Absolutely disgusting behaviour by the FDA - to ignore 70% ORR compared to best standard of care (Jakafi) WHICH was approved via label extension to aGVHD based on a single-arm study.
To go against an ODAC 9:1 vote, which has never occurred for an overwhelmingly positive ODAC AdComm vote in HISTORY.
All I can say is: hold onto your hats.
Absolutely disgusting behaviour by the FDA - to ignore 70% ORR...
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