Totally share everyones disbelief, angst and distress for those kids and familys.
I regard myself as a logical person and all this makes no sense. They, the FDA, could have issued a conditional approval.
They have enough evidence – so don’t know what another trial will offer or prove; and and in that have set a very dangerous precedent, which also, makes me believe there are other influences going on.
If they don’t get approval, I believe there is a legal battle that MSB will have to have because it means over a decade of research and development gone to waste, this as I have read that some have taken to FDA to court and won.
I still have to believe that all will be ok in the end…. And shame on them for asking for another trial for kids; which will says to parents you have less than 5% chance of your child surviving if there is to be a placebo trial.
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