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Great post.
Well said!
Zadie, Totally agree. An MHRA approval of DCVax first, puts pressure on every country to not be too far behind. Behind that pressure will be cancer patients, because knowledge of an efficacious, non-toxic, autologous, and broad-spectrum cancer vaccine will travel the globe quickly.
I also think governments and insurance companies will recognize the non-toxic nature of DCVax potentially reduces cancer and healthcare costs more broadly. Imagine the potential to avoid an entire layer of secondary treatments and costs resulting from side effects, of say chemotherapy (not a doctor, just did a quick look up on the web):
- extended hospital stays
- medications for nausea, vomiting, pain, infection (antibiotics), anxiety or depression
- medical procedures for blood transfusions for anemia
- nutritional support for weight loss, malnutrition
- skin care products for rashes and reactions
- wigs for hair loss
- mental health services for emotional
- home care services for fatigue
- transportation service for frequent treatment and follow-ups
(Thanks Flipper for sharing). The Access Consortium New Active Substance (NAS) work-sharing initiative is a collaborative program that effectively means, when DCVax gets approved in the UK, there will likely be 5 different countries, 5 approvals, and 5 press releases, potentially all within a short order of time.
And that starts with an MHRA approval any day or week now.
So that means from Claude summary:
The Access Consortium New Active Substance (NAS) work-sharing initiative is a collaborative program between regulatory authorities of several countries aimed at streamlining the approval process for new medicines. To answer your questions:
What does the Access Consortium NAS work-sharing initiative do?
The initiative allows pharmaceutical companies to submit a single application for a new active substance (a new drug) to be reviewed simultaneously by multiple regulatory agencies. This collaborative approach aims to:
- Reduce duplication of effort across regulatory agencies
- Accelerate the review process
- Provide more timely access to new medicines for patients in participating countries
- Harmonize regulatory requirements across member countries
Does it allow a drug submitted in MHRA for approval be shared with other countries?
Yes, that's essentially the purpose of the initiative. When a pharmaceutical company submits a new drug application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA), this application can be shared with other regulatory agencies that are part of the Access Consortium.
The current members of the Access Consortium are:
Australia's Therapeutic Goods Administration (TGA)
Canada's Health Canada
Singapore's Health Sciences Authority (HSA)
Switzerland's Swissmedic
United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)
So, if a company submits an application to the MHRA under this initiative, the application would be shared and reviewed simultaneously by the regulatory agencies of Australia, Canada, Singapore, and Switzerland as well.
Long-living patients, non-toxic, and immune memory of DCVax is the reality. Approval and it being an eventual part of cancer therapies in the future, broadly, naturally follows that.
Bullishness is showing in Buys (at the Ask price) momentum this morning (approx 12:20 PM EST, data delayed 15 minutes).
Buys: 1,217,063
Neutral: 53,800
Sells: 408,518
Total: 1,679,381
Buys have a 3:1 ratio over Sells, very positive.
Bright Boy, Agree. FYI only, I asked the AI Claude about the MIA status changing from "Investigational" to "Human".
Dmb2, Very helpful, thanks!
Flipper, Thanks! Very important, especially since DCVax is tissue agnostic. Potentially this could speed up the approval of DCVax for other indications. No idea if possible, but possibly allow a process to apply DCVax to additional indications rather than do a completely new application?
NWBO board on IHub is #1 read because of DCVax disruption and unicorn investment thesis already, that draws in industry, investors, and both sides of investing. I don't think Ihub needs anything else to add posters. In fact, the FUD is meant to discourage and harass potential investors into not posting and investing.
Jesster, Yep. The only thing Shorts and market manipulators of NWBO will communicate is backwards logic or logic laced with a Trojan Horse. Everything they say is intended to manufacture anger. And in that process try to get long term investors to ignore the remarkable opportunity we have with DCVax, that it is...
- about to be approved
- a broad-spectrum cancer vaccine
- efficacious, significantly extends long term survival
- non-toxic, builds immune system against cancer recurrence
- holds the opportunity to cure cancer
- an emerging unicorn company
- and is extremely undervalued from manipulation now
Not surprising, pull back the curtains, and it will be revealed market manipulators are just selfish greedy people. We are not unfamiliar with these types, people who don't care, don't care about honest working people and their investments, and don't care about society. They send out their army of short minions to post on Ihub every day. They are like the Uruk-hai, born from mixing the genes of Shorts and Con-artists, lacking any compassion.
Coincidence?
The one who created the Uruk-hai is Saruman. He had a citadel, Orthanc in Isengard.
Ken Griffin is named in the spoofing lawsuit by NWBO. His company is Citadel and is being sued. Only time will tell if the short minions were born by him.
My feeling is this is the month for approval, September. Only a first step, emerging on the stage, but enough has been done that this will be a very substantial first step.
