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i hope regulatory review doesn't take into account what is provided by shenanigan artists.
Thanks for the feedback. I used to live in DC, when the Metro was fairly well run. Now, the behavior, especially from school kids, is atrocious on the Metro. I would like to attend, but its not really worth the hassle, and I would drive in, but my job is, for no good reason, requiring me to drive to Crystal City twice a week for training I have already had that could be done remotely. I see or are almost in an accident everytime I drive in via the GW Parkway due to the horrible driving of others. But I get the gist of what your saying. Perhaps us longs who are local can one day celebrate in a more convenient setting.
I am quite satisfied with my decision to vote my shares in favor of the board’s recommendations. This past month’s events -the JAMA paper and subsequent presentations have reminded me that they are committed to making DCVAX available to the world. We spent a lot of our time and comments over the last 2 years debating whether NWBO would, indeed deliver results (as DI kept insisting they would). Many doubted the caliber of journal and if even if the company would remain sustainable long enough to make the article happen. It all happened as they said it would and it was grand!
I refuse to buy into the argument that a vote in favor is not appropriate at this point. This is the time that all long shareholders should support the company’s position. I see 500 million shares as a very, very conservative increase. LP and company could have come to us asking for MUCH more. I’m not sure I care if the shares are for a JV or merger or just money to make sure we are manufacturing ready. It’s all good. I can’t wait to see what happens next year (even next month!). Again, it’s all good! Good luck to my fellow longs.
I’m not agreeing or disagreeing with you, but I think the price per share hurdle to get to 15 PPS is not as difficult as you might think. One large push by a few big whales could get this up to six PPS in one day with news. That evening a large pharma could offer 150% premium. Aka 15.00.
The keytruda side effects and potential toxicity was why I didn’t push my mom to try keytruda, opting instead to stop treatments and try to get some months of no treatments/ctscans/side effects before all the metastases would take their toll.
I’ll probably second guess that decision for a long, long time, but the risks of either sudden death, blood counts and infections, pneumonia, etc without hope of significant life extension seemed like a significant risk of shortening and/or degrading the time left.
Had there been more hope that some percentage of people treated would have increased survival with reduced toxicity then we probably would have tried keytruda in that it might not seem so much like playing Russian roulette.
I have no crystal ball into their mindset, nor the hurdles they may face when they look at the costs of commercializing and scaling this technology to tell you for sure that they will do deals. I have no crystal ball to know what timeline they see for expanding the vaccine to other cancers or combinations.
What I can do is look at the proxy statement and make an informed guess.
Time waits for no man or woman and probably some people who would like to see this advance, with much more access to capital, are also aware of the limitations of time:
https://www.sec.gov/Archives/edgar/data/1072379/000110465922122141/tm2231325-1_pre14a.htm
Market has no faith in management. As a long, that pisses me off! Yea, I could sell if I wanted but I’m sure there will be a pump or two remaining to maximize value.
If there was any chance of a JV or buyout, there would be no need for more shares…as everyone overlooks the additional executive comp portion of the 8K!
Let’s hold off on the platitudes until it’s peer reviewed. Right now it’s only the written words of pro-NWBO players. Let’s wait to see how the results stand up to the scrutiny of the oncology world at large. I hope it does but currently the market isn’t impressed.
Without any partner, this is at least a year away from commercialization… it took two years just to announce the trial results.
If "For NWBO the outstanding FTD number is ... under 10k" then I hear you. But if the number of naked shorts are really large as say 500 M to 1 B shares as NWBO seems to think then it seems we have a large problem to deal with. I am hoping that the NWBO lawsuit materializes soon. This might help solve this problem.
I’m not in denial about the process. I simply don’t think that a, this management is super interested in getting out before approval and b, that any big bio would offer the kind of money that we know this platform is worth given the current MC. If we were on Nasdaq and worth 5 billion than sure I could see a deal for 10-15. But we are under 1 billion now and unless they have a trick up their sleeve to magically increase our MC (even though JAMA couldn’t) I just don’t see the timing as right for this type of event. Admittedly I have 0 experience with this side of the equation. I’m relying on my common sense.
