"Similarly high survival rates were seen whether using product made for the Phase 3 clinical trial MSBGVHD001 between 2015-2018 or made with the validated manufacturing process proposed for commercial release and used under Emergency Investigational New Drug (EIND) protocol through 2023.
Mesoblast believes that the totality of these clinical studies, together with additional potency assay data
currently being generated using the IL-2R alpha inhibition potency assay in place during the pediatric
Phase 3 trial, will both support approval for the pediatric indication and provide a link between the
RYONCIL product that was used in the pediatric Phase 3 trial and available commercial inventory.
[...]
In contrast, 100-day survival was 63% after remestemcel-L treatment was used under expanded access in 71 patients aged 12 and older with SR-aGVHD who failed to respond to at least one additional agent, such as ruxolitinib."
https://www.mesoblast.com/images/Mesoblast_-_Corporate_Deck_-_NOV_2023_FINAL.pdf
It started off with a trial of 54 patients, next step was selecting the data from 25 patients and artificially create a control group based, which brought it back to (25+27=) 52 patients. Problem there was, that these 25 patients could have received lots from more than one donor which could be a confounding factor as even one ODAC presented slide showed differences in INFgamma levels between three different donors. And SI has been questioned on this slide during ODAC but shifted the focus to TNFalpha straight away.
(20min delay)