Elite Pharmaceuticals Inc (ELTP)

[Couch]

Total BS. The FDA never said SequestOx wasn't safe. They worried people wouldn't take their meds as directed. Two different issues.

Thanks but let's hear what an actual doctor has to say about the real world and whether SequestOx is safe or not. SequestOx will end up being approved IMO and one isn't going to spin it otherwise.

Nasrat and Eugene will be given a path forward to SequesOx approval.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124153146

I cannot find a single reference or even a single anecdotal report of a patient injury due to opioid overdose caused by taking too much medicine because of a delayed effect due to nonfasting status. The entire concept that the delayed Tmax with fatty meals may contrtibute to an overdose is PURE THEORY, and I cannot find even a single case report. The below article is a very recent, very thorough review of unintentional opioid overdoses. Hundreds of studies were reviewed. Many risk factors were identified-- NONE of them had to do with fasting vs. fed status of patients. Many of the risks were associated with abusive or aberrant behavior. There is simply no medical evidence that I can find that supports the FDA's argument here. I will await to hear what the actual Tmax delay is and what the parties come up with when they meet. Depending on those important details, the next step would have to be a coordinated campaign to bring these actions of the FDA to the attention of newspapers and congress-critters. Public pressure on the FDA has been successful in the past. They need to be convinced by whatever allies we can muster that the quality of the ADF tech for both SequestOx and Avridi is unassailable, and the so-called "safety" concerns are purely theoretical and not supported by the scientific literature. As others have suggested, the question can be boiled to this: just how interested is FDA in preventing abuse of prescription opioids?