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Biobillionair

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Biobillionair

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Tuesday, 06/25/2013 7:03:09 AM

Tuesday, June 25, 2013 7:03:09 AM

Post# of 426487
New FDA combo guidance doesn't look good for AZN if they planned to seek an Epanova/Crestor combo as an initial application.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf

AZN's combo runs into more than one wall in this guidance. It was posted 6-19-2013, same date the Ad Com was announced.
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