Elite Pharmaceuticals Inc (ELTP)

[Couch]

HERE IT IS FOLKS: The Couch BUY Signal has been lit UP once again:
((((ANYTHING UNDER .35))))

Previous Buy Signal was under .115 but considering the following ongoing positives in the last year it has been raised to ANYTHING & EVERYTHING ~~ BELOW ~~ .35.

Get them while you can they won't be sticking around:

1) New CEO in Nasrat Hakim as of August 2013. Previous VP of International Quality Assurance at Actavis. Yes Actavis the 3rd largest generic pharma in the World!

http://www.elitepharma.com/management.asp

2) Several successful Bioequivalent studies for several abuse deterrent opioids and upcoming data results from human liability studies this fall.

http://www.elitepharma.com/investor_relations.asp?goto=385

3) Acquisition of $40 million in Funding for ongoing abuse deterrent trials.

http://www.elitepharma.com/investor_relations.asp?goto=382

4) The going concern to operate from the most recent 10 Quarterly has been removed, first working capital of $3.7 million in 5 years plus additional $5 million from selling their position in Novel and the strongest balance sheet in the history of the company!

5) Continuing to acquire what I feel is the company's best asset.....their Intellectual Property Rights. 3 US Abuse Deterrent patents and 1 Canadian. Awaiting 4 more US patents and 4 International ones.

http://www.elitepharma.com/patents.asp

~~~~ AND should you want additional Due Diligence (DD) on the company here it is. Further, if you have any questions that need answering just ask. The DD longs here are a great source of information.

Best,
Couch

http://www.elitepharma.com/2014_Annual_Mtg_Docs/2014_Letter_to_Shareholders.pdf

http://seekingalpha.com/article/2295735-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q4-2014-results-earnings-call-transcript

http://seekingalpha.com/article/1905051-elite-pharmaceuticals-swinging-for-the-fences

http://seekingalpha.com/instablog/4199131-couch/1941422-elite-pharmaceuticals-eltp-intellectual-property-ip-and-the-right-to-devise-a-better-pain-killer

http://www.drug-dev.com/Main/Back-Issues/ROUNDTABLE-DISCUSSION-Reformulating-Opioids-to-Det-648.aspx

And one last piece of DD that is recent as well!!!

http://smallcapir.com/wp-content/uploads/2014/05/ELTP-CFA-Report.pdf

CONCLUSION
With 7 drugs on the market, 3 launched in the past four months one more due to launch soon and increased demand on the current products, Elite is growing. There are additional partnerships with Mikah/ Actavis (ACT), Hi-tech Pharmacal (HITK), Epic and others on generics and branded products in various stages. Elite also owns 10% of a fairly large Pharmaceutical company named Novel Labs.
In the recent FDA guidelines, the FDA notes the antagonist/agonist approach to abuse resistance. This works by combining the agonist (Opioid) with an antagonist (Naltrexone) in such a manner that the drug cannot be tampered with, without releasing the Naltrexone. Naltrexone fills the same receptors in the brain as does the Opioid. If an abuser crushes the pill up, the Naltrexone is released which negates a sense of euphoria and may even cause mild withdrawal symptoms. It is not abuse deterrent, it is abuse resistant because crushing it and snorting it or injecting it will not get the recipient the desired affect.

Elite's approach is to create a capsule combining beads of the agonist and beads of the antagonist. These are small, indistinguishable from each other and exhibit the same physical characteristics. The patents Elite has received cover their unique discovery of certain polymers and formulations used to sequester Naltrexone in this two bead concept. The Naltrexone passes through the body undisturbed while the agonist relieves pain.

The company has received further protection for these abuse deterrent products with the issuance of two patents, an additional patent allowed in the U.S. and the issuance of one Canadian patent in recent months. We have additional patents filed and pending in the U.S., Canada and Europe. Elite’s technology can be applied to any of the current opioids in the market place, and our goal is to broadly use our technology to reduce the current epidemic of prescription drug abuse.
In February/March ELTP soared to $.93/share based on news of increased revenue and forward movement with their ELI-201 product. The shares have retreated to a level around $.40/share. OxyContin represents a $2.7 billion dollar market within an eight billion dollar opioid market. Naltrexone seems to be a leading candidate to make OxyContin and other opioids drugs that are abuse free.

Even with the share dilution from the Lincoln Park agreement, the potential for the company’s drugs represents a multi-billion dollar value in a company with a current market value around $250 million. My opinion is to remain long on ELTP.