FDA Pulls Amarin’s SPA for Vascepa Trial, Casting Further Doubt on sNDA

In a surprise move, the FDA has rescinded the special protocol assessment (SPA) for Amarin’s ANCHOR study of its heart drug Vascepa, the company’s third setback in two weeks after a disappointing advisory vote led Amarin to slash staff in order to stay afloat as it tries to win an expanded indication.
Washington Drug Letter