Makes a mockery of the ODAC process and to even suggest the possibility of a randomised study for children after the discussion around this in the ODAC is uncouth. However they hold the keys to the cabinet. This is a blow to those kids that are suffering. I hope they have some access in the meantime.
So would this be another P3? Hopefully they can convince the FDA of conditional approval with a P4. It's going to be intriguing to see what happens if the C19 ARDS trial results are solid.
Ann: Update on BLA for Graft Versus Host Disease, page-41
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