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Does anybody get seats at an ASM this year?
Getting really late. Would not be the first time LP decided it was not worth the effort to let shareholders vote.
"Still, how do you submit an maa on Christmas Day?"
MHRA and NWBO are in constant communication and my understanding is: MHRA can decide to accept on any day.
Do the willing participants get the front row seats at the AM with regular retail in the back?
exwannabe,
Very good question!; ). So why would NWBO not apply for EAMS in the interim? Hmm... would they need to use the same manufacturing process for EAMS as in the MAA for use when they get full approval?; ). Thanks for the reminder!; ). Best wishes.
Looks like NWBO's own AI Machine is sounding a little more human.
Bearing false witness, I’m crying 😂😂😂
Oh please JAMA BALA JAMA who doesn't know that IDH1 catalyzes the oxidative carboxylation of isocitrate to alpha-ketoglutarate and the reduction of NADP to NADPH that is necessary for cellular antioxidant reaction.
LOL
The company is in the process of submitting the MAA, fudster. Your banal fud has been of none effect after the publication of the JAMA data. Tough times are ahead before your retirement.
AI generated. Should guessed that.🤪
Speaking of NICE.
Many longs pumped the fact that the NICE review was back to "in process" last year. after being suspended for several years. Then the next day "NICE continues to liaise with the company regarding next steps for this technology appraisal and will provide updates in due course."
NICE will formally get the show on the road by scheduling a meeting once NWBO tells them they are ready. And that is public record. So are many of the documents in the process. The process can take a long time, that is why it is started in advance of MAA submissions.
And now a year later, crickets. LP's cone of silence?
BTW, why has NWBO not asked for EAMS (Early Access to Medicine Scheme)? That is designed to allow drugs that have proved themselves in a P3 to be used while the MAA to be submitted and approved. NWBO hyped how they were in the program. Why hype being in the program and not using it?
Couldn't agree with you more!
WTH?
A happy weekend from Papa JPow! pic.twitter.com/bushiEvPpd
— Pod Caste (@traderpodcaste) December 8, 2023
Jon, while fundamentally I agree with you, the precise timing doesn't matter, I also think that we need to consider the credibility of the company, and that would take an additional big hit if things don't start to happen reasonably soon.
It's becoming more doubtful each day that an Annual Meeting will be held this year. I believe it still could be, but I think it would need to be announced very shortly if they're going to do so. It's not critical, but it's the one time that management does address investors on what they're progress and upcoming plans are, and investors should be entitled to such an update. If they fail to do that, I'd hope that they at minimum schedule the meeting by the end of the year, the anniversary of their last Annual Meeting.
As far as I'm concerned, we're all investors who're waiting for information that we should be entitled to. It's not that I'd sell out of my position if it's not provided, but I'm less likely to mention it to others until I know more about it myself. Like everything else, the guidance provided in the Annual Meeting is not information that's in concrete, it's subject to change, but it at least provides the current thinking on things like, when will the EDEN unit be available for commercial production, when do they intend to apply for approval with the various regulators, etc.
When we've had our application accepted by the UK we've taken a major step, but of course we need an approval. Once that's achieved, I believe that effort can be repeated multiple times as we gain approvals from other regulators, both those involved in the trial, then in much of the remainder of the world who weren't participating in the trials.
I frankly don't know if certain countries will insist on running their own trials. IMGN partnered with a Chinese company for Elahere, and trials are required there before it's approved. I don't believe this will be necessary everywhere, but if the ABBV buyout goes through, it will be up to them to expand it's use worldwide.
Honestly, with approval the financial needs for NWBO will grow dramatically. At much higher share prices they may satisfy them with a substantial offering, but of course other possibilities, like partnering and licensing agreement could bring in substantial funds, with, or without the issuance of substantial new shares, dependent on how things are structured. Besides the costs associated with going after additional approvals, new trials should be initiated ASAP to establish the Tumor Agnostic label, as well as getting DCVax-Direct into the clinic. I suspect that others will at least co-sponsor new trials to use their product along with DCVax-L, these may be in GBM, or perhaps in multiple cancers. If a number of combination trials are initiated, NWBO might not need to sponsor trials using DCVax-L with SOC treatment alone, unless the regulators demand such trials. As for commercial production, it will also be up to NWBO on how this is to be done, it could be very expensive, but long term more profitable to keep it in house, but it's more likely it will involve licenses where the producers may be paying them for the rights, but of course they'll also be profiting from every batch of vaccine they make.
