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Shame to see Denial of NWBO's own statements. Investment community clearly has seen the same SEC and TLD data and they have fled the stock. Down >50% in the last 52 weeks. That's not the stock trend of a biotech with a "successful" Phase 3 clinical trial.
Yes, and those who are bad at market timing come on here to blame management when in fact they're simply bad at trading.
Thanks Bio. So far so good. No recurrence in 24 months. Thanks again,
Roger Stupp and Linda Liau didn't cherry pick anything.
I guessed you missed the NYAS (and other) presentations that clearly disagreed with your post,
On the two endpoints you quoted, the EU/DE site says 3 analysis on each, while the NYAS asserted a single standard K/M on both.
The registries also have:
Sure there is. Even with the best surgery GBM OS at 5 years is 5% tops. That’s a fact.
The true "Gold Standard" would be OS relative to a well-controlled trial's own control group, not comparing to a handful of other trials cherry-picked years after the trial last treated a patient.
The main event to move shares higher was tld, it was a colossal failure for s/p. 12 years waiting for tld.
There is only an approval now to move shares, we are miles away from that, despite being on the 2 yard line.
Asm and ja have been swept under the rug, but not sure either help sp much.
Try this to understand it.
Near total resections are easily stat sig as a treatment compared to all resections and biopsies. That was effectively shown in the NYAS data.
The DCVax-L trial had "intent for near total resection". DCvax-L was not as good as near total resection". Again, that is stated in the NYAS data
How close is "intent for" to actually having? Who knows, as NWBO does not have the data.
There is no way to establish the data is nothing more than better surgery.
So, Bill, you concur that the primary OS-related (i.e., "THE" gold standard) endpoints were met, right?
na, it's true. it was in quotes,LOL
Seriously, you write as if you understand what is going on, but clearly these constant posts show how absolutely befuddled and confused you are about this treatment, despite claims of expertise.
Irdpdx77, thanks for sharing. I hope your treatment goes well and that you are able to achieve the results of the best of the best patients, as some do seem to be apparently cured Irdpdx77. Sending you all my best!
Time for perspective!
XBI up 228% over 10 years.
NWBO down 88% over 10 years.
nwbo pretty much sucks compared to its sector.
No, it has been up immensely in the last 5 and 2 year period. It is normal for microcap biotechs that have no product 1) to dilute; 2) to not generate positive returns until they get closer to commercialization. Some do, by selling out their future early to big pharma, but they reduce the future result and often basically commit to selling out just before full commercialization.
These charts tell a truer story than your factually flawed narrative.
Re $NWBO vs $XBI the bio index - because shorts wrongly taunt longs, and many of us entered after they attacked and averaged down if not. I am not complaining compared to the rest of the market. pic.twitter.com/7Xm5qoWBWp
— biosectinvestor (@biosectinvestor) August 1, 2022
Your point actually reinforces what Exwannabe is saying since so much hope has been pinned on the UK and thus there had been not be an issue with accepting the endpoint change.
Your post misquotes Exwannabe. Nowhere did he say the trial was a success.
Also there is no such thing as “Tweeter” so whatever source that chart that keeps getting posted comes from, it’s pretty suspect.
Why do they drive on the wrong side of the road? It's a Different Country.
MHRA procedures differ from FDA procedures, thus, clinicaltrials.gov and .eu can be different.
I hope no one makes investment decisions splitting those differences.
So, Bill, you concur that the primary OS-related (i.e., "THE" gold standard) endpoints were met, right?
Yep! Then why is this poster saying the endpoints were pfs related? FUD!
We know that.... and he knows it too; Hence, my question, WTF?!
LOL Pfizer CEO has Covid. Wait, so it doesn't work ??
Patients being Alive shows our DCVAX vaccine WORKS !! They should buy us. They are loaded with buyout cash.
https://www.cnn.com/2022/08/15/health/pfizer-bourla-covid-positive/index.html
Time for perspective!
XBI up 23% over 5 years.
NWBO up 244% over 5 years.
