Dr David Jenkinson, Chief Scientific Officer at The Brain Tumour Charity, said:

“The data presented are really promising and we now very eagerly await publication of the final results following peer review.

“Glioblastomas remain the most common and most aggressive form of brain cancer and with so few treatments available, thousands affected by the disease in the UK each year are in urgent need of new options.

“It is fantastic to see that many years of research and innovation may now be on the cusp of delivering a long-awaited new therapy for those living with glioblastomas.

“We need to wait for these results to be independently validated, but we are now really hopeful that DCVax-L may represent the first new treatment able to offer life-extension to people living with a glioblastoma in over fifteen years.”

Professor Michael Jenkinson, Professor of Neurosurgery at the University of Liverpool and Chair of the NCRI Brain Group, said:

“The results of the dendritic cell vaccine trial hold real promise for patients with glioblastoma. This is the first drug trial since the introduction of temozolomide that has shown a meaningful improvement in survival, and that could represent the new standard of care for our patients.“

Message in reply to:
Nice work Biosectinvestor.

Ladies and Gentlemen, we have a BUY signal. I smell the sweat, the anxiety, the impending doom and the lies to try to stave off the inevitable.

Message in reply to:

I regret to say that my sister has passed away. I don't know that DCVax-Direct would have helped, but with her cancer growing I didn't think she had much time, though in her optimism she was planning on a cruise next Fall. Cancer doesn't wait for anyone, that's one reason I don't believe that trials should take a decade or more. She had a good life, but it was shorter than it should have been.

Gary

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Thanks Lykiri, very good information.

But, I do disagree with the authors when they say "these results will need to be replicated before full approval for standard of care."

After the DCVax-L Phase III clinical trial data is unblinded and unblended, the evidence to support DCVax-L worldwide regulatory approvals, and incorporating DCVax-L into the new standard of care (SOC) to treat both ndGBM and rGBM will be overwhelming.

In addition, when you combine the DCVax-L Phase III trial results with the Compassionate Use results, and the Informational Arm results, the results are already replicated and will be more than sufficient to support DCVax-L inclusion into SOC to treat all GBM patients.

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FeMike - just from various discussions I’ve had over the years with Mgt. TLD could have been PR’d by the company months ago but they have made the decision that the credibility of Mgt is damaged to the point that it creates an opportunity to attack the integrity of the data if they just coughed up the results themselves and so to that end they have rightly made the decision that they will release a PR on or around the time that it is published in a leading journal after it’s been through an independent review process by peers appointed by the journal.

So the situation is unique and says to me that they have very good results and this extended delay is created out of a necessity to see any opportunity to attack the integrity killed off. Now I accept this process has taken a lot longer than they probably thought but in a way it’s better everyone reviewing it does a professional deep dive if as a result it may lead to a potential change in how GBM is treated globally.

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These statements are very encouraging, forward-looking, and tells us some of the things NWBio has been spending money on recently:

Quote:
Our operating costs also include the costs of preparations for new or expanded clinical trial programs, such as our planned Phase II clinical trials. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other. Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, in both the U.S. and Europe.


Also, please note that the words clinical trials are plural, in this sentence:

Quote:
such as our planned Phase II clinical trials


And, alsn note that NWBio is expanding manufacturing capacity in the "U.S. and Europe"

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New alpha movie. The DI Movie.

I’ve seen too many people die over the last few years waiting for this treatment.

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https://braintumor.org/share-your-story/gbm-clinical-trial-survivor/

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So if you look at NWBO/Flaskwork’s + FDA + NIH/NIAID as a triangle. They had two parallel motivations.

1. NIH/NIAID and FDA primarily wanted closed system cellular production to avoid contamination.
2. NWBO/Flaskworks primarily wanted automated dendritic cell generator to meet anticipated increased production demand and simultaneously lower production cost.

Of course, they each held the other objectives above critically important as well. For instance, the NIH hoped it would make dendritic cell studies easier to conduct.

LP taught manufacturing and commercialization at NIH.

In June 2015, approximately one month before the screening halt in DCVax-l trial, NIH was temporarily suspended by the FDA from manufacturing Albumin, due to uncharacteristic lassez fair attention to sanitary conditions in producing and storing albumin (some isolated fungal contamination of albumin resulted). The NIH did not, however, supply the Albumin for DCVax-l.