The possibility of a buyout cannot be denied, at any time. Personally I don't want to see it before we really understand the potential of both DCVax's, which could easily take 5 years or more, but something in the next year or two is certainly not out of the question as approval of DCVax-L expands. As I see it, if positive results keep coming on our vaccine in other cancers, there is no reason that our share price won't be growing dramatically for the foreseeable future. I believe if only GBM was the market for DCVax-L, worldwide we' still be generating billions annually and a share price in the $20 to $50 range would be justified. If we add a bunch of other cancers, just move the decimal point one, two, or even three places to the right.
Gary
LC,
Thank you for linking us to the Labiotech site—looks like a solid recommendation!
https://www.labiotech.eu/trends-news/nw-bio-reports-positive-top-line-results-from-glioblastoma-trial/
https://www.labiotech.eu/trends-news/northwest-biotherapeutics-cancer-pip-approval/
Thanks also for reminding us that other advances in the research of cancer may elevate the value of DCVax-L! Each existing, emerging, or recently commercialized therapy in the field of oncology represents another potential opportunity to discover an efficacious combo with the DCVax-L platform!
Combo is King!
Fudster-delusion thinks that he really has a grip on the science with these news clips, but the fudster has zero knowledge of non-IDHmutant GBM. His knowledge in this area is nil.
flipper44,
Agreed but looking at the bigger picture that could change quicker than they would like. Best wishes.
Flip, with respect, I do not understand these "truth or dare" style "submit by XYZ date or I'm done" bets.
The value of NWBO is that vaccine-based cancer treatments will rule the next 50 years of medicine (maybe nano-bot medical technology might replace?). This is the entire thesis of my investment. I wish NWBO had submitted their MAA six months ago, but that's just not how the real world works sometimes. I think we stand a good shot of the MAA going out next week... but if it's in mid Jan I'm certainly not dumping my investment.
I care about the next 50 years, not the next two months.
Congrats meirluc and Dan88 for buying more NWBO shares. Your conviction will be rewarded soon.
Doc, there is no doubt in my mind that with UK approval NICE will reach an agreement on what they'll pay for this dramatically advanced approach to treating GBM, and I believe they'll okay the off label use of other therapeutics as well. DCVax-L is such a game changer for treating GBM, as long as there is nothing comparable I cannot see any regulator or insurance saying no. If some attempt to limit access based on some criteria, I suspect the courts will tell them that if the patient will benefit, you cannot withhold the product.
To me the dumbest example of this is for the person facing a death sentence for a crime. If that person develops a potentially deadly disease, it must be cured before the sentence is allowed to be carried out, and of course the taxpayers are the ones paying for the treatment.
Gary
It is truly a gem of a movie and yes, from what I've read about him, he did 😊
biosectinvestor,
I believe NICE has a reputation for being one of the toughest negotiators for reimbursement which even the bears have made mention of. Not going to make much more of this other than to say even Dr. Ashkan wanted this to be as cheap as possible so all his patients could receive it too. I agree this is technically separate from the submission process. I just suspect more of a wink wink connection to this whole process than others and I could very well be wrong. Thanks for your perspective and best wishes.
Doc, some time ago I was told that with the right equipment, DCVax-L could be made in individual units, something like the incubator that premature babies are placed in, with glove fitted into each unit that allowed personnel to manipulate what's being made in many units by doing everything through the gloves. The units would all be in a larger cleanroom, but the personnel wouldn't need to go through nearly the same procedures and protective equipment changes that would be required to actually work in many different cleanrooms where each must be isolated from the others.
