Ann: Mesoblast Type A Meeting with FDA, page-367

he "baseline" mortality rate is completely irrelevant to whether or not the treatment actually works. That can only be decided by a scientifically accurate properly controlled clinical trial.

Your thinking is confused by your financial motivation and being rationalised by "if it's been deemed safe, what harm can it do"?

Actually it f it doesn't work then the harm it does is by financial cost for no benefit, delays in accessing other treatments and seeding false hopes and misleading avenues of investigation. There's a host of problems caused by believing a treatment works if it actually doesn't, particularly expensive ones which divert funds from better use.