The CRL was issued by the FDA which is run by Peter Marks?
.........
And, as I said.... if the children get approved based on Gvhd001.... that trial provided 4 year mortality data. It does not need surrogate data, and therefore does not need accelerated approval.
I think with my pessemistic hat on.
FDA will turn MSB around and guide them on the size of the trial in adults, the number, severity and primary end points, and I hope Si can turn around and say this is now funded by the centres of excellence. I think that is the most likely outcome.
2023 Next Steps, page-48
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