Replies to post #240878 on Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

Naz should have known 9 months before the guaranteed approval. The dealy for AVRIDI due to Tmax should have been a big red flag, yet we heard nothing

[Couch]

Total BS. All fingers point to the FDA being another government agency that says one thing and then does another.

It told Nasrat a phase 3 trial wasn't necessary and then it told Nasrat not to worry about the TMax timeframe as that was a labeling issue.

BOTH items the FDA said one thing and then did another.

Any TMax concerns became known after Purdue was given an AdCom meeting and thereafter rejected for approval. Purdue's AdCom was well after Elite had already filed their SequestOx NDA.