So you think they outcome is predetermined? That's what SI told everyone twice before. Unfortunately the people at the FDA who make the final decision will end up taking advice from numerous specialists evaluating the BLA submission. It's not a done deal and the people who told them they could resubmit may not be involved in doing the valuations and making the final decisions.
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- Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval
Ann: Mesoblast Resubmits BLA with FDA for Ryoncil Approval, page-181
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