Elite Pharmaceuticals Inc (ELTP)

[senderos]

My correspondence today with Dianne Will:

Dianne:

Can you clarify? NH has been saying that ELI-200 has been promised Fast Track status by the FDA, but some of us think it is really Priority Review, which is somewhat different.

Tom

Dear Thomas,

In this instance, I think they are interchangeable.
This is my personal opinion (and I certainly don’t have the expertise as Nasrat in this area):

I personally use priority review. In my opinion, it may be that the FDA traditionally uses the fast track language and the priority review language has come out of the PDUFA Act. With the PDUFA Act, the FDA is mandated to provide a PDUFA date on when a company can expect a decision by the FDA following the acceptance of an NDA application. PDUFA dates for an NDA are normally a 10 month review cycle for a standard review or a six month review for a priority review. I think it comes down to Nasrat using FDA language and I use the PDUFA language.

IPCI recently also used the fast track language. We just did not issue a press release like IPCI did about not needing a Phase III and the fast track status. Obviously, things can change with the FDA.
However, I don’t doubt for a second that we won’t have a six month review. I believe there is too much of a precedent on this issue for the FDA to change course.

Best regards,
Dianne