The FDA did not say that.
In fact, as we've been over a number of times, they outlined what they wanted MSB to do (RCT in kids or adults), and MSB didn't do it.
The FDA told MSB how to rig the coin flip in their favour, but they didn't do that.
And you're right. Coinflip implies a 50/50 chance, which this is not IMO.
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