$NWBO

1/

Has the MHRA’s new 2025 guidance on external controls anything to do with NWBOs MHRA application?

Let’s examine that claim from here



using the ACTUAL verbatim language from the MHRA guideline. investorshub.advfn.com/boards/read_ms… The MHRA guidance is titled:

“Use of External Control Arms Based on Real-World Data to Support Regulatory Decisions”

It focuses on ECAs in situations where randomization is infeasible or unethical.

NWBO’s DCVax-L trial fits that exact profile.

$NWBO Or in plain english

$NWBO

1/

DCVax-L was submitted to MHRA on December 20, 2023 and validated on March 7, 2024. This started the official assessment under MHRA’s national procedure for innovative medicines. 2/

The MHRA process counts only assessment time when the regulator is actively reviewing the file. When they send formal questions (RFI), the clock stops while the applicant prepares a response.

$NWBO

In two back-to-back announcements, the UK government laid out its regulatory priorities for the next decade. June 16:

- Individually personalized cancer vaccines
- Regulation of Artificial Intelligence

gov.uk/government/new…

$NWBO

For those still unsure about the MHRA and DCVax-L

1/

There’s persistent speculation that DCVax-L is being delayed or sidelined by MHRA.

That we could somehow be ... rejected.

That narrative conflicts with two clear, official sources.

I call BULLSHIT! 2/

1st. source:

Direct email response from the MHRA to a shareholder inquiry (Lykiri) in April:

“This application has not been in backlog or delayed in assessment.”

That is the agency’s formal position on DCVax-L’s review status.

$NWBO

Part 1:
On Replacing Placebo With External Controls

A 7-part series documenting MHRA’s collaboration with NWBO, anchored in the APPGBT report “Pathway to a Cure” and its seven core recommendations. 1/

The first APPGBT recommendation calls for replacing placebo arms in brain cancer trials with external controls. This principle is already reflected in the design of NWBO’s Phase III DCVax-L trial for glioblastoma.

$NWBO

Adding these pieces of information, not least considering the Regulation 17 update in February, makes a rejection out of the question.

$NWBO

Is the new MHRA draft on external control arms a DIRECT outcome of the APPGBT’s years-long glioblastoma inquiries and the Pathway to a Cure recommendations?

And was the DCVax-L trial the precursor that proved the case?

Diving into it ... it seems so.

Yes! 2/

In May 2025, the UK’s MHRA released a draft guideline:

“Using External Control Arms Based on Real-World Data to Support Regulatory Decisions.”

To most, this looks like a global trend.

But looking closer, it seems directly influenced by the DCVax-L trial.

$NWBO

Great find from @HenryMuney 🙏

1/11

Key UK regulatory update for Advent BioServices:

Their Human Tissue Authority (HTA) license was updated on May 19, 2025 to explicitly include "Procurement" of human tissues and cells.

This is a major enabler for Flaskworks Eden.

https://twitter.com/HenryMuney/status/1925273886788395270

2/11

Let’s clarify a common question about $NWBO's Flaskworks Eden rollout:

“If the Grade C labs weren’t built at the time of the MAA… how close are we really to Eden manufacturing?”

$NWBO

The Regulatory Reality: Masaryk’s Murcidencel and Its Link to DCVax-L

A Deep Dive into the EMA’s Active Substance Classification Requirements

The EMA guideline:

ema.europa.eu/en/documents/s… 2/9

In the EU Clinical Trials Register, Masaryk University’s trial lists “Murcidencel” as the active substance.

But here’s the kicker: it is classified explicitly alongside DCVax-L and Canpuldencel-T.

This is not a casual mention.

This is a regulatory declaration.

Murcidencel (DCVax-L) is now listed as "CANCER" on the NHS High-Cost Drugs List (HCDL), not just glioblastoma.

This change could signal broader potential for solid tumors beyond GBM. Here’s why that might be the case. 👇 2/13

Clinical Experience Across Tumors

The Czech trial under Murcidencel includes various cancers:

Brain Tumors (GBM, Astrocytoma)
Sarcomas (Ewing's, Rhabdomyo, Osteo)

Others (Neuroblastoma, Burkitt's Lymphoma)

This suggests potential multi-cancer reach.

