But pushing forward after that... trying to work out these complex issues by advancing an unproven product in children without benefit of randomized, blinded controls... that was a mistake AS A LEAD INDICATION for this therapeutic. The company should have put childhood GvHD on the back burner and proceeded with RCT's elsewhere.
WERE were you calling for this before the FDA did it's latest duck and weave?
As I keep saying and you keep ignoring, if SI's approach had worked you'd be congratulating him and calling him a genius.
It's this, plus the fact that you piled into a falling SP and called him to go and so vehemently, is what has been so damaging.
I'm not a fan of this behaviour.
Not least of all you ignore the ethical reasons why SI wanted to focus on this unmet need.
If SI manages to get a rapid cohort of trial size agreed by FDA and this gets approved in short order, you'll be telling us it's because of your focus.
The reality is the MSB team delivered the potency assay improvements and the manufacturing data which is what the FDA wanted.
Do you think they should halt now?
Unreal.
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