AGVHD process, as a novice of 4 months, what i was read was the...

AGVHD process, as a novice of 4 months, what i was read was the same, FDA were both guiding them on how to conduct the trial, and what outcome endpoint. and giving MSB the green light.. and for single arm, it is criminal to have a placebo with kids with such an extreme already death rate. The FDA then change to goal posts saying not enough? in many trial a discussion is had with the FDA in the design of the trials.
I been told here that my observation of this isn't correct. and the FDA initial told them to do placebo trial with the kids, but MSB decided to go against this and did a single arm.
Am i still getting it wrong?
From the AGM heard si say he would still make the treatment available to kids that need it.. not doubt on compassionate ground... it was one sentence in the whole presentation and hope other heard it too.
..and while those outcomes aren't likely to be presented to the media or in official company announcements i wish they were. ..... a clever journalist might be able to investigate those outcomes and present an overview of success.