July 4C in the year of our Lord 2021
• Regarding SR-aGVHD, FDA’s Center for Biologics Evaluation and Research (CBER) recommended that Mesoblast as a next step discuss with CBER’s review team at the Office of Tissue and Advanced Therapies (OTAT) our approach to address certain outstanding chemistry, manufacturing and controls(CMC) items, including potency assays, which could support a resubmission of the current Biologic License Application (BLA) with a six-month
review period
July 4C in the year of our Lord 2022
Mesoblast will provide these new data to FDA and address all chemistry, manufacturing and controls (CMC) outstanding items as required for the planned BLA resubmission in the current quarter. If the resubmission is accepted, CBER will consider the adequacy of the clinical data in the context of the related CMC issues.
July 4C in the year of our Lord 2023
The Company has worked closely with FDA during the course of the review period and remains in ongoing dialogue with FDA.
2024 4C out early next week. FDA says Clinical data is tickety boo- but what of the remaining CMC issues? Why the F has the company bothered to resubmit in the past if not fully resolved?? Perhaps ex FDA staff did keep shifting the goal posts?
Unlikely to give us any clues in this year's 4C - will be nice to hear they are hopeful re an earlier PDUFA decision.
Reg
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