Dstock, Agree. But more importantly for Retail now is this message. Don't be the one selling any shares (hoping to buy back lower). There will be many more trading days like yesterday, where out of the blue there are two 500K share BUY transactions at the ask price and then price closes up 13% for the day.
Many more of these % increase days. Price is way too manipulated now. I expect hidden new money buyers waiting on the sidelines will be jumping in as we emerge out of each range, the $0.30's, $0.40's... to $1 (I know people have been gaslighted to think $1 is out of reach prior to approval, but I don't think so). So I believe there is no going back. And then we will have MHRA approval, and that catapults us further.
100% agree.
Both 500K trades were at the Ask price, ie buys, very positive.
Well said, 100%. The number one defense against the shorts is "Longs just need to hold onto shares... and add on any dips."
Branster, Agree it will be heavy volume that breaks the manipulation games (the swap trade games driving price down). Until then, the key is those manipulation games are what I call short term, stock price discounts on a unicorn company that has been largely de-risked.
As of 20 minutes before close of trading day, from Ihub Trades tab,
where Buys (traded at the higher ask price) vs Sells (traded at the lower bid price)
- Buys 914K shares
- Sells 510K shares
- Neutral 171K shares
Thoughts
Buys are 1.8X = strong buying demand today
Yet price down ~0.90%, means the sell trades were coincidentally or intentionally positioned to keep prices down.
If intentional (manipulation) and on average the Buys are investments (10X gains) and the Sells (shorts, mark-to-market liabilities, fuel for short squeeze), then Shorts are playing the "win a battle, but lose the war" game.
Kabunushi, Thanks! Excellent information.
I had never looked at the trade tab of Ihub for NWBO. Defining trades as buys or sells, depending on whether the trade was made at the bid or at the ask, is very interesting and has a logic to it.
I had always wondered how to tell, in a day's trading volume, how much was from actual arms length transactions and how much was from swap trading for example (ie manipulation trades between short funds to bring the price down). That still doesn't answer that question but at least it helps a bit.
Specifically, Friday's 917K buys and 629 sells tell me there was more buy than sell volume. That indicates sentiment and trading was bullish for the day, despite the closing price ended the day lower (ie "mark-the-closing price lower" manipulation to make us think things are bearish). Useful tool.
The increase in outstanding common shares may or may not come from new sale and issuance. I did not look into this on the financials, but my guess is, it is the conversion of preferred shares or warrants from earlier periods, after fully vesting, where the holder had decided to convert those securities into common shares.
Krisgo, Makes sense. Because of due diligence, there are certain things that investors can believe with high confidence.
This is what I posted earlier this month when price was at $0.40.
Dan88, Totally agree. With manufacturing inspections scheduled and being the last step, MHRA approval is very close. It can be later this month or in September, or at the latest IMHO in October.
These come to mind:
- Financial term high gamma: the rate of change or sensitivity of stock price to an anticipated event / date, increases at an increasing rate as it approaches this event / date (MHRA approval)
- Pendulum has swung "too far in one direction": market manipulation pushed prices too unnaturally low
And so...
pendulum becomes the catapult arm,
high gamma becomes the rocket fuel,
MHRA approval becomes the ignition,
a unicorn company lifts off (NWBO),
a cancer vaccine forms rainbow in sky (DCVax),
creates an ecosystem of colors (doctors and cancer patients),
high gamma rays are absorbed by NWBO Retail Longs,
which restores DD and investing to a natural balance,
and the butterfly effect of DCVax
as a broad spectrum cancer vaccine is felt across the society.
Fun statistic. Shorts way overplayed their hand. It would take 7 days of continual price rising at 18.7% (today's increase) per day, just to get NWBO to $1.00/sh.
Krisgo, Short manipulators have pushed it down too much. Below $0.60 was already too much, below $0.50 showed their desperation, below $0.40 is their gasping for air. The approval of DCVax is inevitable and there are too many new money buyers on the side waiting to jump in. The only question is when does this erupt.
It is like we are watching a large beach ball being held down, pushed deeper and deeper underwater, by 7 people (MMs),
all while the beach ball is continually growing (intrinsic value),
and the undercurrents are rising (need for cancer cure, for DCVax the broad spectrum cancer vaccine that is non-toxic and builds immune memory to prevent recurrence).
and we all know the beach ball will eventually fly out of the water (stock price).
Today's buyers are front-running the (next) new money buyers sitting on the sidelines,
who are wanting to front-run the exact MHRA approval day (can't),
who are trying to front-run the early institutional investors before they jump in,
who will front-run the later and larger institutional investors,
who will be competing with the shorts trying to cover,
who will sadly realize they have been front-runned by their fellow short minions.
Appears buyers are going to front run the catalyst.
Ilovetech, Your post kind of poetic. Reflecting on that.
The world is about to change.
It’s as if time has slowed to a stillness.
At this moment of turning.
I see it in a Judge about to issue MTD ruling.
