Amarin Corp Plc (AMRN)

[KCSVEN]

XERS was just approved but noticed they had specific reasoning as to why the 3 month PDUFA delay:

" the Company’s recent submission in response to an information request from the FDA constitutes a major amendment to the NDA, and therefore, the FDA is extending the goal date by three months to provide time for a full review of the submission"

Where Amarin has not been given an actual explanation for delay, though, I guess, the need for Adcom is the explanation, if we can understand the need for Adcom...

I wonder if the official letter on delay, likely out last week of September will list a reason for the delay other than need for Adcom.