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Danish Dude, This is an amazing post of information.
AngeloFoca, Thanks for that info.
I believe we need to view the potential market of DCVax differently from other drugs that are typically limited in terms of label expansion and off label use due to their toxicity and that they generally are only for treating sub-segments of a cancer.
Also the difference between a stage 3 brain tumor and stage 4 is just the extent of spreading in the brain. From an oncologist/patient's perspective they both require aggressive treatment.
This is where DCVax-L fits in. Because it will be approved as replacing the current SOC treatment, is non-toxic, and is a vaccine, the dynamics of off-label use will be very different and much more expansive than other cancer drugs. So I look at the potential realizable market for DCVax-L in brain tumors much more broadly. I believe they potentially will capture the entire cancer type, including the early stage benign brain tumors.
It seems to be the natural course, as it is a broad spectrum cancer vaccine, is non-toxic, and creates a more robust immune memory to fight against cancer recurrence. Everybody will demand it. DCVax changes everything.
Having storage capacity for 3M doses should be welcomed, ie usually would not bother people because more capacity is better.
Scenario that 3M dose storage capacity covers:
15K patients per year X 20 doses per patient X 10 years = 3M
Inquirig, I see you are automatically posting a negative reply to many serious and honest posters. I simply ignore you and folks like you, but it is still harassment overall.
Just a message to other posters to ignore these folks and not hold back from posting.
Hyperopia, Here's a possible scenario I came up with for Sawston to handle at least 12K to 15K patients per year. Your thoughts on if this is in the ballpark would be appreciated.
Model of Sawston Mfg Facility
% of totalSq Ft
- Cleanroom/mfg suite 35% 30,921
- QC, Release Testing 15% 13,252
- Cryo cold storage 10% 8,835
- Other, R&D labs 15% 13,252
- Offices, warehouse, etc 25% 22,086
- Total Sawston facility 100% 88,345
- # of Mfg Suites: 28 (28 X 2,200 sq ft = 30,800 sq ft, at 100% capacity)
- Sq ft per mfg suite: 2,200 (2 suites "occupying approximately 4,400 square feet on the ground floor")
- # of Eden systems per suite: 1 (Automolous datapoint: typical cleanroom 100 meter sq (1,100 sq ft) fits 30 digitized workstations)
- # of cartridges per Eden system: 12 (NWBO 2/6/24 press release: "multiple patients (potentially up to a dozen or so)")
- 8 days mfg process, # turns/mo: 3.75 ("manufacturing process today… about eight days for - DCVax-L", 30 days divided by 8 hrs/day)
- Total patients per month: 1,260
- Equals capacity for 15,120 patients per year
Beachhyena,
Exactly. There may be 12K brain tumor patients, but that is only a segment, ie only newly diagnosed brain tumor patients in the UK per year. If USA stats are proportional, there is a 10.6X ratio of patients living with brain tumor to the newly diagnosed per year number. With DCVax-L approval being a watershed moment, the main goal of every patient with a brain tumor will be to try and get treatment.
My speculation of DCVax-L price in the UK is $200K (between $150K to $300K). If there is a pay by injection sales model to accommodate prophylactic use for lesser stage brain tumors and to make this more practical and affordable for insurance purposes, the fully extrapolated price would be closer to $300K.
Once UK is approved, the odds for approval by Canada, USA, Germany/EU/EMA, and ultimately globally, should increase near 99%. My thinking is the early year(s) valuation multiple of sales should also be much higher (to also reflect the unicorn company growth potential), maybe 12 initially.
The USA brain tumor realizable market is over 7X larger than the UK one. With Germany/EU/EMA and Canada, NWBO is amazingly for a small biotech already global. I would think the rest of the world would quickly open up their insurance and markets as well.
Sharpie, This is very encouraging. Thanks for sharing!!!
Yes that one is bashing but seems to be for the purpose to harass retail investors and discourage people from posting and sharing.
CrashOverride, Ready.
Last year was tough. Mining equipment hit rock bottom. The outlook for fluorescent tubing was dim. NWBO’s stock price saw continued manipulation. For those in raisins, the market dried up. All this, while diapers remained unchanged, and every single day toilet paper touched new bottoms.
But everything is about to change. Escalators are on a steady incline. Elevators should follow and go up. Helium is rising on light trading. DCVax-L gets MHRA approval anytime now. That introduces “vaccine” into the cancer drug world. It also makes history and takes today’s cancer therapy into the 21st century real world. The nature of the doctor-patient-cancer-therapy relationship is about to change from managing toxicity to optimizing for curing cancer.
This begs the question, what happens when an unstoppable force (DCVax) meets an unmovable object (Shorts)? Shorts cover and provide fuel for the expansion of DCVax. Shorts become a blip. Retail doesn't look back.
