While you are correct about the back half of Dec to early Jan, it is also true that like all organizations RA's have goals and commitments to meet by EOY. There are a lot of housecleaning tasks RA's handle at EOY as/if they can.
I know the FDA pre-approval mfg site inspection/approval is typically scheduled close to the end of the NDA/BLA review process. The MHRA process is designed to be different with the mfg site approval accompanying the MAA submission but I would not rule out some flexibility there given today's state of all RA chaos driven by Covid.
We will just have to see, only days now and I will retain my expectations given the time that has passed, the patient urgency which is shared by RA's to a large degree, and the signals from NWBO.
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