Replies to post #65529 on Ayala Pharmaceuticals Inc (ADXS)

[James salmon]

Looks like the process is moving pretty quick, good sign: “for adoption.”

[runcaly]

Day 200 CAT adopts the draft opinion and draft Assessment Report and
transmits it to the CHMP.
CAT
By 210 Adoption of CHMP Opinion and CHMP Assessment Report (and
timetable for the provision of product information translations)1
CHMP
After adoption of a CHMP opinion, the preparation of the annexes to the Commission Decision is
carried out in accordance with the following timetable:

DAY ACTION
215 at the latest
Applicant provides the EMEA with summary of product
characteristics, Annex II, labelling and package leaflet and
Annex A in the 20 languages (All EU languages including
Norwegian). EMEA circulates draft translations to Member
States for review.

232 at the latest
Applicant provides EMEA with final translations of summary of
product characteristics, Annex II, labeling and package leaflet in
the 20 languages, taking account comments received from
Member States by Day 229.

By 237 Transmission of Opinion and Annexes in all EU languages to
applicant, Commission, and Members of the Standing
Committee, and Norway and Iceland.

By 246 Applicant provides EMEA with one final full colour 'worst-case'
mock-up of outer and inner packaging for each pharmaceutical
form.