Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

ICER excerpt on "confirmation"

11. Researchers should conduct a real-world observational study to confirm the benefits of icosapent ethyl.

The results of REDUCE-IT, while impressive, have not eliminated uncertainty regarding the potential effects of the placebo composition in the trial, as well as the largely unimpressive evidence from prior omega-3 studies. In addition, the FDA is unlikely to require a second confirmatory clinical trial for this indication. A rigorous prospective observational study of icosapent ethyl that had results consistent with those seen in the REDUCE-IT trial would help alleviate concerns, while a conflicting result would suggest the need for a second randomized trial.


I think this is reasonable, but the constant harping on the "largely unimpressive evidence" from other omega-3 trials is tone deaf and stupid.

It's like saying that a specific vitamin (e.g. B12) had a great trial for something, but it's not definitive because trials with other "vitamins" didn't show the same benefit. Extra, extra, extra stupid.