New survey: FDA-Approval Dates for GILD & ABBV/ENTA HCV Regimens
The PDUFA date for GILD’s Sovaldi + Ledipasvir regimen is 10/10/14; the PDUFA date for ABBV/ENTA’s 3-DAA regimen is 12/21/14. (Please see #msg-96696670 for the phase-3 data supporting these NDAs.)
Q1: When will FDA approve GILD’s Sovaldi + Ledipasvir regimen?
a) October or later b) September or earlier
Q2: When will FDA approve ABBV/ENTA’s 3-DAA regimen?
a) December or later b) October-November c) September or earlier