I really can't say what all must be done to manually process the product, so I don't know if such an arrangement would work, but even if it did it would be man power intensive when compared with the EDEN, but it could be an alternative while the EDEN is being approved.
I have passed the underground labs at City of Hope and seen such devices being used in some of the cleanrooms that could be viewed from the underground passages. It's not somewhere you can just walk into, but as a patient, I was moved between building in these underground tunnels that most don't know exist. I gather that there is a major underground facility there that's function is almost totally devoted to research and development. COH does create personalized products for patients and I know my Dr. had participated in some of the early T-cell work they were doing there.
I hope that we're just months from being able to deploy the EDEN units in commercial production. If not, there are alternatives that will be more costly, but certainly DCVax-L can still be a very profitable product.
Gary
I can’t help that you skipped reading all of Senti’s posts on this since Nov 21.
You're just scared. lol
Danish Dude
A classic, thanks for the post. Gotta believe that Harpo was getting a few feels in during that mayhem.
You’ve been bashing the MHRA’s ability to approve anything, and thought they were giving up on their own approvals of therapies. Now you’re rethinking it.
That pink horse looks like it will match your ensemble.🥸
I can't believe management resorted to that lame excuse. The publisher's being acquired, lol. How does that affect the publisher's work? Normally, it's a seamless process, but, of course, nothing is seamless when it comes to NWBO; they always get affected by uncommon delays. Maybe the publisher is a sole proprietorship with only two or three employees, and now that it is being acquired, they need to integrate with the acquiring business. It's still a lame excuse though.
Let's wait for the next excuse. It's coming soon. LMAO
I am pretty sure I’ve said something to the effect that naysayers talking bad about NVCR is not relevant here. Neither is talking good about NVCR but that’s less common here.
BTW, when those naysayers put NVCR BS on this board, did you give the same suggestion?
Moron, it was not my example. It was au's and flipepr's.
HL,
You really like something definitive. But if everything is so definitive, how could the retailers on the main street get rich?
You don't think the hectic working schedule has anything to do with DCVax-L? I think you do because I find people on this board doublethink.
Fudster, go and read your own post. You gave a Bluebook example. Nothing more.
Put it on the Merck board, not here unless that letter references DCVax-L.
Today as you are posting, people at Merck West Point campus is trying to finish up the manufacturing building 63A.
In case you forgot about how big the building is. Here it is.
Also make a comparison of the freezer facility between Sawston's and Merck's. You may have a rough idea about the manufacturing facility.
Let me get this right.
Flipper an au bring up an example of how fast the MHRA is. I point out that in their example the FDA was faster and MHRA was 11 months.
Longs keep arguing horses are pink. I keep pointing out examples of black, brown, grey and white horses.
And you ignore the real world.
Comedy central there Count.
I did pay attention and was addressing the hypothetical the person made as a clear joke. I doubt even NWBO would dare to insert another publisher to double check the work of the first one but then I didn’t think they’d dare miss the time frame they gave out in August 2023 so I could be wrong.
Pay attention. Senti did not say they hired a new publisher, she stated the original publisher was acquired.
We don't need to predict anything. If we can predict, the dark forces can. If we can't, neither can they. One thing for sure. We are part of the revolution in which the clinical trials are purely biomarker-driven. Seriously take a look at thehttps://t.co/8ZAMby1ozP
— d_stock (@d_stock07734) December 8, 2023
We don't need to predict anything. If we can predict, the dark forces can. If we can't, neither can they. One thing for sure. We are part of the revolution in which the clinical trials are purely biomarker-driven. Seriously take a look at thehttps://t.co/8ZAMby1ozP
— d_stock (@d_stock07734) December 8, 2023
Thanks pgsd. Insightful. Read this and now understand Peter Davis' post better, “Yet another reason why DCVax development of personalized cancer vaccines designed to treat a broad range of solid tumor cancers is the best answer.”
https://www.pharmiweb.com/press-release/2022-10-27/landmark-nature-papers-unveil-dark-matter-shaping-cancer-behaviour
My layman summary
Cancers can evolve without DNA mutations. DNA mutations set the scene but much of the subsequent behavior of cancer is determined by other factors, such as epigenetics. Epigenetics refers to chemical changes in the structure of DNA (folds of protein) that are not because of altered DNA code.
