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BS! nGBM is around 3.2k in UK. Here’s a link from Dr. Paul Mulholland’s profile at UCL:
https://www.ucl.ac.uk/news/2021/jul/brain-cancer-trial-recruits-largest-ever-number-patients
But our addressable market for nGBM will likely be much less because of many factors. For instance, some folks may have tumor in language (speech), motor, vision areas, etc and they decide not to operate. Or they couldn’t get enough tissue, for example. So our addressable market is going to be limited to some degree based on those factors as well.
Also, while majority of these nGBM patients would unfortunately have a recurrence, it doesn’t translate to a direct 2 X multiplier from a revenue perspective. It’s because you will no longer derive full revenue from nGBM patients once they get classified to rGBM.
It’s not so difficult to comprehend that some of the longs here are waiting for a major partnership or buyout news on MHRA or FDA approval. And I am one of them. Although, as more time passes by and as more dilutions occurs between now and then, that likelihood minimizes, at least in my way of thinking….
But other than that, there is frustration that this management is not maximizing shareholder value and doing justice to this platform, particularly with the technology & KOL support they have enjoyed over the years. So I will continue to raise my concerns until I sell 100% of my position.
I have been holding this for over 7 years. Increased my investment many folds in spring/summer of 2020, but also sold around 50% of my position this spring (almost 18 months post data lock) because I don’t have confidence in this management and importantly have no visibility/clarity around the US strategy. I have no doubt we will get UK approval but it won’t move the needle in a meaningful and sustainable way (as most shareholders expect) until we get clarity on the US go to market strategy.
I will likely increase my investment if we get an experienced yet dynamic team to run the show. A team that has a history of communicating clearly with shareholders and go after achieving those goals aggressively, particularly US market. Also, a team that takes ownership/responsibility rather than blaming their performance on nefarious characters. Plus their compensation ought to be tied to share price/market cap milestones. We have fantastic assets so it wouldn’t be too difficult to get an experienced yet fresh team on board to run the show.
Honestly, I will look to sell some more of my remaining shares on major pump/spike whenever that happens in the next 3-6 months unless they reveal their US strategy clearly. Overall, I won’t add more shares at this time, particularly with this management team and lack of clarity around US. And just FYI, I don’t short stocks.
Haha, occurring in dreams for now!!!
Although we did meet endpoints, so you gotta give it to him and the team!!
This management and board have not been able to convince the street despite sitting on good data, all the patents that we have accumulated and our technology. Maximizing shareholder value is one of their core responsibilities and they have either hidden behind the so called quiet period excuse or blamed it on evil shorts rather than taking responsibility. There’s always kicking the can down the road. It’s been 2 years since data lock for heavens sake.
They have been diluting us at these low SP when we ought to be worth a lot more at this time.
Rather than that true up, how about investing in the growth of the company to expedite things by multitasking on RAs. Why no FDA BLA yet? And how about tying their compensation to share price/market cap milestones similar to Elon Musk?
Time does not stay still. How long do we continue with more of the same (team) when the last 10-12 years paint a concerning picture?
Then I am less mad at them. At least, they took some advantage during that window of opportunity and were not a lame duck!
Agreed.
I think the board of directors were voted for 2 years at the last year’s ASM. We also need to vote “No” when that comes due. That’s likely our first step to perhaps forcing a change in management, provided there is no major partnership deal by then. I am fairly certain a buyout is out of the window for the foreseeable future given how things are being handled.
The question is why didn’t they dilute when we were trading at around $1.5 to 2 range in early May? You are now causing at least twice as much dilution by selling in .70 range. One likely explanation could be they expected SP to be higher after May 10 event?
These important strategic insights and decision making are what executives get paid for, right?
Even w/ the expectation of a pending partnership, shareholder dilution remains a big problem.
—-Agreed. What I don’t quite understand is why they didn’t sell some preferred C when we were around $2 in early May? Another blunder from management, in my opinion. We already know from couple of posters that they were being offered C at current SP. I don’t know if I can trust these guys to make a good partnership deal either in the future anymore. ;) It’s also entirely possible that nothing is lined up in terms of partnership….
No, I was talking about manufacturing facility certification for commercial production. We don’t have that yet and it my belief that our MAA will not be accepted until that’s in place.
It’s very likely that all the examples (other than DCVAX-L) that Flipper pointed to already had their manufacturing facility certified before their Final PIP decision letter was issued. Therefore these companies were in a great position to submit MAA closely on the heels of Final PIP decision letter. And in our case, NWBO management may have refrained from submitting MAA until Advent is certified for commercial use.
There are some unknowns around what MHRA inspection might lead to with regards to corrective actions (if any) in connection with commercial production certification. And that could drag on for a month or two longer than normal.
We will see how the timeline plays out in the end, but personally my expectations for MHRA approvals will be Q1.
