MiD, Excellent look into the long term survival rate at 5 years.

I especially like this

I agree. With success, NWBO's platform will be viewed from a mega trend investment perspective. How big is the opportunity, % realizable, # of years to achieve, and rate at which this market share is grabbed. Each is a gate and has a risk value. All are highly subjective variables, so to each, his or her own. And for those reasons and as you say, Smith is very conservative with assumptions and is why he takes his approach.

Exactly. Just like Tesla is valued for its platform for a future energy grid system and software, not just the sales of electric cars. It's the platform.

Smith's $5B to $10B valuation is for GBM only. He gives his thoughts on the valuation of Direct, separately. So he never gives us a forecast for a total NWBO valuation, but he hints it is much, much greater IMO. Here's my try at interpreting his numbers.

"Market capitalization could possibly reach $5 to $10 billion or more in coming years."
"Annual addressable market for ndGBM is $265 million in the UK, $1.3 billion in the US, $145 million in Canada and $1.5 billion in the EU (ex UK)."

- $3.2B ndGBM + (assume similar size) $3.2B rGBM = $6.4B
- assume 25% to 50% is realizable
- Using a 3X valuation multiple = $5 to $10B market cap
- For GBM only

"In the event that DCVax-L gains approval for ndGBM, it validates the dendritic cell therapeutic vaccine technology. The mechanism of action... might also work for any solid tumors [DCVax Direct]... potential for expansion of usage over a broad range of solid tumors resulting in commercial potential several magnitudes that of GBM... over years or decades."

- 1 magnitude = 10X
- For example purposes, let's assume "several magnitudes" means 30X
- that would calculate to a potential DCVax-Direct valuation of $150 to $300B or more.

Clik clik clik ... that guesstimate calculation of 5 yr survival is 6X that of placebo, a blowoff top success however viewed.

The 6X measures amplitude. The magnitude of impact and improvement would, I dare say, be exponentially greater.

Flipper, very thoughtful. Also this is powerful as in could basically be the opening statement to Big Pharma in the negotiation for a partnership or buyout.

Great summary, especially Direct as we don't discuss that much. Thanks for the Star Wars reference.

Thanks. A joke to complement an exciting 13% up day. It is a burst of green coming out from an ocean of red.

Edit: had to re-do the punchline, original was off
_____________________________________

For those who doubt Linda Powers. Know that she is The Most Interesting Woman in the World.

1. When she runs a marathon, her feet don't get blisters, her shoes do.
2. She once went to a financial psychic, to warn him.
3. When she negotiates a buyout with Merck, NWBO shares acquire Merck assets.

Smith on Stocks

Sojourner, nice chart as always. I think TLD takes off at $1.50.

It seemed the drop from $1.50 to $1 was on low volume trading, so I predict that once we break $1, the price should easily go back to $1.50 on the same low volume, as it retraces back. So the key to me is breaking the $1.

I think $1 can be quick with the momentum we see today and the larger expectations of TLD may reporting any day or week now. Plus given the blinded data to-date indicating results, at a minimum, will report a significantly successful trial, just the level of success is to be announced, people and family office investment funds will open new positions and or add significantly IMO.

For those who doubt Linda Powers. Know that she is The Most Interesting Woman in the World.

1. When she runs a marathon, her feet don't get blisters, her shoes do.
2. She once went to a financial psychic, to warn him.
3. When she negotiates a buyout with Merck, Merck shareholders are paid in NWBO shares.

Rare moments are the joy in life.

Another morning of waking up covered in snow at Hotel Park Bench, Groundhog Day.

Every morning repeats...
Old Lady: Can I help you?
Poor Man: No thank you, I'm waiting for TLD.
Old Lady: Aren't we all? Pass the bottle.

Maybe this cycle breaks on the morning of Tuesday, February 2, 2022, which is actual Groundhog Day.

