If I were the Company, I would negotiate with the FDA. Request approval for GVHD for pediatrics label using the updated potency assay in exchange for completing the adult trial with the assay. The FDA would have ability to pull approval if adult trial did not achieve endpoints.
Given history and evidence that adult trial is funded and happening, I think the FDA might be willing to accept this resolution.
Ann: Annual Report to Shareholders, page-45
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