please let us know how to avoid what took place 6 yrs ago ????
Provide evidence that Vascepa reduces the risk of major adverse CV events in patients at high risk for cardiovascular disease, at LDL-C goal on statin therapy, with residually high TG …
Oh, wait: the final results from the REDUCE-IT trial [] submitted to satisfy this deficiency.
Approval is a subject of "what" and isn't the "if".
We will see the BD and the Question(s)* on Nov 12 as the latest published by the FDA (to avoid any doubt: Amarin won't release anything)
* I expect more than one question. e.g.: (i) … elevated TG and and CHD (ii) … elevated TG and and CHD CHD risk equivalent