I share your feeling on this build up of events leading to a crescendo in late February. Thanks for laying out your view of the timeline and events. Counting months, it makes sense to me. I am into the rabbit hole.

Appreciate your insight on FDA and advisory committees.

Indeed everything is in place and in motion now. Tracks a rumbling. Blockbuster results are being delivered on a freight train, moving with unstoppable momentum. My only hope is for retail to own as big a portion as possible because this is the one.

You really do the extra step. Thanks and this is great news.

I highlight your comment, All good things take time.
Indeed.
GLTU

MID, Your comment the FDA may decide to approve DCVax on its own without using an external Advisory committee got me thinking if there is another reason why the release of TLD is tied to the release of a journal.

Pondering here, let's just say the FDA has seen the results and wants to approve DCVax, but it has to maneuver around these considerations:

- DCVax trial is complex, not simple, and offers a new paradigm in treatment that will need explanation
- Potentially disrupts multiple revenue models across many big pharma companies
- These financial interests will push back and "how" can be unpredictable and from internal and external sources
- A release of TLD alone, a year ago, might have pressured the FDA to form an external Advisory committee to review early on and make opinions, that given above, might be crowded with conflicts of interests (maybe even sabotage).

So the FDA and NWBO, maybe early on and together, recognized the right answer is to approve DCVax outright and in a decisive manner. Take the 2021 year as a quiet period. Use it to simultaneously prepare a BLA and a journal. A journal backed by 60+ practitioners from a respected medical journal could be important "cya". Afterwards on release and publication, an FDA approval can be quick and concrete.

Doc, Yes it's a really important point to understand the DCVax platform and potential, where misunderstanding likely means many good intentioned long investors will sell out too early.

I am reminded of Amazon. If one thought Amazon was an online bookstore set up to avoid paying sales tax only, then after Borders and Barnes & Nobles lost market share, one would have thought "done" and would have sold their shares "too early". The key was to understand the "platform" was much bigger and was on the path to dominate e-commerce overall. There was the 1-Click patent, a key advantage, applied broadly for online buying, and allowed Amazon to collect data. There was the acquisition of the robotic company Kiva Systems for factory automation and Amazon's terminating other's use of it.

Nothing is obvious, and I am the first to admit seeing only events and missing patterns. So I do thank the many posters like yourself here on Ihub who point out things, like what is significant and explain things... for example the broad DCVax patents we have built up are emerging now, and the manufacturing potential of owning the Flaskwork's Baton and MicroDen technology and systems have a multiplier effect on quality, cost, and speed.

Worth repeating because people say "BLA" 3 times and get lost.

Yes it does.

Happy new year to you to. I think you are referring to the answer to Gollum's riddle, as so many years have passed by:

This thing all things devours;
Birds, beasts, trees, flowers;
Gnaws iron, bites steel;
Grinds hard stones to meal;
Slays king, ruins town,
And beats mountain down.

The answer is time.

But maybe what is being gnawed away here instead are the industries of chemotherapy and the massive mountains of market manipulators. And what we are actually seeing is the (long) process of remaking the future in cancer treatment.

Agree the price can be higher. If we follow a higher-efficacy-drug gets to charge a higher price model (like UK) I would be happy with that too.

On the other hand, I would like Northwest to be the responsible adult in the house, not too greedy.

Here's a 2014 article that discusses the DCVax-L drug price, seemingly from an interview with Linda Powers. Of course no definitive price is stated, just pieces of the puzzle.

From this, I can see how a $150K drug price, that is used by many on Ihub, can be derived. My vision of a scenario is:
- Maybe 9 to 12 total injections
- Yr 1: 5-8 injections, $100K price
- Yr 2: booster 2 injections, $25K price
- Yr 3: booster 2 injections, $25K price
Total $150K

DD so many great nuggets you compiled, gotta highlight for others this quote from Linda Powers from the 2019 ASM:

Thx for what you do DD. Really great.
The Marc Cohodes video is a must see treasure trove. Of course the Cramer video too, for those that haven't. That's a classic.

