Elite Pharmaceuticals Inc (ELTP)

[rrr2003]

I believe you know why if it's the alcohol dump test you are referring to.

why did it get the CRL in the first place ??????????????

In any case here is Nasrat's explanation from the last CC.

"The [ER] CNS product has the alcohol dumping. Those dumping tests request by the FDA already been completed. That was completed within about a week from the time requested it and the filing took place within two weeks from the time that FDA requested it.

The issue wasn't that it's tough test and we could do it, the issue is that the FDA told us we don't need to do it, that's why we didn't do it. So as soon as they said we wanted done, we immediately did it and that was filed a long time ago.

Is there a chance that this test could further delay a response from the FDA for this ANDA approval?

This specific test, no, because the results were equivalent or better than the brand. That's what they look for, are you equivalent or bottomland brand and we met those criteria. Now the FDA want to come back and ask a different question is within shock me, but I cannot predict that but as far as this one specific example is given, I have no worries that the FDA is going to come back and ask us questions about that."