NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

e❌wannabe,

Thanks for continuing to share your free advice and x-ceptional x-pertise 😶

Let’s clarify the misleading implications of your posts/reposts with some independently verifiable facts:

✅️ MHRA has not yet awarded a full commercial/marketing authorization for any autologous dendritic cell-based therapy in the UK. NWBO’s MAA is the only application of its kind submitted to the MHRA for such a product.

✅️ Autologous DC vaccine technology is recognized by MHRA and accessible to patients through clinical trials, IFRs, or compassionate use (UK Specials Program). An approved MAA would vastly expand availability of a DC platform technology as a commercial pharmaceutical product.

✅️ MHRA has approved the MIA, the PIP, and the Specials Program. They have not approved an MAA yet.

Most cell & gene therapy approvals in the UK have been for CAR-T therapies, stem cell-based products, or allogeneic cell therapies, not autologous DC platforms.

Please refer to the MHRA’s license to manufacture the vaccine and the relevant HTA approval that were cited in NWBO’s 2022 press release:
“Under this regulatory program in the UK, the vaccine is identified as ADCV (“Autologous Dendritic Cell Vaccine”). As previously reported, the MHRA license was received in December of 2021, following nearly two years of preparations.”

Regarding Previous HTA Approval & 2025 Advent Update:

The more recent procurement license update (2025) is important for manufacturing a cell-based product for commercial distribution as opposed to manufacturing for investigational use through HTA approval granted to a hospital…

The HTA Procurement License is required for Advent to be a fully compliant and independent manufacturer of DCVax-L — HTA license is required for full regulatory compliance for commercial-scale operations.

Advent no longer needs to be working with King’s Hospital or any other sponsor to procure human tissue on their behalf to produce DCVax-L.

✅️ Advent can now operate as a fully compliant and independent manufacturer of DCVax-L under UK human tissue regulations.

The update that was published on May 19th includes “Procurement.”

Human Tissue Authority U.K.

HTA Guidance


NWBO 10-Q

DCVax-L Combo PII UCLA

DC Combo PII Roswell Park

NICE UK 🇬🇧 DCVax-L

ASM June 29, 2024

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