Horse,
Is this something like the ARM business model which develops intellectual property in chip developing and licenses to its partners?
I don’t agree that we should be writing blank checks to management. If they want more shares they need to explain why. Remember, we own the company. The science has proven itself, now it’s time for the business side to pick it up and that includes communication with the check writers.
Shouldn’t be too much of an issue if multiple licensing deals, and they all use murcidencel in their combo treatments so everyones successful combo equals murcidencel revenue plus licensing fees.
Of course ALL companies at this stage do a cash raise for the next stage, going from development company to commercial company. And of course they can't be living on fumes to negotiate with potential partners. That doesn't cancel out ANYTHING that has been said about what typically happens at this stage, which is JV, Partnership and buyout offers and that many companies just get bought out at this stage.
Skepticism of the natural development stage of companies like this at this stage is not actually skepticism. It's denial. Some people are just in the stages of denial. The trial was successful. Of course they are going to have those conversations, of course there are going to be potential deals of all kinds offered to them and they will need to decide if they offer advantages or they do not. The key is never to accept a first offer, and whether these offers have been in negotiation for years or moths or just started, they can take some amount of time or not happen.
But the notion that one needs to be skeptical that this would be a reasonable time for deals to materialize, is just denial.
But you do understand that the authorization is just an AUTHORIZTION, not an issuance of 500 million shares, and they were out of shares authorized to continue to maintain the company, so this is also just an ordinary course life cycle event and a necessity for the company to stay in business. But also, at this stage in a company's existence, not having any shares available to do deals with potential partners, is not helpful to negotiations, nor would it be helpful to shareholders who want to see the value of the company's shares increase with such deals and the validation of higher valuation that they typically bring. So facilitating those negotiations and deals is what shareholders who are reasonable, would of course need to do unless they are unfamiliar with such things and are completely clueless.
I’m sorry but I remain cautiously pessimistic about all this BO JV partnership talk. They are low on cash and need more of it to bring approvals in. Why is this not the simplest explanation for the increased share authorization? I REALLY hope that I’m wrong but have not seen any conclusive evidence from management that they don’t want to go it alone.
I still have not decided how I will vote my 960k shares. Without more information about the business side of things I am leaning towards a no. I will try to get in touch with DI to communicate my sentiments to him.
Happy holidays everyone
No, actually it looks like she just googled and wrote a story based on quotes from other articles that were available. I think she doesn't know much about Glioblastoma or the treatment and decided to add "the controversy" because it spiced up her article, not because it's a thoughtful approach to the issues. Presuming Adam Feuerstein is thoughtful is problematic, but this is a problem of the press. Wrong things get repeated over and over again when reporters are not all that inquisitive and post derivative works.
They, nwbo, will find ways to at least partner and get the leverage of their partner’s infrastructure and sales.
When you hold the enabling ingredient and the IP, you are an attractive dance partner
Robot, I have attended their ASMs before and they’re always on a Friday afternoon, though one was Saturday, usually right before Christmas. It’s pretty easy if you tak3 the train in. You get a different feel when you attend because you’re talking directly to Linda, Les, and others. Their direct comments to me have helped me stay positive through these long years. Every time I’ve gone I’ve spent time talking to other investors, some on this board, others I don’t know. It’s always been enlightening. You also see who the management really are, and I’ve liked what I have seen in them.
Whether my husband and I attend will probably depend on weather since we’ll have a long drive, then catch the train into DC. There’s a train stop just a block or so from the office they use, and I think it’s the same one for this year. I’m glad we have the option to attend by Internet, and I may choose to do that.
Either way, I expect it to be rewarding.
"Liked" Grip should educate himself
Thanks for the links to the video and more details, you and Lykiri. Here is stuff I have gathered over the years, plus a link to the SPORE grant.
Yes, the video says that, and there is reference someone gave for the NIH funding.
