just my opinion, but I reckon fda will ask for phase iv trial which occurs after approval. Given ODAC approval and the unmet need categorisation for SR aGVHD in children my feeling is FDA will be inclined to approve on the current phase 3 data. All imho.
https://www.google.com.au/amp/s/www.news-medical.net/amp/health/What-is-a-Phase-4-Clinical-Trial.aspx
Cell Therapy News/Articles, page-5679
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