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Re: BioInvestor3 post# 385144

Thursday, 08/04/2022 5:08:19 AM

Thursday, August 04, 2022 5:08:19 AM

Post# of 426487
Bio...QUOTE..."REDUCE-IT randomized 8179 'STATIN -TREATED PATIENTS'(i.e. in combination with Vascepa or placebo) with qualifying triglycerides ≥135 and <500 mg/dL and low-density lipoprotein cholesterol >40"....

R-IT was a phase 3 study, which already showed that a combination of treatments with a statin plus Vascepa was safe and effective in reducing CVD.

This 'combination' has already received approval from the FDA...This IMO makes it unlikely that the FDA would now demand that Amarin repeat this study in order to have an approval of an NDA for a STATIN-VASCEPA combo drug.(especially if presented in a blister pack)
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