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Northwest Biotherapeutics Inc (QB)

Northwest Biotherapeutics Inc (QB) (NWBO)

0.3104
0.0049
(1.60%)
Closed October 06 3:00PM

Your Hub for Real-Time streaming quotes, Ideas and Live Discussions

Key stats and details

Current Price
0.3104
Bid
0.3064
Ask
0.3188
Volume
1,162,898
0.3063 Day's Range 0.32
0.29 52 Week Range 0.929
Market Cap
Previous Close
0.3055
Open
0.3199
Last Trade
500
@
0.3104
Last Trade Time
Financial Volume
US$ 360,160
VWAP
0.309709
Average Volume (3m)
2,311,018
Shares Outstanding
1,248,237,358
Dividend Yield
-
PE Ratio
-3.29
Earnings Per Share (EPS)
-0.05
Revenue
1.93M
Net Profit
-64.37M

About Northwest Biotherapeutics Inc (QB)

Northwest Biotherapeutics, Inc. is a development stage biotechnology company focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer. The Company operates in the United States, the UK, Germany and Canada and is i... Northwest Biotherapeutics, Inc. is a development stage biotechnology company focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer. The Company operates in the United States, the UK, Germany and Canada and is incorporated in Delaware, USA. Show more

Sector
Pharmaceutical Preparations
Industry
Pharmaceutical Preparations
Headquarters
Wilmington, Delaware, USA
Founded
-
Northwest Biotherapeutics Inc (QB) is listed in the Pharmaceutical Preparations sector of the OTCMarkets with ticker NWBO. The last closing price for Northwest Biotherapeutics (QB) was US$0.31. Over the last year, Northwest Biotherapeutics (QB) shares have traded in a share price range of US$ 0.29 to US$ 0.929.

Northwest Biotherapeutics (QB) currently has 1,248,237,358 shares outstanding. The market capitalization of Northwest Biotherapeutics (QB) is US$381.34 million. Northwest Biotherapeutics (QB) has a price to earnings ratio (PE ratio) of -3.29.

NWBO Latest News

Biophma Announces Exclusive In License for Dendritic Cell Technology, Sending Shares Higher

Imagine a new weapon in the fight against cancer, a personalized therapy that utilizes the body's own immune system to attack tumors. Science fiction? This biotech company just secured exclusive...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.0292-8.598351001180.33960.33960.30515677000.31710465CS
4-0.0064-2.02020202020.31680.340.29620506190.31815724CS
12-0.0871-21.91194968550.39750.40990.2923110180.33474238CS
26-0.2496-44.57142857140.560.570.2919620650.39149226CS
52-0.5545-64.1114579720.86490.9290.2918903170.52491085CS
156-0.9396-75.1681.252.050.2921682060.72860816CS
2600.0741531.38624338620.236252.540.00523653810.84366911CS

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NWBO Discussion

View Posts
bas2020 bas2020 2 minutes ago
Thanks for your admission...
If you dare go against them, you are a fudster working for the MMs.
👍️0
SkyLimit2022 SkyLimit2022 3 minutes ago
Gary,

A member of the Nobel committee mentioned the possibility of DC technology playing a role in the treatment of other diseases such as MS and diabetes (pasted below), so the question you raised is an excellent one. There was also a recent Lancet paper about a French/Swiss study involving DC technology for HIV. I would also mention that I believe the novel DC technology at Roswell (that NWBO now owns) does not have to be loaded with antigens from the tumor and might have the potential for broader application. I believe I read that it is easier to make too.

Some love Halloween time 🎃 and the beginning of the fall season. As a science enthusiast, I love October because it’s Nobel season!

It’s a great time to remember that NWBO is a company that was built on a rock-solid foundation of Nobel Prize-winning science, and brilliant physicians like Dr. Linda Liau and Dr. Pawel Kalinski could also one day be candidates for the Nobel Prize for their ground-breaking discoveries of novel combination therapies to overcome tumor resistance!








Dr. Steinman was awarded the Nobel Prize for discovering the dendritic cell. In 2018, James P. Allison and Tasuku Honjo were awarded the Nobel Prize in Physiology or Medicine for their pioneering work in cancer therapy through the discovery of immune checkpoint inhibitors.

Today, Dr. Linda Liau and Dr. Pawel Kalinski are combining dendritic cell technology with checkpoint blockade technology to reach new levels of efficacy and healing for patients! UCLA and Roswell are studying how these two Nobel Prize-winning discoveries can be combined to treat multiple distinct cancers!





