"If that is the case why would the FDA allow mineral oil in the REDUCE IT trial to be used as the placebo?? i wonder if this will be an issue with the FDA for an NDA?"

You can google and find various stories on the history between the FDA and Amarin on the use of mineral oil and on FDA approving Vascepa for lowering triglyeride after MARINE and ANCHOR trials completed. This history includes litigation between Amarin and other parties including the FDA. Not a pretty picture. Mineral oil had already been approved for use in MARINE and ANCHOR trials. These trials reported top-line results prior to the start of REDUCE-IT. The FDA did push back on the use of mineral oil after seeing some of the interim and final MARINE/ANCHOR data, but not hard enough and still allowed mineral oil to be used in REDUCE-IT. Lots of blame to throw around: Amarin, clinical steering committee, FDA. It is probably too late in my opinion for the mineral oil issue to get in the way of FDA approval of Vascepa for cardiovascular indication. It is clear that Vascepa has benefit. But also pretty clear that mineral oil has harm. What a mess.

BDAZ