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MNBioMike

09/11/19 3:23 PM

#213785 RE: MNBioMike #213783

I’m not able to look now, but was there a small cohort in R-It for statin intolerant patients?

VuBru

09/11/19 4:35 PM

#213807 RE: MNBioMike #213783

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.