This tells me why there might be heterogeneity in a tumor environment and therefore why DNA tests might not be able to predict with 100% accuracy how cancers will respond to a particular treatment. And therefore why cancer treatments that will target only a single/couple antigen can be off target.
So this is more confirmation to me that DCVax’s approach of being 100% personalized, targeting all the tumor antigens, and engaging the entire immune system, is the best answer.
654615
Thanks for frequently reposting your thoughts about the MAA status. We appreciate all the posts from LC and ex highlighting the MHRA and FDA—we will soon shift our focus to the regulatory review process…
Following the independent peer review, we are entering a new phase for the landmark DCVax-L cell-based platform technology. The regulatory environment also seems to be evolving to embrace a whole new paradigm—we are now in the era of RWD and immunotherapy!
Exciting times … Combo is King!
Some links that seem highly relevant:
https://www.raps.org/news-and-articles/news-articles/2023/8/fda-finalizes-guidance-on-real-world-evidence-in-d
https://www.raps.org/News-and-Articles/News-Articles/2023/9/FDA%E2%80%99s-Califf-Expect-to-see-more-RWE-based-regulato
https://www.fda.gov/media/171667/download
https://www.uclahealth.org/cancer/researchers/spores/ucla-spore-brain-cancer/research-projects
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.merck.com/news/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three-daiichi-sankyo-dxd-adcs/
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
I would also recommend that you review the forthcoming NICE appraisal of the DCVax-L cell-based technology.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.kcl.ac.uk/people/keyoumars-ashkan
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-provides-update-on-final-preparations-for-marketing-authorization-application-301995932.html
It is important to appreciate that the first filing was not only an enormous undertaking, but its significance is monumental and its voluminous catalog of documents must be presented in good order.
Just as the independent peer review process required a lot of groundwork, preparation, and coordination, the MAA does as well. NWBO is a small pre-commercial biotech. The executive team includes well-educated and experienced leaders whose business acumen is formidable. They have enlisted the support of consultants to ensure that regulatory applications are complete, accurate, and fully compliant with filing guidelines.
Here is some further commentary from an AI app about the importance of enlisting expert filing support:
“A Marketing Authorization Application (MAA) filing with the Medicines and Healthcare products Regulatory Agency (MHRA) or any regulatory agency involves submitting comprehensive documentation to gain approval for marketing a medicinal product. Both a publisher and a quality control team play crucial roles in ensuring the success and compliance of the MAA filing. Here's why:
1. **Complexity of Documentation:**
- MAA submissions are highly complex and involve a vast amount of documentation, including clinical trial data, manufacturing processes, quality control measures, safety data, and more. A dedicated publisher helps organize, format, and compile these documents into a coherent and compliant submission.
2. **Regulatory Compliance:**
- Regulatory agencies like the MHRA have strict requirements regarding the format, structure, and content of submissions. A skilled publisher ensures that the MAA complies with these regulatory guidelines, increasing the likelihood of acceptance and speeding up the regulatory review process.
3. **Accuracy and Consistency:**
- Quality control teams are crucial for ensuring the accuracy and consistency of the information presented in the MAA. Any inconsistencies, errors, or inaccuracies could lead to delays in the review process or rejection of the application.
4. **Adherence to Standards:**
- Quality control teams ensure that the submission adheres to the highest quality and data integrity standards. This is particularly important for critical sections such as clinical trial data and manufacturing processes, where precision and reliability are paramount.
5. **Risk Mitigation:**
- Thorough quality control processes help mitigate the risk of regulatory issues or deficiencies. Identifying and addressing potential problems before submission increases the chances of a successful review and approval.
6. **Efficient Communication:**
- A well-organized submission facilitated by a publisher enables efficient communication between the applicant and the regulatory agency. Clear and organized documentation helps regulatory reviewers navigate the submission, leading to more effective communication and a smoother review process.
