Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

Submitting the kind of data they submitted and then try to get it fixed by labelling it is just plain lazy

Completely off base and inaccurate. When the data was originally submitted to the FDA NH had mentioned a concern with Tmax to the FDA. At that time the FDA had told him that this could be addressed with a labeling. Then the FDA did a 180 and addressed Tmax concerns in the CRL.

The first attempt at a better formulation was thought to be much better than when they presented the original data to the FDA. This reformulation NH did not even bother presenting to the FDA because he knew it was not good enough to meet FDA criteria.

This current reformulation(s) in the pilot study does present itself to be good enough to pass the FDA criteria for Tmax fed study. Does not matter who is impressed or who is not impressed. If it is good enough for the FDA guidelines, it is good enough, and should get approval.

Getting nervous?