Athersys, Inc. (NASDAQ: ATHX), a cell therapy and regenerative medicine company developing MultiStem® (invimestrocel) for critical care indications, announced today that the Company has been granted a clinical Type B meeting with the U.S. Food & Drug Administration (FDA). The Company was previously granted Regenerative Medicine Advanced Therapy (RMAT) and fast track designations for the use of MultiStem in the treatment of ischemic stroke. These designations enable sponsors to work closely with the FDA and receive its guidance on expediting advancement of designated programs. In the Type B meeting with the FDA, scheduled for late March, the Company intends to discuss proposed modifications to the ongoing pivotal Phase 3 MASTERS-2 clinical trial, which is under special protocol assessment (SPA) agreement.
Athersys Granted Clinical Type B Meeting with FDA for MASTERS-2 Clinical Trial Protocol Discussion
Feb 14, 2023
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