I feel it in MHRA about to sign an approval.
I smell it in SEC / DOJ about to shake a whistleblower’s hand.
Much that was lost, will be reborn.
And then some.
For NWBO is about to emerge and change things forever.
Dstock, Exactly. Stock price manipulation is just another gaslighting tactic against retail shareholders. It is a financial glass ceiling to keep people down. Until we get revenue, it is all about focusing on what matters, the depth and growth of DCVax intrinsic value, not the miserable gloom and doom mind-loop-trap of stock price manipulation.
VMLG17, Thanks for sharing that. It is an interesting video. Every industry has a dark side, good to know about that. Given DCVax potentially disrupts the broader cancer industry, it could be an additional or a gray-area reason why NWBO needed to be strategic in everything it does and to put its best foot forward, an example being to apply for marketing approval with the MHRA first.
Dstock, Thanks for pointing that out. Agree.
Starric, Thanks for sharing this article. Yes it is very interesting. It is another UCLA clinical trial launch. This time it is DCVax for adolescents and young adults.
Thank you!
DocLee, Thanks for this most important insight.
“There has been a Mutual Recognition Agreement ("MRA") between the MHRA and the FDA since 2021 which has initially only encompassed "Pharmaceutical Good Manufacturing Practices" (GMP) in the field of 1] Vaccines for human use; 2] Plasma derived pharmaceuticals; 3] Investigational products (clinical trial material).”
Possibly DCVax is already included in the above.
From the FDA
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra
Mutual Recognition Agreements (MRAs) between FDA and foreign regulatory authorities allow drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if FDA determined those authorities are capable of conducting inspections that met U.S. requirements.
MRAs:
Yield greater efficiencies for U.S. and foreign regulatory systems by avoiding duplication of inspections; and,
Enable reallocation of resources towards inspection of drug manufacturing facilities with potentially higher public health risks across the globe.
FDA has MRAs in force with the European Union, Switzerland, and the United Kingdom.
DCVax is recognized as a vaccine in UK (Cancer Research UK) and USA (JAMA), note the titles of reports.
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-a-vaccine-called-dcvax-l-for-glioblastoma
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma
A Phase 3 Prospective Externally Controlled Cohort Trial
(Gemini) How does the FDA differentiate between a drug and a vaccine?
Excerpt
Vaccines: Prevent diseases by stimulating the body's immune system to produce antibodies against a specific pathogen.
Drugs: Typically treat or cure an existing disease or condition by directly interacting with the body's systems.
Vaccines: Are often licensed under the Biologics License Application (BLA) process.
Drugs: Are typically licensed under the New Drug Application (NDA) process.
VikingInvest, Thanks for posting. It is great information. You are on a roll, a series of excellent posts.
For unicorn company investing in NWBO, my strategy is time invested, not timing.
Time invested = long term investing
(time invested in the due diligence, in holding the stock, and in buying at the various low price entry points)
Timing = short term trade
(see stock price has been on an escalator down trend. If MHRA approval is likely not this month, then sell today. Hope trend continues and buy back at a lower price later.)
Market manipulators have set a (escalator down) trap to convert Retail from investing to trading, to steal their shares on the cheap.
MHRA approval is…
Chase the price trend…
On the first, nobody knows.
On the second, it requires thinking MMs will continue pushing prices further down so Retail can buy back at a profit. It also requires thinking that there is no new money on the sidelines competing to buy shares at that “perfect time”. It also requires believing there is a perfect time and one will "actually" seize on that opportunity.
Investor discipline and due diligence is better
NWBO is an asymmetric risk-reward investment opportunity - major upside
Market manipulators hold short positions that are major mark-to-market financial liabilities to them - desperate to buy NWBO shares.
Therefore…
“buy back later” - a trap to get Retail to sell shares
“at a lower price” - a trap to get Retail to sell shares
All is IMHO.
Margin Buu, Thanks for calling that out. Blame diversion is sad. I would normally say to them, "I understand where you're coming from, but let's focus on the problem at hand." However it seems in this case it is manufactured anger to divert from the real issue, that market manipulators were raiding the stock today.
By the way, to all Longs who bought shares today to fight off the bear raid, THANKS!!!
The last 45 minutes of trading had about an aggregate of ~300K buys pushing the price up, so we did not close at the lows of the day.
I think MMs wanted to mark-the-closing price for the day and month-end. But I believe they pushed it too cheap. We are just too close to approval, and the stock price to intrinsic value ratio is too low, to not be a green light for many. Let's see if that comes to be and if we get a new up trend tomorrow and for the month of August as we wait for approval.
That reminds me of one of Idaho Falls, Idaho. There is a waterfall there, measuring a mammoth 20 feet high.
Congrats!
Sounds like a great experience.
On stock price though, I envision the YTD has been a slow escalator down and at the foot is a high speed elevator up.