FDA to Athersys: Design of large stem cell trial looks good
Story excerpt provided by Crain’s Cleveland Business.
Written by Chuck Soder.
Federal regulators have told Athersys Inc. that the design of its planned Phase 3 clinical trial looks good.
So if stoke patients in the trial respond well to Athersys’ adult stem cell therapy, the company should be able to apply for the right to begin selling MultiStem – which would be the company’s first product. The Cleveland company aims to enroll 300 patients in the Phase 3 trial.
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Originally published September 28, 2016.
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