$NWBO

1/8

Would this explain the delay?

It would!

🔥 Major Update: Murcidencel (DCVax-L) is no longer listed as just for "Glioblastoma" on the NHS High Cost Drugs List.

It's now classified simply as "Cancer". This is not just a name change-a signal of something much bigger. 2/8

💡 Why This Matters:

A shift from a specific cancer (Glioblastoma) to a broad "Cancer" label means the NHS is ready for broader patient access.

It opens doors for Individual Funding Requests (IFRs) across multiple solid tumor types.

$NWBO

Canpuldencel-t has been deleted april 1st. from NHS High Cost Drugs list.

What does this mean for NWBO? 1/11 🚀

Big news for $NWBO:

Canpuldencel-T is officially gone from the NHSPS (NHS Payment Scheme) list.

Why is this important?

Because it signals the full regulatory transition to the new INN name:

Murcidencel.

Murcidencel's NHS Listing and MHRA Approval — Are They Aligned? 1/16

Murcidencel was officially added to the NHS High

Cost Drugs List (Version 20.0 – Final, April 2025).
Indicated for cancer treatment.

Accessible via Individual Funding Requests (IFR).

Murcidencel's Global Recognition & NHS High Cost Drug List

MILESTONE 1/18

Murcidencel, the WHO-assigned INN for DCVax-L, has achieved major regulatory milestones:

Included in WHO INN Proposed List 128 (2023)

Advanced to WHO INN Recommended List 90 (2023)

Confirming global recognition for NWBO's DC vaccine.

NHS: April 1st.
NICE: April 2nd.

$NWBO

Czech Trial: The Missing Link

With the help of @d_stock07734's due diligence, it seems like we are able to uncover what must have been quite a challenge at that time for Masaryk University.

The manufactoring of the dendritic cell vaccine for the trial. Please follow @d_stock07734 for additional due diligence regarding the Czech Trial results and other possible links.

🙏

https://x.com/d_stock07734/status/1919062992500543831

$NWBO

Allow me to entertain a hypothesis, that is probable "far out", but which I somehow still find believable, knowing Linda Powers setup several dormant companies in 2014, obviously trying to predict a few chess board moves over the last decade.

Let's say she did that. 1/

Something extraordinary may have just come together for NWBO - and many missed it.

A Czech trial, once unrelated, now bears the name Murcidencel - the official WHO name for NWBO’s DCVax-L.

Coincidence?

ChatGPT and Perplexity says otherwise.

$NWBO

1/

Laura Posner (Cohen Milstein) & Columbia law prof Joshua Mitts filed a powerful amicus brief in Slack v. Pirani, arguing that modern tech makes it possible to trace stock origins—a key issue in securities fraud.

Source:

cohenmilstein.com/laura-posner-d… 2/

In the case, the Supreme Court ruled that if you sue under Section 11 of the Securities Act, you must prove your shares came from the registration statement you’re challenging.

That’s called traceability

$NWBO

1.

The Czechia 🇨🇿 trial has just been updated 20.00 local time. It’s a public holiday in many countries and after business hours in Europe,

That’s the 4th consecutive update in 4 days.

But why now, and from where? 2/

First: this is not a recruiting trial.

It ended in 2024, is marked “Not Recruiting,” and was migrated into CTIS for administrative purposes.

Yet it’s getting multiple backend updates — and the latest occurred at 8PM local time on a national holiday.

$NWBO

Read!

Best news this week. 👍🏻

$NWBO

UK Parliament Response on DCVax-L (April 28, 2025)

One of Sarah Owens’ questions has been answered.

questions-statements.parliament.uk/written-questi… 1/5

Official UK Parliament answer confirms:

•DCVax-L is not yet licensed by MHRA.

•NWBO has submitted the application and is fully engaged with MHRA.

No rejection, no pause — review ongoing.