Note the term I was focused on, being “registration trial”. Registration trials are about real world, as opposed to clinical, evidence.
This company’s Remestemcel product will rely on from now on for label extensions (plural) on real world evidence. It’s gone past the clinic.
This is worth applauding - if the potency work is done to the FDA’s satisfaction. It will no longer be confounding when it happens. The time and money invested in the additional potency assay work in the most difficult years in global healthcare history will hopefully not prove to have been a waste, but rather, lay a solid foundation for a class of therapies.
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- Ann: Mesoblast Type A Meeting with FDA
Ann: Mesoblast Type A Meeting with FDA, page-98
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