$NWBO @DCarnival46

#CancerMoonshot today will not only be about glioblastoma, but about the horrible DIPG (diffuse intrinsic pontine glioma) occuring in children and young adults.

You know who got their PIP plan approved last year by the MHRA in the UK? Image
You know who ANNOUNCED a new center of cancer excellence in Sutton in the UK two months ago, 130 miles from Sawston, focusing on DIPG? Image
You know who donated 2.5 million pounds to the center and that Hugh Adams works for them and have helped NWBO meeting british politicians and he wrote the "Pathway to a Cure" report, where politicians urges MHRA and NICE to get DCVax-L to patients? Image
SAME DAY MHRA announced this

"This new funding will accelerate the delivery of cutting-edge treatments like cancer vaccines" Image
One week later the MHRA announced this. Image
The new Quarterly SEC filing says

"We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit."

You know NWBO already had planned DCVax-Direct trials in 2019 targeting DIPG?

nwbio.com/wp-content/upl… Image
Just saying.

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More from @FlemmingBruce

Jul 3
$NWBO

Excellent news from @peter_brit on NICE.

Isn't it funny how MHRA Draft Guidance on External Controls, 10 years health plan on personal individualized cancer vaccines, POC and PICV frameworks ... it all seems to "come together" RIGHT NOW?

Read about it in a week on Ihub! Image
1/ Image
2/ Image
Read 6 tweets
Jun 30
$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…Image
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.
3/

“While the guideline is specifically aimed at sponsors planning to use RWD ECAs, many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”

Covers trial-based comparators like DCVax-L’s.
Read 10 tweets
Jun 29
$NWBO Image
Or in plain english Image
Let's carve it even more out.

Here’s what it means, in significance:

MHRA’s 2025 guidance is titled “Use of External Control Arms based on Real-World Data…”

But explicitly includes historical clinical trial data (i.e. published RCTs) as valid sources.
Read 6 tweets
Jun 27
$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. Image
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.
3/

Each RFI pause allows up to:

• 6 months for the first
• 3 months for follow-up
• 6 months for CHM representation if issued

These pauses are expected in complex cases.
Read 17 tweets
Jun 24
$NWBO

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

- Individually personalized cancer vaccines
- Regulation of Artificial Intelligence

gov.uk/government/new…Image
2/

June 24:

Today came the first one to "fruition"

- MHRA to lead global network for AI regulation.

One down ... one to go.

Which was that?

- Individually personalized cancer vaccines

gov.uk/government/new…
Read 9 tweets
Jun 24
$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! Image
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.
3/

2nd. source:

UK government press release on MHRA reforms (June 2025):

“All clinical trial approval backlogs are cleared”

“MHRA will now focus on the most complex and potentially transformational new treatments - like individually personalised cancer vaccines”

CARVED OUT! Image
Read 8 tweets

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