Amarin Corp Plc (AMRN)

[HDGabor]

It is not possible. Too much elements in a lot of study should be determined for placebo (ie.: I do not know the color and exact smell of coconut oil, but I assume it is not good for Vascepa’s trials as a placebo).

FDA (and every authority) has to be proactive as issuing clear guidance for new issues, and acting fast and according to laws, rules. FDA is not top of it.

btw: Meanwhile they did a lot of unacceptable, unrealistic action in case of Vascepa they handled the placebo “issue” correctly. They done their job when analyzed the possible effect of mineral oil (placebo arm was the basis of eff., doubt is exist regarding mineral oil, lipid changes were atypical) and I have to say they were totally correct: check all possible reason (not just the oil) and come to the conclusion: strange, but ok. I do not think that anybody could criticize them for this. Furthermore, maybe they could set-up a better argument based on the placebo arm (mineral oil) to screw AMRN than the referred studies, but they did not use this “issue” against AMRN.