In summary, the collaboration of a skilled publisher and a robust quality control team is essential for preparing a high-quality, compliant MAA filing with the MHRA. This collaborative effort increases the chances of a successful regulatory review and approval, allowing the medicinal product to be marketed and distributed to patients.”
—ChatGPT
Bullish
BULLISH
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
https://nwbio.com/northwest-biotherapeutics-announces-positive-votes-at-annual-meeting-reviews-2022-progress-and-looks-forward-to-strong-2023/
During 2023, the Company anticipates that additional key areas of focus will include:
continued preparations for scale-up capability, with further implementation of streamlining product “release” processes;
expansion of the operation in Sawston following completion of the Phase 1B buildout;
continued development of the Flaskworks system, including choice of the system version to take forward;
commencing the pediatric clinical program required under the PIP;
as resources permit, pursuing clinical trials with combination treatment regimens.
Linda Powers, the Company’s CEO, commented: “2022 has been a year of major accomplishments, and we look forward to an even stronger 2023. We are very grateful for the ongoing strong support from our shareholders, as reflected in the exceptional voting results of the Annual Meeting.”
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823001633/nwbo-20230630x10q.htm
Overview
We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.
Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for glioblastoma brain cancer (GBM).
The trial results were presented at a scientific conference in May 2022, and were reported in a peer reviewed publication in JAMA Oncology, a top scientific and medical journal.
In June 2023, the Company presented substantial information from analyses conducted by independent experts on the underlying biology and mechanism of action of its DCVax technology at an Industry Theater presentation during the ASCO (American Society of Clinical Oncology) conference. The Company is pursuing further analyses by independent experts, and plans to present further information at an appropriate future conference.
The Company is now in the final stages of preparing an application for regulatory approval of DCVax-L. The Company is working with teams of specialized consultants on preparation of the application package as well as related activities. One of the pre-requisites - obtaining regulatory approval of a Pediatric Investigation Plan (PIP) - was completed during 2022 on an accelerated basis, including regulatory approval to use the same trial design with external controls as was used in the Company’s Phase 3 trial.
In parallel with preparing the application for approval of DCVax-L, the Company is working with the contract research organization (CRO) and with specialized consultants on preparing the Trial Master File and sites to be inspection-ready for regulators.
The Company and the CRO continue to conduct long-term follow-up in connection with the Phase III trial of DCVax-L, as there are still patients alive.
The Company and Advent are working together to prepare for potential commercial operations. The buildout of Phase 1B of the Sawston facility, which had been under way since last year, has been completed. On July 24, 2023 the Company changed the name of its UK subsidiary from Aracaris Limited to Northwest Biotherapeutics Limited.
The Company’s wholly owned subsidiary, Flaskworks, is continuing its development work to optimize a system for closed and automated manufacturing of DCVax-L products, including optimizing yields. The Company views this as a centerpiece of efforts toward scale-up for potential commercial operations.
Supply chain issues and equipment backlogs continue to be factors affecting operations both for Advent and for Flaskworks. This includes months-long backlogs for certain equipment and materials. However, the work is progressing in spite of the backlogs.
The Company is in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed
26
Table of Contents
and it included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823002304/nwbo-20230930x10q.htm
Contents
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December 31, 2022 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not place undue reliance on these forward-looking statements.
Overview
We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.
Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for glioblastoma brain cancer (GBM).
The trial results were presented at a scientific conference in May 2022, and were reported in a peer reviewed publication in JAMA Oncology, a top scientific and medical journal.
In June 2023, the Company presented substantial information from analyses conducted by independent experts on the underlying biology and mechanism of action of its DCVax technology at an Industry Theater presentation during the ASCO (American Society of Clinical Oncology) conference. The Company is pursuing further analyses by independent experts and plans to present further information at an appropriate future conference.
The Company is now in the final stages of preparing an application to the U.K. regulatory authority for approval of DCVax-L. The Company is working with teams of specialized consultants on preparation of the application package as well as related activities.
