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Wednesday, July 10, 2019 6:38:10 AM
To date, the FDA has not informed Amarin as to whether it plans to convene an Advisory Committee meeting (AdCom) to review the sNDA. As previously disclosed, Amarin continues to prepare in the event that an AdCom is convened. If Amarin is informed definitively that there will or will not be an AdCom, the company plans to update investors accordingly.
So, according to AMRN, they will essentially relay to the public the feedback obtained at the mid-cycle communication. It is then they will find out definitively if FDA plans to hold an AC meeting or not. The FDA will either tell Amarin they are planning one and the date, or they will say "we are not currently planning on holding an Advisory Committee meeting." Simple as that.
Amarin does not have to PR the outcome of the meeting regarding what FDA communicates on AC if FDA says they are not planning one (they have to if FDA says they are planning one, as the date will soon become public beyond their control), but they state they will in any event.
So, no news means no mid-cycle communication yet. When it happens (and should be any day now), you will soon after (perhaps following morning) get your PR on AC meet yea or nay.
Regards,
-MRC
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