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elichen

08/18/16 4:10 PM

#222406 RE: Couch #222402

Yes, 2002 FDA guidance AS WELL AS 2014 specific statement to ELTP THAT IT WAS ONLY A LABELING ISSUE!!!!!!!!!!!!!
i.e. pull the rug out from under ELTP at the last minute, after granting 2.5 mil filing waiver AND priority review!
Under "leadership" of new FDA director Robert Calif, well known to Congress as having been a lobbyist for BP. Coincidence? I think not.