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I sort of fall in the same bracket as you in that I trust the KOLs supporting our technology but not a fan of most on this management team. The only consistent exception is Marnix Bosch (for science and technology) and Navid Malik from their board (for the support he has mustered in the UK over the years).
Even though I am playing on house money at this point, the opportunity cost coupled with the lack of transparency, relevant biotech experience, and sloppy execution are what bothers me the most.
Agreed, but unlikely with the current team. Street won’t trust them to execute in a decisive and timely fashion. Even with JAMA oncology and support of 70 KOLs, we are languishing. Will not change anytime soon.
Even oncology drugs with a far bigger addressable market than GBM doesn’t get $5B market cap just on MHRA approval alone. Show me one that does! However, you will see quite a few examples where companies do get such market cap valuations ($5B or more) at FDA approval alone because that’s the big fish. As I said, 50% (US) vs 5% (UK) of the global revenue.
GBM is a relatively modest addressable market size (as compared to say lung, breast, prostate cancers, etc) so keep that in mind as well.
BS about FDA. I have worked many times with FDA and EU bodies. FDA by far is more organized and easier to work with, especially in the last 6-8 years. Also, they tend to be supportive towards small to mid size corporations.
Don’t fall for these excuses. It’s really just excuses to kick the can.
Although reimbursement discussions with Medicare and private insurers is a different ball game! This is where Dendreon struggled, but I don’t see us having these challenges in GBM space.
A good strategy indeed. Buyout or partnership is not coming anytime soon. Outside that and FDA BLA acceptance, I don’t think we will have significant price appreciation that will stick for more than a few days.
“MHRA approvals are a nice to have, but will have little impact on the SP long term, maybe a short term pop. The focus needs to be on the FDA, and an approval by MHRA obviously does not guarantee the FDA will follow.“
Agreed. FDA approval and reimbursements in the US give you access to about 50% of the global revenue. UK is about 5%.
Although I am fairly certain FDA will approve ours as well. Reimbursement approvals in the US shouldn’t be a challenge either given that DCVAX-L is more cost effective and offers better quality of life than Optune. This was one of the challenges with Dendreon. Dendreon vaccine didn’t make economic sense in that indication with minimal improvement in survival. On the other hand, ours is a true winner in all the categories! In fact, FDA approved their vaccine as well. However, it was the lack of reimbursements coupled with high manufacturing costs that killed them.
As to why NWBO team are not going to JPM like big investor meetings is a mystery. They are probably happy diluting it to their friends, who will never question them and are happy with status quo?
”I believe that U.K. approval will put us into a substantially different trading range.”
You should go back and check what valuations were put through the course of last year on TLD and journal article. I will stop there!
Gary, this is what I mentioned couple of days ago. These presentations are not going to move the stock. A large part of the medical community is in support of the results. It’s going to be all about fast paced execution on the regulatory and commercial side.
NWBO management has failed to bring credible new investor or big pharma on board at a higher valuation. That’s one of the biggest missing pieces. 2023 will be another lost year with these guys in charge. But as usual folks will continue to blame it on evil shorts, OTC, so on and so forth… however, the fact of the matter is if management can not bring spotlight and big investors at much higher valuation at this stage (when 70 odd top neurosurgeons have backed them) then I don’t know when they would. For example, they ought to have been networking and presenting at JP Morgan biotech investor meeting in San Francisco last month. Novocure was there. Unfortunately, there is no sense of urgency or respect for retail shareholders.
Nope. It could only mean one of two things. The guy had no idea what he was talking about in the sense that UK approvals involve PIP approvals, commercial manufacturing certification, etc before even being eligible for MAA….
OR
That statement was made to support his friends to sell high and rinse and repeat!
Take your pick!
Less than 4-6 weeks.
You didn’t respond to LG comment! Do you trust leaders that make such public statements?
“It looks like NWBO is going after them in combination. We will likely see multiple RA submissions close together in time.”
I don’t trust it until I see it. But if true, we will likely see significant price appreciation with an accepted BLA and PDUFA date. Not many folks are expecting both UK and US submissions close together in time. This is the wild card!
“Of course. We need to trust the guys that promote far flung criminal conspiracy theories designed to scare long term shareholders into selling, right?!”
Alternatively you can trust an executive of the company (LG) that said in summer 2020 on a public platform UK approval imminent!