Sukus, Excellent example. Yes the world of valuation metrics and multiples have changed.

Good example. Agree actual revenues will come in much faster than expected, not your normal forecast model timeline for ramp up to a peak sales.

Kaisenman, I think the DCVax-Direct opportunity of being best-in-class and first line treatment for multiple solid tumors is too big a business to pass up. So I think they take on the big pharma role of mfg/sales and try to capture the larger value there. Licensing and partnerships of Direct can be reserved for combination therapy and second line treatment options.

So the big question is how. I think a big pharma partnership on DCVax-L gives them time and money to make the hard transition from an outsourcing “everything” model to a becoming a global commercialization and sales company (big pharma). That means new mgmt, build out sales, etc… all above my pay grade.

My guess, $50/sh by 1/1/2023, assuming approval and a partnership.

Because approval means
- DCVax-L gains steady adoption on a country by country basis globally during the next 12 months as the best-in-class, first line, standard of care treatment for GBM
- DCVax is validated as the safe, efficacious, autologous immunotherapy platform.
- DCVax-Direct narrative as a possible disrupter to current solid tumor cancer drug companies gets legs, so the market cap then begins to reflect this valuation because it is currently not.

Because Partnership means
- A strategic decision was made that Big Pharma will end up paying manyfold more in a buyout a couple years later, than now. Because by then, all will know and shall bow to the dendritic cell and immune system.
- It is not a “go-it-alone” but rather a gain-commercial-partner strategy.
- Maybe a partnership strategy for DCVax-Direct, in the same way Merck licenses Keytruda for combination treatment clinical trial studies, as in 200 clinical trials across 30 tumor types.

DD, Thanks for creating a nice resource for information.

big gulp as I read that.

Poor Man, I know what you mean, it's surreal. Why do we need a Cofer Black type person in a role for a small biotech company that is running an otherwise normal R&D clinical trial on cancer?

But I read Smith on Stocks talk about a pack of wolves that coordinate (Game Stop, Melvin Capital loses $6B shorting, but is saved by so called "competitors" Point 72 and Citron). Multi-hundred billion $$$ of money in cancer treating drugs are at risk of being compared to the most effective treatment of all, our body's own immune system, of course with autologous support through DCVax. This is within the backdrop of extreme wealth concentration in a few who want to keep it that way.

So maybe the question is not about Cofer Black working for NWBO, but instead it is about DCVax being a piece within a grander strategy of people trying to reform healthcare costs at a societal level and about the forces working against that. This thought too is surreal.

Poor Man, That is just too hilarious. Should be a comedy scene in a movie.

Hspooner, Taken is a great movie. Required watching for all young invincible adults traveling abroad. At least all parents should require it, especially if they are paying for any part of their kids trip.

Doc, Appreciation is my primary feeling regarding what we have here with NWBO. So much so this is the only stock I have recommended to family and to some coworkers and friends over the years.

And your point is important. There are not many opportunities in life, that some form of destiny presents and lays before us, to invest early in a company that are revolutionary and will change the landscape for generations and is something that is meaningful to society.

Thanks Bio and merry Christmas!

Very interesting thought.

The DC strategy relative to others is becoming clearer and its position to maintain cellular health, whether it is destroying mutated cancer cells or DNA infected virus cells. In the end it is the same to our immune system.

I hope I am not too far off here. Whereas CART-T unnaturally create super soldier T-cells assigned with a single task, DCVax is superior. It gives the General (dendritic cell) the information on who the insurgents are to attack. The benefit here is the General decides how best to fight and win a guerrilla war, knowing they have access to the full breadth of weapons available in the immune system, not just T-cells. There are considerations like collateral damage and ability to identify a constantly adapting enemy. The immune system does that. And not just during the fight, but the benefits of this continue into deploying systemic defense mechanisms afterwards.

Same to you and Merry Christmas everyone.