Northwest Biotherapeutics Inc (QB) (NWBO) News

NICE News for Life Sciences :
July 2025

https://mailchi.mp/nice/reminder-nice-news-for-life-sciences-7861360?e=d01f2bdbca

https://nice.org.uk/news/blogs/nhs-10-year-plan-empowers-nice-to-get-patients-better-care-faster

NICE ANNUAL REPORTS AND ACCOUNTS 24/25

https://nice.org.uk/Media/Default/About/Who-we-are/Corporate-publications/Annual-reports/NICE-annual-report-and-accounts-2024-to-2025.pdf

NICE News for Life Sciences :
July 2025https://t.co/dAlg0I6gohhttps://t.co/6dO7qKOjjz

NICE ANNUAL REPORTS AND ACCOUNTS 24/25https://t.co/cSH53cPbMv pic.twitter.com/VbFWLrc5qk— Peter Davis (@peter_brit) July 8, 2025

How do you know the email is real?


Do you read before responding?

I contacted the poster on X and he was very forthcoming.

I did not write the post on X, only communicated with the author on X. He shared the MHRA email thread with me through email. Nothing more, nothing less. I 100% believe its real.

This stock is honestly making people crazy. I hope you find sanity if and when DCVax gains MHRA approval.

Have a great day!

You're conflating clinical indication with administrative access, these are not the same thing.

1.The NHS did not revise the indication from "GBM" to "Cancer"
What likely happened is that an internal NHS database or IFR reference used the broader term "cancer" for administrative simplicity.
This is not a label change or indication expansion. Only the MHRA can approve a change in therapeutic indication.
The term “cancer” in NHS internal systems does not reflect a regulatory decision—it reflects access classification.

2. Again Individual Funding Requests (IFRs)IS NOT Approval
An IFR is not market authorization. It is a case-by-case exception where a doctor requests access to an unlicensed therapy when no alternatives exist.
These are approved by local NHS commissioners, not the MHRA or NICE. Saying “NHS approved it” is misleading. What actually happened is NHS granted a few patients access under special request. That’s all.

3. Why the NHS may say “expecting approval this year”
They may be referencing what MHRA is expected to do, but they do not control the approval timeline.
It’s not confirmation, and it doesn’t mean MHRA has already decided.
NHS doesn’t approve drugs; they reimburse and fund after MHRA approval.

4. No, I’m not guessing
IFR documentation is publicly verifiable.
NWBO has not received MHRA approval.
NWBO has not filed for all solid tumors, NWBO will have to run several trials for other cancer indications, that's just basic biotech common sense.

You are basing conclusions on a secondary interpretation of loosely phrased correspondence. I’m relying on how the UK regulatory and reimbursement systems actually work.

Can you tell me why NHS revised the GBM indication to Cancer ? NHS respond to an inquiry about this change and they said they are expecting this indication approval this year. How you come up with a few IFR granted or approval what's the difference ? I assume you are guessing just like me.

The NHS has not formally approved DCVax-L. A few Individual Funding Requests (IFRs) have been granted, which is not approval.
IFRs are exceptional access mechanisms for unlicensed medicines. They are patient-specific and non-generalizable.
IFR is NOT HTA approval or NHS listing. "...which means the MAA has to be revised to reflect as such all solid tumor MAA..."
That is false logic. IFR decisions do not impact or force a revision of an MAA. They are:
(a) Temporary,
(b) Not binding regulatory judgments,
(c) Issued by NHS commissioners, not MHRA or EMA.

The MAA remains based on the indication and clinical data submitted—likely GBM only.
Expanding the MAA to “all solid tumors” would require entirely new data, new trials, or supplemental submissions (variation applications), which NWBO hasn't done.

So stop spreading this kind of BS

I took that to mean it was under review/clock on. aha I took it to mean that the MHRA does not consider the application in backlog because its NOT under their review anymore. Now this could either be because they have additional questions or worse provided NWBO an RFI that NWBO is struggling with or (which I think) its because the application is on hold waiting for regulation (the ECA/RWD guidance).

NWBO submitted a MAA for New and Recurrent GBM indications. NHS approved DCVAX-L for Cancer indication under IFR, which means the MAA has to be revised to reflect as such all solid tumor MAA otherwise the original MAA does not drive with the approval. I believe this shouldn't take too long to get this iron out. GLTA

Andrew Caravello, DO
@andrewcaravello
To Whom It May Concern

I’m not here to argue with trolls. I’m here because this matters. $NWBO matters

I’m a board certified emergency and internal medicine physician. I’ve worked countless night shifts helping people through their worst moments, then spent my days building something of my own.

