"If all goes well we should start marketing in Europe by spring of this year"
In December, Avanir said they expect the CHMP decision around the end of the first calendar quarter (would be March) and a decision on Eurozone approval about 3 months later (would be June) .
So, what does the CHMP meeting do in terms of N approval? Is it a preliminary review? Do they make an approval recommendation? Does it affect potential labeling? What needs to happen after the CHMP meeting if approval is to occur? Please comment.
CHMP Meeting Dates For January 2013 are 14th -17th
CHMP is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines. It does not currently publish the minutes or agendas of its meetings. It does publish highlights after each meeting.
KK Statement during the 12th December Conference call.
“On the regulatory front, 12 months ago we had only just submitted our marketing authorization application to the European Medicines Agency. Today, we are a month away from an opinion on our application. I’m excited about what 2013 holds in store for Avinir. “
On the basses of KK statement above, the CHMP announcement would follow shortly after the 17th January