It's elementary @JB1975 - if you look up from all the weeding!
Mesoblast was planning to do an adult study to clear the FDA CRL, but they met with FDA and after this formal discussion, the company pivoted and reverted back to the old plan. i.e. get approval for Ryoncil Pediatric first then proceed with the adult trial later - simples.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-252
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