Elite Pharmaceuticals Inc (ELTP)

[Hike]

MR. FRANGELLEONE: Okay. Finally, I met you in the Spring at one of the meetings. The big question I guess everyone is waiting on; do you have any confirmation on, if we need efficacy trial or not, for this particular NDA we’re trying to get pushed by December?

MR. HAKIM: And that is the subject that I have mentioned many, many times to everybody before. I went by the letter of the law and we have done everything that we believe the law requires. The FDA keeps coming back that they may want to see an efficacy and that’s what we’re negotiating with them. If they do, and as I’ve said, I have anticipated that they may ask for it; because if I was in the FDA there are certain things I may or may not ask for; and if they do, that is what I said; they will delay us a few months but they will not stop us because everything else we’ve done has been to their liking. And frankly, we are on the uphill of business and everybody knows, uphills happen as occasions for a hundred years. It’s not a matter of you’re going to say, in my opinion again, it’s a matter of going through the motions. So if they want us to go through the motions for one more thing, we will do it and we will do it right and we will get this approval.
And the great news for Elite is that; once we complete this first product, the ELI-200, and that’s why I’m focusing on it. Once we complete it, then we know exactly what the FDA wants for all the other products. So we start to go after them without having to wait for the FDA to tell us because they’ve already answered the questions for the first one. That’s why the first one takes the longest and it’s the hardest. Once we’ve established the criteria, we’ll move forward -- of all the others.