Flipper, how can you be certain that Evinacumab and other examples you pointed earlier didn’t have their manufacturing site commercially certified before their respective Final PIP Decision Letter? Our situation is unique in this sense and that’s why I don’t expect approvals this year.
My sense is that our next PR will be around the manufacturing facility certification (commercial production).
I agree with you. Inflation is more a result of the loose monetary policies and printing money over the years rather than Russia-Ukraine war so much. Russia-Ukraine war did add to it, but certainly wasn’t the trigger point. At some point, the Fed had to hike interest rates to bring this under control and it was going to be painful regardless.
My sense is they will not issue a TLD statement as they are worried about legal ramifications. And I think they are still concerned about FDA. Otherwise there is no reason to not aggressively go after US market when it offers almost 10X revenue potential than UK.
We will simply have to wait for MHRA approval in Q1/Q2 2023. In between, we will get a couple of PRs indicating commercial manufacturing approvals and MAA acceptance. And likely a journal article.
“The journal article will inform clinicians about the trial results. Demand will come from that event as well as the surrounding PR that accompanies regulatory approval”
— You can’t rely on this if you wish to scale quickly in the healthcare world. Of course, the word will spread eventually to a vast majority but you will lose many months in that process. You got to have people on the ground. Clinicians don’t read publications on a routine basis. Very few are up to date. A lot of new business is relationship based and you have got to have people on the ground connecting the dots, otherwise things don’t change quickly in the clinical world unfortunately. I work with neurologists and neurosurgeons on a daily basis!
Only one thing makes sense with this strategy - a buyout or a partnership. We will find out by MHRA approval at the latest, if a buyout or partnership comes to fruition.
Otherwise they have been taking us along for a ride. Good luck!
Building a manufacturing facility is great, but it won’t generate the business for you. You got to build a commercial team to scale up, and you can’t flip a switch just like that! It takes time.
In my view, we won’t see a sustainable SP increase outside of a major partnership or of course buyout. They haven’t done anything meaningful to prepare us for a commercial launch. We are ways off, if they stay independent, so the market will punish us after a brief spike around the news!
Also, as you know, there are a series of issues with pricing in the EU, as each country effectively negotiates its own deal, irrespective of a broad EMA approval.
—- This is correct. This is why I continue to believe that they must go after FDA immediately and not EU, in parallel with MHRA. Individual country reimbursements within EU will take a while to resolve for a relatively small percentage of addressable revenue.
My offer still stands - provide your response to my detailed message in a point wise fashion like I did! I promise I won’t deflect like you and respond back in a systemic way addressing every argument you make.
Haha, for all factual and real debate!
If you want to have a real and factual discussion, address each of my points with your arguments. Here it is again, for your reference (in red).
1) Let's use UK as a base for building infrastructure, production, manufactoring, the compassionate use program because something tells us, that DCVax-L could disrupt BP's cancer market to a degree, where we could meet rough resistance by BP, hedges, news medias, big pharma and maybe FDA, making it harder for us to finish the trial and get approved.
-- Good job! Although, I'd argue that they could have done this an year or two earlier when they were waiting for the data to mature. That had many years to plan for this before data lock. This way, we don't have to wait for our MAA submission as we currently have been for manufacturing and other processes to catch up. Both PIP and commercial manufacturing approvals could have been done over an year ago so everything would line up. And just so you know, about 5-7% of the global revenue stream comes from UK. So you can continue to pump about UK, but until they get FDA approval, we will remain a small shop.
2) Let's extend the trial, because we risk FDA won't approve DCvax-L even though we have excellent data, because we are not able to supply demand with the current DCVax-L manufactoring method.
-- Extending the trial was a great decision, but BS argument on manufacturing. Quite a few CAR-T drugs are approved by FDA. And the manufacturing process of these drugs is even more involved than DCVAX-L. Plus these approved therapies have a much bigger addressable market than say a nGBM & rGBM! In essence, FDA has a history of approving drugs with limited and manual production for even a bigger addressable market as long as the data is rock solid, it addresses an unmet need, and the company has solid plans to scale up manufacturing. It's in the best interest of the agency to make such therapies available to the patients rather than keeping them in the closet until manufacturing scales up to produce tens of thousands of vaccines. Utter BS!
3) So ...let's buy Flaskworks and develop their technology to be able to automate and scale the production of DCvax-L and then we can also gather more data to the tail of year long survivors.
-- Good move. Although, we don't know whether Flaskworks will be approved for commercial production this year just yet. Again, not super critical that we have Flaskworks certified right off the bat. The agencies will work with us as we ramp up production, as I mentioned above. Besides, CRL is always an option with their presence worldwide while we continue to do V&V work on Flaskworks in UK. I still have my doubts that Flaskworks gets approved this year for commercial production!
