So,
No safety concerns.
No detrimental side effects.
No Manufactuing concerns
No Consistent of product potency concerns.
Trials conducted on the most server form of GvHD
Long term durable positive outcomes for children treated in an area of unmet need.
FDA has the blood of children on their hands, I wonder who could have possibly influenced the FDA into this decision.
Meanwhile big pharma seems to be able get drugs with no efficacy approved.
I guess this result will make mesoblast a cheap takeover target for big pharma.
This truly is a sad day for a democratic capitalist society showing the best of innovation in science and the worst of behaviours.
Ann: Update on BLA for Graft Versus Host Disease, page-114
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