That “something” is a wellness and weight loss clinic I opened under the Medi-Weightloss brand. Within a year, I was asked to serve as Vice President of the Medi-Weightloss National Advisory Committee due to the consistently strong clinical outcomes at my clinic. While I no longer hold that role, I remain an active member of the committee today and have since expanded my involvement as Medical Director of multiple other clinics across the country.

I became interested in Northwest Biotherapeutics after losing people close to me, people I personally cared for, to glioblastoma. One was a childhood friend, a mother of three. Another was a friend I helped care for, who we hoped could receive DCVax, but the opportunity came too late. I’ve followed this company since before the JAMA Phase 3 publication because what they’re building isn’t just biotech. It’s personal.

Yes, I use AI. Not as a shortcut, as a tool. It helps me accelerate research, synthesize information, and amplify what I already know as a physician. I rigorously fact check my work. A broken link or obscure error may slip through here and there, but the science stands. And when it doesn’t, I fix it.

If you actually read what I write, you’ll see I don’t hype. I build. I analyze patents, regulatory filings, and scientific mechanisms. I connect immune strategies to clinical delivery platforms. I break things down because this technology deserves clarity and so do the patients and investors trying to understand it.

I once thought
@DCVaxDefender
was a Trojan bull. I later realized I was wrong and publicly apologized. I even tried to reach out directly to make amends, but we had each blocked one another by then, and there was no way to connect. It didn’t go anywhere, and that’s okay. I’m not expecting to become friends, but I do believe in forgiveness, and I’ve asked him for it. Hopefully one day we’ll be laughing over this with a beer in hand. I just didn’t want to keep arguing over semantics when deep down I believe we both want the same thing: to see this succeed.

Let’s be honest. This isn’t a game. This is about lives.

I’m not doing this because I expect the world to understand overnight. I do it because I’ve seen what this therapy represents when you look beyond the headlines, when you study the filings, the patents, the regulatory shifts, the hidden alliances, and the quiet patterns most overlook. I’ve read every CTIS listing. I’ve traced Flaskworks through FDA roundtables and patent filings. I’ve followed the threads from Mayo to Mill Creek to the MHRA. This isn’t casual interest. It’s strategic immersion. And yes, I believe we’re witnessing the slow emergence of a platform that could redefine immunotherapy from the ground up. If I’m wrong, I’ll own it. But if I’m right, and I still believe I am, then it’s worth every hour spent connecting the dots.

I’m not trying to cosplay as a biotech insider. I’m a physician who saw a scientific platform with transformative potential and who decided to speak up when the conversation got hijacked by misinformation. I care about the truth. And I care about the people trying to find it.

So I’ll keep posting. Not for attention. But because patients and investors have asked me to. Because they feel less alone when they read what I write. Because they’ve told me it helps.

And if even one of those people were your friend, your parent, or your child, you’d understand why I keep showing up.

To Whom It May Concern

I’m not here to argue with trolls. I’m here because this matters. $NWBO matters

I’m a board certified emergency and internal medicine physician. I’ve worked countless night shifts helping people through their worst moments, then spent my days building…— Andrew Caravello, DO (@andrewcaravello) July 8, 2025
Gregory Zivic, MD
@metacollectiveG
·
10m
$NWBO A beautiful post. He puts the complex & abstract into words/formats others can understand and shows how available information can be used to piece together plausible narratives that may seem disparate to most. AI helps articulate our collective intuition/logical analyses.

Neurosurgery Breakthroughs Championed by Dr. Linda Liau :
23 Jun, 2025

Dr. Linda Liau transformed brain cancer treatment through groundbreaking work in immunotherapy and neurosurgery.

Revolutionary work in brain cancer immunotherapy has made Dr. Linda Liau a distinguished figure in neurosurgery.

In the late 1990s Liau pioneered one of the first personalized vaccines to treat glioblastoma, the most aggressive form of brain cancer. This approach uses a patient’s own tumor and white blood cells to boost immune response. The method has continued to evolve through numerous clinical trials and is now credited with doubling the 5-year survival rate.

The 2,000 brain tumor surgeries she has performed has made Liau an eminent figure who attracts patients from around the world. In 2013 she was elected to the Society of Neurological Surgeons, and in 2018, to the prestigious National Academy of Medicine.

