What FDA delay? FDA hasn’t posted Ad Com to Federal Registry yet, doesn’t post Monday. Who from the DMEP Ad Com doesn’t already have AHA obligations? Probably most of the committee members will attend AHA 2 days after “proposed” Ad Com.
Instead of label negotiations FDA tells Amarin they are scheduling an Ad Com but don’t tell anyone yet....
FDA needs cause to delay PDUFA date, Amarin stakeholders have to assume the FDA started label negotiations with threatening Amarin of an Ad Com.
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