As foreshadowed in the recent company presentation. This will be more like a Phase 4 trial. We know it works, just confirmation in a real life setting that will put any concerns FDA has to bed. Other Pharma companies don't want Mesoblast to succeed and have been lobbying the FDA to put the go slow on Stem Cell treatments. Theory is once the first approval is received, it will open the flood gates. No timeline given in this announcement though.
Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial, page-4
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