Recently, we commemorated the loss of the great Dr. Ralph Steinman 13 years ago on September 30th.



“We know he will live on through his scientific contributions.”

Dr. Steinman’s legacy is changing the field of cancer immunotherapy today, and his invaluable Nobel Prize-winning work lives on at UCLA, King’s College and Roswell Park, among other cutting-edge institutions.

The recent evolution of dendritic cell technology has been vast, and Dr. Steinman’s prophetic words foreshadowed the future and DCVax-L. In the last 3 minutes of the YouTube video, Dr. Steinman describes the “first generation of this approach” which used only ONE single antigen. Consider that DCVax-L can present HUNDREDS of distinct antigens today!










The Nobel Prize in Physiology or Medicine has proven significant historically, and a great number of the discoveries that were awarded the prize have proven quite impactful.

The award represents the credible collective opinion of the 50 distinguished members of the Nobel Assembly and the opinions of any number of distinguished international medical experts whom the members may choose to consult. By their own published criteria, their decision to award the prize means that they believe the medical breakthrough will impact humanity globally.

To put the relatively recent awards for dendritic cell discovery and PD-1 in perspective, consider that checkpoint inhibitors have only existed commercially for 10 years. Drugs such as Keytruda have been blockbusters, and the full impact of PD-1 as a drug class is yet to be realized as the technology continues to evolve to include additional new products, such as subcutaneous versions.

Other examples of Nobel Prize-winning medical breakthroughs include:

X-Ray Technology, 1901
Penicillin, 1945
Insulin, 1923
MRI Imaging Technology, 2003
Monoclonal Antibodies, 1984
CRISPR Technology, 2020

These discoveries and many others that won the Nobel Prize have gone on to either revolutionize medical practice or create entire industries around their commercialization.



https://www.nobelprize.org/prizes/medicine/

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175149927
👍️0
drugrunner drugrunner 4 minutes ago
lol NED NOSURNAME…

Every chance u get ..you pretend anyone can do what NWBO does

That DCVAX is nothing special or unique…

Oh yeah … it’s so worthless that you have spent more than 10
Years telling us is worthless

More than 10k posts
Virtually every day for more than 10 years

Hmmm but u have no
Financial interest in NWBO ..

Ur just here to save poor newbie investors from investing in NWBO

I CALL BS ON EX / NED NOSURNAME
👍️0
dstock07734 dstock07734 7 minutes ago
Great reply, Horse.

I wrote a blah about Baker Brothers. Your comments are welcome. Note that one JAMA coauthor mentioned Incyte in Conflict of Interest part.

As shown in one of the Dr. Liau's publications, the inclusion of PD1 inhibitor and CSF1R-I into the combination of DCVax-L with poly-iclc makes tremendous difference in the final efficacy of the treatment. Note that DCVax-L in the figure is actually the combination of DCVax-L… pic.twitter.com/wpGpfwlRjy— d_stock (@d_stock07734) October 6, 2024
👍️0
brooktrail1933 brooktrail1933 7 minutes ago
Yes, great comment.

This guy is all over those he refers to as "extreme longs". The same guy who told us in no uncertain terms that "folks, Flaskworks is dead" about 12-18 months ago. How did that bit of prescience work out for him?
The same guy who berates posters for using foul language on the board, when in fact he has used obscene language to disparage me and other posters who disagree with his off-the-wall commentary.
Sure, some people here tout unrealistic scenarios and outcomes, but anyone with an IQ above 60 has the faculties to discern between them and reality, and don't need Professor Sure Of Myself to help them out.
👍️0
Horseb4CarT Horseb4CarT 8 minutes ago
Happy Birthday!!!

I hope we all get a gift if you know what I mean
👍️0
skitahoe skitahoe 9 minutes ago
I was in IMGN for far longer than NWBO has been in business. Each failure still led me to believe in the technology, it only needed to be tweaked some. When they gained approval in Kadcyla it proved the technology, but they monetized it, so they didn't gain a stream of income coming in routinely. With Elahere they finally had a potentially blockbuster product that was wholly owned, but instead of waiting they sold the company. After all those decades I'd gladly have waited longer, I believe it would have been worth far more. I hope I don't have to ever say the same about NWBO.

