The FDA could be wrong too... as @otherperspective points out.
Maybe they're holding Mesoblast to a control standard that's too tough. I don't know
Why is this admission so buried, made so late? Best to put it in your signature so it underscores all your comments.
Because it's a real and serious possibility AND you ignore that there would be more data with post approval studies after an AA.
Which could have been done and asked for by the FDA long ago.
Plus the context which you still hide from about the comparison between patient need, mortality and benefit.
The context of what pharmaceutical drugs approvals get away with couldn't be more stark.
But you could be wrong, so let's fire SI, and create a ruckus when there was already blood on the floor just to prove you're the GOAT poster?
Context is everything.
Along with this one about being driven by emotion rather than logic quoted with approval:
"I really hate to fire people. It's very uncomfortable, hard-to-do, disruptive, risks demoralizing others on the team, and could lead to an even worse situation....
So, I never do it. Until the morning I wake up and mere contemplation of the act brings me joy."
Emotion. And nastiness. Firing SI is not at all productive but you continue to advance it. Because why? emotion, yours.
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