MAA will also be meh in my opinion. NICE will take a while after UK approvals and without reimbursements in play, it will be very challenging to accelerate adoption. We have seen that first hand with specials!
Not sure why they wouldn’t go after FDA aggressively and give that a higher priority. Seems like they are waiting on something - either manufacturing in the US or release of ph 2 combo data in early 2024? Otherwise doesn’t make sense to not go after FDA first which is almost 10X the size of UK market from a revenue perspective. All this notion and stories that FDA is corrupt and won’t do the right thing is BS. Just excuses to kick the can!
One thing is clear you can not trust this management and their loyal supporters with their stories. They have treated retail shareholders very badly while allowing big warrant holders to profit and reinvest their earnings again at a discounted price. This cycle will unfortunately continue for a long time. It’s best to play that game alongside them! ;)
“t would be a very bad scenario for the company to remain status quo just waiting around for the UK MAA. So something will have to give.“
I think FDA BLA news is going to be extremely important from a significant price action perspective! MIA and UK MAA will likely be perceived as meh because everyone is expecting that and considering the size of UK market. It’s the unknown and the big prize (US market size) that could move the stock in a meaningful way.
PM, my sense is we are not going to see major partnership or buyout anytime soon. Two observations:
1) It appears they hired a scientist/analyst/investor relationship kind of guy in Dec 2022.
2) LP got another 3 years as a board member, per the latest voting at the ASM in Dec 2022. If a buyout was around the corner, she would have asked for one or two years at the max.
The usual suspects will continue to dangle carrots in the name of partnership/buyout but I doubt it’s coming anytime soon.
The issue is NWBO management treats retail investors badly (or stupid to say it bluntly). LG coming on that big booze show during summer 2020 saying UK approval imminent. How can you say that? Was he pumping for his friends or totally ignorant? Not a good situation either way.
Agreed. Or at least bring in big pharma as a partner!
Now do the same comparison for the last 2 and 10 years? ;) it will be fun!
No one is arguing the science, but it will only be approved for nGBM and rGBM and not other solid cancers with the data they have. So no “big fish” to fry, sorry! If approvals were granted in thin air like you’re proposing then we all ought to be super concerned.
I, as a shareholder, try not to connect every positive policies and frameworks that comes out as being centered around NWBO and try to stay grounded in reality, particularly with the history and experience of this management in this space.
NWBO will have to run clinical trials and this management could potentially take another decade and over a billion dollars to bring the next approval to the finish line, if shareholders are lucky! ;)
All excuses for delays! I will guarantee that Flaskworks will not be part of the initial application and approval. I will go on a limb to say Flaskworks won’t be approved in 2023. In fact, it won’t get certified for commercial use in H1, 2024 either at the pace at which things get done and how things typically work in this space.
LOL! GBM or brain cancer in general is less than 1% in terms of impact (people) and revenue in the world of cancer. So while KA is extremely influential in terms of MHRA direction for various forms of brain disorders (not just GBM, he is also a master at PD), the fact is that only constitutes 1% or less impact in terms of improving people’s lives suffering from various forms of cancer. By the way, I have worked with some of his neurology collaborators at KCL!
The fact remains MHRA will also listen to KOLs that have a say for the other 99%. I will leave it all that and not talk about the cost/benefit/scale of mRNA vs fully personalized vaccine like DCVAX.
Again, the more time this management takes to bring this to finish line, the more opportunities and trust they continue to lose. That’s a fact and the other fact is that they haven’t been able to establish credibility and such relationships.
I like the optimism but keep in mind there are dozens of other small and big biotechs that qualify. Everything is not centered around NWBO! ;)
Why did UK pick mRNA instead of DCVAX as their long term bet for personalized cancer vaccine therapy trials?
Agreed. Even MHRA application submission won’t lead to significant and sustained appreciation, IMO. On the other hand, if they come out with FDA BLA acceptance news then that will be a big surprise and could lead to significant upside. However, I don’t expect that this quarter.
This upcoming MHRA news cycle will simply be a momentary pump and dump cycle for existing warrant holders and new preferred C share holders from early Q4.
Outside the FDA milestone, the only other piece of news that can lead to meaningful price appreciation would be partnership or big investment from an extremely credible firm.
Shorts know that this story will take an extremely long time to unfold with this management behind the wheels. They are not stupid and will not give up easily until a big pharma or credible new investor comes in at much higher valuation. They know there will be minor pump and dump cycles along the way to support the previous warrant holders and new investors that are purchasing C shares at 70 cents.
