Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

I agree that elite MAY gain market share in the acute pain market IF their tech is any good at all

I would note that this is a $4 billion dollar market just for immediate-release opioids.

...however, I do not see the ultimate leap into the chronic pain market. For once, there is the convenience issue, if you could take a once or twice a day product vs three times a day, the preference in every market research study is for the more convenient dosage form..

ELTP 2 bead pharma-based ADF is totally modular and can be applied to any opioid agonist and time-release characteristic. ELI-201 is 12 hour oxy and ELI-216 is 24 hour oxy. 12 and 24 hour versions of hydrocodone, hydromorphone, oxymorphone, and morphine easily doable.

But, the larger issue is that off label use in the opioid market is rapidly changing. The FDA is unlikely to approve promotion without chronic use clinical data (a two year program)...

I know you follow IPCI, and their management claims FDA has formally informed them that Rexista (12 hour oxy with mechanical ADF) would not require Phase 3 if bioequivalence to OxyContin is proven. Assuming this is true, does this not indicate that FDA is willing to forego years-long studies to prove efficacy for chronic pain? Another strategically-prudent maneuver by NH... prove the ADF tech with quick & dirty acute pain indication and then line up the chronic pain 12 and 24 hour formulations for FDA blessing without lengthy chronic pain studies.

the DEA tracks how these drugs are being prescribed and seeing scripts for long term use of products approved for acute pain only is s big red flag, and more importantly, the payors are very unlikely to pay for off label use in this field.

Immediate-release opioids are used for chronic pain all day every day as prescribed by just about everybody with a DEA license, including me. FDA has already proven their ability to revolutionize the acute pain market with one simple decision. Vicodin (acetominophen/hydrocodone) used to be #1 prescribed opioid BY FAR, right up to the minute it was taken off the market due to too much acetaminophen. Other hydrocodone formulations quickly moved in to take its place. Why? Because hydrocodone was Schedule III and could be Rx'ed by phone, fax, NP, PA, dentists, refills, etc, etc... But now hydrocodone is moved up to Schedule II where it belongs, just like the other opioids. Now it is Rx'ed one month at a time on a signed, paper script that must be picked up in person and presented to pharmacy in person. Takes away all the prescriber convenience of hydrocodone, and I suspect you'll see hydrocodone start to lose market share precipitously. The point being simple decisions by FDA can and will cause upheaval in the market now and in the future, and ELTP 2 bead pharma-based ADF is perfectly positioned to take advantage of the changing landscape of opioid pain management.

So, elite, MAY have a nice little product here, but that is about it .

That's all we need...to start...