Agreed @otherperspective - this is so disappointing!
I'm just disappointed that we were on the cusp of approval only to have the rug pulled under our feet.
I don't understand the FDA reasoning at all.
Why push for this now... they had all the data in front of them.
Could they tell this to Mesoblast during the aGVHD P3 trial design?
Could they tell this to Mesoblast during the BLA submission?
Could they tell this to Mesoblast during the rolling review?
Could they tell this to Mesoblast during the priority review?
Could they put this up to an ODAC vote?
Nope, nada, none, zilch, nothing!!!
I believe in the science and will continue to HODL - but, I'm just feeling gutted actually
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