Recently, Athersys reported progress with both US and Japanese regulatory authorities. The company reached a deal with the FDA for the design of its pivotal Phase III trial for MultiStem in ischemic stroke under a Special Protocol Assessment (SPA) and should be able to file with just one 300-patient Phase III trial run in North America and Europe. Other clinical data, including the results of its trial in Japan (the design of which has just been accepted by the PMDA), will be used to support
27 Oct 2016
Progress on all fronts
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Progress on all fronts
Recently, Athersys reported progress with both US and Japanese regulatory authorities. The company reached a deal with the FDA for the design of its pivotal Phase III trial for MultiStem in ischemic stroke under a Special Protocol Assessment (SPA) and should be able to file with just one 300-patient Phase III trial run in North America and Europe. Other clinical data, including the results of its trial in Japan (the design of which has just been accepted by the PMDA), will be used to support