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Re: None

Tuesday, 04/30/2013 11:00:31 AM

Tuesday, April 30, 2013 11:00:31 AM

Post# of 425920
Something about AMR 102 in the statistal review for the Anchor indication?

Page 117 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000StatR.pdf

"In patients who were on background statin therapy, the placebo-adjusted TG reduction was greater than in patients not on background statin therapy."
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This statement happen to be made in the conclusions and recommendations.

-Anchor sNDA will most likely use same medical review document as it contains both Marine & Anchor
-Anchor sNDA will contain separate statistical analysis from the Phase 3 Anchor data
-AMR 102 will use all the same reviews from marine and anchor making it quick.


AMR 102 is the $10 billion per year market.




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