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TheFollower

07/16/25 4:50 PM

#776332 RE: jesster64 #776311

MHRA response to several questions about info on their website and others.

"Thank you for you enquiry.
You can find the guidance for the approval process listed on this link:
https://www.gov.uk/guidance/national-assessment-procedure-for-medicines
Please note that:
We do not share updates of the applications externally.
We have a statute requirement to make determinations within 210 days which does not include periods where companies may request more time to answer questions.
We hope this information helps. Please do not hesitate to reach out to us if you have any further questions regarding this query.

Kind regards,
Angel
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, London E14 4PU
Telephone 020 3080 6000
gov.uk/mhra
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ilovetech

07/16/25 5:11 PM

#776336 RE: jesster64 #776311

I trust my common sense and intuition. I look at all the information and consider what the probabilities are accordingly. As new information comes to light, I take what resonates and decide if it changes the equation, one way or another. The system is designed to keep the public in the dark. Under these circumstances, I try to examine the trends and patterns, which either move in the same direction, come in conflict, or have no impact. With that said, both the recent regulatory changes, and label determination seems to make the most sense that would suggest we're on the final stretch for a decision to drop.