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AVII77

05/26/17 8:43 AM

#106932 RE: ggwpq #106931

Given V's safety profile compared with other lipid agents in the market, if Amarin is a "person", it has a serious case of discrimination Vs. the FDA.



Had they continued to approve other drugs based on lipid effects after they lost faith in surrogate outcomes in this space then I would agree with you.


iwfal

05/27/17 12:03 PM

#106971 RE: ggwpq #106931

Given V's safety profile compared with other lipid agents in the market, if Amarin is a "person", it has a serious case of discrimination Vs. the FDA.



Until you've run a big outcomes RCT you don't really know the trade of safety vs efficacy. I'll make the wager that some kind of p<0.1 safety signal pops up (although it may take 5 years before it is acknowledged - because that is the nature of these things. Eg almost 20 years to acknowledge statins cause increase in T2D)