Elite Pharmaceuticals Inc (ELTP)

[jour_trader]

Q3 2017 Call

Not an issue FDA will expand to ER or any others in industry. Specific to Elite only. Here are CEO's words. I may be misinterpreting, but don't think so.

Nasrat Hakim, “The reason that they - the FDA made a big deal about the Tmax in our case is because there is a delayed effect when you take oxycodone with food. That is also to even for the brand oxycodone. Historically, the FDA or the Doctor and the pharmacist will tell the patient to take the product an hour before food or two. The FDA is thinking if somebody eats and then they are in pain, they don’t get the effect within 20 minutes, then they go ahead and take a second or a third dosage and end up with that. This has never historically been the FDA's policy or anybody's policy because usually you take rescue medication, you will take in case if you eat and you cannot take oxycodone, you will take a prescription strength Ibuprofen, okay.

So this is not an issue that the FDA is going to expand I believe to ER or the rest of the industry. It was a unique thing in this very specific case that they thought about two years after they give us green light to move forward. So there will be no real formulation for any of our ER products or anybody in the industry that for the reasons I just explained.”