Probably been posted before, but the ODAC Briefing Document (https://www.fda.gov/media/140988/download) gave cause for caution on results to date. They clearly needed to be convinced of the technology, safety and consistency of product.
Trials continue, so I personally don't see the FDA advice as a setback, but rather an opportunity for Mesoblast to prove beyond doubt the efficacy of the Remestemcel-L treatment.
It took a while for people to get their heads around plugging a car in to a power outlet and running it on electricity. Such is life.
Ann: Update on BLA for Graft Versus Host Disease, page-236
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