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Broke .62, which has held at least 4 times in the past several months. Need buying or this could be an ugly day.
More deception
"It takes at least a year for NWBO to get to an possible approval. Will take at least 6 months to prep an application, 2 months to for FDA to decide if they accept the application and them from 6 -10 month to review the application for approval consideration. That's deep into 2023."
There is a high probability that the MHRA is close to approval based on the fact that they already approved simple manufacturing process at Advent, UK, late last year. Any assessment of the FDA is based on yur opinion with smoke and mirrors.
"DCVax-L will be way too expensive to be SoC and payers' control what happens. Chemo will never be close to the cost of full customized immunotherapy. Just look at CAR-T."
There is no was that DCVax-L will cost more than current SOC chemo poison.
My research indicates that DCVax-L could be used on solid tumors hopefully breast cancer. The average costs for breast cancer are estimated to costs approximately $1.6 million and, in some cases, 3X this amount, as more aggressive breast cancer is being detected. DCVax-L cost estimations are $180,000, but additional research using the Flaskworks devices may in fact reduce the costs of DCVax-L as by a factor of 20% or more.
"Doubtful this trial will be sufficient for approval in the states. A totally manipulated trial , tossing out failed primary endpoint and redoing the protocol, endpoints, comparator and SAP post hoc. FDA hates manipulated trials and this is a doozy. The add confounded naive OS data and small. first time recurrent OS arm. Nothing smells right. That's why the investment community ain't buying it - NWBO down >50% in the last 52 weeks and AFTER the TLD."
Again, personal opinions are not founded on the truth of the matter.
Get off the PFS bandwagon as the OS "gold standard" prevails with NWBO.
NWBO stock was down after 5/10 based lies, deception, and MM action. Only 8% of the total stock was affected. Interesting that the false information was in fact redacted after the real data was validated and both media sources had to remove their false statements. People can spin their negative bias, but the truth of the matter is DCVax-L works and will in fact be able help save lives, and that is the bottom line.
650k puked out so far, the monster puke is coming.
Go linda, dilute away!!!
The only speculation that the bears can raise at this point is that the FDA may not go for the ECAs. The January 2022 FDA paper in the AOO on the ECAs makes it abundantly clear of their criteria on the ECAs for acceptance in such trials. The rest of the issues being raised are of zero consequence.
Wrong! It was sponsored by Innovate UK which is a UK government initiative. Advent going to Canada had nothing to do with expansion into Canada but actually learning from innovations Canadians made in Toronto and Vancouver!
We have pretty much the data and it is outstanding. There is no other therapy that is more efficacious against the non-IDH-mutant GBM. So, the issues in your post are irrelevant.
30 minues in, vol = 50% entire day, based on 10 day avg volume.
They are working hard to knock this below the .62 support. Could be a flash crash if it doesn't hold.
Yes indeed, plus the fact that there are many doctors who are also excited about the OS results, and they are looking forward to NWBO helping the cancer patients that are the ones that are in need.
Secondary endpoints. Not primary. We haven't seen the secondary end points results yet.
LOL, it was a conference. standard for professionals to attend these
Based on the original or revised endpoints? I thought the new SAP covers that and the crossover and pseudoprogression cover even the original endpoints based on the data?
what?! The primary is OS. NWBO has no problem here as they can show beating hearts at 5 years. This has nothing to do with PFS.
Yes the event was for them to make contacts into Canada so the next step would be to venture into Canada
LP knows how to build manufacturing plants and with the sale of Cognant make money on the sales that Nwbo has paid for and recieved little to what it paid for.
Poeple, Canda/Advent was JUNE 23-ish.. Gosh
https://www.adventbio.uk/post/innovate-uk-s-global-business-innovation-programme-to-canada
"We were delighted to be part of Innovate UK's Global Business Innovation Programme to Canada focusing on Biomanufacturing of Advanced Therapies. "
And Kristyn Power was not there.
Absolute nonsense. Our understanding of science evolved. PFS was no longer a good indicator and OS was the gold standard. Before being unblinded to the data NWBO swapped to OS, the gold standard. Regulators will love it. Hard to argue beating hearts.
That's a positive, nwbo gets their money and Linda can start trial on direct as she knows lysate is 50/50 in uk.
I'd refer back to the October 2020 PR for answers. We are still waiting on the JA.
waiting for your $15 end of year price target as well!
My guess is the first and second secondary ends points are problematic as they are both based on pfs. They need a presentation in a prestigious journal to explain those results. It has been speculated here that nwbo failed at least one of those end points. It's possible they failed both.
