Providing the EAP for the GVHD cohort in the absence of effective FDA alternatives has proven the worth of Ryoncil to patients, their families and the medical community. However having it as a fail safe to the demographic has ultimately reduced the urgency factor for the FDA. There has been no rush leading up to the two CRL’s because assurances must have been made that the EAP would continue regardless of the FDA’s decision. Hopefully Si has similar assurances this time round re approval.
MESO Nasdaq update, page-5750
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