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Re: sts66 post# 25136

Friday, 02/07/2014 1:01:24 PM

Friday, February 07, 2014 1:01:24 PM

Post# of 448110
"It's now clear, even though they didn't say it, that they tried to get "reduced CVE risk" on the ANCHOR label."______________________________________________________________If this statement is correct, it was most certainly a wrong direction to take and it pissed off the FDA no end. However, it was even more wrong for the FDA to rig the ADCOM and rescind the SPA in an effort to teach Amarin a lesson because, in the process, a large number of Americans were hurt. The FDA could have spoken to JZ beforehand and told him to retract all mention of CV events until REDUCE-IT was finished. It is said that politics is a blood sport and this is a good example.
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