Liau became the second woman in the U.S. and the first Asian American woman to head a university neurosurgical department in 2017 when she was appointed to chair UCLA’s department of neurosurgery. Her total annual compensation for the 23-year UCLA Health veteran is listed at over $1.3 million.

Liau’s research has been funded by the National Institutes of Health for over two decades, resulting in over 230 published articles and the 2000 textbook Brain Tumor Immunotherapy.

She is listed as an inventor on 4 U.S. patents related to methods to detect and treat neural cancers, including the individually tailored glioblastoma vaccine.

Further demonstrating her commitment to advancing the field of neuro-oncology Liau served as editor-in-chief of the Journal of Neuro-Oncology from 2007 to 2017.

Linda was raised in Los Angeles by parents who emigrated from Taiwan. At age 16 she enrolled at Brown University where she earned bachelor’s degrees in biochemistry and political science in 1987. After completing medical school in 1991 at Stanford she completed her residency at UCLA Medical School in six years before joining its faculty in 1998. Since then her academic pursuits at UCLA earned her a 1999 PhD in neuroscience and an MBA in 2016. Liau, 58, is married to fellow UCLA neurosurgeon Marvin Bergsneider. They have two children who are currently in medical school.

https://goldsea.com/article_details/neurosurgery-breakthroughs-championed-by-dr-linda-liau

#dcvax $nwbo #gbm

Neurosurgery Breakthroughs Championed by Dr. Linda Liau :
23 Jun, 2025

Dr. Linda Liau transformed brain cancer treatment through groundbreaking work in immunotherapy and neurosurgery.

Revolutionary work in brain cancer immunotherapy has made Dr. Linda Liau a… pic.twitter.com/HmpxAnpaNw— Peter Davis (@peter_brit) July 8, 2025

Yes, we all know they said they would remain silent during the process, but its not unreasonable to ask for some news from the company since no one expected it to take over a year and a half. Even Les was at least 6 months off in his "later, in the fall" comment. After all, this is the same company that had no trouble contacting shareholders when it came time for bonus approvals. Yes, frustration is setting in. On the plus side, another day closer to keytruda patent expiring.

There's a big difference between simply following the rules and acting with ethics and courtesy. Even when the rules are on their side, a strong management team shows goodwill—offering transparency and respect to help long-term investors maintain their trust. This is my final word on the topic—no point in debating further. I’ll leave it to your judgment.

I know, and my post was purely in gist, but in reality, almost every biotech seems to move at a snail's pace. In part, you can blame the way the regulators operate, but I also believe that most CEO's etc. tend to believe things can happen faster than they do.

Back where I worked we had an expression, they never give us the time to do it right, they always give us the time to do it over. There was a great deal of truth in that statement.

In biotech's and pharma's there is even more pressure to do it right, but when the regulator is the judge, right may be different to different people and the only one who matters is the judge.

You can get information on tax issues from the IRS, but if the tax court says otherwise, it doesn't matter, you're wrong.

I have no idea what kind of questions were asked in the RFI's the company received. I wouldn't be surprised to fine that many of the answers may have been in the 1.7 million pages they had. To a great extent, that's the problem, the filing is far to complex, even 10,000 pages to me is over 9000 pages too long.

In the Journal, in just a few pages, nearly all that should have been needed was presented. Sure, it should be expanded some, and a section on commercial production added, but in under 100 pages it ought to be possible to see enough to make a decision.

As for the decades to approval, I suspect that if you look at most products from genesis to approval, 2 decades or more will generally be used.

Clearly to me genesis is when a product is first created, well before preclinical and then clinical testing. I believe it should be greatly streamlined, clearly, they did that with the Covid 19 vaccines, but without similar treatment for other diseases a couple decades can easily be spent.

I've often wondered if a Manhattan Project type of approach was taken to a given form of cancer, IE experts from all the companies and research institutions all got together, if a much-improved product couldn't be developed, then all who participated share in the profits.

When Michael Milken had severe prostate cancer while in prison, he spent a small fortune in researching prostate cancer. I can't say if what was developed then helped him, but I believe he's still alive, and it's been decades.

Gary

This is the email response I got from MHRA for CHM meeting schedule inquiry. Base on this example the email response from MHRA that the MAA is with the company seem legit !

I am sure they are tire of responding to all desperately awaiting patients, investors and alike for the status of the MAA; therefore, now they are deflecting all inquiries from them to the company since they got the MAA back with the decision from the MHRA IMO - It seems legit with the Peter responding.


