To support Vascepa's approval, Amarin undertook several clinical trials, including two conducted pursuant to special protocol assessments (SPAs) with FDA. 2 FDA subsequently rescinded one of the SPAs (for the ANCHOR study) after an advisory committee found "substantial uncertainty" regarding whether the "reductions in triglycerides" demonstrated in the study "would reduce cardiovascular risk." 119 F.Supp.3d at 211. FDA then (1) refused to approve Amarin's supplemental ANCHOR study-based new drug application seeking approval of Vascepa for treatment of adult patients with "persistently high" triglyceride levels, (2) refused to allow Amarin to include the ANCHOR study efficacy results in the Vascepa label, and (3) warned Amarin that Vascepa would be "considered to be misbranded " if it was marketed for treating "persistently high" triglyceride levels. Id. at 211-12.