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Car-T therapies found to "cause" cancer. https://thehill.com/newsletters/health-care/4425233-fda-warns-of-risks-from-cancer-treatments/
I do not understand the discussions regarding DCVax efficacy. As a 13 year "Long", I have taken the time to personally sit down and talk with Drs. Prins, Liau, and Bosch at different medical conferences. The efficacy of DCVax is not in question.
If you ever listen to Warren Buffet talk about his investments, he talks about the quality of individuals that are behind his investments. The doctors that are behind DCVax have impeccable credentials. These are ethical individuals. Having lost a step child at 14 to GBM and personally witnessed the horrible QOL that Temodar (Temodal in Europe) and radiation created in his final days at home, I searched for answers.
DC Vax works now, under present constraints. By constraints I mean that every individual in all 3 phases of the trial had to undergo existing SOC. Anyone who has witnessed the "treatments" of Temodar and radiation knows that the body's immune system is devastated. DCVax works with the body's immune system to fight GBM. (And many other cancers) If those bodies were not being forced to undergo today's SOC, I logically postulate that DCVax's efficacy will increase as the body's immune system, in its normal state, alerted by DCVax, will increase the lifespan beyond the limits seen in our trials.
As for our President Linda Powers and our V.P. Les Goldman, I personally have complete trust and admiration. Linda does not personally need the potential wealth to be gained from DCVax. She and her husband have been successful in their previous business and government involvements.
As for Les, I will never forget that in our dark days, when payroll was an issue, he personally reached into his pocket for payroll and lent the company $100,000.
We are being led by a group of talented individuals. I am betting on them.
In a conversation some years back, I remember a statement from LP at one of the conferences I was attending. She was upset at the time. She mentioned that SOC was "weakening everything". She would not elaborate more deeply. The context was a postulated "what if" DCVax testing was done without the requirement that subjects undergo QOL lowering SOC prior to entering trials. I have always believed that the mechanisms of DCVax benefit from an immune system that is not under attack from the impact of chemicals and radiation.
Once we get through this first hurdle I believe that our patents will then be put into use against many other human maladies. The premise of DCVax, "identifying", "illuminating", "enhancing " and then "targeting" the elements of human misery with enhanced natural defenses can be applied to any event where the body has a natural response mechanism.
NWBO is the real deal with first rate science led by Bosch, Liau, and dozens more. If you have ever met the people on the science side of the NWBO project you would know that individuals of this caliber would not waste their time.
Stay long. Support the staff at NWBO. Buy when you are able. Wait patiently.
I could not agree more.
The Linda-Lindas know the cards they are holding. DC-Vax has always been a "platform" methodology for treating a number of tumors. I would be very surprised if Linda #1 accepted a buyout. The team is mature, not old. NWBO has always been the tightest of ships. They will bring on personnel as needed and as funds allow.
Vator - This has been a long wait, but not as long as I stated.(I counted wrong) 9 years and waiting. This investment has required patience. What kept me in it were the people as much as the science. I also liked that Linda and Les ran a tite ship with staffing and expenses. I never felt that they were wasting the stock holders money. I thought they have done well in a situation where they had to stand against the prevaling winds of Big Pharma, Adam Feuerstein, and a phase III test that required the participants to have taken SOC. I have always believed that SOC worked against the body's immune system and therefore was counter to the biological effects of DCVax. Having seen what SOC does to the human body, If I were ever in the situation requiring treatment for GBM, I would choose to take my chances with DCVax and if operable, a quality surgeon.
Linda Powers and hubby are worth about 300 million, not counting their NWBO stake. One of the reasons I am still here, after 14 years, is that she could do anything she wanted with that level of wealth. She chose to get behind NWBO, and stay throughout all the difficult years. When you add in Les Goldman and his integrity and experience, I have never questioned NWBO'S direction and ethics. From the science side, the impeccable credibility of Doctors Liau, Bosch, Subbiah, Ashkan, and a dozen other preeminent researchers, told me to stay and add to my position over the years.
Some of you may remember me from years ago. I got involved with NWBO 9 years ago after losing a 12 year old to GBM. The worst of it was the horrific effects of SOC on a young body. If I had it to do over again I would never recommend SOC. I'm a believer in NWBO and the QOL that an afflicted patient obtains from the relatively mild side affects of our treatment. I also am a ardent supporter of management. Over the years I have talked to Dr. Liau, Dr. Bosch, Les, Linda and several of the leading researchers behind the DCVax-L trials. Every person I have met with that has been involved in the development of the family of NWBO treatments has been a person of integrity. In 9 years I have never seen any researcher or member of management try to hype this stock. There is no "flim-flam" here. No squandering of our capital on personal luxuries. We are in good company with people I trust.
