Baloney - outright lies. The actual text from the FDA BD's says this:
During a pre-IND meeting with the applicant in July 2008, however, the Division noted that there was a lack of prospective, controlled clinical trial data demonstrating that pharmacological reduction of non-HDL-C (or TG) with a second drug, in patients with elevated TG levels at LDL goal on statin therapy, significantly reduces residual cardiovascular risk. The Division referenced trials ongoing at the time (e.g., AIM-HIGH, ACCORD-Lipid) that, while not able to assess the effect of specifically lowering non-HDL-C (or TG) on clinical outcomes, would be expected to provide important information on the incremental benefit of adding a second lipid-active drug to statin therapy. It was stated that before an indication would be entertained for Ethyl-EPA as add-on to statin therapy in patients with elevated TG levels, the applicant at a minimum would have to provide results from a 12-week study with lipid endpoints as well as initiate an appropriately designed cardiovascular outcomes study. This outcomes study, known as REDUCE-IT, is ongoing and is investigating whether the addition of AMR101 4 g daily ameliorates residual cardiovascular risk among patients at high CV risk who have moderate hypertriglyceridemia at LDL-C goal on statin therapy. The study designs for both ANCHOR and REDUCE-IT were agreed to by the Division under special protocol assessments.
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