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Re: shopboy post# 18451

Monday, 10/21/2013 8:02:46 AM

Monday, October 21, 2013 8:02:46 AM

Post# of 426911
IMO that is wishful you thinking. If you read the the briefing document and watched the panel meeting it was quite clear what FDA was thinking. They want outcome data. As it is most likely outcome would be Anchor denial. However, this would mean they reneged on the SPA.

I think there is a small possibility that with strong public outcry and with future discussions with AMRN, FDA might be pressured for a conditional agreement- where negative outcome study would result in to withdrawal of Anchor indication. That could only happen with enormous legal pressure and public outcry.
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