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WRT= With respect to…
For only $3,250 you can get what regular biotech's give away to investors through cc's, presentations, and real analyst coverage. Eye rolls.
https://www.researchandmarkets.com/reports/5899244/dcvax-l-emerging-drug-insight-market-forecast
Happy Mother’s Day everyone. Sharing again my hopes for NWBO to realize its unicorn company potential. Maybe this can be a sequence of events for DCVax’s technology platform to take society out of a medieval period where cancer treatments do not cure the underlying cancer and into a renaissance period where it does.
It starts with DCVax clinical trial results
• A new SOC for GBM to increase long term survival 2.3X, from 5.7% to 13%
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
• Add Poly-ICLC (adjuvant to DCVax) for stage 3 and 4 brain tumors to improve long term survival further, to increase median OS 6.8X, from 7.7 mos to 52.5 mos. Certain cohorts of patients are all alive, ie cured.
https://www.nature.com/articles/s41467-024-48073-y
Society then realizes there is a new paradigm
• Vaccine, not drug with major side effects
• Drugs with severe toxicity risk OUT
• Robust immune memory IN
• Therapy means to cure the cancer
DCVax transitions into a base layer, as a super umbrella for combination therapies
• First for early stage and benign brain tumors, as a prophylactic
• Next on a few other type late-stage cancers
• Then on a few other type early-stage cancers
• Become recognized as a broad-spectrum cancer vaccine for all solid tumors
• Finally as a modular therapy to optimize and cure (DCVax as base layer, add adjuvants from a menu)
Then maybe there are potential new applications
• Immunization against cancer (personalized against a set of cancer antigens)
• Anti-viral vaccine (personalized therapy against chronic viral conditions like long-covid, herpes, HIV)
All the while it is transforming the role of doctor-patient
• From imperfect solutions: balancing the pros/cons of efficacy against toxicity in various cancer drugs, along with the regimen of second layer drugs to deal with the anticipated toxicity and side effects
• To optimizing for a holistic therapy: for cure, for prevention, and for the quality-of-life of the patient
Thanks Tryn2.
After approval, companies will be knocking down their doors out of fear of missing out. Make no mistake they will control the combination therapy market. He who controls the data will become King.
The classical definition is:
With
Respect
To
Hope this helps...🙂
Maybe they could afford to run those trials had you and all your friends not been bashing the share price every day for the last 15 years. They could’ve raised the funds at favorable terms and run all kinds of other trials but with yourself and others in the Wolfpack, creating fictitious lawsuits doing everything within their means to keep this drug off the market
My only fear, once MHRA grants approval and SP also jumps, will dilution also increase? I realize they have to keep the lights on, but if they start printing shares, then I can only conclude its mngmt controlling SP , not MM's. We shall see. To state the obvious, everyone has a theory, everyone has an exit strategy, and no one knows anything concrete. But I feel the next 6 weeks will be very interesting and I dont want to hear any BS about summer slowdown.
wrt=with regards to?
With regards to that question you are now blocked.
snoopycomic - and what the hell does "wrt" mean.???
So all of this crap is gonna be done in the next few months. LOL. (several times)
Start thinking spring of 2025.
So they have to physically inspect and hopefully accept 86 fuckin locations spread out around the world before NWBO gets the approvals that most posters on this board says is gonna be wrapped up in a few months. Please tell me I am SOOO wrong.
Big hitter, the Lama....
"Hey, Lama, hey, how about a little something, you know, for the effort, you know." And he says, "Oh, uh, there won't be any money, but when you die, on your deathbed, you will receive total consciousness." So I got that goin' for me, which is nice
Yes they expected a response in 8 weeks and got none (ever) so they knew it didn’t work.
You’ve been corrected 100 times on your made up 5% number. There is no control arm with the same inclusion/exclusion criteria as the treatment arm that the company will divulge. They won’t release that data.
The 5% is from ALL GBM patients including those with biopsy only and those with a terrible prognosis at diagnosis. They were excluded from the trial. Why can’t just admit you are wrong?
Jester, I'm looking forward to MA approval in the UK because I think it will open the door to all the other news that's been waiting on this first APPROVAL! And that is the franchises/partnerships that will bring in the big money from Pharmas and other companies. Once retailers/institutions see BP teaming up with us they will be buying shares. I also think news on uplisting is waiting on this first approval. Also, announcing a MA submission to the FDA will bring in big buyers, IMO. So, I doubt we'll see a dearth of news after UK approval, which longs believe is coming soon. But I do agree with you that it's the partnerships/licensings/franchises that will move the share price needle the fastest and furthest.
Nobody does. He’s an idiot.
$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) May 11, 2024
The 2 most important sentences in the Q.
"On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission."…
Nothing is guaranteed wrt SP.
NotSure2, you miss the point, IMO.
Agreed. I think bump in SP on UK approval, but only 2-3$, then walkdown in price again because of media blackout when they submit to FDA. I have no faith in lawsuit of short squeeze. But MHRA approval begins the snowball rolling downhill. Revenue rolling in and more combo trials. But I stopped believing in quick 20$ a share buyout. In the long run, it will be worth much more with partnerships, especially when keytruda patent expires. So patience. But 4x investment when MHRA approval, at least we got that going for us, gonga, la gonga in the words of the dali lama.
