Per the guidance, once the clock starts (Validation or "Acceptance") Assessment phase I will be completed within 80 days. During this period, eligibility for grant of orphan status is also determined. If there are issues requiring clarification (RFI), the clock turns off and RFI should be address within 60 days. NWBO can request an extension of an additional 60 days, but these are granted only for exceptions (not common).
Once RFI is addressed and sent to MHRA, clock turns back on and they have 70 days to provide a decision on approvability.
Max time: 80-Phase I+60-RFI+60-RFI Extension+70 = 270 days - > September 30th approval
Min time: Either no RFI (improbable) or RFI for simple things -> Approval a few weeks after CHM meeting scheduled for March 21 & March 22.
I think there is a possibility that we are approved by MHRA by the end of March, early April. The MHRA knows the treatment well, has been through the manufacturing facility several times, and the safety profile of the treatment has an excellent benefit/risk profile.
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