Title Committee for Medicinal Products for Human Use (CHMP): 10-13 December 2012
Location European Medicines Agency, London, UK
Summary The Committee for Medicinal Products for Human Use (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.
ISIS should receive European approval by year end. Remember this application addresses larger markets as they are seeking approval to treat both HoFN and HeFN, the latter being a much larger market opportunity.
Following European approval we expect FDA approval on or before the PDUFA data of January 29th. ISIS is a buy under $12.