MOMO'S BREAKOUT BOARD

[Bngo]

According to Elite's CEO, Nasrat Hakim, once this technology is approved with Elite's first formulation, ELI-200, this same technology can be applied to 16 other formations with various opioids.

Thus, we are not just looking at just 1 formulation but a total of 17 formulations covering most if not the entire opioid treatment class.

I worked for AstraZeneca for 9+ years and my sister works for Merck for 25+ years, yet I have zero stock with either company at this time.

100% of my investment is with ELTP!

Why?
Because we are dealing with opioids and naltrexone that have been in the market place for years and have been deemed safe and efficacious.

In my opinion, the Human Abuse Liability study was the most significant study where it shows that Naltrexone did not leak when taken as intended orally, and patients also did not get a greater high/euphoria when Eli-200 was crushed and snorted.

I had expected the Phase 3 to pass easily because again we are dealing with generic compounds that have been safe and effective for years already in the market place.

I expect the same Phase 3 results for the other 16 formulations moving forward.

Many companies out there have interestining/novel drugs in clinical Phase 3 trials treating various diseases that I would also like to invest in as well.
If approved, these drugs can bring in $Millions and perhaps $Billions to these companies.

However, because they are new compounds and not generic, I am still worried about potential renal failure, liver damage, cardiovascular risk, or psychotropic events, etc. that would end their attempt for NDA quest.

Again, this is why 100% of my money is with Elite Pharmaceuticals vs. other bigger pharma companies like AZN, MRCK, or PFE at this time.



Elite Pharmaceuticals Announces Positive Top-Line Results From A Pivotal Phase 3 Study For Abuse-Deterrent Opioid ELI-200
Meets Primary and Secondary Endpoints
NORTHVALE, N.J., Oct. 21, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced positive top-line results from the Phase 3 pivotal trial of its lead opioid abuse-deterrent candidate, ELI-200, for the treatment of moderate to severe pain.

The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial.

Elite intends to submit a New Drug Application to the U.S. Food and Drug Administration for abuse-deterrent ELI-200 by year-end.

"I am pleased with completing this important step in the commercialization of our first abuse-deterrent product, ELI-200," said Nasrat Hakim, President and Chief Executive Officer of Elite. "The next significant step will be the submission of the NDA for ELI-200 which I expect to occur by year-end."

About the Phase 3 ELI-200 Trial

The Phase 3 study evaluated safety and efficacy following dosing of ELI-200 for the treatment of moderate to severe pain following surgery. It was a multicenter, randomized, multiple-dose, double blind, placebo-controlled, and parallel group study. The clinical trial was conducted at five study sites in the United States which randomized 163 patients into the clinical study.

About Elite's Abuse Deterrent Technology

Elite's proprietary abuse deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid 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 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. Elite's pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.