Replies to post #204342 on Elite Pharmaceuticals Inc (ELTP)

[IB_]

Nasrat better unload Elite as soon as he can because Opioids are becoming more and more out of favor in the medical community !! These "committee members" are sounding as if they are not recommending any new opioid drugs even if they meet the standards already in place just because "they don't like opioids" !!!

IF SequestOX is approved, Nasrat should broker the sale of Elite to the highest bidder ASAP and be done !!!


IB_

[lasers]

Excellent article. My same observations exactly as I watched the telecast. The experts mostly cited very negative details and then proceeded to vote yes in favor as they felt they had no recourse to set a higher standard. IMO More bodybags coming IF the FDA votes yes for Vantrela and Troxyca both of which are easily abused to release the full amount of the agonist instantly.

[toofun]

quote:

Gerhard noted that abuse-deterrent labeling could give patients and physicians the wrong impression: "If prescribers think it's safer and that patients are less likely to get addicted,...

Really? If I give a patient an opiate that is abuse deterrent he's safe from addiction. Its this kind of specious reasoning thats creates a air of professional incompetence that is helping bring down what input the highest level of direct care givers have - the physician.

Not that the FDA shouldn't need a broad swath of opinion but some of these contributors are making things more difficult to treat in the real world, outside of the ivory tower.

[Couch]

Nice find! And nice overview of the issues at hand. The quoted sentence below highlights one of the points that I've made previously. Elite has a novel pharmacologic ADT - how is society and the FDA going to tell if it actually detours abuse over an extended period of time?? They are going to have to approve it and wait for the post-marketing results to fully answer this question.

Plus, even if the opioid reduces snorting and injecting it that is way better than an ER easily abused Roxy that one can snort and inject.

What has more street value Opana or Pfizer's Troxyca - clearly Opana and it will also cost society at large way more in expenses to addiction than Troxyca will......but then again that's what the postmarking studies will be asked to prove.

"This technology is already on the market," Campopiano said. "We have the opportunity to make a better informed decision if we wait for that postmarketing data."

[Jimmy Joe]

Uncertainty was evident during the meeting as different doctors
offered their comments.

The one aspect I took away from this is that something is very much needed to stem the prescription opioid abuse. Many of those doctors
although somewhat negative more or less admitted that it was better than what was currently available.

Elite's ADF for extended release has better deterrent properties than ALO-02.
So with the recommendation from this advisory board it looks as though ALO-02 will get approval and partial ADT labeling.

Good for Elite. Look for an NDA submission by Elite soon after ALO-02 approval by the FDA. Just my opinion.