From: MHRA Customer Services <MHRACustomerServices@mhra.gov.uk>
Date: Sunday, April 14, 2024 at 6:16 AM
To:
Subject: RE: CEC 179545 - Personalized Cancer Vaccine CHM meeting scheduled in March 2024

CEC 179545

Dear K

Thank you for your email and we apologise for delay.

We checked this with our Governance group and they have advised that unfortunately it wouldn’t be possible to listen in on Committee meetings.

Kind Regards

Peter
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data protection rights, please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC

skitahoe Its not so much the 500+ days but let's add the 10 years before that which is the object of share holders frustrations.

You’re defending it as if you wrote it yourself.

Ding ding ding!

Maybe it was? But then it got kicked back to MHRA who then kicked it back to NWBO? And there’s always Nem’s version too.

I really don't know why we're complaining about the time they're taking. Sure it's been 500+ days, but we know that in the UK people by Friday spend most of their time planning their weekends, there have been about 75 weekends x 3 days each, so let's deduct 225. Now we also know they have many more holidays than we do, so let's take 25 more days for holidays. That gets us down to 250 days, but we know they've asked us some questions, allow 60 days for each time they asked, say 3 times, that's 180 less, so realistically, the Brits are at day 70, however, with 75 weeks in, aren't they entitled to time off for tea, that's a must, take one day a week and we're now at day minus five. That means in 5 more days they'll start to work on the 1.7 million pages they've got to review.

Gary

I was just thinking, whatever happened to the narrative it was referred to CHM and on the verge of rejection? Anyone remember that one?

That’s a red herring, this has nothing to do with getting an update on Direct. They won’t provide an update on the MAA application while the MHRA is reviewing, that’s what is typically done by companies and they explicitly stated that for the peanut gallery who just can’t get it through their heads.

Agreed. Plus they are only talking about 15-20 patients, so unlikely to generate any excitement even after they end the trial given the sample size and everything NWBO. My sense is its just another hook to trap the bag holders for couple more years, and justify the authorized increase in share count as well as ongoing dilution in pennies post UK approval.

Also, not a single patient will be dosed in 2025 even though they have been pumping that since Q4 2024 and forecasted formal announcement of a new trial by end of Q1, 2025.

There will be no direct this year , just like every other years for last 10 years , except in cultists and apologists imagination, in my humble opinion : 

Yes . Tell that to the cult and apologists . 

How do you know the email is real? You’re defending it as if you wrote it yourself. If you did, why the anonymous act? Are you still trying to hide behind a new name? Fireman or Firman, it’s all the same. Most of your points have consistently lacked substance. You still haven’t admitted it, but the writing style reveals the truth. The only thing consistent is the mental gymnastics.

haha

I get it, Doc—they’ve probably been busy dealing with the MHRA on the MAA. But as a long-term investor, I think it's fair to expect some reassurance, especially with the approval dragging on and the stock stuck below 30 cents—regardless of what they wrote in the 10-Q to cover themselves legally.

My point is if we follow everything based on the Qs—we’re already in Q3. So where’s the update on DCVax Direct? Have they started it? Are they planning to? And if so, when—by year-end? I know, I know… your answer is probably: “Wait for the next 10-Q,” right?😃

In relation to my post, it’s irrelevant. Thats not an interim update on the MAA application review process for DCVax-L. Providing an update on the DCVax Direct program doesn’t contradict the previous 10Qs

You may type in ALL caps, but at least you know the difference between 'must have' and 'must of'. I appreciate the remnants of proper use of the language.

Flipper reads the posts. I know because I've seen him give thumbs up or down to them, including one of each for two of my posts. And on one, a toilet thrown in to give a more solid measure of his disagreement with my thoughts.
I very much appreciate them!

KRISGO,

The clock can be off if waiting on comments from others than MHRA or NWBO. There is room for this kind of hand off to others in the guidance due to the perceived need of outside expert opinion. No one is actually talking about this; ). Best wishes.

"Some people don’t read the 10Qs and post here daily that the company should make some interim announcement but these posters really have no clue."

The following is from the latest 10-Q—what’s your take on it?