4) The PFS endpoint doesn't work with immunology, because of pseudoprogression. It is an initial flare-up of the tumor after immunotherapy, which may change to a more favorable response. We need to be sure, that FDA agrees on that.
-- We must thank Dr. Linda Liau and the KOLs for their relentless efforts. But Dr. Bosch is instrumental as well.
5) We need to get FDA on the wagon regarding the use of crossover trial design, which was necessary for feasibility and ethical reasons: Necessary for enrollment and retention of patients in era when immune therapies not yet generally viewed as promising for cancer Important to justify all patients undergoing invasive leukapheresis procedure. No benefit to placebo patients unless they could receive their autologous product made from the leukapheresis. There's a necessity to differentiate between crossover patients and originally DCVax-L randomized patients, which is why the new secondary endpoint was introduced. OS endpoints could not be within-study comparisons of DCVax-L patients vs. placebo patients, because placebo patients received DCVax-L following crossover. So, the OS endpoints compared DCVax-L patients with external controls. This approach fits well with growing commentary in support of streamlined trial designs and use of external controls where classic within-study comparisons are not feasible.
This is why external controls were used; because internal controls, the actual patients, found DCVax-L so good that they went for it en masse. (excerpts of text from Seeking Alpha article)
So ... there it was. An article from FDA by 13 FDA employees including Pazdur, that greenlit the use of ECA.
-- Again, good work by the KOLs. However, you make it sound like all this FDA action is done with NWBO in mind. We are simply a drop in the bucket for FDA so snap out of it. If these things at FDA were being done with specifically NWBO in mind, then our management wouldn't be shying away from BLA filing here in the US. We'd have at least gotten PDUFA date, if not approvals by now!? US is around 50% of the global pharma revenue and here we are working towards UK approvals, which is 5-7% of the global addressable revenue. So there is some mystery here to say the least!
6) Let's keep NWBO slim and "buyout'able" and move the CDMO part over into an external entity Advent Bioservices, that could exist both after an eventual BO, but also as a separate entity, if a suitor wouldn't want that "to go". We've learned from Dendreon.
-- This strategy is good if a buyout is on the table, but we don't know. However, if that doesn't come through, this would get ugly because they have done next to nothing to prepare for a go-to market strategy. When you have a break through therapy (that will be approved in short order) then you start building a commercial team many months in advance. This is not happening. Why is that? Are they not confident in approvals? Are they leaving it too late? Or is buyout pretty much a done deal? I will tell you from my 20 years experience in neurology and neuroscience world that hiring talented folks with relevant experience in this domain is quite challenging and time consuming....in case, they wish to stay independent, it's already too late to see any meaningful revenue traction in 2023 and you can sticky this post for that! So in short, in absence of a buyout, we will remain a boutique shop and not be able to scale meaningfully in 2023 and the markets will punish us whether you like it or not. Perhaps management is not thinking that far ahead because they are strapped on resources? How about voiding the true up and using that to fund ongoing operations to scale up quickly?
By the way, what about all the missed deadlines with publication and TLD based on their official PRs in 2020? Did they not anticipate the challenges when they said months and we are now years? LG saying UK approvals imminent on big booze show in the summer of 2020. Again, either incompetence (or put it across nicely inexperience!) or BS.
I am not even going back to their missed statements from mid 2010s when they were talking about data lock and results soon, etc. What does that indicate or were they BSing us? There seems to be some sort of pattern
Gary,
Agreed. We really don't know what they are doing. And understand this, if we longs do not know what is going on despite following this company passionately for so many years (I have been invested since 2015, I think), I don't know how they will convince the street?
From an outside, it appears that buyout or a major partnership in the next 4-6 months would fit in with their way of handling things so far. Outside that, I am having a hard time making sense of their strategy and their nonchalant behavior....
What option other than CRL do they have for US FDA application, if they stay independent? Could they go with Advent in UK or wait another 2-3 years to build/certify a new manufacturing facility in US before FDA application? I'd tend to think CRL would be the most logical option and they could have flipped that switch earlier...so there is a bit of mystery as to why they aren't going after FDA BLA submission, which is almost 10X bigger than UK in terms of potential revenue...
Exactly my point!
Also feel free to educate this board on how they might handle US manufacturing otherwise for FDA application? Will they wait 2-3 years to build/certify their own and then apply for FDA or will they handle it from UK?
BS again. Just contract it to out to CRL with annual contracts as they have worldwide presence. They have already had this relationship!
DNDN failed because they tried to build their own facilities which requires significant investment…Plus they were a bit ahead of the times.
NWBO didn’t have to do that because CRL can make that available for them with minimal upfront investment. Smaller margins initially than going via their own like Advent, but they get to market sooner. Unless of course you want to give excuses for lack of timely execution! ;)
Are you proposing that NWBO build their own manufacturing facility in the US and go through another 2-3 years of waiting for the facilities to be certified? That would be stupid when CRL is available.