That's an interesting thought, but I think the big picture is the large bulk of shares are held by longs who are long term investors and understand the unicorn nature of NWBO and will not be tricked by penny moves here and there. I talked about it in post 680988.
Very good points.
Possibly their thinking is a lower price today will translate to a lower buyout price, if that were to happen.
Shorts short to keep the price down, so their mark-to-market naked/legal short liabilities don't blow up in their face. It will blow up on them regardless, very soon, and upon approval, but the shorts are trying to manage that. That is the basic premise. Your response of why shorts would continue to short and statements that they do short as defying logic seems to be an insincere response.
But I do understand why shorts would not want the shorting topic to go on right before MHRA approval. It is because that opens up the awareness and possibility for a major short squeeze to happen. That is the short's worse fear. That fear was also my response to the original question of "Why would they be keeping price down for a buyout?" To be clear though and as a long investor, shorting is a secondary or third level matter of importance as well, as MHRA approval and adoption are the key drivers going forward.
When shorts are continuing to short, they are by definition not covering. In the situation of approval being days to weeks away, they are digging a deeper hole. When intrinisic value continually grows, to manipulate the price lower, it requires a continually significantly larger quantity of shorting. That is why I believe over the years, their naked/legal short position has grown to become a very large position, maybe a "too big a naked-short position to cover". That is my speculation.
Yes, they could have covered years ago. They could have also decided not to short a unicorn company that provides the foundation of curing cancer, but they did not.
Eagle8, Same here, feeling very good. Shorts have a closing window on manipulating stock price. The more they manipulate, the bigger the coming reversal and price discovery will be. NWBO's intrinsic value is landmark, game-changing, and substantive, enduring. Soon, we get approval. On the other side, the landscape and conversation changes dramatically. The shorts will be on one knee and the activity will be mostly replaced by institutional buying. We just have to know what we are holding and know what we are doing, unicorn company investing. IMHO.
Hankmanhub, This is my layman’s thinking on why DCVax can potentially use “non-self” cancer or viral antigens and still be substantially non-toxic.
DCVax-L process
- target (malignant epitopes from tumor lysate, antigen)
- dendritic cell (leukapheresis)
- education, maturation
- equals DCVax-L
DCVax-L as a best therapy
- both the target and drug/vaccine are from self
- 100% personalized, non-toxic, most efficacious
- Equals a 100% match between target and actual cancer
DCVax as a (potential vaccine) immunization against a set of cancer antigens
- The dendritic cell has to be from self. Otherwise the immune system would destroy it upon entry
- The target can be off-the-shelf (a bank of epitopes/antigens).
- The education and maturation of the DC with target epitopes has to be done outside of the body (DCVax manufacturing process).
- Once matured, DCVax should not create an immune reaction. Why? Because these “non-self” epitopes would being carried by the DC. They get a free pass. After all, that is the job of DCs, to carry "non-self" and malignant epitopes to the lymph nodes for presentation and to activate an immune response.
- That process would then result in unique memory T cells and B cells becoming activated, one for each of the malignant epitopes, ie the immunization against a set of cancer antigens.
I would also refer to Doclee’s post here.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174000850
Gary,
Yes good change is coming, these clinical trial things like real world evidence and external control arms are all really overdue.
And needed change: today's cancer drug don't cure the underlying cancer but should.
DCVax (vaccine) brings forward a more robust immune memory, and that is the foundation for curing cancer.
And that will drive the evolution of a doctor's role from one of balancing a drug's efficacy-against-toxicity to one of optimizing therapy, vaccine, and quality of life.
And more change, DCVax's continual innovation into other potential applications:
- A vaccine against some late-stage cancers (therapy)
- A vaccine against some early-stage cancers (therapy, prophylactic)
- A broad-spectrum cancer vaccine for all solid tumors (therapy, prophylactic)
- A modular therapy (to optimize and cure, DCVax as base later, add adjuvants from a menu)
- A personalized cancer vaccine (immunization against a set of cancer antigens)
- A personalized anti-viral vaccine (a therapy for chronic viral conditions like long-covid, herpes, HIV)
Eagle8, Yes lots of desperation.
Chiocca, who advises competitor companies researching GBM, resorts to misrepresenting DCVax on a podcast.
Naked shorts, who potentially hold a massive inventory of mark-to-market naked/legal shorted shares, cannot cover otherwise NWBO price surges, resort to continual shorting.
For a regular tsunami, a sign that it is approaching the shoreline is the water may recede from the coast and expose a bit of the ocean floor.
For a financial tsunami, a sign that approval is coming is the FUD, lies, and shorting may increase and expose a bit of their desperation.
