Per stocktwits Biobillion -
FDA Marine Medical review contains permission for Anchor to be labeled after REDUCE-IT 50% enrolled Pg 10 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
Thank you, Sharonconl. The following extract (from pg 10 of FDA document) clearly supports your statement:
"This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients
with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a
minimum, 50% enrollment of a cardiovascular outcomes trial was reached."
AF will blow a gasket......how could this be.........AF did not give permission to the FDA to allow this.......I am starting to feel sorry for AF now that people do not pay attention to his ill informed rants, just think of the guys self esteem, it must be shot to pieces at this stage :)