Interim Report January-September 2018
“Following the positive CHMP opinion for Buvidal®, we have ramped up our commercial activities and are ready for launch in the first wave European markets” Business highlights third quarter 2018 · CHMP adopted positive opinion recommending European approval of Buvidal® (CAM2038) for treatment of opioid dependence · Regional teams established on the first wave European markets · FDA issued 26 December 2018 as PDUFA target date for US approval of CAM2038 · Positive top-line Phase 3 results announced from pivotal study of CAM2038 for the treatment of chronic pain ·