"and FDA knocks it back on manufacturing concerns"
Where do you get this from? The announcement does NOT say this at all. It doesn't even say te FDA have denied approval. Or anything. It simply boasts about how much they've achieved and says they've changed their minds and decided to do another trial.
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- Ann: Update on BLA for Graft Versus Host Disease
Ann: Update on BLA for Graft Versus Host Disease, page-115
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