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Re: CaptBeer post# 425605

Friday, 06/14/2024 11:05:39 AM

Friday, June 14, 2024 11:05:39 AM

Post# of 426152
Capt...."Reasons for the seemingly peculiar effects of EPA when administered alone are unclear, but appear NOT directly related to the decrease of triglyceride levels"

The FDA indications for Vascepa, as promulgated in the Adcom of 2019, included patients, who have triglycerides of "equal to, or over 150 mgms./dcl."

Amarin should (in view of this new information having been just released)...return to the FDA and ask for a new Adcom for the purpose of approving Vascepa for patients, who do NOT have have triglycerides above150 mgms./dcl, but who do have have cardiovascular risks such as previous heart attacks, diabetes, or hypertension ??

Generic companies are selling gV ostensibly on the basis of high triglycerides rather than on the basis of reduction of CVD...Now we know that high triglycerides are NOT the reason why Vascepa is so effective in reducing CVD...This could be a game changer for patients and for Vascepa.
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