Elite Pharmaceuticals Inc (ELTP)

[RLSJ84]

It could very well deal with the label for ADF. Perhaps Nasrat wanted the best label available and FDA did not agree.

I do not know what the "application" is like or what specifically it asks for in detail. But it does seem like CRLs are issued for minor details sometimes. Things that are cleared up easily.

A Priority Review given is not just given because they asked for it. There has to be real evidence shown to improve current technology or drugs available.

FDA granted that Priority review or a reason. Also if they had any thought the technology was bad they had PLEBTY of time to schedule an ADCOM in advance of July 14th. And even so could have given one yet still today with a "delay" to allow an ADCOM. However they DID NOT do so. That's why I personally feel it is something minor.