The Science Will Do The Talking, page-131

this is out of control.... why are you constantly on here? The CyP forum was quite balanced for a long time, now it’s starting to resemble the disaster that is the MSB forum. You constantly pick snipets of information to argue on, get schooled then change the goal posts of the argument? You can mange this argument in the local bar, but when it’s all written in plain English you just look stupid. You are allowed to be wrong barman, it’s a good trait to admit that.

I am too shocked at the FDA s decision regarding GVHD, given its children, and there’s little alternative.
MSB went after the one indication which on the surface appeared a done deal. No one is arguing that it’s largely free from adverse reactions but clearly they aren’t sure the treatment is safe. Safety in that it cannot be shown all kids would receive a treatment of comparable efficacy, or maybe they would but MSB have no way to prove that to the standard the FDA wants........ multiple donor / expansion...... ie manufacturing problems.
Paediatric GVHD was a strategic move by the company to gain FDA approval for their manufacturing platform, thus making a smoother process for other indications. I think the FDA have now said, nice try

CYP on paper have the answer to this problem, but the slow progress, management issues etc mean it’s still just that....