Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

IMO there most definitely is FDA and $ELTP discussions to get Reformulated SequestOx ASAP without any further testing and monies.

First of all, there is no "Reformulated" in this PR to discuss.
It is SequestOx period, no ifs ands or buts. Does anyone know what the time to max concentration was during the first go around? Maybe there was no significant change in Tmax with the reformulated version of SequestOx.

Secondly, all other testing is suspended until Elite meets with the FDA to discuss other options Elite may have or not have.
Tmax data for this study was not within the expected range, equal to or better than the comparator, therefore it makes no sense to go ahead with further testing until one meets with the FDA for a discussion on current results. A 1.2 hour average over the comparator is not very good. 15-30 minutes would have been much better IMO. Anything over that is why there was disappointment about the results. That said, it is what it is.

Will just have to wait and see what gives. You are right about Eugene Pfiefer, that he has experienced such matters in his long career, of that I am sure. Whether he can be of some help in this matter, I do not know.

Maybe they revisit the labeling again. Who knows?

The ONE THING we all know Lasers, is that there is a desperate need for an abuse deterrent formulation that can actually deter abuse without being compromised. Elite has that formulation.
Now what Scott Gottlieb does with this IR drug is up to him.
If proper labeling is given as to not to take this an hour or two before or after eating a fat heavy meal, or however the FDA deems fit, then maybe it flies with labeling. Who knows?