You get lot more evidence from an RCT than anything you listed in your post.
I disagree with whytee, I don't think it's 50/50, likely lower.
It may get through. But the FDA spelled out clearly what they thought was necessary. MSB jumped through hoops to not do what they wanted.
Will the FDA ask why they didn't do an RCT? Of course. And what will be their answer?
Keen to find out soon
You get lot more evidence from an RCT than anything you listed...
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