I understand what a surrogate endpoint is, but in this case with Ryoncil - the efficacy question has been answered. I.e. IDAC 9-1 vote. It’s black & white - no doubts!
The only thing outstanding is potency assay to ensure batch to batch consistency.
Can that be a surrogate end-point ?
And if so, it definitely won’t take as long as you are currently thinking
2024 Here we go again., page-190
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