Interim Report January-September 2017
“The FDA has set a PDUFA target action date for CAM2038 of January 19, 2018. If approved, this would trigger a US commercial launch early next year.”Business highlights third quarter 2017 · NDA submission to FDA for CAM2038 weekly and monthly buprenorphine depots for treatment of opioid dependence. · MAA submission to EMA for CAM2038. · CAM2038 NDA acceptance with Priority Review by FDA. · CAM2038 MAA validation by EMA. · CAM2043 IND submission to FDA. · Phase 3 long-term safety extension study of CAM2038 initiated in patients with chronic non-cancer pain patients. ·