Jake7 schreef op 24 januari 2019 17:29:
Mogelijke witte rook enkel bij:
Action: for adoption
De scope is nu helaas echter anders namelijk
Scope: request by the applicant for a second clock stop extension
Blijkbaar heeft Kiadis meer tijd nodig om een nieuwe statistische benadering van de bestaande data voor te leggen...
Nog extra info:
On receipt of the responses from the applicant, the clock is re-started (day 121) and the rapporteur and co-rapporteur prepare a joint assessment report of the responses by day 150. Any issue(s) identified are discussed on day 180 during the plenary CHMP meeting and a decision may be made on whether to issue a positive CHMP opinion. If there still are any outstanding or unresolved issues, the clock is stopped again. Applicants normally respond within 1 month but in exceptional circumstances, a further extension of 1 month (or maximum 2 months) may be granted if justified by the applicant and agreed by the CHMP
. Day 181 is the re-start of the clock when the response is assessed and an oral explanation may take place. On or before day 210, the CHMP adopts its opinion. The opinion requires a consensus or an absolute majority from its members. The deadline for adopting an opinion and finalization of the CHMP Assessment Report is day 210 of the procedure. A CHMP opinion, whether positive or negative, may be the subject of a re-examination (an appeal), a procedure that has its own time frame. In terms of the assessment phase and the clock stops during CHMP review, these periods averaging 168 days and 118 days, respectively, for all drugs given a positive opinion during 2009–2011 inclusive. The interval between a CHMP opinion to a binding decision by the EC averaged 58 days during the same 3-year period .www.ncbi.nlm.nih.gov/pmc/articles/PMC...