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VuBru

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VuBru

Re: ziploc_1 post# 97593

Wednesday, 01/04/2017 5:01:17 PM

Wednesday, January 04, 2017 5:01:17 PM

Post# of 430174
That is a fair point - The ADCOM moved the goalposts in the middle of a kick. That was unfair and indicates that whole process was flawed. That said, I agree with Raf that the FDA was probably justified in saying proof of actual effects on CV outcomes rather than surrogate measures (TG levels) was needed before V could be marketed as a drug to treat CV disease. AMRN just got caught in the middle of a sea change. I think it would be great if they granted expanded approval before R-It, but I am very doubtful that will happen.
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