Over the years. Doc Logic occasionally reminded us about the peculiar timing, and also pointed out the Germans also concerned about addressing biological production, and they concluded closed system production was needed (as some of us researched in due diligence from German patent documents. They even slowed some NWBO patent down on this matter, but eventually approved it.

Anyway, go back to December 10, 2014 (six months earlier) and an NIH professor on manufacturing and commercialization, was wearing her other hat, CEO of NWBO, and telling us that the only ultimate answer to meeting high demand was closed system automation.

By June 2015, you’d think NWBO investors would be told that NIH and NIAID were going to fund genius Shashi Murthy in that same month, to develop a closed system automated dendritic cell generator. Although the info was publicly announced, everyone here had no idea about the project that was anticipated to take four years, which it did, and was completed in 2019. The patent was granted in August 2020, and a few weeks later, we learned NWBO bought all of the NIH/NIAID funded work by Acquiring Flaskworks for a very reasonable sum.

In my opinion, NWBO knew about this project all along. They knew it would address production capacity to meet future anticipated demand whilst lowering manufacturing cost, and they knew it would meet regulator external need regarding manufacturing dendritic cells without threat of contamination. They also knew it would add another layer of IP and trade secret protection to the manufacturing process.

Why keep this parallel track hidden from investor view for five years?

It could be because the dendritic cell generator also provides another layer of patent protection in the DCVax-l manufacturing process, that now goes out to 2040. So they may not have wanted competitors to know NWBO was going to swoop in after Flaskwork obtained their patent. It could be they possibly did not want investors in June 2015 to know this dendritic cell generator project was expected to complete in June 2019 (Aug 2020 to get a patent grant), because that would then put a whole different angle on the six year and counting wait since the enrollment completion/halt.

Why do we think the regulators are supportive? This was a regulator funded project that was one way to address another regulators concerns about safe biological manufacturing.

Wonder why we haven’t yet been wrist slapped on clinical trials.gov? You might have a NIH professor, the NIH, NIAID and indirectly the FDA’s appreciation to thank for that.

Do I think investors should have been apprised of this possible scenario back in 2015? Yes, but it’s water under the bridge. I’m not gonna go there. For various reasons.

LP stated in December 2014, they were thinking a “lot” about how to meet unimaginable demand for DCVax-l. Her conclusion? Closed system automation was the only answer.

Message in reply to:

A mini wedge on the pullback from 1.25. Ready to move again. We might even see 1.23 - 1.25 later today or by tomorrow.

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Captain, SHARES OUT 890,882,057

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You obviously have never really understood how big an impact the approval of this technology will have on oncology. You are looking at a completely disruptive technology impacting billions of billions of dollars currently being accrued by BP who not only control how patients are treated but how the many side effects are also treated. This paradigm shift will also impact companies like Novacure drastically as well as many thousands of emerging tech companies trying to find the answer to cancer. When the survival data is revealed for the hardest to treat cancer how many patients with other types of cancer will demand off label usage of L and D in the not so distant future. LP is being cautious for a reason and IMO her waiting for TLD at the same time as publication is critical in revealing irrefutable proof that a new SOC is about to be approved. NWBO has been relentlessly attacked for many years and the reasons are obvious. A major disruption is about to occur and how this is presented to the world is critical. All IMO. GLTY.

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Watch out for Monday bear raid. Open low close high.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164444344

With the motto “turning discovery into health,” the National Institutes of Health’s (NIH) mission is to understand and improve human health by supporting rigorous and innovative medical research through more than $40 billion a year in grants.

To that end, the NIH in 2020 awarded more than $590 million in grants to the David Geffen School of Medicine at UCLA, putting it second in the nation among all academic medical centers in NIH support.

Among those to receive research grants to study cancer were UCLA Jonsson Comprehensive Cancer Center members Dr. Linda Liau, who is collaborating with research faculty in neuroscience, oncology and immunology to develop those brain cancer vaccines and other novel treatments for brain diseases, and Dr. Mark Litwin, who's team work is focused on finding innovative new therapies and using precision medicine to treat patients with prostate, bladder and kidney cancer.

