Anyone have an exact date for the 80 day assessment report out of EMA CHMP? ECYT gave a press release on 11/27/2012 but the December 2012 Applications for new human medicines under evaluation
by the Committee for Medicinal Products for Human Use report was dated 11/29/2012 with the contents compiled on 11/22/2012.
I listened to the presentation. I only heard a reference to the 120 day list of questions at the end of March. The 80 day assessment report is a formal process with CHMP and should have preliminary conclusions. 80 days should be very close.
Day 80 Action
Receipt of assessment report or critique from rapporteur and co-rapporteur by CHMP members and EMA. EMA sends assessment report to applicant making clear it only sets out preliminary conclusions and is sent for information only and does not yet represent the position of the CHMP.