The FDA decides to hold an expert panel review of Vascepa after all — and Amarin shares tank on unexpected delay
Mark your calendars for November 14.
After slowly and cautiously raising its hopes to the point where company execs believed an AdCom on its supplemental label for Vascepa was “unlikely,” the biotech put out word late Thursday that the FDA has pencilled in an expert panel meeting for them in mid-November.
And investors — who were growing increasingly warm to the idea that the company could be on a cakewalk to a crucial, and potentially blockbuster, approval on the September 28 PDUFA date — panicked. Shares $AMRN plunged 22% on the news.
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