Cell Therapy Plots European Conditional Approval For Heart Regeneration Product

Cell Therapy Ltd says that following a pre-submission meeting with the European Medicines Agency (EMA) in September, it now plans to begin applying for a conditional marketing authorization (CMA) for Heartcel, its lead allogeneic stem cell therapy, which has been designed to regenerate the heart. Filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017.