Gary
👍️0
Hopeforthefuture3 Hopeforthefuture3 12 minutes ago
Gary, listen to some of the presentations by Bosch on direct. It injected into the tumor where it is to pick up the antigens and then the dendritic cells transfer the target to the t-cells. Phase 2 was to inject multiple tumors and more than 1.time. held promis but as of yet never happened
👍️0
Horseb4CarT Horseb4CarT 22 minutes ago
I’m not qualified to state method of application with any authority, however one guess is that a lysate might be produced from processed virus cells if that is possible.

If one could assemble enough viral material, possibly even a blend if viral materials to cover multiple strains, and process it (maybe like tumor processing ir maybe different) and pulse the immature DCs, then that would be similar to the cancer approach.

The company that dstock posted a link to seems to already include virus(HIV) in their plans so they may be a good place to look for information on their approach?
👍️0
Hopeforthefuture3 Hopeforthefuture3 25 minutes ago
Pretty much all you posted is not really 'alluded' but are direcr quotes from LP or LG. In dec2022 LP specifically said RAs as in more than 1. LG on biz show had us alternatively on the 2 or 1 yard line. Quote I like best was 'on the home stretch' from about a decade ago - long home stretch. Hope that q4 of 2024 at last finds that finish line
👍️0
Horseb4CarT Horseb4CarT 31 minutes ago
I see, thanks for explaining it to me. Sometimes i’m a little slow.

RevImmune is also a coinventor on a patent (nwbo, ucla, revimmune, and the former nwbo CDMO that CRL acquired - having a senior moment trying to remember the name) and it may be the original combination treatment patent, but I could be mistaken.

I believe LP is directly associated with nwbo, advent, revimmune, and more! One of the companies LP is assovisted with added Dr Liau to their Scientific Advisory Panel I think, and I believe Bigger Capital has a large position in it.

I rely too much on memory and my retention and recall isn’t what it used to be. If I weren’t so lazy I would diagram all this stuff out and collect it in a file or database. But since I’m only invested in the nwbo part of LP’s world I figure I can get away with being lazy and I am strictly buy side for the duration with the exception of about 10% for personal family needs that I will need to sell, letting the rest ride and fulfill the greater potential.

The disclaimer: this is not investment advice
👍️ 1
bas2020 bas2020 49 minutes ago
In other words, you've met your match with Sky and now crawling back under your rock.
I'm not reading your crap anymore. It's worse than AI Kusterer's postings.
👍️0
ilovetech ilovetech 51 minutes ago
It's my birthday day tomorrow. LET'S GO!! 🚀
👍️ 5
skitahoe skitahoe 59 minutes ago
I know many say that DCVax has the potential to go against viruses and possibly other diseases, but I'd like to understand how. In DCVax-L the tumor plus leukapheresis is used to make the vaccine. In Direct, you don't have the tumor, but Direct is injected into it to essentially make it on site.

I understand that essentially DCVax-Direct can be made for anyone, but where should it be injected to achieve the desired result.

I'm not saying it won't work, just trying to understand how it would work.

If DCVax-Direct, or some variation of it that's covered under NWBO patents truly works for other diseases, even my wildest predictions of where NWBO could go with success in solid cancers would be way too low.

Gary
👍️ 2
manibiotech manibiotech 1 hour ago
As I said even that is 100 times better than your level of genius . So I will stick with that
👍️0
dstock07734 dstock07734 1 hour ago
Horse,

Who is the founder of the company? Yves Levy. He is also the director called Vaccine Research Institute. The current company is a spin-off of VRI which happened in August 2020.

Yves Lévy wrote a bunch of papers on trials using CYT107 solely owned by RevImmune. The company is also the partner of Oncovir. The HIV vaccine the company did the trial does include poly-iclc as adjuvant. No obvious and direct connection which would trigger SEC filing from NWBO. But indirect connection does exist.
👍️ 1
learningcurve2020 learningcurve2020 1 hour ago
Your Direct story is hackneyed.
🤓 1 🥸 1
Horseb4CarT Horseb4CarT 1 hour ago
Looks to me they are trying to commercialize a very similar (in concept) immunotherapy vaccine platform, so similar that one wonders about whether they are infringing or intend on licensing the nwbo patents.

However I remember something about the DCs/vaccine themselves not being patentable but rather the production process and key features being what the patents sre on, as well as a broad combination of dcvax set of patents.

