You forgot one important part; subject to agreement on the suitability of the potency assay for the product to be used in adults.
This must happen and then the FDA will approve trial.
Note: the additional data Mesoblast will provide (see above, we are talking about the same assay). This will determine if agvhd under 12 is good to go or wait for adult trial to confirm. More delays, thus Mesoblast needs funding to take them to 2025.
Regardless if it's early 2024 or 2025, Mesoblast gets cash the god damn thing will be approved. Cash is king! yeah!
Cell Therapy News/Articles, page-17311
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