Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

What Nasrat said...

My understanding differs here. My understanding is the FDA told Nasrat he wouldn't have to worry about the TMax issue when he questioned them about it prior to running Elite's phase 3 trial. The FDA told him it would be a label issue and then changed their minds thereafter.

Comparing the profile of SequestOx under fasted versus fed conditions indicated that a fatty meal slows down the Tmax, not the Cmax or AUC but the Tmax. Historically this has been a labeling issue whereby the product is labeled and the doctor and the pharmacist will instruct the patients to take the product an hour before a meal or two hours after a meal.

The italicized section is Nasrat's opinion, not the FDA's.

In our meeting with the FDA in November of 2014, Dr. Hertz requested three extra studies: an efficacy study (a Bunionectomy), an anti-abuse study and a BE study - sorry, it was a withdrawal study and a BE study. We indicated that we know that there is a food effect on our product so why are we doing another BE study for fed?

Very clearly the FDA was expressing skepticism by requesting a new PK study, and just as clearly, NH was dense to it. Based on this, one has to wonder if the reason the bunionectomy was required might be due to the lack of bioequivalence. Maybe a reformulated bioequivalent bead would have been approved without the need for a Phase 3 bunionectomy.

FDA clearly stated that this is not a pass or fail, it’s a BE for labeling issue. We complied and we ran the study.

When you do not achieve the one you thing you must achieve (bioequivalence), it is silly to come back later and plead ignorance. "I didn't I know they would expect bioequivalence" sounds kind of silly coming from a supposed expert.