Agreed. It’s not a science game anymore. Various talks by LL and KA have laid it all out in the last 2 years. Plus we have JAMA Oncology.
It ought to be tight commercial execution. That’s what will convince the street. And this management team is sluggish to say the least.
Agree with you. It’s kind of baked into the price already. Not much they will do will move the price significantly until they bring in big pharma or a big credible investor as a partner. Alternatively, news of FDA application acceptance and/or PDUFA date could create a significant upside. In my mind, even UK MHRA application acceptance will be perceived as meh with this management in charge because there will be no clarity or guidance on NICE reimbursements.
Don’t blame you! Execution or to put it mildly timely execution is not their forte. No one in their team has any experience bringing a drug to the market. If the past 10 odd years is any guide (including the last 2 odd years from data lock) they will continue to limp going forward. They will remain a boutique shop (geared towards warrant holders) until they bring a big pharma with experience and credibility.
Not unique to NWBO. There are dozens and dozens of companies that do this every year and no one complains about the lengthy application process or provide excuses. They just get it done and it typically takes 6-9 months from data lock and not 30.
You have to submit an application before regulators can approve. Almost 30 months since data lock and they haven’t submitted the application yet. No one takes this long and there is no one to blame but them. I can not imagine how they will handle reimbursement discussions and commercialization!
I don’t think we will see $2 until FDA approval and that’s not likely until Q4. And that timing is quite optimistic given the history of their execution.
Agreed. RAs including FDA will accept manual production.
I don’t think Flaskworks will be approved for commercial purposes in 2023 or even 2024 at the rate NWBO does things.
Agreed. It’s time for them to step aside if this company were to accrue value for shareholders going forward. Folks still don’t realize how challenging and time consuming reimbursement pathways will be in different regions. And until reimbursements are sorted we will remain a boutique operation even after RAs. By the way, it’s also becoming clear that a big pharma partnership that some of us expected is not coming anytime soon.
There is no substitute for real experience. And none of the management folks have this, unfortunately. For those that are well entrenched in this world can do a fairly decent job of planning and estimating the timelines.
Flaskworks will not be a part of the first approvals. And it’s not required for any RAs.
“That timeline by Dr Zivic is as absurd as his previous timeline estimate of last fall for approval; that were nonsense. He asserted why he knew the MAA had already been submitted, and turns out it was not.”
I agree with that statement. He has been pumping and putting false timelines and revenue estimates over the last year or so. Not sure he understands how these regulatory processes work and how backlogged these regulatory folks are.
However, NWBO will receive RA from all 4 agencies. That’s pretty much guaranteed. Just not as quickly as folks here anticipate.
Continuing to blame Citadel and MMs won’t get us anywhere. Ultimately, it’s the failure of the management to get credible investors on board. Instead they continue to dilute us at 70 cents!
The data can be shared publicly with investors (including JAMA Oncology paper comprising of 70 odd top neurosurgeons). Why weren’t they pitching at JPM investor conference last month?
I thought I’d share some snippet from an investor pitch I saw today at the JPM meeting in San Fran.
(A company I won’t name) is developing a modular, scalable platform that automates final-mile cell therapy handling and administration.
Why Now?
The cell therapy industry is at an inflection point;
• The US market alone is projected to reach $48 billion by 2027.
• There are 1800+ active cell therapy clinical trials worldwide.
• Efficacy and toxicity issues have stalled solid tissue cell therapies.
• Costs are high; cell therapies cost upwards of $100,000 per dose.
I agree with your take.
I am not disagreeing with you. I have not been a fan of this management team either. Without a credible big pharma partner, I don’t think we will see meaningful appreciation in SP. Once we are approved by MHRA, the manipulators will say FDA won’t approve….once FDA approves, they will say our GMs are too low and we won’t be super profitable given the complexity in manufacturing. The cycle will go on and on….
I do believe a partnership is in the works. Hard to justify their actions otherwise.
I see that Novocure is at JPM conference in San Francisco next week. Why is NWBO not there?
You expect healthcare companies of all size (public and private) and focus areas to be there. I plan to be there as well. Again, the only reasonable explanation is NWBO has something in place that is waiting for additional milestone(s).
Regardless of how things are handled, I think there is easily 3 to 4 x return in 2023. It’s clear they are going after multiple RAs in 2023 and LP touched upon US manufacturing during the call today, which is quite bullish, IMO.