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HDGabor

09/12/19 1:44 PM

#214001 RE: concapk #213999

c-

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

Best,
G