Saturday, June 28, 2025 4:59:31 PM
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
followed by this
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
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
Following the consultation, the MHRA will amend and publish the guideline document as well as publishing an anonymised summary of the public feedback.
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
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