They accepted the initial submission as well.
Then provided recommendations on how to succeed on the resubmission.
Then accepted the next resubmission, knowing full well they didn't do what was requested.
The FDA recommended an RCT in adults. Don't use the "save the kids" heartstring tugging on me bud, I've worked with paediatric haematology patients and I worked with adults suffering from aGVHD. It's terrible.
But rushing through some unproven drug because "think of the children" doesn't actually do those kids any good, and the only reason you're all happy with this drug company cutting corners is because you're financially invested.
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