The longer the kids wait for this cure the more kids die.I believe this was negotiated a long time ago when the FDA were playing it overly safe with cell therapies.
I dont believe there is any wait for safety for LVAD (as again waiting will mean more deaths)
If they plan on approving LVAD quickly then GVHD shoud be just as fast
I say approve and keep tracking patients in trial for safety....thats if they have any smarts at all.
180 day wait for safety is ridiculous
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