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Re: Whalatane post# 223946

Saturday, 11/09/2019 6:22:44 PM

Saturday, November 09, 2019 6:22:44 PM

Post# of 425847

Atom are U suggesting that the FDA will not include diabetics with 1 additional risk factor because the RRR is ONLY 12% ??



Yes.


Ezetimibe is approved for what I recall is even less the that .



As far as I'm aware, Ezetimibe is indicated for dyslipidemia, not CVD (as Amarin is looking for).


Its a risk / benefit analysis based on data . What the risk for including these primary prevention diabetic ....?



The FDA is not typically known to approve labels on the basis of, "what's the worse that could happen?"
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