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dennisdave

06/28/25 4:59 PM

#773335 RE: kfa670 #773334

Hey kfa,

The article had June 30 wrong or the deadline has been postponed.

The MHRA is now saying this 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

Summary We invite feedback on the clarity and wording of our new draft guideline on the use of external control arms based on real-world data to support regulatory decisions. This consultation closes at 11:59pm on 14 July 2025

followed by this

Following the consultation, the MHRA will amend and publish the guideline document as well as publishing an anonymised summary of the public feedback.

so that means they have the guideline already in place. A few amendments and an anonymised summary will be a week max.
So I really do believe that the decision should come right after that so before August 1, max mid-August perhaps... IMO

It has been a terribly long wait