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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-108

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  1. 6,597 Posts.
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    Thanks, LED. But just pointing out that someone already noticed a difference in language between the last 2 applications...

    https://hotcopper.com.au/threads/ann-fda-accepts-mesoblasts-bla-resubmission-for-remestemcel-l.8110020/page-62?post_id=74876192

    Just thinking if management had gone for a smaller target after their CRLs but were encouraged enough after the FDA feedback recently to go back to full U18 approval which I am pretty sure was in their initial ODAC application.
 
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