Further to that - it's the PDFUA date is calculated from the date of the BLA resubmission, not when the FDA respond to Mesoblast on the BLA resubmission.
So, if the submission wa 14/06/2024 - then add either two months or 6 months to that date.
IMO unless the BLA resubmission clearly meets the Class 1, the FDA will set the PDUFA date at 6 months e.g. 14/12/2024, to give themselves enough time to meet it - they can always respond quicker than the full 6 months and therefore met their KPI on BLA resubmissions
Ann: Change in substantial holding, page-190
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