Click here to read the UCLA Health Connect blog.

Bright Boy Monday, 03/15/21 03:28:01 PM
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I think you might be right!!! Although the MM's on the OTC can make the best poker player in the world very sorry they ever picked up a deck. Unfortunately, we have no real buyers/support. Most of that volumes is between the MM's. It's identical to what we see all the time in the penny stock game where the buyers and sellers are in the same room working for any number of OC syndicates creating the illusion of liquidity, only to discover that the only trades that are filled are those that the MM's want you to see. Think about it. WE traded all the way to $1.80 on a supposed 4 million volume then back down $.23 on only a million. How does that happen??? The MM's are not going to let an outsider steal $.23 from them in a matter of a couple of hours. Remember they see the board, all buys and sells. We see the screen only and the board they see is the one they created!!! A very close friend of mine was one of the originators of HFT.

DavidW2 Sunday, 03/14/21 11:06:10 PM
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Jondoe wake up early today at UK.

He is long term BEAR for NWBO. Better be watch out! LOL.

Bob_LobLaw, I disagree that this loan for $11 million means that the new DCVax-L BLA process has not already started. Especially if the DCVax-L top line data (TLD) is as good as we all believe it is.

I believe that the FDA is the lead regulatory agency (RA), and it will review the DCVax-L TLD first. I am already on record stating that I believe NWBio may already be using the new FDA Real-Time Oncology Review (RTOR) program, that allows new and supplemental drug & biologic applications to be submitted, reviewed, and approved faster. NWBio only has to submit the DCVax-L TLD to the FDA to get the DCVax-L BLA process started via RTOR.

https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program

In fact, the average time from submission of a new BLA or NDA to FDA approval was 3.3 months under the FDA RTOR program:

https://clincancerres.aacrjournals.org/content/27/1/11

DCVax-L is perfectly suited to take advantage of the FDA RTOR program.

Quote:
The FDA’s Real-Time Oncology Review (RTOR) pilot program aims to create a more efficient review process that ensures treatments are made available to patients as early as possible. The FDA Oncology Center of Excellence launched RTOR in 2018 to allow sponsors to submit clinical data supporting the NDA as they become available, rather than waiting for the full NDA. This effort is a testament to the importance that regulators have placed on advancing innovations for cancer patients

https://www.amgen.com/stories/2020/12/decoding-5-recent-regulatory-and-development-steps-for-sotorasib

The FDA oncology group is clearly reinforcing the very deliberate message that cancer patients would not be forgotten even as the pandemic became public health priority number one.

Quote:
It is, however, in keeping with recent efforts in the Oncology Center of Excellence to innovate and accelerate regulatory processes. Most notably, the adoption of so-called “Real Time Review” is clearly accelerating the timeline for action on cancer applications with unequivocal efficacy results.

So ahead of schedule approvals are also becoming almost routine in oncology. The various cancer divisions at FDA approved 10 new drugs more than a month early in 2019 and seven in 2018.

https://pink.pharmaintelligence.informa.com/PS143715/US-FDAs-Three-Review-Speeds-Standard-Priority--And-Oncology

Not only do I believe NWBio may be using the FDA RTOR program for DCVax-L, I also believe NWBio may be using the FDA new Project Orbis program in conjunction with the RTOR program.

The FDA Oncology Center of Excellence (OCE) established Project Orbis to allow for the concurrent submission, review and approval of new oncology drugs and biologics in 6 different countries, by 6 different regulatory authorities at the same time.

These countries include: US, UK and Canada. I believe that DCVax-L could be approved in at least 3 different countries at the same time, and within 3 to 6 months from submission of the completed & accepted new BLA.

Quote:
Project Orbis is intended for high-impact oncology products – those products that have the potential to benefit patients the most. A driving factor behind establishing Project Orbis was to bring highly effective therapies to patients with cancer earlier, especially in countries where there would otherwise have been delays with regulatory submissions. Companies with applications seeking to participate are generally expected to meet the criteria for FDA’s priority review, which include a medical product that is intended to treat a serious condition and that, if approved, would provide a significant improvement in safety or effectiveness.

https://www.fda.gov/news-events/fda-voices/project-orbis-strengthening-international-collaboration-oncology-product-reviews-faster-patient