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Monday, January 15, 2024 5:58:31 PM
I think it’s possible MHRA had an Oncology Expert Working Group advising NWBO prior to submission.
I really didn't and don't think MHRA wants DCVax-l to hit bumps once NWBO submitted their maa. Therefore setbacks, if any, were to occur before submission.
I think SWIFT, motivated by cancer vaccine type technology (“high impact”), oncology working groups and veteran special teams assigned upon submission will get this done at lightening speed.
MHRA still has some of the best and most qualified regulator professionals on the planet. Their restructuring post Brexit wasn’t going to slow the UK down for long. Now, imo, patients will soon reap the benefits.
I agree flipper44.
This is a quote from Dr. Laura Squire-Chief Officer – UK MHRA
UK Regulatory Update – 26 September 2023
International Recognition
“From 2024, MHRA will move to a different model which allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe or Japan.
At the same time from next year they will set up a swift new approval process for the most cutting edge medicines and devices to ensure the UK becomes a global centre for their development.”
Dr. Laura Squire
https://www.gov.uk/government/news/mhras-new-chief-healthcare-quality-and-access-officer-begins-important-role
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