Hi all - I noticed that the application for OD status with the European Medicines Agency had gone a bit quiet for my liking..... so I contacted Neuren for a comment on this, they replied with:-
Thank you for your enquiry. The EMA process is a little different to the FDA process. There is a “pre-submission” phase, which we are in at the moment. The idea is that you discuss your application with the agency before it is formally submitted, which hopefully addresses any questions in advance.
I have checked in the EMA announcements for this month and STILL nothing.... could do with some good news....
http://www.ema.europa.eu/ema/index....ng_000349.jsp&mid=WC0b01ac05805083eb#section1
BN
EMA Application for OD Status
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