Committee for Advanced Therapies (CAT) Agenda for the meeting on 08-09 Sept. 2016 (no mention of ADXS)
Site 17 - Evaluation of ATMPs (section 2) New applications (sections 2.1 to 2.12)
Section 2.1 is for ATMPs nearing the end of the evaluation and for which the CAT is expected to adopt a draft opinion at this meeting on whether marketing authorisation should be granted. Once adopted, the CAT opinion is transmitted to the CHMP for final adoption. The CHMP opinion will be forwarded to the European Commission for a final legally binding decision valid throughout the EU.
The assessment of an application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is interrupted by at least one ‘clock-stop’ during which time the applicant prepares the answers to questions from the CAT. The clock stop happens after day 120 and may also happen after day 180, when the CAT has adopted respectively a Day 120 list of questions (section 2.3) or a List of outstanding issues to be addressed by the company, which is listed in the agenda.
If we get the Draft Opinion from the CAT at the October Meeting (5 - 7.10.2016) and further the final adoption from the CHMP at the October Meeting (10.10.2016) then we can get at best and without "clockstop" the EC Decision (approval) in end December 2016 !