Don’t disagree that a GVHD trial in adults couldn’t have proceeded without agreed remestemscel potency assays - however they were deemed to “appear to be ok” at the start of 2022 from memory.
CLBP assays for rexremestrocel were “agreed” before that as was the 12 month end point.
Old mate SI ploughed on his single track on aGVHD for children nonetheless.
Interesting also that despite constant reference to nothing available for U12s - that the resubmitted BLA wasn’t targeted just at that cohort.
Very obvious that it’s SIs was or the highway at MBS. Rose et al get the odd cameo at various CCS - but centre of corporate gravity appears to be way to far in CEO space. The rest merely nodding in the background from what I can tell.
CEO Itescu needs to go, page-23
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