Athersys announced that a scheduled meeting with the FDA was held to discuss the results of its recently completed clinical trial involving the administration of MultiStem to patients being treated for leukemia or other conditions that place them at risk of Graft versus Host Disease (GvHD).
- Additionally, the company discussed with the FDA its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design.
- The company intends to provide further information about its plans as it finalizes development of a detailed trial and statistical plan and receives additional FDA feedback.