The trial was up to 18 years. The original BLA submission and each resubmission has always been up to 18 years. People get confused about this because there is a lot of talk about the lack of treatment options for patients under 12.
Maybe they don't have so much to review that 6 months is needed, but 2 months was just too tight a deadline.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-58
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