Are you suggesting a direct connection between the companies and/or their products, as in dcvax being used or the IP licensed?
👍️0
bas2020 bas2020 1 hour ago
Hey genius... if you really think that the owner of the next SoC in cancer treatment isn't having dialog with various BPs, then you surely lack common sense.
👍️0
dstock07734 dstock07734 2 hours ago
Horse,

That's not my intention to let you read the website.

IMO, the DC technology that the company adopted is deeply connected to the one developed by NWBO.

Linkinvax doesn't develop its own patent. But it depends on the patent pool licensed from 17 institutions. Can you see if there is another institution other than RevImmune that has DC technology? The answer is no.
👍️ 2
dstock07734 dstock07734 2 hours ago
How many companies have both PD1 and CSF1R inhibitors approved by FDA? I can only find one so far. As shown in the animal model, the combination of this two with DCVax-L which $NWBO has filed plenty patents about over the past many years can deliver truly amazing results.

Incyte trims cancer drug pipeline in R&D refocus
https://www.biopharmadive.com/news/incyte-cancer-pipeline-cut-refocus-pd-l1-lag-3/722753/

FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel

Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD)

https://investor.incyte.com/news-releases/news-release-details/incyte-and-syndax-announce-us-fda-approval-niktimvotm-axatilimab
👍️ 1
biosectinvestor biosectinvestor 2 hours ago
It’s distraction. That’s what they do… you’re about to get approved for something and they are problematizing some other thing…
👍️ 2
Horseb4CarT Horseb4CarT 2 hours ago
Dstock,

I skimmed the linked document and see that this other DC platform technology is attempting to address cancers and viruses, thus supporting the development of dcvax being able to address the same.

Imo dcvax should be the more effective platform than those that target a more limited subset of enemy antigens, since dcvax DCs present as many antigens as possible for the DCs to pick up from the lysate.

That’s why dcvax L has been the most successful against gbm, because the informed immune response is against hundreds of antigens and gbm is very diverse to begin with and highly mutational. In fact dcvax works better against “hot” tumors than less “hot” tumors.

In summary, yes there is potential for dcvax cancers, viruses, and possibly more!!!
👍️ 5
Lykiri Lykiri 4 hours ago
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure.

