Hmmm, igual no es la conclusión de aceptación o no. Y no pone accelerated approval como otras... Pero no concuerda con las palabras de la EMA de la semana pasada.
The clock stop happens after day 120 and may also happen after
day 180, when the CHMP has adopted a list of questions or outstanding issues to be addressed by the
company. Related discussions are listed in the agenda under sections 3.2 (Day 180 List of
outstanding issues) and 3.3 (Day 120 list of questions).
CHMP discussions may also occur at any other stage of the evaluation, and these are listed under
section 3.4, update on ongoing new applications for centralised procedures.
The assessment leads to an opinion from the CHMP by day 210. Following a CHMP opinion the
European Commission takes usually 67 days to issue a legally binding decision (i.e. by day 277 of the
procedure). CHMP discussions on products that have received a CHMP opinion and are awaiting a
decision are listed under section 3.6, products in the decision making phase.
