Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-275

And you keep inferring that they wouldn't carry out steps in the approval process without having completed a previous step ie. already made a decision to grant approval.



Not what I said at all in not one but two separate posts .... just to be clear:


"the FDA must have been at least somewhat satisfied with the data in the BLA resubmission"


"they weren't at least somewhat happy with the data provided by Mesoblast in the BLA resubmission"


..... neither of these statements make claims that a decision has been made to grant approval causing the inspection to be undertaken .... more lies from you - do better !