So we are doing much better than our entire sector.
Disagree. Open Market order of, say, 500,000 shares would jack the price. I have noticed quick 10-15% bumps, quickly taken down of course, on simple 100k orders. So, it would be shrewd to buy the "C" for 'bigger' buyers. Waiting 90 days is nothing with this company's future. (yes, fingers and toes crossed over, lol)(yes, 90 days is nothing to wait for this company, lol, said it for you)
PFS is not even secondary:
Primary Outcome Measures:
1. The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma.
[ Time Frame: Until death ]
Secondary Outcome Measures:
1. The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM.
[ Time Frame: Until death ]
https://clinicaltrials.gov/ct2/show/NCT00045968
I can imagine this is not a good situation for anyone. I assume every time the company throws a birthday party for management and directors, lighting the birthday cake would be considered a fire hazard in most parts of the country.
If you are buying for long-term and a large number of shares, buying the C's makes perfect sense. You get a great price and don't drive up the price with your purchase. It is not for the short term investor or someone who needs access to their funds quickly.
Gary
Agreed, unless an investor is looking for a large allotment and doesn’t feel the need to have the liquidity, open market purchases would make more sense.
Crash, thanks for sharing.
Primary Endpoint is OS.
https://clinicaltrials.gov/ct2/show/NCT00045968?term=dcvax&draw=2&rank=4
Outcome Measures
Go to sections
Primary Outcome Measures :
The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma. [ Time Frame: Until death ]
Secondary Outcome Measures :
The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM. [ Time Frame: Until death ]
I understand your comments and agree, I used the price of $180K based on some old information so I used it as a baseline. Hopefully, the true costs will be evident soon.
Back to update chart but will be away rest of this month. Don't see much action in the interim.
Volatility is again at it's lowest in weeks. The last time this occurred was back in July which staged a brief rally to 82 but didn't find legs. At this time, it could go either way, only time will tell.
Will it retest the 59 lows and rebound (double bottom)? Possible. Just as it was back when it touched 14 over a several month period to form a double bottom.
There is minimal advantage and possible disadvantage to buying the Cs here. The open market may be the better deal if you plan on selling depending on price action.
Roman, the reality is that no one knows what NWBO intends to charge for DCVax-L. The price charged often seems to have no relationship to the price it costs to make it. Granted, most drugs have very expensive production facilities and research costs, but when all of that has been paid back many times over does the price come down. Often it is just the opposite. Look at drugs like insulin, epi-pens etc. Look at all the people who buy Bayers Aspirin rather than the generics, do you think that Bayer couldn't make a healthy profit selling for less than the generics.
I believe that DCVax-L will probably cost more to make than many cancer drugs, but what it will sell for is up to the company and I think that they can be very profitable selling at prices that compete with the competition and their products will prove to be far superior.
Gary
Journal may take 3-6 months for peer review so still possible time to publish given I believe it was submitted around NYAS on 5/10.
I believe they changed the primary endpoint to OS, PFS was secondary.
WTF?! Did you read the trial info or listen to the presentations?! The primary endpoint is based on pfs?! Please stop the bs!
Nwbo has been in the doldrums for well over a decade.
Company lacks a basic timeline.
If the trial had failed based on ex his false claims NWBO would should have disclosed that info ions ago. Unless ofcourse the company is selling Cs now fully aware about this material event.
What, that they are finding their commercial manufacturing and application process? Doesn’t seem like it deflated anything to me. This is August doldrums.
This stock started the year at .70, and went up .07 on the first trading day of the year. We’re at .62 while in the doldrums of August, and after the rest of the market tanked as interest rates have gone up in 2022. Hardly earth shattering.
What price did they offer you?
That would have been the only useful information.
I am guessing like 52 cents as Linda powers is making the next amgen, and that's what amgen would do!!!
Smh
That was a smart decision
Nope, that does not work. My ignore list wipes out about 50% of the post here that are not worth reading, and the share price keeps sinking. There will be zero news here until some made up date in 2023, if then and if the world is not blown up by then.
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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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