Replies to post #6039 on Ayala Pharmaceuticals Inc (ADXS)

[runcaly]

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.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000266.jsp


Pre-Submission
Day 1

List of Questions
Day 120

List of outstanding issues or opinion
Day 180

CAT draft Opinion
Day 205

CHMP final adoption
Day 210

EU final decision
Day 277

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 !