Replies to post #285264 on Elite Pharmaceuticals Inc (ELTP)

[Dante Fantasia]

Well, ran back up as one more question came to mind: if the new ADF is not using naltrexone as the ADF, then while this one seems to have the potential for solving the T-max issue, does it also have the same opioid-abuse-od-saving properties, or is the new formulation just another type of deterrent alike (but not as potentially harmful) the ubiquitous acetaminophen per Norco etc?

Part of the big benefit of naltrexone was to counter the opioid effect. Is this new one a patch, or a fix?

[WeeZuhl]

More importantly, however, are my other questions (and that is what they are--questions) regarding how a new formulation will be treated by the FDA with respect to being still under the SOx application waiver per the Priority Review, or if it means we have to do another separate application? And again, what are the implications with Epic and the milestone?

Maz,

As I understand it, this is a new and separate entity. This has nothing to do with SequestOx or the Epic milestone. This new formulation would be a different NDA. It probably would qualify for Priority Review but not guaranteed. It is most likely a physio-chemical ADF similar to Roxybond approved in January. If both were approved, it would be a direct competitor of SequestOx. It would be much cheaper to make (and presumably less expensive for consumers), but it probably would not be as hearty an ADF as SequestOx.