dennisdave
2 hours ago
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.
dennisdave
3 hours ago
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
eagle8
5 hours ago
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.
pgsd
5 hours ago
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
jesster64
7 hours ago
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.
skitahoe
9 hours ago
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
MarauderWarlock33
9 hours ago
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
12 hours ago
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
KRISGO
13 hours ago
"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.