buy. Hold. Accumulate." kind of guy. (-cancelled a rare sell order at .94 this
morning) DARN! Your strategy is sound. I just don't have the $$$ to avail myself of the excellent opportunity today's price movement provides. To top it off, I am owed quite a lot that I doubt I will ever recover. Call it a collusion of the elements rendering me temporarily myopic. I am still learning. I am still learning. . . Ouch! Ooch! Eech! Ouch!
It could be argued that for my lapse I deserve to sell and watch the stock sky-rocket. In any event, I'll take a bad day in ELTP Land over most other places anytime. I forget this is a "blip", a "hiccup", a "rain-shower. Frequently, "flipping" is rightly characterized as "greedy" behavior with all the attendant consequences such entails. An argument exists which asks the question, "Why would you ever do such a thing?".
and. . . So long ELTP board. (LENT/ No pun intended)
Geeze! Just that sometimes it seems to have it's hand in my pocket.
"Duly noted, Sir or Madam." Good call MOJO, ie. "80's".
Buy now or forever hold your. . . Mojo?!!!
Dr. Lowenstein stole his mojo!
To think this all started with a dog barking at a conference call!
ELITE PHARMACEUTICALS REPORTS SUCCESSFUL PIVOTAL BIOEQUIVALENCE STUDY
FOR ABUSE DETERRENT PRODUCT ELI-200
NORTHVALE, N.J. – March 5, 2014 – Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite’s undisclosed abuse deterrent opioid product, ELI-200. The study results demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 42 subjects under fasted conditions and 38 subjects under fed conditions.
The formulation utilized Elite’s proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were also evaluated and dosing of Elite’s intact formulation resulted in almost no exposure levels to naltrexone (LOQ of 4 pg/mL) and its metabolite 6-b-naltrexol (LOQ of 10 pg/mL) as intended. Elite will proceed with the development program for this product including completion of a human abuse liability study. Elite expects to file an NDA for this product by year end.
"As I have stated before, we have set in motion several initiatives that will have significant impact on Elite’s future,” commented Nasrat Hakim, Elite’s President and CEO. "Following the success of the pilot bioequivalence study in December for ELI-201, we are delighted with the results of this pivotal bioequivalence clinical study for ELI-200, our second opioid abuse deterrent product. ELI-200 is expected to be filed this year and will be the first NDA product filed by Elite with the U.S. Food and Drug Administration.”
The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
About Elite’s Abuse Deterrent Technology
Elite’s abuse deterrent products utilize the Company’s proprietary pharmacological abuse deterrent technology. Elite’s abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
About Camargo Pharmaceutical Services
Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite’s lead pipeline products include abuse resistant opioids utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
This news release contains "forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, 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, its 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 risks and other factors, including, without limitation, the Company’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, intellectual property protections and defenses, and the Company’s ability to operate as a going concern, 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 undertakes no obligation to update any forward-looking statements.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
Just bought a new car.
The 2014 KIA Cadenza.
The great Consumer Reports review prompted me to take
a test-drive. I was also considering; Chevy Impala, Buick
Regal, Acura TL, and Nissan Maxima. The KIA comes with a great
warranty, but what sold me was the wishbone suspension. It reminded me of an old car ad where a guy cuts a diamond while the car is driving over railroad tracks. Driving around now, I am amazed at how many KIA's I see.
It has been a bumpy road for ELTP, but looks like clear sailing ahead. I had to sell my sailboat a couple of years ago, but thanks to the excellent work of the folks at ELTP I'm looking forward to being lost in pea-soup fog once again. ELTP- A beacon in the night!
As per the Form-4's/ MoneyTree's posts:
In my inbox from "Penny Pick Insider's":
New insider filings for ELTP: ELITE PHARMACEUTICALS INC /NV/
First-Class Insider (President & CEO): Hakim Nasrat A
Acquired 2,616,580 Common Stock (Non-Derivative security at $0.111) on Feb 25, 14. Direct holding 11,714,141 shares/units after transaction. Holdings increased 28.76%.
First-Class Insider: NARINE JEENARINE
Acquired 220,106 Common Stock (Non-Derivative security at $0.091) on Feb 25, 14. Direct holding 6,177,728 shares/units after transaction. Holdings increased 3.69%.
First-Class Insider (Chief Scientific Officer): NIGALAYE ASHOK G
Acquired 220,106 Common Stock (Non-Derivative security at $0.091) on Feb 25, 14. Direct holding 12,275,289 shares/units after transaction. Holdings increased 1.83%.
Acquired 2,000,000 Common Stock (Non-Derivative security at $0.063) on Feb 25, 14. Direct holding 14,275,289 shares/units after transaction. Holdings increased 16.29%.
Sold 2,000,000 Warrants (Derivative security at conversion or exercise price: $0.063) on Feb 25, 14. Direct holding 1,333,333 shares/units after transaction. Warrants expires on Jun 3, 16. Holdings decreased -60.00%.
Senior Officer (CFO, Secretary, Treasurer): Ward Carter Julian
Acquired 330,159 Common Stock (Non-Derivative security at $0.091) on Feb 25, 14. Direct holding 875,582 shares/units after transaction. Holdings increased 60.53%.
Director: WHITNELL JEFFREY A
Acquired 220,106 Common Stock (Non-Derivative security at $0.091) on Feb 25, 14. Direct holding 977,399 shares/units after transaction. Holdings increased 29.06%.
