Replies to post #774308 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

You’re ignoring the distinction that matters: DCVax-L isn’t just autologous, it’s a cryopreserved, multi-dose, patient-specific vaccine manufactured with tumor lysate, not a shared antigen or fixed design. The MHRA had never reviewed or approved a therapy with this structure, delivery model, or logistical complexity. Pretending otherwise is either misinformed or deliberately misleading.

[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

Manufacturing Technology























AI Fact-Checking

[skitahoe]

I assume you're speaking of Provenge, and that's true, the huge difference between the two is Provenge made a tiny improvement on the treatment of prostate cancer whereas DCVax-L can make a tremendous difference for GBM and possibly many other types of solid cancers.

Dendron had the problem of both high production costs and very low demand. After bankruptcy they managed to form a private company that still makes Provenge available, but demand is low, and I don't believe they've had the funds to develop other products they had planned.

Personally my only exposure to DNDN were a few options that closed worthless, but I know people who made a lot with it, and others who lost a lot.

I believe that this is a very different proposition. With EDEN we have a way to keep the costs reasonable, meet high demands, and most importantly have a product that's far more effective than the SOC.

Of course, until there are additional trials we won't have the proof of the capability of DCVax-L, but anecdotally it already exists. The question may be, how far does off label use expand before it's actually approved with label changes. If I'm right, well before that time it will be recognized, and insurance will pay for it.

I don't know if compassionate use data will ever be revealed, but I believe the regulators know all about it, at least anecdotally.

Gary