DCVax-Direct Program. The Company believes it is on track to submit the initial INDs during Q2 of this year, as previously projected, for clinical trials of the Company’s new DCVax-Direct product. The trials are designed to be compact and streamlined, by using Simon two-stage designs to start small (e.g., with just 12-20 patients) and then expand if encouraging results are seen, and by focusing on tumor response endpoints. These trials are the culmination of two years of technology transfer and process development work to establish manufacturing for DCVax-Direct products in Sawston, and to develop a new version of DCVax-Direct to replace an ingredient for which there is a persistent worldwide shortage. During Q1, the final stages of the process were being carried out, including engineering runs and validations.

If you read Flipper’s last post he isn’t going to post again until after approval. He never said anything about selling! Go back and read his last post!

FLIPPER MUST HAVE SOLD ...HE SEEMED VERY KNOWLEDGEABLE BUT IM SURE HE LOST $$$$$ LIKE MANY OF US .

That’s correct and typically what companies do and NWBO stated this in their 10Q:

The Company and its teams of consultants continued to be actively engaged in the MAA process. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Some people don’t read the 10Qs and post here daily that the company should make some interim announcement but these posters really have no clue.

Didn’t they say they were tight with the MHRA (buddy-buddy relation)? Based on how they spoke at the ASM, no one—including management—would have expected the approval process to drag on this long. Meanwhile, the stock has been stuck under 30 cents for over six months. How is it possible that no one feels responsible enough to offer even a basic update or reassurance to long-term investors that things are still moving and there's nothing to worry about?

"well we know that the clock on days are over since the MHRA said that there are no more backlogs."

I took that to mean it was under review/clock on. Everything is under review or has been reviewed.

Really? I said nothing about who needs to explain anything. You made that crap up as is the the usual custom.

My point was clear.

In your twisted world shareholders owe an explanation . But in actual, real universe , it is the public company who is accountable to shareholders . I do appreciate that it is very weird and strange concept for you and the apologists .

literally today is day 210: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176382502

We are closing in on 500 days past march 7th 2024.
P to the M

Just because there is no backlog does not mean that 250 clock on days have elapsed.

No backlog means there are no applications that are not being worked on, i.e waiting to be processed.

That says nothing about how many clock on days have happened on the NWBO application.
My point is simple, all we do know for sure is that the application was filed and it has taken an insanely long time.

What the breakdown of clock on / clock off / RFIs / other bureaucratic processes is not known.

People coming to conclusions about all of this are just making guesses based on very little solid information.

I make no claim about the number of days in clock on or off. All I know is the number of days since the application was filed.
I did just look to see if NWBO PRed the acceptance of the application and didn't find a PR about that. If you have anything on that please share it.

Edit. This reply was meant for Ex not you dennisdave. Sorry.

Correct.

>>What is a fact is that NWBO is free to discuss if they wish. They elect not to.

So, either MNRA is flat out lying to their own government, or NWBO has been on the clock for at least 250 days (and maybe a lot more).
well we know that the clock on days are over since the MHRA said that there are no more backlogs.
why do you pretend that 250 clock on days are a bad thing? Its not bad or good news (if true).

In other words you are not making any point with your repeated claim that the application is 250 days clock on (other than that its insanely taking long, but no one is disputing that)

No, you need to explain how you came to the conclusion that there have been over 250 clock on days.

So, either MNRA is flat out lying to their own government, or NWBO has been on the clock for at least 250 days (and maybe a lot more).

Yeah, so your math.

So you actually know how many clock off days the MAA has.... OK. Care to share that info?
Is subtraction a concept I need to explain?

We know the total time. We know max clock on days. All the rest are clock off.

Dom I really need to show the math?

That is not what the posts said.... It said "The MHRA has made it quite clear they are okay with the company updating the public on its application status,.."
That is an affirmative statement.

"FWIW: It does appear management has the green light from MHRA to update shareholders and we haven’t heard anything."
Where is this green light?

That is a fair question for a definitive statement.

So you actually know how many clock off days the MAA has.... OK. Care to share that info?

I guess you missed the word "often" and "may".
NWBO has announced the MAA submission.
NWBO has said it will not provide updates until a final decision has been reached.

100%.... lol


Regulatory Submissions: Biotechs will announce the submission of applications, such as a New Drug Application (NDA) or Biologics License Application (BLA).
FDA Review Updates: Companies may provide information about receiving FDA comments, addressing questions, or securing special designations (like Breakthrough Therapy) that can expedite the review process.
Important Considerations:

There are a few knowledgeable skeptics. There is a larger number of bashers.

There are a few pumpers. There is much larger number of longs, some of which do express frustrations.

So much of the negative posting is attacking people rather than the company. Why is that?

Neither being one of the straightest of shooters.