Bit annoying that FDA still wants to sit on it for 6 months. When they have reviewed almost everything already a few times! Not something that Mesoblast has control over, unfortunately! They are doing what they must do to bring their first ever approval. Will be approved this time. Mark my words!!
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- Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-14
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