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MedResCollab

07/11/19 1:04 PM

#201081 RE: ggwpq #201078

ggwpq,

You’re right—that would certainly make an Advisory Committee (AC) meeting being held to discuss the Vascepa efficacy supplement a bad omen, signifying that FDA may consider the purported efficacy of Vacsepa from the REDUCE-IT study as dubious.

Regards,
-MRC

Remember Repatha, a far less safe and efficacious CVD drug with much more trial patient data, was approved in 6-month time without AC. Vascepa will be a far easier and quicker decision for the FDA. -ggwpq