It’s coming you don’t want to buy this… hold and watch at best
The event was to gather experiences from professionals in Canada. If you don't want Advent staff to get feedback which could benefit the quality of our own product well I am glad you don't work at our CDMO!
They had no choice they were failing PFS and winning in OS and had to change the SAP and get it approved
Probably never but once you embrace the mantra that LP is the smartest CEO in the world, the suppressed stock price is just an illusion and we can’t PR because of the embargo on the phantom journal publication, everything will make sense.
Then you’ll hear:
Sell your shares
You don’t know what you’re talking about
Everything is on plan
Totally derisked
Then you look at the trends and current price of $.62 and proceed to shake your head! Hope that helps
Why aren't they sharing that info then? Where is our PR? Where is the Journal? This is beyond ridiculous.
are you able to provide an example of a GBM treatment with actual 5 year data of beating hearts ala the DCVax-L trial?!
lol! professionals go to conferences all the time.
Can anyone provide scenario where a biotech with a completed phase 3 trial waited 2 years to PR topline results?
Why waste the staff time unless it about manufacturing and possibility of another plant. No matter which way you spin it is all about manufacturing
This staff is not proficient in restaurants.
I totally agree with you Crash. I know of several large NWBO holders that never post here or anywhere for that matter, But they know of Flipper & reads his posts.
Flippers making hugely supportive/informative contribution here but once in a long while he allows frustrations to be expressed in a post like the one you referring to..
Fantastic days are coming IMO...
VERY LONG NWBO!!
I brought up the PPA a number of times here and nobody cared about it. I'd bet you anything this Washington centered management has put plenty of effort into moving it along.
Seems to me, like much of the rest of our government these days, the usual FDA / SEC circuit breakers are being disabled as the agencies are running woke. That "FUD" article someone posted yesterday was a perfect example of a woke tactic to push almost anything through. Just imagine a law firm trying to shut down skeptical opinion on an OTC company...Even individual skepticism. Has anyone seen the SEC warning language on OTC stocks? We'll see how long it stays up. Lol.
So, in conclusion, I wouldn't be shocked to see DCVAX get approved in some capacity, but for wrong reasons. Investors should know who holds shares in all of these OTC companies. Shine that light!
I have to believe that management are aware of their legal rights and will do everything possible to protect shareholder value. AACR retraction was only the beginning in my opinion.
Networking event with others in the field.
If Murthy or Powers go to Boston that doesn't mean we are opening a facility in Boston!
https://www.adventbio.uk/post/innovate-uk-s-global-business-innovation-programme-to-canada
Confounding after a highly successful P3 trial is an impossible task.
As Dr. Steven Toms, one of the P3 clinicians tweeted to someone on Twitter - "I see the pathological lying about the data continues. Before I head to surgery I was wondering if you had the dignity or data to reply to my earlier challenges to your lies. Waiting for a cogent response to why anyone would care about PFS in immune therapy"
The data is outstanding. It will eventually result in approvals by the RAs.
lol, Advent going to a meeting in Canada is not the same thing as setting up a manufacturing facility there. complete nonsense.
I totally agree. She looking at worldwide dominance. Instead of building 1 manufacturing plant and getting Dcvax approved and working from there and using money from approval to expand. LP is building again another manufacturing in Canada setting back Approval for Dcvax and using investor as a bank.. That is why all the BS from the board on approvals. I bet she has not filed the MAA and keeping the PP lows keeps investors trapped in the stock
You have not provided any evidence to support the rumor you created that Advent are starting production in Canada. The only thing that mentions Canada on their website was a networking event which hardly translates to a production facility. Given the longstanding criticisms of Cognate, creating this type of rumor only misleads the thousands of people who follow you closely in this forum. You may not take this responsibility seriously but you should in my opinion given the positive impact DCVax will have for millions of cancer patients.
Absolutely a correct assumption BobLob. Based on history you can’t ignore the obvious. And like sands thru the hour glass, so are the days of our lives
FDA doesn't explain a thing . It is up to the company to explain what the halt was about.
More nonsense. Advent has met every single timeline. No reason to doubt the commercial mfg cert timeline.
Have a good one Bobber.
- TS
Very much agreed.
NWBO Boom is coming & no one can stop that...
VERY LONG NWBO!!
Ok, I will bite.
It is in quotes. Anyone important say or write it?
We aren’t getting a damn thing Q3 and unlikely all yr. 250million 60 cent offering is the primary clue why
"DCVAX Approval for MGMT Methylated Tumors Irrespective of Tumor Location" proposed?
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Moderators flipper44 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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