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Re: KCSVEN post# 10834

Thursday, 07/18/2013 3:29:12 PM

Thursday, July 18, 2013 3:29:12 PM

Post# of 426232
Addition of the Anchor data to the label was an agreement made with Marine approval. REDUCEIT was required to 50% enrolled...I'll see if I can find the document. As far as adding the JELIS study, that's news to me but would fall inline with the new Guidance document posted at the FDA.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

I posted this before but got no takers at the time. Vascepa would qualify under this guidance for early REDUCEIT approval before the outcome study is fininshed. It was posted 6-25.

Will
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