All solid Tumors, consider the Market Cap. 50.00 is too low.
Not so fast NotSure2. The examples you provided are material in my book. An inspection is not unless they found some Major 483s/ Warning Letter stuff (Ie showstoppers). Look, I'm not going to argue they did have these inspections but I'm not convinced they did not.
EDIT: Also, they could have visted the facility and performed the inspection but not officialy presented the results to NWBO.
He's all about flipping shares. Adds nothing.
I don’t believe a buyout was ever on the table, even just going back a few years when they admitted that they had no meaningful offers. And in fact said — to paraphrase a bit —they would sell the company if an offer is received they couldn’t refuse. That was literally said to me in response to a question I asked Les!
A catch and kill concern for a BP buying Vax is very far-fetched, and generally only has application in sectors or products where there’s a near monopoly or monopsony. Horse can speak to that during his time with Bell.
Having said that, it’s become increasingly obvious there’s significant value in combination with CIs and adjuvants as well as with other indications. So it makes sense (in theory) as a financial strategy that the company enters into a series of JV and licensing agreements, perhaps spins-offs…going back to some discussions less than couple of years ago.
I watched the Tom Brady Roast on Netflix. Man that was raw, explicit adult entertainment. Not for everyone.
Agreed! They not sellin’!!! Of course everyone of us has our price but once approval is received in a few weeks and EDEN is validated this freight train will be rolling downhill and it’s all light work from there! Watching the decimals point move left on your life’s work is a great hobby! They’re not throwing the baby out with the bath water.
I’m using Schwab (originally Merrill) and have mine locked up $25/share.
Ex - Understood, as it's not an area I've ever researched.
As for:
Always thought this. It has been a difficult decade to witness. Looking forward to a change in stock direction and company performance.
I do actually agree with every aspect of your projected forward looking viewpoint, in regards to third party combination dendritic cell treatment manufacture.
BUT how will you, as an NWBO investor benefit ?
Are they not separated out standalone entities now ?
Has nothing to do with thinking ahead for an application to the FDA.
If you look at the trial location sites, youll notice that ~70 of the 86 locations are in the USA.
This is why they are dealing with lots of experts from the U.S.A.
https://www.clinicaltrials.gov/study/NCT00045968#locn
Only 4 in UK, 9 in Germany, 2 in Canada. 71 in USA. (hospitals/university/etc...)
The Company does not know when MAA - related inspections may take place.
LP is a fan of Dirty Dancing I bet:
Nobody puts DCVax in a corner!
Well, we’ll have the time of our lives
BearTrap
You’re smarter than the average bear
Hey Boo Boo, Mr Ranger will approve and our pickanick baskets will be full!!!
As I understand the UK operation post approval, I believe that everything supporting the manufacture, storage and distribution of the vaccine is centered around Sawston doing it with manual manufacturing. If this is the case, any inspections needed prior to approval should be in Sawston.
On the other hand, if EDEN has entered the picture, then several facilities might rightfully require govt. inspections in a variety of places in the world. NWBO has a FlaskWorks unit that would have to be inspected, and that unit will be purchasing components that come from many source throughout the world, they too should probably be inspected and approved for supplying components used in the EDEN including the disposable cassette from St. Gobain's Glass, which may contract for parts that go into the disposable cassette.
I short, if multiple inspections are ongoing in multiple locations, I'd suggest it's for the EDEN, not to initiate commercial manufacturing manually at Sawston to support the UK approval.
Gary
Inspections for export of human tissue and import of vaccine?
Why certainly, nyuck! Nyuck! Nyuck!
The various regulators review the trial to insure that patients are treated ethically. They are not insuring that the drug is safe or effective at that time. It would be an obvious chciken/egg issue if otherwise.
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Peter Davis
@peter_brit
·
May 11
#dcvax $nwbo #gbm
After the amazing DCVax/Poly-ICLC's combination results peer-reviewed in Nature and the excellent prostate cancer results using Poly-ICLC, it begs to question whether plans will be made for a combination of DCVax and Poly=ICLC for prostate cancer bearing in…
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Gregory Zivic, MD
@metacollectiveG
$NWBO I believe a Prostate trial with Poly ICLC is in the works and we’ll know before year’s end. It just makes sense; large market, already have an approved trial with DCVax. Now add Dr. Liau’s paper and LP’s foresight 2 years ago and presto…
Or just that the data for approval was largely based out of the US so the UK regulators may want to examine those sites as well.
Honestly, I'm a bit confused. Wasn't the trial designed, approved, and run under regulatory guidance to the extent, that data and periodic checks and verifications were made throughout? As it is with interim reviews to assess safety and benefit compared to standard care? Are we saying that in the three years BTW DL and Jama, that the regulators were not involved, as part of a verification process, so as to avoid having to do it as an afterthought long after? The latter seems to be a weapon of mass bureaucratic slow walking if I've understood correctly imo.
I am also not on the computer 24x7, but any good news about NWBO and i'm sure my phone will blow up from friends and family I convinced to invest. Also, news can hit anytime but usually its the next morning when things explode. I have no fear of missing out. In the words of moe howard, have no qualms or trepidations. Or was it larry who said that...
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“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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