Replies to post #196816 on Elite Pharmaceuticals Inc (ELTP)

[steve9465]

No. It's 7/14, 7/14, 7/14, 7/14, 7/14, and so on and so on and so on!!!!!!!!!!!!!!!!#######, etc.

[Sixman]

That's interesting. Can you post a link to the calendar?

Good info.

[rollin2nyte]

The response from IR, last week Thursday, was that most abuse deterrent formulation NDA's are referred to an advisory committee. The FDA needs to inform the applicant 15 days in advance. As of this point the FDA hasn't notified Elite.

I tried to benchmark the dates with other NDA submissions but couldn't draw a parallel between PDUFA date and advisory date notification. KMPH was notified 68 days prior to PDUFA and Collegium was around 65 days. That's quite a variance. If we haven't heard anything by June 29th we haven't been referred to the advisory committee. I suspect that's a great sign but I'm expecting an advisory committee.

Next week KMPH has theirs and it's public record. Should get a good feel for the process really quick.

Hope this helps.