Athersys and its Japanese development partner Healios are on track to begin a 150-200 patient registration trial for MultiStem in stroke in Japan. We expect the company to file an IND with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in mid-summer and begin enrolling patients in Q416. Importantly, a successful trial of this size could enable them to gain full approval in Japan instead of conditional approval and could potentially be used as part of a registration package in
30 Jun 2016
On track for a big Japanese trial
Sign up to access
Get access to our full offering from over 30 providers
Get access to our full offering from over 30 providers
On track for a big Japanese trial
Athersys and its Japanese development partner Healios are on track to begin a 150-200 patient registration trial for MultiStem in stroke in Japan. We expect the company to file an IND with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in mid-summer and begin enrolling patients in Q416. Importantly, a successful trial of this size could enable them to gain full approval in Japan instead of conditional approval and could potentially be used as part of a registration package in