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Re: north40000 post# 213839

Wednesday, 09/11/2019 6:19:26 PM

Wednesday, September 11, 2019 6:19:26 PM

Post# of 423567
North- Amarin could actually get full requested label wording in high risk metabolic syndrome patients...this is an easier regulatory matter for FDA if they approve full label 9-28, but restrict population until after Ad Com...this is in the full privy of FDA regs. This would also prevent any public safety issues with SOC regarding diabetics... Cards haven't completely committed to SOC change....IN US. Europe appears to have smarter cardiologists....

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