Doc Logic, Inciteful and makes sense.
Joeycav11, Very good point. Long tail survival is what matters most to cancer patients. What's the difference between a 12X increase in GBM cancer survival 5 years post-treatment and cancer cure? It may become hard to distinguish, maybe 3 years later we see that substantially 60% survival applies to 8 years as well.
Hope4patients, I definitely agree, as MM fud posters have incentivized me to buy extra shares many times too. Investing here has turned into 360 degree investing: wealth building, unicorn company investing, for the patients, for a better way of medicine, to be a part of history as NWBO goes on to cure cancer, and now also to root for financial karma (NWBO lawsuit, buying shares knowing MM will have to pay multiple 10X's to cover).
XenaLives, Also I try to summarize DCVax-L and immune memory fitting in, on a post of mine 676900.
XenaLives, Yes. Really critical. Here is where the immune memory derived from DCVax-L is talked about, by Dr. Marnix Bosch ASCO, June 3, 2023. See the Proteomics Analyses - Observations section at 12:19 mark.
The healing force is within you. Best!!!
Evanstony, Very well said. This is like "a picture is worth a thousand words" and encapsulates the essence of a 100 things many of us share.
To counter the Short’s continual manipulation, I wanted to share my belief that NWBO’s intrinsic value is worth at least $10/share today at this pre-approval stage from an “at least” perspective. Here is my thinking.
Complexity
It is similar to early investors trying to figure out what Amazon was worth, and year after year “suddenly realizing” it was worth more.
- A new kind of book selling company,
- wait, it is e-commerce,
- wait, it is massive customer driven data personalization,
- wait, it is massive logistics and supply chain,
- wait, it is massive cloud computing with AWS,
- wait, it is massive AI and machine learning,
- wait, it is approaching $2T in market cap…
DCVax is a disruptive technology platform
It continually adapts by leveraging our immune system that is already forever adapting to new diseases. A possible scenario…
- A new drug for late-stage (GBM, malignant brain tumors)
- wait, it is for early-stage (non-toxic, ideal as prophylactic)
- wait, it is SOC for the entire cancer type
- wait, it is state-of-the-art, low-cost manufacturing of live cell therapies
- wait, it is a broad-spectrum cancer vaccine (for multiple cancers)
- wait, it is a modular therapy (to optimize and cure, DCVax base layer, add adjuvants from menu)
- wait, it is SOC for multiple cancers
- wait, it is anti-viral (vaccine for chronic viral conditions like long-covid, herpes, HIV)
- wait, it is approaching $2T in market cap…
Narrow example to illustrate relative size of realizable markets
Kite Pharma (Car-T) was sold to Gilead for $12B in 2017, had only a completed Phase 2 trial, only for relapsed or refractory large B-cell lymphoma (LBCL). Ignoring inflation, $12B today is roughly $10/sh for NWBO today.
Kite for NHL drill down
- Based on Phase 2 clinical trial
- “Relapsed or refractory” means only for a subset % of a % of a % of cancer population
- LBCL is a subset of non-Hodgkin lymphoma (which is a subset of lymphomas)
- Relapsed refers to recurrent LBCL only (not for newly diagnosed)
- Refractory refers to 2nd line of treatment (for patients that did not respond to initial treatment or SOC)
- Only approved in USA
- Car-T is known for high toxicity risks
- Newly diagnosed LBCL in USA – 18K per year
- 30-40% of LBCL will need a 2nd line of treatment – 5K to 7K per year
https://www.kitepharma.com/news/press-releases/2023/12/us-fda-approves-label-update-for-kites-yescarta-car-tcell-therapy-to-include-overall-survival-data
- Calculation (per Bard, Yescarta has maybe 50% of LBCL) - ~3K patients
DCVax-L for GBM drill down
- Based on Phase 3 clinical trial (landmark success)
- MAA submitted in UK is to treat GBM (upside, all malignant gliomas)
- Both newly diagnosed and recurrent (all GBM)
- As SOC therapy (as the 1st line of treatment)
- Global clinical trial, means global markets (UK, USA, Germany/EU, and Canada)
- Efficacy, non-toxic, and immune memory
- Upside, anticipate off-label use in benign brain tumors
USA Brain Tumor statistics 2023
https://braintumor.org/brain-tumors/about-brain-tumors/brain-tumor-facts/
- Newly Diagnosed is 94K per year (28% GBM/malignant, 72% benign)
- Living with brain tumor is 1,000,000
To roughly extrapolate for the aggregate UK, Canada, and Germany/EU/EMA addressable markets, I count the cancer incident rates by country is approx 1.9X of USA.
https://www.wcrf.org/cancer-trends/global-cancer-data-by-country/
Comparing the two
NWBO should be worth multiple times more than Kite.
