On some level, I can't really seem to get myself worked up to worry about this one -- and believe you me, I'm not good at Polly-Anna silver-lining thinking.
The standard of care in this trial was "watchful waiting," i.e., nothing. All it had to do was be better than nothing. And it did so -- quite certainly.
They don't really have to look at subgroups to justify approving this. The math works fine as is.
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