Elite Pharmaceuticals Inc (ELTP)

[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.