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Re: jessellivermore post# 220177

Monday, 10/21/2019 1:14:25 AM

Monday, October 21, 2019 1:14:25 AM

Post# of 428803
JL, there is a part of the actual story thats missing in this message about ANCHOR. I dont know if you remember but originally the sNDA about Anchor was reducing TG for patients between 135 to 499. Thats all that was, extension of Marine. However when the briefing documents came out we found out that Amarin had changed the sNDA and included the CVD wording in it. Stock starting falling like crazy. Obviously the Adcom question was changed to focus on CVD rather than TGs. This was not FDA, or perhaps not FDA alone. Amarin was being oversmart and their behind was handed to them at Adcom.
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