Elite Pharmaceuticals Inc (ELTP)

[Hike]

He stated that the FDA will be getting back to us with any further questions and or requirements. They (the FDA) needs to huddle amongst themselves and determine what else, if anything, they want from Elite before they file. It's a process. Nasrat was very clear that the FDA may require efficacy studies and pediatric studies. My read is that the FDA would like to give us the go ahead but as they haven't seen a formulation quite like this one they want to review internally to determine the most responsible path forward.

I for one don't take issue with the December promises. I knew full well that the FDA might delay this and Nasrat has stated that several times.

For that matter we don't know for sure yet if they will indeed delay. We need to wait for the FDA to reply and then Elite will PR that.

I think its great that he sets an aggressive goal for his folks to shoot for.

Would you prefer he just says "we will file when we file"?

No way, you would crucify him for being "wishy washy" or evasive or whatever.

Instead he stuck his neck out. I like that.