In parallel with preparing the application for approval of DCVax-L, the Company is working with the contract research organization (CRO) and with specialized consultants on preparing the Trial Master File and trial sites to be inspection-ready for regulators.
The Company and the CRO continue to conduct long-term follow-up in connection with the Phase III trial of DCVax-L, as there are still patients alive.
The Company is pursuing preparations for the pediatric clinical trials that are required to be conducted in connection with an application for approval of a new medicine for adult patients.
The non-proprietary name for the Company’s DCVax-L product, murcidencel, was finalized and published in rINN List 90 in October 2023. The name was originally assigned by the WHO on May 6, 2022, and then had to go through a series of additional steps and notice periods to become final.
The Company and Advent are working together to prepare for potential commercial operations. The buildout of Phase 1B of the Sawston facility, which had been under way since last year, has been completed. On July 24, 2023, the Company changed the name of its UK subsidiary from Aracaris Limited to Northwest Biotherapeutics Limited.
The Company’s wholly owned subsidiary, Flaskworks, is continuing its development work to optimize a system for closed and automated manufacturing of DCVax-L products, including to optimize yields. The Company views this as a centerpiece of efforts toward scale-up for potential commercial operations.
Supply chain issues and equipment backlogs continue to be factors affecting operations both for Advent and for Flaskworks. This includes months-long backlogs for certain equipment and materials. However, the work is progressing in spite of the backlogs.
26
Table of Contents
The Company is in active discussions in regard to certain combination treatment regimens and is planning for certain strategic trials with such combination treatments.
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed and it included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit. We are pursuing the prosecution of existing patent applications and adding intellectual property that we consider complementary to our existing intellectual property.
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18 hr. ago
“Supply chain issues and months-long backlogs for certain materials and equipment” may help explain some delays and slow progress.
LC, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh
Thanks for frequently reposting your thoughts about the MAA status. We appreciate all the posts from LC and ex highlighting the MHRA and FDA—we will soon shift our focus to the regulatory review process…
Following the independent peer review, we are entering a new phase for the landmark DCVax-L cell-based platform technology. The regulatory environment also seems to be evolving to embrace a whole new paradigm—we are now in the era of RWD and immunotherapy!
Exciting times … Combo is King!
Some links that seem highly relevant:
https://www.raps.org/news-and-articles/news-articles/2023/8/fda-finalizes-guidance-on-real-world-evidence-in-d
https://www.raps.org/News-and-Articles/News-Articles/2023/9/FDA%E2%80%99s-Califf-Expect-to-see-more-RWE-based-regulato
https://www.fda.gov/media/171667/download
https://www.uclahealth.org/cancer/researchers/spores/ucla-spore-brain-cancer/research-projects
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.merck.com/news/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three-daiichi-sankyo-dxd-adcs/
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
I would also recommend that you review the forthcoming NICE appraisal of the DCVax-L cell-based technology.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.kcl.ac.uk/people/keyoumars-ashkan
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-provides-update-on-final-preparations-for-marketing-authorization-application-301995932.html
It is important to appreciate that the first filing was not only an enormous undertaking, but its significance is monumental and its voluminous catalog of documents must be presented in good order.
Just as the independent peer review process required a lot of groundwork, preparation, and coordination, the MAA does as well. NWBO is a small pre-commercial biotech. The executive team includes well-educated and experienced leaders whose business acumen is formidable. They have enlisted the support of consultants to ensure that regulatory applications are complete, accurate, and fully compliant with filing guidelines.
Here is some further commentary from an AI app about the importance of enlisting expert filing support:
“A Marketing Authorization Application (MAA) filing with the Medicines and Healthcare products Regulatory Agency (MHRA) or any regulatory agency involves submitting comprehensive documentation to gain approval for marketing a medicinal product. Both a publisher and a quality control team play crucial roles in ensuring the success and compliance of the MAA filing. Here's why:
1. **Complexity of Documentation:**
- MAA submissions are highly complex and involve a vast amount of documentation, including clinical trial data, manufacturing processes, quality control measures, safety data, and more. A dedicated publisher helps organize, format, and compile these documents into a coherent and compliant submission.