4 October 2024
EMA/821278/2015
Human Medicines Division

5.2.2. When can I expect a pre-approval GCP inspection and how are they conducted? Rev. Oct 2024

Clinical trials included in any marketing authorisation application (MAA) in the EU and in any subsequent application to the initial one are required to be conducted in accordance with Good Clinical Practices (GCP). GCP inspections are conducted in accordance with Article 15 of Directive 2001/20/EC and Article 78 of Regulation (EU) No 536/2014. The requirements which apply for the conduct of clinical trials included in a MAA are set out in Recital 16 and Article 6(1) of Regulation (EC) No 726/2004 as well as in Annex I to Directive 2001/83/EC, as amended (Introduction and general principles - sections 4 and 8 - and Part I - Module 5). Requirements for the conduct of clinical trials and GCP inspections are published in Volume 10 of the Rules governing Medicinal Products in the European Union.
The EMA relies for the scientific review of centralised applications for marketing authorisations for medicinal products on the expertise located in the Member States. The same approach exists in the area of inspections, where inspections are conducted by Member States' inspectorates if requested by the CHMP. These inspections are co-ordinated by the EMA if they pertain to centralised applications and in the case of GCP inspections, they are conducted by Member States' inspectorates in accordance with Article 15 of Directive 2001/20/EC and Article 78 of Regulation (EU) No 536/2014. There is a GCP Inspectors Working Group, composed of GCP inspectors from the Member States, which meets quarterly at the EMA.
EMA inspection sector reviews all new applications for evidence of GCP compliance and other validation aspects. All new applications are examined to assess the need for GCP inspection(s). The EMA Inspections Sector liaises closely with the Product Lead, Rapporteur and Co-Rapporteur during the presubmission phase and in the period during and after validation to discuss the need to request GCP inspection(s). A need for inspection(s) may be identified at this stage, based on previous relevant experience of the Inspections Sector and the Member States’ national inspectorates. In addition, a need for GCP inspection(s) may also be identified during the review by the assessors, in particular during the initial assessment phase up to day 120. In case a need for inspection is identified for an application under accelerated assessment, the inspection will be requested as early as possible. Please refer also to question “Is my product eligible for an Accelerated Assessment”.
GCP inspection issues are usually addressed in the List of Questions (although the inspection may commence earlier once adopted by CHMP), and therefore are usually adopted at Day 120. The GCP inspection(s) of the concerned site(s) can then take place in parallel with the “clock stop” period.
However, GCP inspection(s) may be requested by CHMP at any stage of the assessment.
It should be noted that clinical data submitted as a result of specific obligations/follow-up measures, or within variations, extensions or other information received after the initial authorisation (e.g. in relation to safety updates, risk management plan etc...) may also trigger a GCP inspection request.
The Reporting Inspector appointed is usually from the inspectorate of the Member State of the CHMP Rapporteur or Co-rapporteur unless the site(s) to be inspected are located in a single EEA state (or small number (3 or less) of EEA states), in which case that Inspectorate is usually designated as the Reporting Inspectorate.
In addition to the Reporting Inspector, one Lead Inspector is designated per site to be inspected. The Lead Inspector is usually from the Inspectorate of the Member State where the site to be inspected is located (for inspections in the EEA). The Reporting Inspector may also be the Lead Inspector for one or more sites.
In the case of third country inspections, the Reporting Inspectorate and the inspectors are usually from the Rapporteur/Co-Rapporteur country inspectorates.
The applicant is asked to provide information in the application in order to facilitate the review and where needed the preparation of GCP Inspections. This information should be provided in the Individual Clinical Study Reports and their Appendices (Module 5) in line with the “Note for Guidance on the Inclusion of Appendices to Clinical Study Reports in Marketing Authorisation Applications” (CHMP/EWP/2998/03), and the “Note for Guidance on Structure and Content of Clinical Study Reports” (CPMP/ICH/137/95).
Some of the key information to be provided for each study are listed below with the specific references to the section numbers given in the “Note for Guidance on Structure and Content of Clinical Study Reports” (CPMP/ICH/137/95). Please note that some of this key information also needs to be extracted and included in the form “Information required for identification of a need for pre-authorisation GCP inspections”, which should be appended to the cover letter.:
• A clear description of the study administrative structure (clear identification of the sponsor and of the parties who have performed the monitoring, data management, statistics, laboratory assessments, randomization, site(s) of manufacture, site of release in Europe, medical writing, other applicable activities and the location of the trial master file) preferably in a tabular form and indicating name and address of the site where each activity was performed, responsibilities and scope of each activity. These should be identified in the clinical study report of each study, for instance in section 6, or appendix 16.1.4.
• A list of investigators (name, address, country), preferably in a tabular form, showing the number of patients enrolled by each site, and the total number of sites. In addition, a table with the number of patients enrolled per country should be included. These should be identified in the clinical study report of each study, for instance in section 10.1 or appendix 16.1.4.
• Audit certificates (indicating the sites audited, the dates of audit, the type of audit and the auditor). These should be identified in the clinical study report of each study, for instance in appendix 16.1.8.
• Signature of the principal or coordinating investigator(s) according to Annex I to Directive
2001/83/EC as amended and in line with the “Note for Guidance on Structure and Content of Clinical Study Reports” (CPMP/ICH/137/95), and not only the signature of the sponsor’s responsible medical officer. These should be identified in the clinical study report of each study, for instance in appendix 16.1.5.
A list of inspection(s) conducted or planned by other regulatory authorities, related to the product and trial sites involved, should also be provided, as part of the form “Information required for identification of a need for pre-authorisation GCP inspections”, which should be appended to the cover letter.
Each clinical study report should contain a statement indicating whether the study was performed in compliance with Good Clinical Practices (GCP), including the archiving of essential documents.
According to the Notice to Applicant, Volume 2B, the clinical overview (Module 2), should assess the quality of the design and performance of the studies and also include a statement regarding GCP compliance.
In addition, in accordance with Article 6(1) of Regulation (EC) No 726/2004, a statement should be provided, where applicable, in Module 1.9 to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC or Regulation (EU) No 536/2014. This statement should indicate that “clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC or Regulation (EU) No 536/2014,” together with a listing of all trials (protocol number) and countries (outside the EU) involved.
Regarding the importance of GCP compliance for marketing authorisation applications, applicants/marketing authorisation holders are invited to refer to the EMA Position paper on the nonacceptability of replacement of pivotal clinical trials in cases of GCP non-compliance in the context of marketing authorisation applications in the centralised procedure.
References
• The Rules governing Medicinal Products in the European Union, Volume 2B, Notice to Applicants, Common Technical Document
• Directive 2001/20/EC
• Directive 2001/83/EC, as amended
• Regulation (EC) No 726/2004
• “Note for Guidance on the Inclusion of Appendices to Clinical Study Reports in Marketing Authorisation Applications” (CHMP/EWP/2998/03)
• “Note for Guidance on Structure and Content of Clinical Study Reports” (CPMP/ICH/137/95)
• “Clinical trials”, The Rules governing Medicinal Products in the European Union, Notice to Applicants, Volume 10
• Regulation (EU) No 536/
👍️ 5
learningcurve2020 learningcurve2020 4 hours ago
"UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures"

