OK, found that reference (likely again):
Initially when I read the following statement, I thought he was talking about EAP 276 (
https://clinicaltrials.gov/study/NCT00826046?cond=GVHD&term=mesoblast&viewType=Table&rank=2 - adults Grade C-D finished in 2014/2015):
"Mesoblast has generated pilot data through its emergency IND program in adults showing a survival benefit with remestemcel-L in this target population."
https://www.biospace.com/article/releases/mesoblast-receives-complete-response-from-u-s-food-and-drug-administration-for-biologics-license-application-for-steroid-refractory-acute-graft-versus-host-disease-in-children/That would have led us straight back to your 11 data points and old data newly packaged (and as you have demonstrated, not even that).
That was in August 2023.
The resubmission did show an improvement in survival and subsequently CRL #2 read different to the first one, now asking for:
"more data to support marketing approval, including potency assay or clinical data."
https://www.mesoblast.com/images/pdf/MSB_2023_Annual_Report_Online.pdfAfter re-reading the announcements I saw that despite there not being a reference like EAP 276, patients appear to have been treated using the improved process right up to (including 2023):
"Mesoblast presented consistently high survival in patients treated in RYONCIL, in children with
SR-aGVHD in the EAP between 2008-2015, in the Phase 3 trial MSB-GVHD001 between 2015-
2018, and in the Emergency Investigational New Drug (EIND) protocol from 2015-2023."
2015-2023 and therefore after GVHD-001/002, after CRL #1 and also after CRL #2.
That should allow for many new data points generated after all the patent applications we have discussed, to further show that the potency assays TNFR1 and IL2Ra as used in GVHD-001 are consistent with the batches used in EINDs between 2015-2023, which are the same as the ones ready for commercial release.
Historical data, GVHD-001 and EIND data as recent as 2023 (which is likely where the 71 100 day patient data is coming from).
(20min delay)