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Re: Double_Bagel post# 712

Monday, 11/24/2014 9:01:53 AM

Monday, November 24, 2014 9:01:53 AM

Post# of 2950
EU approval is 100% insofar as the EU Commission has never rejected a drug endorsed by the CHMP.

FDA approval by the PDUFA date is not quite 100%, but is pretty close to it, IMO. The facilities inspections have already occurred and ABBV says there is no indication that FDA will convene an advisory panel.

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