MHRA has plenty of leeway with regard to how they handle an application and you admit this. This puts them in position to string things out to the point they see as necessary so a company can prove that they can take care of initial demand that MHRA wants to meet. No one knows what that level is because there is no set number ever shared publicly but clues can come from intervening company or affiliate actions. Advent increased space that likely is in support of meeting a need for apheresis centers because of a shortage in capacity that has been a known issue for several years. There is also the change in plans from expansion of Class B clean room suites to Class C conversion from Class B set aside space designated for Class B clean rooms. This strongly suggests that future space development will be only for Flaskworks as this smaller conversion space is expected to double the manufacturing capacity which obviously is needed to be part of the plan after inspections took place since this announcement came after the inspections were done. Bottom line is that MHRA appears to have wanted increased dedicated apheresis space and Flaskworks ready for expansion of capacity sooner rather than later. Though you dismiss the requirement of Edens, the readiness for Flaskworks expansion sure looks to be an MHRA priority. There would otherwise have been no need to push forward the expansion of capacity planning with converted Class B development space to Class C for the sake of saving time, cost and space for future use. Best wishes.
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