Ryoncil: ODAC/FDA Meeting Discussion, page-1132

Yep, dude, have you noticed the lady on ODAC standing committee who no matter how many times its explained to her that its an FDA co-designed trial and that no, those numbers she's looking at aren't the right ones, the ones are actually the positive ones, just keeps saying in the voice of doom (which I can't help but feel speak more to her mentality, than anything to do with the data in front of her.. which she seems very, very concerningly incapable of comprehending...) "yes, but its not a very big trial"...

And then poor ole Kurtzberg has to keep explaining "look, the reason why we didn't have any placebo and its a single arm, is because none of the parents wanted their kids to die,and we all already know Remstemcel works".

I never thought I'd side with Trump - but honestly, if this is how the FDA works, they are terrible. Genuinely, terrible. They should be sidelined. This is a travesty and a mockery of sound governance. Wait. Dammit, before this, I thought that was just Trump...