Replies to post #105946 on Elite Pharmaceuticals Inc (ELTP)

[lasers]

Elite’s 1st Generation Triple Patents and their Purpose

Many Shareholders have asked that I post a simple easy to read non-technical clarification of $ELTP 1st generation 3 Patents.

Elite’s 1st Generation Patents

8,182,836 Patent….Patent Application 12/478,952
8,425,933 Patent….Patent Application 12/640,344
8,703,186 Patent….Patent Application 13/863,764

8,182,836 Patent….Patent Application 12/478,952

This is the 1st of the Triple Patents and has been awarded to $ELTP based on its ADT Pharmacological approach of neutralizing opioid agonist abuse with an opioid antagonist that have been administered together.



8,425,933 Patent….Patent Application 12/640,344

This is the 2nd of the Triple Patents and has been awarded to $ELTP based on its 2-bead modular approach of identical physical attributes for separate agonist bead and an antagonist bead. This 2-bead tech is $ELTP Preferred Embodiment and is graphically illustrated on $ELTP website.

http://www.elitepharma.com/How_AR_Tech_Works.pdf


8,703,186 Patent….Patent Application 13/863,764


This is the 3rd of the Triple Patents and has been awarded to $ELTP based specifically on the manufacturer details for the 50 mg Naltrexone bead and its sequestering polymer to absolutely minimize Naltrexone leakage. The 50 mg Naltrexone bead is premade and can be used with any agonist opioid both type and expected dosage ranging up to 24 HR ER. The Preferred Embodiment supports the 2-bead modular technology outlined in $ELTP’s 8,425,933 Patent where unidentifiable agonist and antagonist beads are mixed together in one capsule.

In addition general broad-brush reference is made to a non-modular single bead technology manufactured with layering the agonist on to the antagonist but no specific manufacturing illustrations are given that can actually be patented. So it remains as a trade-secret or basis for a possible future single bead patent or simply $ELTP keeping its R&D “possibilities” open.

I hope this helps explains the reasons for the 3 patents. I will over time update this explanation as needed. Any questions please ask.

[lasers]

Lot of nervous investors, it seems! I guess the +12 mil Naked Shorters reported RegSho to FINRA for Apr2014 to date may be thinking of buying-to-cover??

Yes indeed a 2 to 3 mil vol day is exactly what $ELTP PPS needs for the $0.40s heading to the $0.50s.

[Steges]

Embeda, a morphine/naltrexone combination delivered by capsule, was approved by FDA for use as a Schedule II drug, with the label: Embeda can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Embeda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. The key point is that there was no data filed with the registration suggesting that there was evidence that Embeda is less likely to be abused than other extended-release morphine drugs. In addition, in a clinical trial, 11% of patients have naltrexone showing up in their blood stream. Net, Embeda is viewed as a marginal improvement over morphine alone.

So we have Embeda we have a lot of emphasis by the vendors, manufacturers, drug companies, pharmaceutical agencies to try to develop substances which have deterrents against abuse. That doesn’t really solve the problem because for every system there is somebody who has the wherewithal, the knowledge, the background, the training, the experience to kind of thwart the efforts at limiting the abuse potential of every agent that has ever been developed. However, you need to be able to produce the drug without stability issues!

It has been since March 2011 and Pfizer obviously has not been able to correct the stability issues. Pfizer said it would have this fixed in a matter of months.

How this relates to Elite: Well, if they can prove that they do not have stability issues with their version of Embeda, things get very interesting. Furthermore, Elite's ART is the first I have seen that actually can mitigate those aforementioned folks with the wherewithal, knowledge and background to thwart the abuse resistant properties of the drug. This will be proved in the upcoming human abuse liability studies.