@kervio, if the reason is all because FDA want to cover their asses then how can you rule out accelerated approval where they can withdraw it if the binding RCT fails. It's a way of saying, ok we understanding the treatment is safe, it shows efficacy but we are not convinced until it can measured with the gold standard (RCT) so we will let it treat the sick kids for now and you (MSB) need to prove its efficacy with RCT. If successful you will be granted full approval, if not we will withdraw it
Wouldn't you think that would cover their asses not them not be seen as heartless pricks.
@kervio, if the reason is all because FDA want to cover their...
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