Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

Let's try this again...….

I did not say anything about the FDA approving or not approving.
This is totally about getting guidance for what comes next with regard to SequestOx.

All they have the authority to do is tell us the remaining studies required.

WRONG.
The FDA can say that pilot study data was not
conclusive enough to merit another full blown BE test even though it was. There is no science here. This is purely political as it was with the labeling issue and much much prior as it was with the Lodrane BS.
FDA does what they want to do despite all the good talk from them about ADFs and alike. FDA has the power to pull the plug Ama. This is why NH wants to meet with them and get everything in order before starting a full blown BE.


Historical perspective:
FDA told NH SequestOx Tmax problems originally nothing more than a labeling claim. Enter Elite's CRL for Tmax concerns from the FDA.


Elite works on a reformulation which they thought may work, does their BE and NH realizes results are not good enough to submit to the FDA.


Pilot study on a further reformulation of the two bead SequestOx shows that this reformulation is as good or better than comparator that already has FDA's Tmax blessing. Elite submits this data to the FDA and now waits for a response (guidance from the FDA).