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Wednesday, March 22, 2017 7:54:34 AM
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.
Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.
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