An entirely reasonable post. Not sure of the relevance of the other letter to Mr Lassman.
No obvious relationship to the Remestemcel BLA? Although in broad terms it does refer to the reasons for denying approval of a new drug according to the FDA's protocols regarding assesment of safety and efficacy.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-999
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