Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

This is a trick question.

if the fda gives Sequestox the same approval as PFE's drug (I.e., adt labeling for iv and nasal but not oral), it's not going to help us - we need all 3 adt labels (iv nasal oral) to be profitable.

Right?

SequestOx does prevent oral abuse by chewing/sucking, but it will not have labeling for oral abuse. When the FDA is referring to oral abuse, they are referring to an abuser's ability to tamper with an ER/LA drug and thereby turn it into an immediate-release drug. Since SequestOx is already an immediate-release drug, this question is irrelevant to SequestOx, and an oral abuse label will not even be an option. It will be an extremely relevant question, and a very important part of the ADF label, for ELI-201 and ELI-216, but not IR ELI-200. As far as I'm aware, there were only nasal abuse studies done for ELI-200 (B. Setnik's poster), and I have never seen any oral abuse data for any ELI drug.