Yes they had a rolling BLA submission from May 2019 but that communication process ended in february 2020 when it was submitted. The FDA accepted the submission in April agreeing to a priority review. They set the action date and advised there would be a committee meeting to discuss the application.
It is not a simple matter of FDA saying do "xyz" and we will approve. It is more like do "xyz" and we will accept the application and review it.
MSB to dispute FDA finding in Type A meeting, page-321
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