It was a difficult day from the investment side. I bought 6700 more shares after the price tanked. NWBO has never been an investment for the faint of heart.
I suggest we all read "Smith on Stocks" analysis of the NWBO results. It will calm your souls.
Presentation at the New York Academy of Sciences on Final Results of DCVax-L Phase 3 Trial Showing Impressive Efficacy (Part 2)
POSTED by LARRY SMITH on MAY 10, 2022 • (0)
Earlier today, I put out the first of a series of reports that I plan to issue on this presentation. As I write this, the stock is down over $1.00 even through the results were extremely, extremely impressive. The presenter of the paper stated that DCVax-L represented the first major advance in treating glioblastoma (GBM) since the approval of temozolomide 17 years ago. Audience participants agreed with this statement and so do I.
To my amazement and probably any objective person listening to the presentation, the stock was hit with an enormous amount of shorting, probably most of which was illegal. Hedge funds usually have paid bloggers who put out negative information that seemingly justifies this price behavior. The latter are stating that the trial failed because it was not statistically significant on the median progression free survival endpoint and that regulatory agencies will not accept historical controls for the control arm. In my earlier report, I intended and I believe I succeeded in debunking these arguments.
Now I will go through the actual data that was presented at the New York Academy of Sciences which is shown on this link. My approach will be to refer to pages in the slide deck that was presented today. You can follow along to see my comments on certain pages. This is my first brush and I will follow with more comments in later reports. The key findings of the trial were as follows; these results are far beyond impressive.:
Note that Kaplan Meier analysis showed that DCVax- met the median overall survival endpoint in newly diagnosed GBM with a strong p value of less than .002. In recurrent GBM, DCVax-L met the median overall survival endpoint with a p value of less than .001. Remember p less than .05 is usually required for approval. DCVax-L blew the doors off on these endpoints.
The survival tail in ndGBM showed 13.0% of patients alive at five years versus 5.7% in control group. This is every bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, cancers which are roughly equivalent to glioblastoma in terms of survival. Note that it was the demonstration of the survival tail that made Merck’s Keytruda and Bristol-Myers Opdivo multi-billion drugs.
The survival tail for DCVax-L in recurrent GBM showed that at 39 months 11.1% of GBM patients were alive versus 5.1% in the control arm.
Page 10
Median progression free survival was not the primary endpoint in the trial so before the trial was unblinded, overall survival was designated as the primary endpoint. Obviously median overall survival is the gold standard end point for any oncology trial.
Pages 12, 13
Cross over design of the trial required the use of results from the control arm of GBM trials that ran concurrently with the DCVax-L trial. Fortuitously, this allowed for the trial to show median overall survival in both newly diagnosed and recurrent GBM.
Pages 13 to 21
The methodology employed to determine results in control groups from other GBN trial that ran concurrently. Note on page 13 that this was done by an independent expert firm (not Northwest) that selected the most closely matched patient populations using 14 criteria: i.e. contemporaneous, same patient population, same SOC, RCT design, etc.
Page 23
The study achieved statistical significance on the primary endpoint of median overall survival in both newly diagnosed and recurrent GBM.
Page 24
Key data points showing results for DCVax-L versus historical control arm.
Page 29
Kaplan Meier analysis shows that DCVax-L met median overall survival endpoint in newly diagnosed GBM with a strong p value of less than .002.
Page 30
Survival tail in ndGBM showed 13.0% of patients alive at five years versus 5.7% in control group. This is ever bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, cancers which are roughly equivalent to glioblastoma in terms of survival.
Page 39
Kaplan Meier analysis shows that DCVax-L met median overall survival endpoint in newly diagnosed GBM with a strong p value of less than .002.
Had you taken the time to get to know any of the management, staff and researchers behind DC- Vax, you might have something much different, and of more value to share in your commentary. I have taken the time, I have spoken with management, staff, Dr. Liau and the other researchers. I have watched and invested in this company for over 5 years. I have not seen another group of individuals to match the small, dedicated team we have. I bet on people, not just technology. NWBO will come through. I hope they get the opportunity to bring DC-Vax to market for childhood brain tumors. The QOL is unmatched compared to the torturous methods of SOC. But again, you would have to have the experience that I have had to understand what this means.
Senti - After I read your post I had an "Aha" moment.
Senti - This matches my take on the PR, exactly.
