And I'm wondering if the BLA process will take the normal amount of time, allowing for the fact it has RMAT, given;
Overall Day 180 survival for the entire remestemcel-L treated group was 69%. Historical survival rates in patients with Grade C/D disease and failure to respond to steroids have been only 10-30%
Children were taken out of the P2 double blind placebo trial very early on and directed toward the Expanded Access Program for much the same reason. Those on placebo had a very high death rate.
The 180 day results reinforce that thought.
Ann: Day 180 Survival Outcomes In aGvHD Phase 3 Trial, page-21
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