Elite Pharmaceuticals Inc (ELTP)

[Pranksalot]

Now, two of the three products that I mentioned are needle movers. So let me say a few more words about that. Regarding the CMS application, the FDA asked us to make a couple of minor adjustment.
Tighten the spec, move this over here and there, nothing of relevance. But the FDA did request an extra month to review the DMF for the API supplier.

So our PDUFA date is November. That was very nice of FDA to do that, because they found that our application itself doesn't have any issues or all the issues we had, we resolved them over the past year.

They had a question to the DMF supplier, and instead of saying, take this back and call us back in a year or in six months or whatever, they actually said, we need another month to resolve some issues, which is really very promising. And we will update you in November once we hear - if we hear from FDA and what their verdict is.

But he literally said that the FDA is asking for another month 😅