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dennisdave

09/27/25 4:19 AM

#790099 RE: cptbac #790063

Thanks DD. I forget if you or someone else said a while back could be as late as January/ February before complete. Is that correct? Thanks

welcome. I personally think that this "We are analysing your feedback" https://www.gov.uk/government/consultations/mhra-draft-guideline-on-the-use-of-external-control-arms-based-on-real-world-data-to-support-regulatory-decisions will be finalized before Nov 1 2025 and that right after that the MHRA will come with a decision.

I never said anything about January/ February. Having said that there is no way of knowing what the working pace of the MHRA exactly is.... they sure seem to take their time with many coffee breaks to analyze the feedback on the-use-of-external-control-arms-based-on-real-world-data 😬