Paion has discontinued its European Phase III trial of remimazolam for general anaesthesia in patients undergoing cardiac surgery due to slow recruitment. The US Phase III in colonoscopy is still on track to complete recruitment in the current quarter, but completion of the bronchoscopy Phase III may be pushed into 2017. Paion remains on track for a potential US filing in 2017, while a pre-NDA meeting with Japanese regulators in Q116 could clear the way for a filing in Japan, ideally with a p
10 Feb 2016
A setback in Europe, but US on track
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A setback in Europe, but US on track
Paion has discontinued its European Phase III trial of remimazolam for general anaesthesia in patients undergoing cardiac surgery due to slow recruitment. The US Phase III in colonoscopy is still on track to complete recruitment in the current quarter, but completion of the bronchoscopy Phase III may be pushed into 2017. Paion remains on track for a potential US filing in 2017, while a pre-NDA meeting with Japanese regulators in Q116 could clear the way for a filing in Japan, ideally with a p