Hi Index…,batch to batch consistency was an issue along with evidence of MOA. Regarding the trial….Ryoncil was a therapy targeted at children 12 yrs and under. There still remains no approved SOC for this demographic however a better SOC exists for adults with GVHD. Whilst the FDA expressed concerns regarding batch consistency & MOA despite a 9-1 ODAC vote in favour of approval, the FDA allowed MESO to continue to treat the 12yr & under cohort since they slapped the CRL on Msb.
Ann: Uni of Newcastle Heart Protection Collaboration Extended, page-47
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