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Re: Lykiri post# 791725

Thursday, 10/09/2025 2:57:22 AM

Thursday, October 09, 2025 2:57:22 AM

Post# of 822335
Thank you Lykiri

The October 6 2025 CGT Catapult Autolomous white paper might actually tell us why MHRA has taken so long with DCVaxL.
The project, funded by UK Research & Innovation, validated a fully digital GMP environment using Autolomous’ autolomate platform showing a 65 % faster QA review, near-zero data-entry errors, and complete paper-elimination in a real MHRA-licensed facility. Advent Bio/Sawston manufactures DCVax-L on that same digital infrastructure. So the MHRA hasn’t just been reviewing a therapy; they’ve been validating the entire digital manufacturing backbone that will define how future autologous cell therapies are regulated in the UK.

If thats the case, and Im personally 95% sure now then this was never just about GBM efficacy it’s about system-building.
Murcidencel/DCVax-L is the pilot case for embedding digital GMP and data-integrity standards into UK regulation.
Now that this government-backed validation is public, MHRA finally has everything it needs to close the review.
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