Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

Did I mention the fact that in the original 163 person BE study there was not one incident. Nothing. Subjects were told to eat anything they like.

No mishaps. Look the results up yourself.

So why after this 163 person BE study with no problems whatsoever did the FDA balk at giving Elite a labeling claim? Take 1 hour before a heavy meal or two hours after a heavy meal. Simple solution.

But as you point out, that is all in the rear view mirror.

And how do I know that this reformulation for their IR ADF SequestOx will
carry pretty much the same results if Elite is asked to go forward with a new BE test? And why may Elite go through with a submission of this pilot
study to the FDA in hopes of expediting the process without going through another larger expensive BE study?

One thought comes to me, and it is a very simple solution to the capsule versus the tablet release. A J&J subsidiary comes to mind. So simple and many companies are doing it.

Yeah.... I'd be nervous if I was betting against Elite. Very nervous.