Sounds like a ‘by the book’ whilst throwing the book at mesoblast by the FDA. They have made numerous odd decisions…..Aduhem AD meds ….most recently…a side effect …..’death…..2 patients after they approved it ffs….no issues either with the 10-0 Against approval from ODAC. Si could be arrogant or humane to attempt to expediate Ryoncil to address this urgent GVHD issue with children. I would like to see the doctors, patients & parents show some support for meso with the FDA this time around. The FDA were always going to play ‘hard ball’ with a first use therapy and that’s exactly what they have done. SH are entitled to expect management to prepare for different scenarios if they know their stuff.
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