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DewDiligence

10/23/14 1:59 PM

#183134 RE: Bickema #183132

ABBV/ENTA's PDUFA date for the 3-DAA regimen is on or around 12/21/14. ABBV issued the PR for the NDA submission before the open on 4/22/14, suggesting that the submission may have occurred on the 21st.

The FDA does not publicly disclose PDUFA dates.