FDA noted that the lack of a suitable potency assay for the RYONCIL product used during the
Phase 3 trial MSB-GVHD001 for the pediatric acute GVHD indication has prevented the trial from
being considered an adequate study for the purpose of demonstrating substantial evidence of
effectiveness required for a marketing approval.
Based on the above, if MSB prove it's suitable to FDA requirements, yes to your question.
FDA noted that the lack of a suitable potency assay for the...
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