MSB 1.86% $1.32 mesoblast limited

Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-258

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  1. 17,161 Posts.
    lightbulb Created with Sketch. 2422
    Look the FDA simply said "appears to be sufficient" for resubmission. There is no way that they could determine whether it is sufficient to grant approval or make a decision about an adult trial until after the submission has been examined. Posters here constantly overstate the position, but that's understandable given that SI does the same.
    Last edited by whytee: 05/08/24
 
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