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polaco3us

04/23/18 7:35 AM

#65472 RE: runcaly #65468

CHMP can take up to 210 "active" days .. EC takes up to 67 days.
We are on track ... there is a time stop at day 120 at CHMP.


Go Zen
Cheers

I really like the science



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runcaly

04/23/18 8:49 AM

#65529 RE: runcaly #65468

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.

2.7. New applications
2.7.1. Axalimogene filolisbac - EMEA/H/C/004473
Intended for the treatment of cervical cancerScope: timetable for assessment
Action: for adoption


http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2018/04/WC500247632.pdf

So, I am right that after our application is adopted it remain 72 days to EC decision ???