„as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.
Fine - but the FDA cut off discussion of any of those secondary endpoints in the AC, meaning inflammatory markers.
I agree with you.. The notion that Amarin, or Amarins principals somehow "overstepped" remains unproven. Of course R-IT is about CVD. There is no way the company turns down nNDA label expansion by insisting on wording that does not represent the facts.
The individual who made this claim and then refuses to provide his source is IMO not a credible source.
News 
Market Data 
Discover 
