Can I question and understand if FDA has now acknowledge the additional data submitted being sufficient, and Mesoblast has already ticked other things off why still they are asking mesoblast to resubmit the BLA and go through the full blown process again? My research into the topic tell me, the full approval could come even without needing to file BLA again as long as MSB has addressed agency's concerns. Thoughts?? Why add more time length again to delay the assistance to children who are suffering??
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-207
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