https://pink.citeline.com/PS155283/UK-MHRA-First-Half-New-Drug-Approvals-Show-Overwhelming-Use-Of-EU-Reliance-Procedures
👍️0
Lykiri Lykiri 4 hours ago
I’m not sure how things work in the UK, but I do know that for a GMP inspection conducted by the EMA, there are strict timelines. For example, as mentioned in this text, inspections related to a marketing authorisation application must be conducted, and the final report submitted to the EMA and CHMP within the 210-day evaluation period. The inspection team works with the company to agree on dates, and the report is finalized within specific deadlines, such as by Day 181 for standard 210 days assessment.

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure.

4 October 2024
EMA/821278/2015
Human Medicines Division

5.2. Inspections.

5.2.1. When can I expect a pre-authorisation GMP inspection and how are they conducted?

5.2.1.9. Timetable for Inspections.

Inspection(s) requested in connection with an application for a marketing authorisation must be carried out and the final report(s) sent to EMA and submitted to the CHMP in accordance with the 210-day time limit for the evaluation of the application by the CHMP.

Once an inspection request is adopted by the CHMP, EMA will write to:

• the applicant explaining that an inspection(s) will take place, giving details (target date for carrying out the inspection, inspection team, scope of the inspection, contact person in the relevant authority responsible for arranging the inspection)
• the Rapporteur and Co-Rapporteur for information.
The Inspection Team will contact the Company to agree inspection dates within the agreed target date.
Inspections usually take place in parallel with the “clock stop” period.

5.2.1.10. Inspection Reports

Inspectors will send the draft Inspection Report to the manufacturer within fifteen days of the Inspection for comments on major factual errors, point of disagreement or remedial actions. Where necessary, the manufacturer should respond within a further fifteen days to provide comments and, if necessary, an action plan with a timetable for implementation. This will be considered during the finalisation of the Inspection Report.
The timing of any discussions, further actions and/or the provision of additional information arising from the inspection will be agreed with the Inspectors and communicated by the Inspectors to the Rapporteur, the Co-Rapporteur and EMA.
Inspectors will finalise the report and send it to EMA by Day 181 (or by Day 121 in case of product or process related inspections) at the latest and the Rapporteur, Co-Rapporteur will receive a copy. In case of a non-satisfactory inspection outcome, a non-compliance statement may be issued, and it will not be possible to have a positive opinion until the relevant issues have been resolved.
👍️ 4 🚀 1
Horseb4CarT Horseb4CarT 4 hours ago
Thanks I will look at the reference and let you know what I think.

Regarding HIV, I am aware of the postings, and I believe in a Dr Bosch presentation, that imply that the same basic approach that applies to cancer antigens should apply to other (non cancer) entities that should not be present for normal cells.

I haven’t spent the effort to perform that due diligence yet however I am assuming probable applicability unless shown differently, and the cancer opportunities are so humongous that in the short term they should propel the company and the stock, and help a great many people.

Generalization beyond cancer is ginormous and mind boggling, and if successful could be the biggest medical treatment platform technology of all time!!!
👍️ 1
cptbac cptbac 4 hours ago
Regardless, the scheduling of inspections affirms in my mind that the timeline is back on track and we are well within the window…. We are near
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manibiotech manibiotech 5 hours ago
It’s usual blame game . If someone has differing opinion , they are being paid for expressing those opinions. It’s quite amazing .
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dennisdave dennisdave 5 hours ago
I dont think these Spanish "scientists" are paid by Nevercure or any other competing pharma. I think they are just old-fashion ignorant and commented on the DCVAXL data and trial design based on narrowed thinking.
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RobotDroid RobotDroid 5 hours ago
As far as ChatGPT, garbage in garbage out. Its only as good as what data its given assumed to be true, which of course, is flawed.
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dstock07734 dstock07734 6 hours ago
Horse,

Once funding is not an issue, the more programs the company has, the more attention will be triggered.