2. **Regulatory Compliance:**
- Regulatory agencies like the MHRA have strict requirements regarding the format, structure, and content of submissions. A skilled publisher ensures that the MAA complies with these regulatory guidelines, increasing the likelihood of acceptance and speeding up the regulatory review process.
3. **Accuracy and Consistency:**
- Quality control teams are crucial for ensuring the accuracy and consistency of the information presented in the MAA. Any inconsistencies, errors, or inaccuracies could lead to delays in the review process or rejection of the application.
4. **Adherence to Standards:**
- Quality control teams ensure that the submission adheres to the highest quality and data integrity standards. This is particularly important for critical sections such as clinical trial data and manufacturing processes, where precision and reliability are paramount.
5. **Risk Mitigation:**
- Thorough quality control processes help mitigate the risk of regulatory issues or deficiencies. Identifying and addressing potential problems before submission increases the chances of a successful review and approval.
6. **Efficient Communication:**
- A well-organized submission facilitated by a publisher enables efficient communication between the applicant and the regulatory agency. Clear and organized documentation helps regulatory reviewers navigate the submission, leading to more effective communication and a smoother review process.
In summary, the collaboration of a skilled publisher and a robust quality control team is essential for preparing a high-quality, compliant MAA filing with the MHRA. This collaborative effort increases the chances of a successful regulatory review and approval, allowing the medicinal product to be marketed and distributed to patients.”
—ChatGPT
The submission stuff belongs to LP's domain. Whatever she decides to do suits the best interest of investors. She is the one who has spent one third or one half of her professional life bringing this revolution from concept into reality. She deserves the trust from the longs. BTW, Cofer Black only gave her briefings. So LP has the whole picture not the outsiders.
On another note, have you realized the significance of the following figure? I don't mean to brag. Am I the first one on this board who correlated the figure from ASCO present with the p3 trial? You may think all my other dot connecting stuff is probabilistic though you may prefer to call it BS which is fine with me. But the figure and the data are deterministic. They don't lie. It should get you full attention.
This figure is about expansion of T cell receptor (TCR) clones, one of key measures adopted in the combo trial.
The higher number of total TCR clonal expansion indicates better immune response.
In addition to the favorable results discovered in this data, it is also crucial to note that there was an early decrease in T-cell receptor diversity and potential killing of tumor-associated T-cell receptor clones with concurrent chemoradiation, which could imply harmful consequences for immune response. This information warrants further clinical studies navigating differential sequencing of chemoradiation and immune checkpoint [inhibitors]
LOL. Soldiers here would bill it as "A publisher's Publisher".
I think a better contest would be to guess who here will be the first to launch a derivative lawsuit.
It was actually a very happy moment for me when PP's management was finally shown the door after stringing retail along on a cancer cure for twenty plus years.
HappyLibrarian,
I mostly agree that you have considered the impact of the various forces in play and kudos for that. I do think there will be a bit of a rally cry amongst retail bloggers that cover this and I expect Cambridge to be absolutely stoked with media coverage there about this milestone for their City. I think that as anticipation builds in the UK there will be spill over coverage back into the US especially when the motion to dismiss in the spoofing lawsuit gets denied.
NWBO of course will not be doing much talking but if history holds up there will be plenty of naysayer talk to stir up interest and draw the interest of a fired up retail base. They will gladly spell it out for those not already in the know about the history of this little company and how the pathway to a cure through this platform technology applicable to all solid tumor cancers and beyond has been made ready for prime time by passing through the gauntlet laid down by “the process” of approval and illegal manipulation of share price in the attempt to bankrupt the company.
All of this will create a very significant new following around which a new rallying cry for reform within government agencies and an end to high speed trading abuses and law breaking will occur. Exposure of those in government who have served the interests of or have been trying to cover for the perps will also draw the ire of the folks who have been the victims or would be if left unchecked.
