Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial, page-16

"Prior to implementation, the clinical trial protocol will be reviewed by two independent National Heart, Lung, and Blood Institute (NHLBI)-appointed committees. Mesoblast will then submit the final protocol to FDA, as agreed at the Type A meeting with FDA in September."

[no way FDA can knock that back if successful]

"Mesoblast also intends to provide FDA with additional potency assay data for RYONCIL product manufactured using the current FDA-inspected process, linking product which was used in the pediatric Phase 3 trial, which met its primary endpoint, with product which will be used in the proposed registration Phase 3 trial in adults. Showing that the product used in the pediatric and adult trials is standardized, together with data showing that future product is well characterized for commercial release, could support approval for the pediatric indication given the absence of any approved therapiesb for children."

i.e. if you read between the lines, we will be pushing very hard for the FDA to make this a post approval confirmatory trial per Peter Marks recent suggestions regarding novel therapies in areas with pressing (i.e. fatal outcomes) unmet medical needs.