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Re: OldYeller187 post# 164148

Friday, 11/30/2018 9:33:30 AM

Friday, November 30, 2018 9:33:30 AM

Post# of 447226
Oldyeller, securing Anchor label will allow us to reach out the general public thru DTC ads where Amarin can publicly say cardioprotective language including reduction of heart attack and CVD reductions by 25% and so forth. Presently they are not doing it scared of FDA enforcement action. This will be humongous reaching out to the consumers while in the interim sNDA for RIt can be in process both here and in the Europe. Anchor control required us to provide CVD evidence and the Anchor voting question was about cardioprotctive. So by obtaining Anchor label, Amarin can do DTC commercials directly to the public on the efficacy of V in CVDs. Please ask Elizabeth are they pursuing? if not, why they are NOT pursuing Anchor. Give them your valuable FDA regulatory guidance from your past FDA experience. If thy get Anchor label, DTC commercials on CVD prevention is unlimited, imo.

Anchor label will ensure no enforcement fear from FDA.
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