The FDA have been addressing the needs of children with GVHD over & above the poor outcomes of the SOC they have ‘approved.’ The therapy / treatment they have not yet approved has achieved amazing outcomes, did achieve PE, was voted 9-1 approval by their own hand chosen ODAC & has been permitted to operate at no cost to patients for the 4th year this year ….still no approval ??????? Very difficult to justify on a fair playing field particularly when the FDA have agreed Ryoncil is effective & efficacious ….
Cell Therapy News/Articles, page-17532
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