Have you included the scenario of fighting HIV with DCVax technology?

By all means, go through the following website. It has some fascinating stuff. IMO, it is deeply connected to the DC technology that NWBO owns.

https://ennodc.com/
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dennisdave dennisdave 6 hours ago
*UK MIA 54923 certification issued for commercial manufacturing on September 10, 2024. Therefore, those scheduled site inspections have or had been ongoing and IMO likely have been completed by now.
thats an assumption you should not be that sure about
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ilovetech ilovetech 6 hours ago
Basilisk - It's not that the NHS isn't aware, but rather It's Dcvax - L, not Dcvax - Direct that is approved for compassionate use at this juncture. The latter would be the appropriate treatment modality for his type of cancer.
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Zadie420 Zadie420 6 hours ago
Exactly.
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Horseb4CarT Horseb4CarT 6 hours ago
I remember some earlier information, maybe from Dr Liau or Dr Bosch, that dcvax monotherapy (added to SOC) response depended on remaining tumor load, thus maximum removal of tumor was thought to be the goal of the surgery.

I don’t know if current knowledge has modified the thinking.
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Basilisk Basilisk 6 hours ago
BBC article today: Immunotherapy Saved My Life.

lhttps://www.bbc.com/news/articles/c153pg278npo

Man with recurrent melanoma receives unspecified immunotherapy that cures him, but with significant side effects. UK NHS is funding multi-million pound studies to elucidate why through lack of testable and usable biomarkers. NHS seems unaware of DCVax-L with few side effects and available biomarker data. Powers et al. should educate them and take the money.
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Horseb4CarT Horseb4CarT 6 hours ago
The biggest takeaway I have regarding DCVax Direct is that LP and others at nwbo clearly stated that Direct is being taken out of “dormant on the shelf mode” and are going to actively pursue it in some manner again!!!

This is important because with the additional insights gained over the last five years, including DCVax modus of action and deeper knowledge of tumor micro environment and cancer’s mechanisms to evade being destroyed, the decision to reactivate Direct implies both positive “science” and timing (opportunity) factors being more “promising” enough to allocate efforts and (somebody’s) funding to the renewed Direct efforts!!!
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dstock07734 dstock07734 6 hours ago
If everything were so direct and obvious, how could you and dark forces get trapped? How could the NWBO longs have generational wealth?

That's why I suggest you be equipped with science and know science before betting against it. Too bad you never get it.
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dstock07734 dstock07734 6 hours ago
Gary,

The dendritic cells trained by NWBO technology is not picky at all. It can swallow lysate from tumors on human, mice, dog and other mammals. Recall what Les said about patients with 15 types of tumors.

Seems to me NWBO only needs to take care of different immunosuppressive characteristics which can be tumor type dependent. Of course, you know that NWBO has the technology to increase t cell counts.
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skitahoe skitahoe 7 hours ago
Thanks Dstock, that discusses some of what I was getting to. The big question is, what if you only need to remove a tiny part of the mass to make the vaccine. If treatment with the vaccine and other therapeutics is as effective as removing the entire tumor, it may be found that we can fight cancer without massive surgeries.

I still don't know if the scientists can explain the tremendous increase in T-cells when using DCVax-L, but if in fact it occurs in all sorts of solid cancers, I believe it's the key to why the DCVax's will work on many cancers when used in combination with other therapeutics that work with those T-cells.

Aspirin has been around for well over a century. They still don't understand all the things it does that make it effective, but they know it is. Perhaps some day the same will be said about our DCVax's.

Gary
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learningcurve2020 learningcurve2020 7 hours ago
https://news.cuanschutz.edu/cancer-center/answers-about-brain-cancer-after-the-death-of-nba-star-dikembe-mutombo
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learningcurve2020 learningcurve2020 7 hours ago
https://childrenshealthdefense.org/defender/heart-failure-risk-myocardial-infarction-patients-covid-vaccine-infection/
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manibiotech manibiotech 7 hours ago
How dumb can one get to connect isolated dots in such a way .
So with all your intense research why don’t you ever answer the question that what is Baker Brother’s holding of NWBO?
If SIO and Bigger can be long , why wouldn’t Baker Brother not be able to find a way to be long NWBO?
But let us guess , they would rather beat around the bush and not just directly buy NW in which they are allegedly actually interested in .
Sparkles of a genius as usual .
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dstock07734 dstock07734 7 hours ago
I asked a couple of posters on this board to do some investigation on Baker Brothers' portfolio as a way to verify if there is a possibility that Baker Brothers may have something to do with NWBO. But none would do it. Is it so boring subject? Anyway I did the preliminary investigation on my own. Note that I only share something I truly believe.