All is IMHO.
Skitahoe, I always appreciate your thoughtful points. All in all, a number of positive events are converging over the next couple of months. Best.
TTsr, Absolutely!
Skitahoe, I think the key is whether on a net basis, the Shorts can cover. Let me use this to explain how I am seeing this. Straw man numbers below, just to show how I am thinking why Shorts cannot cover without blowing themselves up, if it happened today.
1. 50M shares (cum 50M), $0.50: Traders and weak holders are bought out. Maybe a bear raid. Shorts and Retail longs compete to buy. Start to end, price is back to where it started.
2. 50M shares (cum 100M), $2: Holders with no sense of NWBO intrinsic value willing to sell here. To net buy/cover, Shorts stop their daily naked shorting. Shorts and Retail longs compete to buy. Price rises steadily, early sense of FOMO.
3. 100M shares (cum 200M), $5: Holders who bought into FUD, think $3 is FMV, so selling at $5. Broad set of buyers come in and compete to buy these shares. Anticipate uplisting soon. Recent price action (10X) creates sense of next major move up.
4. 100M shares (cum 300), $10: Only true longs left. Holders who believe in MHRA approval but willing to settle, maybe trade. At $5, uplisted and institutional buying has started, quick runup.
If the below 2B shares shorted really is the case, there is so much more to go. Might as well just say let the short squeeze starts after step 2, skip step 3, and continue up from there. But to be clear, I do not think that is the case because the Shorts do not want to trigger a short squeeze. That is why they do not or cannot cover and why they have to continue shorting.
Skitahoe, I do not believe the Shorts have an out. Their first mistake was strategic, to short a unicorn company. Not so smart. Their second mistake was to double and triple down, after DCVax-L Phase 3 clinical trial results reported landmark success and after NWBO submitted a 1.7M page MAA.
Skitahoe, Like you I think there is a substantial naked short position, but I don’t think the Shorts are covering here. If anything, my suspicion is they are digging a deeper hole for themselves. Why? Because MAA approval results are right around the corner, and on net, retail investors are buying shares, maybe even concentrating their holdings.
I think the misconception here is that low stock prices make it easier for Shorts to cover, so they must be. I don’t think so. I think it means Retail is not selling shares. Shorts are forced to continue shorting, so the price doesn’t explode up. The manipulated stock price and 24/7 FUD on IHub is a clear sign Shorts are working overtime to counteract legitimate stock buying activity and hide the on-the-ground real progress and increase in intrinsic value being made.
The Shorts are desperate. Time is running out. That is their reality.
That is why their tricks will continue to fail in the face of reality.
- Manufacture a false sense of misery. But DCVax-L is on the verge of approval.
- Push a false sense that “if $3 is FMV, then $5 would be smart to sell”. But $5 is when institutions start buying.
- Harass Retail’s optimism on IHub. But The Force is strong here (due diligence, unicorn company investing, battle-hardened).
Tryn2, You are exactly right. With regulatory approval coming soon, there is only one reality. Real investors are buying.
Short positions are "mark-to-market" financial liabilities that will blow up in the MMs and their minion's hands. This daily stock price manipulation is temporary and not substance. It's only last-incremental-share traded value. Any news and price does a step change up in the morning.
No amount of manipulating stats will change this (# shares available to short, wash trading, borrow/lend games, and shifting shares between naked / legal short buckets). Real retail shareholders are not selling. If anything, they are buying, maybe even concentrating. That is the substance of the situation. It is the reality of retail investor's due diligence, confidence in regulatory approval, and in knowing it is this period right before approval that MMs will act most desperately.
Or possibly shorts having to do more of the same wash trading between entities to get the same effect because with MAA approval results around the corner, there is more net buying on the legitimate side.
XMaster, Agree. With MAA filed, the shorts have stretched their old rubber band just a bit too thin. An injunction, anything... and it will go snap!
This daily stock price manipulation is temporary and not substance. It's only last-incremental-share traded value. The substance is NWBO's marathon running Intrinsic Value. That is the 800 pounds gorilla mass that is continually getting bigger. Any injunction or news event and price does a step change up in the morning.
Maybe the short manipulation tricks work on other stocks, but nobody's falling for it here, nobody who has done their due diligence. I just see discipline, buy, and buy-and-hold. I guess that stretches the short's concept of unethical business-as-usual practice. But at some point they got to realize their "mark-to-market" financial liability will blow up in their face.
You mean this quote. It does put context into the situation.
It's a nice article to help set the stage, "Cancer Vaccination as a Promising New Treatment Against Tumors. Vaccination has beaten back infections for more than a century. Now, it may be the next big step in battling cancer" for when NWBO makes the grand entrance.