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Re: SkyLimit2022 post# 791592

Wednesday, 10/08/2025 4:29:24 PM

Wednesday, October 08, 2025 4:29:24 PM

Post# of 822358
If you connect the dots, it’s starting to look like the MHRA isn’t just reviewing DCVax-L for GBM. They’re quietly shaping the regulatory framework for the entire autologous dendritic cell vaccine class with DCVax-L (murcidencel) as the first-in-class pilot.

This isn’t “trouble at MHRA.” It’s system-building. The UK is positioning murcidencel/DCVax-L as the prototype for all autologous DC vaccines a global precedent. The MHRA’s prolonged review of DCVax-L mirrors what the EMA did with the first CAR-T approvals in 2017–2018 — they weren’t just approving a single product but creating the regulatory framework for an entirely new therapy class.
DCVax-L is simply the pilot case for autologous dendritic cell vaccines, just as Kymriah and Yescarta were for CAR-T.

Very interesting
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