I too appreciate all the great DD. ELTP! "To infinity and beyond!"
Some NEWS would be welcome right about now. . . What's on tap?
I would guess that today's trading might follow a horseshoe pattern- high in the morning, then low, then high again in the afternoon. I am perfecting my home office with some of my ELTP profits. I'll put a horseshoe over the door! GLTA
It's lunchtime?
New insider filings for ELTP: ELITE PHARMACEUTICALS INC /NV/
10% shareholder: EPIC PHARMA LLC
Sold 275,000 Common Stock (Non-Derivative security at $0.126) on Dec 5, 13. Indirect holding 71,004,867 shares/units after transaction. Holdings decreased -0.39%.
Sold 23,626 Common Stock (Non-Derivative security at $0.118) on Nov 26, 13. Indirect holding 71,279,867 shares/units after transaction. Holdings decreased -0.03%.
First-Class Insider: NARINE JEENARINE
Sold 275,000 Common Stock (Non-Derivative security at $0.126) on Dec 5, 13. Indirect holding 15,621,069 shares/units after transaction. Holdings decreased -1.73%.
Sold 23,626 Common Stock (Non-Derivative security at $0.118) on Nov 26, 13. Indirect holding 15,681,569 shares/units after transaction. Holdings decreased -0.15%.
First-Class Insider (Chief Scientific Officer): NIGALAYE ASHOK G
Sold 275,000 Common Stock (Non-Derivative security at $0.126) on Dec 5, 13. Indirect holding 21,301,460 shares/units after transaction. Holdings decreased -1.27%.
Sold 23,626 Common Stock (Non-Derivative security at $0.118) on Nov 26, 13. Indirect holding 21,383,960 shares/units after transaction. Holdings decreased -0.11%.
Trend Analysis
MarketClub’s Trade Triangles for ELTP
The long term trend has been UP since Aug 13th, 2013 at 0.090000
The intermediate term trend has been UP since Nov 29th, 2013 at 0.125000
The short term trend has been UP since Nov 26th, 2013 at 0.104500
Smart Scan Analysis for ELTP
Based on a pre-defined weighted trend formula for chart analysis, ELTP scored +100 on a scale from -100 (strong downtrend) to +100 (strong uptrend).
Insider Trading Alert
New insider filings for ELTP: ELITE PHARMACEUTICALS INC /NV/
10% shareholder: EPIC INVESTMENTS, LLC
Sold 25,000 Common Stock (Non-Derivative security at $0.121) on Nov 27, 13. Direct holding 71,403,493 shares/units after transaction. Holdings decreased -0.04%.
Sold 357,000 Common Stock (Non-Derivative security at $0.121) on Nov 26, 13. Direct holding 71,428,493 shares/units after transaction. Holdings decreased -0.50%.
Sold 39,000 Common Stock (Non-Derivative security at $0.123) on Nov 11, 13. Direct holding 71,785,493 shares/units after transaction. Holdings decreased -0.05%.
10% shareholder: EPIC PHARMA LLC
Sold 25,000 Common Stock (Non-Derivative security at $0.121) on Nov 27, 13. Indirect holding 71,403,493 shares/units after transaction. Holdings decreased -0.04%.
Sold 357,000 Common Stock (Non-Derivative security at $0.121) on Nov 26, 13. Indirect holding 71,428,493 shares/units after transaction. Holdings decreased -0.50%.
Sold 39,000 Common Stock (Non-Derivative security at $0.123) on Nov 11, 13. Indirect holding 71,785,493 shares/units after transaction. Holdings decreased -0.05%.
First-Class Insider: NARINE JEENARINE
Sold 25,000 Common Stock (Non-Derivative security at $0.121) on Nov 27, 13. Indirect holding 15,708,769 shares/units after transaction. Holdings decreased -0.16%.
Sold 357,000 Common Stock (Non-Derivative security at $0.121) on Nov 26, 13. Indirect holding 15,714,268 shares/units after transaction. Holdings decreased -2.22%.
Sold 39,000 Common Stock (Non-Derivative security at $0.123) on Nov 11, 13. Indirect holding 15,792,808 shares/units after transaction. Holdings decreased -0.25%.
First-Class Insider (Chief Scientific Officer): NIGALAYE ASHOK G
Sold 25,000 Common Stock (Non-Derivative security at $0.121) on Nov 27, 13. Indirect holding 21,421,048 shares/units after transaction. Holdings decreased -0.12%.
Sold 357,000 Common Stock (Non-Derivative security at $0.121) on Nov 26, 13. Indirect holding 21,428,528 shares/units after transaction. Holdings decreased -1.64%.
Sold 39,000 Common Stock (Non-Derivative security at $0.123) on Nov 11, 13. Indirect holding 21,535,048 shares/units after transaction. Holdings decreased -0.18%.
Calm Before The Storm?
Opportune time to "get all your ducks in a row."
In any event, news is immanent. Hope they
"open the floodgates" and we sail past .30 short-
term. Even then, I may only sell a small percentage
of my shares. GLTA longs.
Previous share conversion impacts upon PPS
What makes this a big deal?
-like to see a series of solid gains, but
I expect the price to maybe hit .14 and
settle in between .11 and .12. Better up
than down. Am I missing something?