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Re: rafunrafun post# 223875

Saturday, 11/09/2019 3:33:09 PM

Saturday, November 09, 2019 3:33:09 PM

Post# of 426439
raf....

Regarding many questions...Actually the FDA likes to use one question...The panel question...That was the case in 2013...The AdCom panel was charged with only one question...

Paraphrasing the question was.. considering the Marine and Anchor trial results how confident do you feel Vascepa will lower CVD event risk..The answer was obvious since neither MARINE or ANCHOR addressed the issue of CVD event risk..(please understand I know this is not the exact wording of the Mary Parks question)...Both MARINE and ANCHOR were surrogate (blood level trials and were not CVOTs...

R-I is a CVOT...a cardio vascular outcomes trial....It would be very nice if the FDA asked," Considering the R-I trial how confident do you feel Vascepa 4gms/ will lower CVD event risk....The panel question is usually posted 48 hours before the AdCom....

":>) JL
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