Lucky for us and the children many experts do not agree with...

Lucky for us and the children many experts do not agree with your views. The overwhelming 9:1 ODAC vote is testament to this. They were of the opposite view that the Phase III trial results demonstrated that Rem-L for paediatriac SR-aGVHD patients was both an effective and safe treatment. Not to mention the strong opinions of the principal investigators treating said patients on the ground and the real world lives saved in Japan etc.

I know it is in the downramper's cult playbook to throw shade on everything, but this is a special circumstance where running a placebo arm would have be considered unethical (would have seen children needlessly die, investigators and clinicians did not want a bar of involving a placebo arm and therefore neither did MSB - and rightly so IMO). And in the recent meetings with FDA/OTAT not a mention of another trial in children required before BLA re-submission once CQA ticked off.

So I guess quite a few would chalk this trial up as a success (that met its' primary outcome).

And don't get me started on the DREAM Phase III trial for CHF. We knocked it out of the park unless you would prefer to market another drug to reduce non-decompensated heart failure hospitalisations as opposed to the real deal reducing Major Adverse Cardiac Events (heart attacks, strokes and cardiac death).