Replies to post #247427 on Elite Pharmaceuticals Inc (ELTP)

[Don'tDrinkTheKoolAid]

Well Nasrat says he has to resubmit and pay 2-3$ million at the end of the year. If FDA takes their good ole time 6 months added onto end of year be about March to June 2018 for approval. Considering no CRL this time.

[Couch]

Couch, what is the timeline to approval of SequestOx now?

Hey Pete - nice to hear from you. Great question - my understanding is Elite will have to conduct 2 PK studies - one already started - finish them and refile Elite's previous NDA by years end. Then it will take the FDA about 6 months to make a decision. So my thinking is we should have an answer in 12-15 months.

The good thing about this timeframe is Elite's new generic pipeline should have several products approved by then. Elite's intrinsic value about to meet up with Elite's market value.