Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

That is the max time before approval. Remember Elite filed an
IND with the FDA a while back before testing even started for ELI-200.

Everything is right on schedule now matter how it is spun. Some just dont know what they are talking about.
One has to fill out an application and pay an up front fee... which in Elites case was waived. After the application is reviewed and accepted then Elite "will immediately" submit their
505(b)2 for a review of 8 -12 weeks.
When the FDA gives the green light with nothing further for Elite to do to satisfy the FDA then the FDA accepts the filing.

Approval can happen anytime after the filing is given the official "review and accepted" by the FDA 6-12 weeks from now.
Approval can happen that quickly or it can be stretched out to 6 months.

There was IND filed with the FDA from the beginning.