As to specifics, that’s always hard to tell but I believe a rally to over $2 is possible after submission because the price right now is being suppressed for that kind of jump which can be justified just because a look at the numbers for approval percentage after submission is so high. I believe that media attention from Cambridge and bloggers following NWBO will get this there and that follow on stories in various news outlets will help sustain this momentum. Don’t forget that primary completion of the combo at UCLA is expected in January so follow on news from that is likely in the hopper during MAA submission review. That will be more fuel for the fire. Now depending on when and where NWBO chooses to uplist there could be a lot more fuel added to the fire and I believe they could uplist after submission news but that is not my decision to make and will likely depend on what kind of rally the share price goes through. The real battle could be near where institutional interests can be more involved at around $5 but that would likely require some type of partnership or co-development news or very strong speculation about it. Best wishes.
If NWBO were to reveal that they hired a second publisher do you think it is more likely or less likely that their supporters will justify it instead of saying the new delay is a problem?
True LC as much as u try
U influence no one
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Moderators XenaLives sentiment_stocks CaptainObvious Poor Man - Doc logic JerryCampbell |
“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”
~ Winston Churchill
Stylized Dendritic Cell featured on NWBO board since 2015
- Dr. Linda Liau, PhD, MBA, Professor and Chair, Department of Neurosurgery, David Geffen School of Medicine at UCLA
Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind)
UK (MHRA): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
DE (Germany - PEI): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III
Dendritic Cell Vaccine for Patients with Brain Tumors (NCT01204684) - Phase II - at UCLA - Randomized (Open Label) testing DCVaccine with Resiquimod and DC Vaccination with Adjuvant polyICLC
Pembrolizumab and a Vaccine (ATL-DC) for the treatment of Surgically Accessible Recurrent Glioblastoma - Phase 1 (NCT04201873)
Dendritic Cell-Autologous Lung Tumor Vaccine (DCVax-L) and Nivolumab in Treating Patients with Recurrent Glioblastoma - Phase 2 (NCT03014804)
Dendritic Cell Therapy for Brain Metastases From Breast or Lung Cancer (NCT0368765) - Phase 1 - Collaborator: Mayo Clinic
Announcement of DCVax-L and Anti-PD-1 Monoclonal Antibody (Pembrolizumab) for Patients with Liver Metastases of Primary Colorectal Carcinoma Phase 2 Trial - November 17, 2016 - University Medical Center (UMC) of the Johannes Gutenberg University of Mainz
Cognate Bioservices - Owned by Charles River Labs
Website
Company Contact Info
Investor Relations:
Les Goldman (Company) (202) 841-7909 lgoldman@nwbio.com
Sign up for Northwest email list here (hit the subscribe to email list button in the lower right)
Company Headquarters
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814 (240) 497-9024
NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs. NW Bio’s proprietary manufacturing technology enables them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines.
Their lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. This trial is currently underway at 69 locations thoughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.
Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.
They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
DCVAX Survival Stories & Testimonials
Alice - Metastic Merkel Cell patient from Florida - ASCO 2018
Brad Silver - GBM patient from Huntington Beach, California - ASCO 2018
Sarah Rigby - GBM patient from Hong Kong - ASCO 2018
Kristyn Power - daughter of GBM patient from Canada - ASCO 2018
Kat Charles - GBM patients from UK - ASCO 2018 - as related by her husband Jason (Kat's Cure)
Prospective patients may contact NW Bio at patients@nwbio.com
UCLA Jamil Newirth DCVax-Patient Video - 2015
Allan Butler Video - National Geographic Vice President - DCVax-Direct patient from Phase 1 Trial with Pancreatic Cancer
NWBO - Patients Sunday Dennis and Jami Newirth - Enrolled at UCLA - Vimeo, Uploaded approx. May 2015
NWBO - Vaccine Helps Keep Brain Cancer Patient Alive (Jennifer Sugioka) - NBC Channel 4, Southern California, February 24, 2015
NWBO - National Geographic's Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
Presentations
UCLA Agreements
Prostrate
DCVax-Phase II
DCVax-Booster
Upcoming Events
Videos
Linda M. Liau, MD, PhD, MBA - April 24, 2019 at University of Washington, Neurosciences Institute
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