It wont happen if the FDA don't give it a tick. If they do, AA on children!
- Mesoblast intends to perform this trial in partnership with world-leading investigators at the Blood and Marrow Clinical Trials Network (BM CTN), a body responsible for approximately 80% of all US transplants, with the costs expected to be covered by previously announced reductions in operational spend.
- FDA indicated its willingness to consider Mesoblast’s proposed registrational trial design in adults, subject to agreement on the suitability of the potency assay for the product to be used in adults.
Cell Therapy News/Articles, page-17309
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