More definitively was the previous trial record at clinical trials.gov which indicates that there had been a trial scheduled, and it was put on hold for contract negotiations. But a review of so much suggests that that trial is likely to move ahead shortly.
I had written also about some research around the early time I started commenting most here, about UCLA's PR about using DCVax-L with the drug PLX3397, which is a drug that is, in fact, a CSF-1R inhibitor.
https://newsroom.ucla.edu/releases/combination-therapy-for-glioblastoma-shows-promising-results-in-early-stage-research
I do not agree. This was a soft bash as per my previous post.
This is NOT a positive story. It is a soft bash. It leads with "People who got the treatment had double the average survival rate — but the results aren’t as clear as they seem."
Then it continues to quote Donald O’Rourke, a professor of neurosurgery who was in the STAT hit piece by AF with his false conclusion. then it quotes Merit Cudkowicz, the chief of neurology that this was a "post hoc analysis." Finally it concludes that : "To find out, though, Northwest Bio will need more trials, designed in such a way that the results are indisputable.
This is definitely a soft bash - not at all a good article about DCVAX.
The Lady Pamela made reservations for us at the Crown Plaza Crystal City, about 10 minutes from the ASM location, Thursday, leaving Saturday AM, in case anyone wants to dine after the meeting. I think it's possible this will be the last ASM as NWBO, so it could mark the end of an era.
Managed "NWBO" publication was well versed on the JAMA and their publications.
Its very close for me, but I hate rolling into DC, especially on a Friday. Plus, I wonder if they have enough space for all attendees. Thus, I will remote in. Although, it would be cool to share a few beers together after...
Russian exit good for world, good for markets, imo.
JAMA Oncology is prestigious, and they conducted a rigorous review of NWBO.
I’m thinking about attending, Gary. And May bring my husband, who is also invested.
JAMA Oncology is very rigorously peer reviewed.
Once again!
"JAMA Oncology is a member of the JAMA Network family of journals, which includes JAMA, 11 JAMA Network specialty journals, and JAMA Network Open. JAMA Oncology is published online weekly, every Thursday, and in 12 print/online issues a year."
https://www.linkedin.com/showcase/jamaoncology#:~:text=JAMA%20Oncology%20is%20a%20member%20of%20the%20JAMA,Thursday%2C%20and%20in%2012%20print%2Fonline%20issues%20a%20year.
Cut the crap “Voting NO means BK” narrative. For sure LP can find a way to get fundings by selling those C shares and stay afloat.
I don't know about that but thank you Bright Boy. Very kind of you to say.
A couple of quick questions for EX. Question #1) As demonstrated by your posts on this board, how did you get to be so smart/so well informed? and Question #2) Did your parents instill in you, your deep seated sense of social responsibility and social conscience or was it naturally acquired?
Cheers,
BB
Bio,
Thank God you weren't in my debate Section in Constitutional Law class at Stanford !!Heaven couldn't have helped me if you were!!!:):):)
Terrific reply!!!!!
Cheers,
BB
Grip, you should educate yourself on basic shareholder issues, such as the date of the ASM, and perhaps even become a shareholder yourself.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384 NEED TRANSCRIPT, PLEASE.
"i'll be voting yes because, as a shareholder, i don't want to bankrupt the company on the verge of finalizing success."
Bravo! Voting yes seems straightforward answer. LP needs ammo to wrap up the final success. By all means, give it to her.
ATLnsider
Re: Lykiri post# 539443
Sunday, November 27, 2022 4:02:11 PM
Post#
539470
of 539476
Thanks Lykiri, when the questioner asked Dr. Liau about a possible human study that combines DCVax-L + PD-1 + CSF-1R inhibitor, and whether are not UCLA had already done some mouse studies using this, Dr. Liau specifically said the following:
”great question, that is actually our next Spore project, we have a collaboration with BMS on a CSF-1R inhibitor”
Dr. Liau went on to say that “we do have some animals studies that showed a great response”
So, that tells me that the animal / mouse studies have already been completed.