As shown in one of the Dr. Liau's publications, the inclusion of PD1 inhibitor and CSF1R-I into the combination of DCVax-L with poly-iclc makes tremendous difference in the final efficacy of the treatment. Note that DCVax-L in the figure is actually the combination of DCVax-L with poly-iclc. The combination of CSF1R-I and Keytruda/Opdivo with DCVax-L has been investigated thoroughly by UCLA research team.

https://academic.oup.com/neuro-oncology/article/19/6/796/2927952

There are several PD1/PDL1 inhibitors approved by FDA and more are ready for RA filing. But when it comes to CSF1R inhibitor, there are very few FDA approved drugs. As a matter of fact, there used to only one drug approved by FDA and it is PLX3397 from Daiichi Sankyo. But in August 2024, FDA approved an IV version of CSF1R inhibitor which is Axatilimab from Incyte.

What I found more interesting is that Baker Brothers are the largest share holder of Incyte which accounts for 25% of their portfolio. Axatilimab was originally developed by Syndax and in September 2021 Incyte formed a collaboration with Syndax to develop Axatilimab together and the collaboration was concluded with FDA approval in August 2024. Is that interesting for Incyte to reach out another company to develop CSF1R inhibitor from which Daiichi has not generated any significant revenue? As the largest share holder, Baker Brothers must push for or at least approve the move. Again when was the last time Dr. Timothy Cloughesy had a meeting with Merck? March 2021!

IMO, it seems like Baker Brothers have been trying to empty all their positions in precision medicine as listed below. Note that I only took a look at companies which focus on cancer and accounts for over 0.1% of their portfolio, and the timeline started from June 2022. It should be pointed out that if a company has pd1 inhibitor under clinical trial, they would keep its position. Is precision medicine the direction of cancer treatment that makes all the BPs jump on board over the past a couple of years? What could make Baker Brothers dislike precision medicine?

My conjecture is that Baker Brothers' investment decisions might be connected to the breakthrough from $NWBO. Time will tell if my conjecture is right.

https://fda.gov/drugs/resources-information-approved-drugs/fda-approves-axatilimab-csfr-chronic-graft-versus-host-disease

https://incyte.com/our-company/our-leadership

https://whalewisdom.com/filer/baker-bros-advisors-llc

Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases
https://ir.syndax.com/news-releases/news-release-details/syndax-pharmaceuticals-and-incyte-announce-global-collaboration

List of companies
Merus (T-cell engagers)
https://merus.nl/pipeline/

Legend Biotech (CAR-T)
https://legendbiotech.com/research-development/pipeline/

ImmunoGen Inc. (ADC)
https://immunogen.com/what-we-do/our-pipeline/

Cue Biopharma (T-cell engagers) George Zavoico used to be Vice President, Investor Relations and Corporate Development of the company before joining $NWBO.
https://cuebiopharma.com/pipeline/product-candidates/

SpringWorks Therapeutics Inc
https://springworkstx.com/pipeline/

Day One Biopharmaceuticals
https://dayonebio.com/clinical-trials/







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learningcurve2020 learningcurve2020 7 hours ago
https://www.oxcode.ox.ac.uk/news/funding-to-create-world2019s-first-ovarian-cancer-prevention-vaccine#:~:text=Researchers%20from%20Oxford%20have%20been,earliest%20stages%20of%20ovarian%20cancer.
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dstock07734 dstock07734 7 hours ago
Gary,

There are several funding allocations which are trying to address the part you are concerned about. Does the following answer your question?

https://arpa-h.gov/news-and-events/arpa-h-announces-awards-develop-novel-technologies-precise-tumor-removal
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learningcurve2020 learningcurve2020 7 hours ago
https://www.washingtonexaminer.com/policy/healthcare/3178363/vaccine-ovarian-cancer-scientists-optimistic-eradicating-disease/
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manibiotech manibiotech 7 hours ago
Please do
They must be trembling in their shoes at that thought .
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exwannabe exwannabe 7 hours ago
Thank you.
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