Replies to post #212549 on Elite Pharmaceuticals Inc (ELTP)

[RLSJ84]

I agree. First approval. However given the cross referenced other opioid companies who HAVE obtained approval with labeling and seeing data that has overwhelmingly showed ELTP technology to be stellar. I think we can say proof of concept is almost a given at this point. No ADCOM! Priority review! As of yet no CRL. The CEO stating in the CC he and his team has answered ALL the FDA questions they have had.

But yes. Approval is needed "officially". However I am fairly confident with the above mentioned "coincidences" we will receive approval with best labeling.

[Doctor Detroit]

Ugh, I was holding TTNP when that CRL came through, not a fun night. Makes me a little jumpy right now. But that CRL came after a rather scathing FDA review document at an Ad Com, and blistering commentary from the FDA staff.

In this situation, while I fully realize a CRL or delay is possible, no one has really explained what the justification would be based on clinical trials. Possibly a labeling issue I guess, which can be easily corrected and doesn't require further testing. But from my understanding of the trial results, there is nothing to support any labeling issues.

Is it possible the FDA wants to be out front on this one? In other words, because it relates to opioids, they want their press release issued first, and are finalizing that before notifying ELTP?

Who knows. But in all candor, the waiting stinks.