The meeting is scheduled to take place on August 13, 2020 from 8am to 5pm ET. The ODAC will vote
in the afternoon session on whether the available data support the efficacy of remestemcel-L in
pediatric patients with SR-aGVHD. This session will discuss the Phase 3 trial results and supporting
clinical data included in the BLA. The morning session will be non-voting and will discuss issues related
to the characterization and critical quality attributes of remestemcel-L.
Voting is to support the efficacy of remestemcel-L inpediatric patients with SR-aGVHD. The bold text above is the FDA issue raised today but efficacy should be granted.
Ann: Update on Scheduled FDA Advisory Committee Meeting, page-111
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