Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

An IND basically allows Elite to perform studies with a new formulation of drug interstate, which Elite did.

It also allows Elite to keep the FDA informed on testing so they may use the FDA's guidance.
I believe the FDA has been kept in the loop so to speak during this whole process.
The 505(b)2 for ELI-200... which Elite has had help in doing from Camargo... is now a packet... probably rather larger... sitting with the FDA for review over the next 6-12 weeks awaiting acceptance by the FDA within that 12 week max period.

Once deemed accepted by the FDA with no further data needed the ball is then in the FDAs court.

Tic Toc Tic Toc