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Red_Right_Hand

01/13/25 3:43 PM

#743560 RE: RobotDroid #743556

What delay?

If the clock started on the 1/24/24 validation, and there were 60 clock-off days for an RFI, then NW's MAA is at day 295, while the MHRA-reported average clock-on days for the last 12 MAAs granted July-November is 296 days.

So there is no evidence that we are delayed any more than MHRA's general delays. https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines#full-publication-update-history