Elite Pharmaceuticals Inc (ELTP)

[Steges]

Senderos -

FDA gave Elite a PDUFA date of 7/14 which is roughly a six month review period. Theoretically one would deduce that in the initial stages of the FDA review -- after ensuring they have everything they need in the application to begin the formal review process -- they would decide whether or not this needed to go through a ADCOM vote. The logical committee to review Elite's technology and data would be the same one that met last week re: Pfizer and Teva (Anesthetic and Analgesic Drug Products Advisory Committee).

They don't meet again until September: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm414515.htm

It makes no sense why Elite would not be included in those meetings given the timeline of this reviewing period because the FDA would have known they needed to get Elite's application in front of the committee.

Furthermore, the FDA is getting pushed like they never have to a) make approvals in a timely fashion and b) deal with the opioid crisis. It's not like they are currently inundated with ADT applications reviews and had a scheduling mishap.

In my opinion, Elite packaged everything on a platter for the FDA, meeting with them to ensure that they were giving the FDA everything they were looking for and Elite clearly has superior data to back it up. They will have approval anytime from now to mid-July with at worst ADT labeling for IV and snorting.

Additionally, last week the FDA give Endo an ADCOM date in the fall. Endo's PDUFA date was July 29 and they also did not have Priority Review. This only adds more credibility to the fact that Elite should be seeing an imminent approval.