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Re: MNBioMike post# 213783

Wednesday, 09/11/2019 4:35:20 PM

Wednesday, September 11, 2019 4:35:20 PM

Post# of 423945
TO ALL - If you read the full text of the FDA notice, it is very clear that there is no consideration of V approval without statins:

for the following proposed indication: to reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or
greater) and other risk factors for cardiovascular disease



They just used confusing wording later in the document.
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