As far as asking about this at the NWBio ASM, I don’t believe that NWBio is part of this collaboration because they are not providing any funding, nor are they producing any of the DCVax-L through CRL. I believe all of the DCVax-L was produced in the UCLA GMP lab on campus. So, I don’t believe Linda Powers will answer any questions related to this study.
However, I do believe that NWBio will be the Sponsor of the Phase III registrational DCVax-L + PD-1 inhibitor + CSF-1R inhibitor combo trial after DCVax-L is approved in the US, Canada, UK, Germany and the rest of the EU.
Bullish
BULLISH
0
Quick question that may clear up other’s preparations as well:
In the event of a new company starting, NWBO dissolves and our shares roll over, what happens to the short shares (whether naked or real, or fully-clothed)?
I understand they have to cover, however, here is my question:
If a ‘squeeze’ happens, and NWBO goes to, let’s say, $20 but the new company IPOs at $8 for an even swap of share count…does this leave us in the position of a decision to sell NWBO at $20/share before the new IPO opens because it has more ‘current’ value than the newer company at $8?
I’d like to see if I/we need to contemplate options of sell points if this is the scenario that may be created.
That’s the undying narrative everytime someone disagrees they have to sell the shares. lol. What’s the point of voting? what’s the point of ASM? If I disagree better sell my shares? what crap is that.
it'd be great if people read the replies to tweets before posting them here as questions.
If you read down further, this is for the renewal of LP and Dr. Malik's 3-year term.
— KnowWhatYouHold (@KnowWhatYouHold) November 27, 2022
when i "hate to say" things, sometimes i just don't and think about them to myself for a bit, in silence. i find this especially important when i don't have any evidence for my assertions...just something i have learned that i wanted to share to another NWBO long
The market will first have to decide if there is going to be intervening news and then how the vote will go.
If you’re right and as your post implies the market prices it in as bad news then I will probably buy a little more and I doubt I’ll be the only one.
Warren Buffet commented a number of years ago that Berkshire votes in support of management’s recommendation because they don’t want to interfere.
If they have a problem with a company/management that’s significant enough they get out of the investment.
Disrupting LP and Company’s plans now would be a self inflicted unforced error, and given what has now been accomplished and that nwbo has identified the remain8ng steps to approvals and executing them, I’m giving nwbo full support knowing their success is our success!
Thanks Lykiri, when the questioner asked Dr. Liau about a possible human study that combines DCVax-L + PD-1 + CSF-1R inhibitor, and whether are not UCLA had already done some mouse studies using this, Dr. Liau specifically said the following:
Dr. Liau went on to say that “we do have some animals studies that showed a great response”
So, that tells me that the animal / mouse studies have already been completed.
As far as asking about this at the NWBio ASM, I don’t believe that NWBio is part of this collaboration because they are not providing any funding, nor are they producing any of the DCVax-L through CRL. I believe all of the DCVax-L was produced in the UCLA GMP lab on campus. So, I don’t believe Linda Powers will answer any questions related to this study.
However, I do believe that NWBio will be the Sponsor of the Phase III registrational DCVax-L + PD-1 inhibitor + CSF-1R inhibitor combo trial after DCVax-L is approved in the US, Canada, UK, Germany and the rest of the EU.
Grip it and Sip It,
Shorts are definitely scrounging for shares so they think this is steak to chew on. If they cook it up right I might take a bite too; ). Best wishes.
martyDg,
Anyone really in for the long haul and for the patients is voting with Linda. Protest vote at this point with no additional news will be observed but powerless. You are along for the ride on this train to the launch pad or you can disembark whenever you wish. Moaning about management doesn’t get this treatment to patients any sooner than “the process” allows for. As one of our other posters has said “don’t do something, just stand there”; ). Best wishes.
If you'd like to dream about how big we could be some day, ask yourself how many Flaskworks units would be needed worldwide if DCVax-L and Direct became part of the SOC for most solid cancers. I think a good assumption to make is that each Flaskworks unit will make about 50 batches a year.
Gary
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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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