Even without Linda "seeing" the data, it is evident that She now knows, through basic calculation, that the trial has met it's endpoint, by a substantial margin. Germany will move first, hence the discussions. Note that the stoppage of screening was predicated on the discussions taking place. What could be the reason for discussions? I only see two. One - to change the protocol, due to a substantial "finding" from the trial, ethically requiring a protocol mod. (Good news) or discussions about formal approval where the data is so substantial that it would be unethical to give enrollees a placebo. (Good news)
Beach - Good point. The preciseness of word choice does matter.
Looks like the PR confirmed my statement. Keep your cool. Add if you can. We move forward, unfortunantly, at an uneven pace.
In for a penny . . . in for a pound.
I could not resist in taking advantage (I hope) of the freefall. When it dropped below $7. my judgement forced me to act. I believe that there is no reason to have panicked here. I believe that the worst possible news here is that a prelude has begun to approval in Germany. This has nothing to do with "availability" of funds (Linda could, and I believe would, write that check if it was necessary.) It is most likely a change in protocol, that coincides with discussions on a halt for efficacy.
I have placed my trust in "our team" for these several years, and continue to do so. I put my money where my DD is and bought 12,000 shares today, under $7.
Why is RLGT tanking? Details, please.
RK - You have earned the title, "Goddess of the NWBIO Universe".
I have been thinking about DCVAX for pediatric GBM. There is evidence of younger patients having a stronger, more adaptive, immune system than the elderly. I believe it would be a worthwhile endeavor to test DCVAX for pediatric GBM. Does anyone know of a way to calculate the size of a proper Phase 1 trial and what the costs might be? I understand that NWBIO could not justify (economically) such an undertaking, but a fully funded, charitable effort might be possible. There is bound to be significant cost savings by capitalizing on the existing trial framework. SOC for pediatric GBM4 wreaks havoc on children's bodies and QOL. DCVAX, if available, would offer alot of hope to those afflicted.
Sir Flip - Very timely of you to bring this back up. Linda clearly understood the mathematics of approval. She has put us in the proper position to win. She has funded us to the point of being able to obtain independent sources of funding. Wisely, she prepositioned the design and development of manufacturing having identified it, correctly, as a possible point of failure within the approval process. The company's relationships within the research and science of immunotherapy are the best in class. The international/political part of bringing out the product in Europe are in place. We appear only unpositioned, for now, in Asia.
The rest is out of her hands. If the science works within the parameters of the trial, Boynton, Bosch and Linda Liau will share a Nobel prize in medicine and Linda will become one of the richest most powerful women, on the planet. If the science within our trial is somehow ill constructed, we will crash hard financially, but will have paved the way for further, future exploration by others.
As I see things, the most important step would be to obtain a joint trial with a megapharma. That would propel us past $50/sh and deleveridge the trial from an investment standpoint. Each day, unfortunantly, can bring news of either success or failure. This represents the ultimate in volitility as we wait for "our science", as constructed, to prove itself.
Does anyone know if the September options pop out on Monday?
Why September event in UK is important? It is likely that DCVAX-L will be added to the UK's £340 million Cancer Fund approved drug list for 2016.
It will be identified as a "Primary Adjuvant Therapy" for GBM. It's launch has been planned for since 2014.
http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4815
See also, page 42 of this document (Google it):
Prescribing Outlook - New Medicines 2014 - UKMi
Steppenwolfie - Saw clear sign today. I bought $5 warrants (Dec. 31, 2017) for $.20 cents/sh cheaper than the $5 Leaps (Jan. 20, 2017) I sold to pay for them. There is only one answer to the above. Someone needs cash. Notice that the $1.10 premium, that held for months, is gone on the warrants?
Truly outstanding work Senti. Your analysis is revolutory and perhaps some of the best analysis done on this board. A major contribution to the board. It is not often that we get true "answers" to the questions postulated from the bits and pieces of data. You have added a significant piece to the puzzle of analysis. Please post this on YMB and iVillage.
Interesting trial history from DCVAX Phase 2 participant that progressed and is alive 2 years later. Now being added to "compassionate use" arm.
Fund Manager says NWBO worth $2 Billion, now. Branko Krstevski, a Top-Ranked Fund Manager at Marketocracy.com, that specializes in Biotechnology and Medical stocks (US & Australian market), is excited about NWBO'S prospects.
