The ridiculous thing is, if MSB started an RCT when the fda said they wanted one, they'd likely have the results by now.
Why didn't they do that?
The facts are:
1) FDA wanted an RCT 2) MSB had enough time to design, recruit, and at least get one year data by now 3) If the trial was successful, approval would be a sure thing 4) If the cells worked, you would expect the trial to be successful.
So why would MSB gamble with its whole future by not simply doing what the FDA wanted? Unless they were worried they wouldn't meet primary endpoints. But, we want a product that works. Not a product we hope works, but for some reason can't, or don't want to, prove.
I honestly don't have the answer to that question. It just doesn't make sense to me. And no one here seems to know either, they just hope there's a reason.
Maybe it will make sense to the FDA. They have more information than us.
(20min delay)