Thank you, Hodge, for setting the record straight. It has been a different journey for those that have been fighting for their life or the life of a loved one. To be invested here is one thing, to be part of the actual trials is something else, entirely. Those that have never faced the beast of Cancer can not understand the mental and physical energy that is consumed in each day's fight to simply make a little progress. Your words carry the true weight of the experience. I hope that as your journey continues, the struggle is eased and that the possibilites of Phase 2 brings you and your wife further toward a successful outcome.
Afford - you amaze me. You are truly either the smartest or luckiest NWBO investor that I have had the pleasure of meeting on this board. 23k shares . . . Long, and you are the biggest skeptic. I just have to smile. Whatever you lost in the past, is about to be made up for here. Pyrrhonian, was, as his name implies, a complete believer in whatever side he believed in, at that moment. NWBO will turn out to be much simpler than all the technical examination he (and us) applied to it.
The area I have the greatest difficulty is your judgement on our management. I am 180°degrees from you. I find them "open" when they can or need to be, strong defenders of the retail investor, and when I have talked with several employees, they were truly appreciative of NWBO's retail "longs". I like how Linda and Les "punch back" when someone wrongly attacks the stock. I like her investment insight, planning and her willingness to back her idea with millions of her dollars. Personally, "I'll sell, when Linda sells."
Gee, I guess we're "A-OK", according to Adam F'stains Market Capitalization rules for Biotech . . .
Sir Jack - You are our "eyes" over there. If you could take a picture or two it would be much appreciated.
I think they are going to lose a lot of money. The only thing that could bring us down to those puts being worth anything is a well planned, thorough hit piece that actually had some truth or a well placed cruise missle.
Jack - Nice find on the "need to invest in Immunotherapy" quote by the Brits' NHS. Gee, I wonder what immunotherapy was chosen by the Brits' Promising Innovative Medicines scheme as their very first drug? Oh, yeah, that's right . . . DCVax!
I've read through the budgeting notes that identify integration of DCVAX into the British medical system. It is planned to begin in 2016. I could not determine the month as that level of detail was not provided.
I can not see how it is ethically feasible to have a "placebo-based" control in the later phases of DCVax-Direct testing. We are going to ask one out of three people, with stage 4 cancer, to "please come into the office for your tumor injection" of what, a "grapefruit juice-saline solution"? That is a death sentence. A crossover would also be pointless. Is there an ethical protocol here?
For those of you that must know . .
I am the walrus. Cookoo cachu.
At this point, in order for Pyrr to be correct, Linda Powers, Les Goldman, Drs. Boynton, Bosch, Subiah, et al, Liau, Prins, and another 80 or so are in a "Rosemay's Baby" type consort.
I think not.
Pure price manipulation at the close. 3:55 P.M. + $.15: Demand jumped and the price moved up then got walked down continuously as volume jumped. Price went erratic until dropping at 3:59, then 220,000 shares swapped hands in seconds.
This could only be tried in the U.S. if DCVAX we're to be designated a "first line" therapy. The FDA requires that the SOC be administered prior to any treatment that is in a trial. I believe that existing SOC, as currently administered, would likely hamper the patient's outcome if they were getting DCVAX after a post resection Hyperthermia treatment. From what I see, SOC (Radiation + Chemo) should be contraindicated with immunotherapy. The FDA has not reached that same conclusion. If DCVax survives it's present SOC required trial, we will someday get the chance to see what it does with less damaging adjuvants. I expect that would occur in Europe and be scheduled post 2022.
This is the treatment that I believe holds the greatest promise at this time. In combination with a trial-proven, FDA approved, DCVax, Hyperthermia holds the greatest potential to mitigate Cancer's growth, or produce remission while enabling the highest level of QOL. The body's immune system is left intact, which should help DCVAX promote it's Dendritic Cells more efficiently.
Map- I have been the buyer of a good number of those Leaps. I just cannot understand the willingness of the seller to assume such enormous risk . . . for a maximum 6% return for 19 months? What circumstances would provide such motivation? I could not justify their short play unless they had "certainty", as in 100% certainty. Even then, why play for such small potential return?
Eagle- Perhaps you could explain the motivation of the seller of these 2017 Leaps? Particularly, the January '17 $5's. The premium amounts to 6% for 19 months! The potential loss is enormous compared to the miniscule premium. I don't get it.
If this were equivalent to a horse race, the seller is taking some unusually long odds.
Anything to the coincidence that IMUC is speaking just before NWBIO? I do intend to listen to their presentation as well. Price should stay within a few cents of where it is until the webcast factors in. Then we will get a move.
IC - Smell the coffee. I'm an editor. Also picked this up from "a source". The styles are clearly the same. He is also using another "skin", occasionally, on YMB.