Keeping Flaskworks initially at Advent is the right strategy, but Flaskworks is not required for any RA initially.
1) Let's use UK as a base for building infrastructure, production, manufactoring, the compassionate use program because something tells us, that DCVax-L could disrupt BP's cancer market to a degree, where we could meet rough resistance by BP, hedges, news medias, big pharma and maybe FDA, making it harder for us to finish the trial and get approved.
-- Good job! Although, I'd argue that they could have done this an year or two earlier when they were waiting for the data to mature. That had many years to plan for this before data lock. This way, we don't have to wait for our MAA submission as we currently have been for manufacturing and other processes to catch up. Both PIP and commercial manufacturing approvals could have been done over an year ago so everything would line up. And just so you know, about 5-7% of the global revenue stream comes from UK. So you can continue to pump about UK, but until they get FDA approval, we will remain a small shop.
2) Let's extend the trial, because we risk FDA won't approve DCvax-L even though we have excellent data, because we are not able to supply demand with the current DCVax-L manufactoring method.
-- Extending the trial was a great decision, but BS argument on manufacturing. Quite a few CAR-T drugs are approved by FDA. And the manufacturing process of these drugs is even more involved than DCVAX-L. Plus these approved therapies have a much bigger addressable market than say a nGBM & rGBM! In essence, FDA has a history of approving drugs with limited and manual production for even a bigger addressable market as long as the data is rock solid, it addresses an unmet need, and the company has solid plans to scale up manufacturing. It's in the best interest of the agency to make such therapies available to the patients rather than keeping them in the closet until manufacturing scales up to produce tens of thousands of vaccines. Utter BS!
3) So ...let's buy Flaskworks and develop their technology to be able to automate and scale the production of DCvax-L and then we can also gather more data to the tail of year long survivors.
-- Good move. Although, we don't know whether Flaskworks will be approved for commercial production this year just yet. Again, not super critical that we have Flaskworks certified right off the bat. The agencies will work with us as we ramp up production, as I mentioned above. Besides, CRL is always an option with their presence worldwide while we continue to do V&V work on Flaskworks in UK. I still have my doubts that Flaskworks gets approved this year for commercial production!
4) The PFS endpoint doesn't work with immunology, because of pseudoprogression. It is an initial flare-up of the tumor after immunotherapy, which may change to a more favorable response. We need to be sure, that FDA agrees on that.
-- We must thank Dr. Linda Liau and the KOLs for their relentless efforts. But Dr. Bosch is instrumental as well.
5) We need to get FDA on the wagon regarding the use of crossover trial design, which was necessary for feasibility and ethical reasons: Necessary for enrollment and retention of patients in era when immune therapies not yet generally viewed as promising for cancer Important to justify all patients undergoing invasive leukapheresis procedure. No benefit to placebo patients unless they could receive their autologous product made from the leukapheresis. There's a necessity to differentiate between crossover patients and originally DCVax-L randomized patients, which is why the new secondary endpoint was introduced. OS endpoints could not be within-study comparisons of DCVax-L patients vs. placebo patients, because placebo patients received DCVax-L following crossover. So, the OS endpoints compared DCVax-L patients with external controls. This approach fits well with growing commentary in support of streamlined trial designs and use of external controls where classic within-study comparisons are not feasible.
This is why external controls were used; because internal controls, the actual patients, found DCVax-L so good that they went for it en masse. (excerpts of text from Seeking Alpha article)
So ... there it was. An article from FDA by 13 FDA employees including Pazdur, that greenlit the use of ECA.
-- Again, good work by the KOLs. However, you make it sound like all this FDA action is done with NWBO in mind. We are simply a drop in the bucket for FDA so snap out of it. If these things at FDA were being done with specifically NWBO in mind, then our management wouldn't be shying away from BLA filing here in the US. We'd have at least gotten PDUFA date, if not approvals by now!? US is around 50% of the global pharma revenue and here we are working towards UK approvals, which is 5-7% of the global addressable revenue. So there is some mystery here to say the least!
6) Let's keep NWBO slim and "buyout'able" and move the CDMO part over into an external entity Advent Bioservices, that could exist both after an eventual BO, but also as a separate entity, if a suitor wouldn't want that "to go". We've learned from Dendreon.
-- This strategy is good if a buyout is on the table, but we don't know. However, if that doesn't come through, this would get ugly because they have done next to nothing to prepare for a go-to market strategy. When you have a break through therapy (that will be approved in short order) then you start building a commercial team many months in advance. This is not happening. Why is that? Are they not confident in approvals? Are they leaving it too late? Or is buyout pretty much a done deal? I will tell you from my 20 years experience in neurology and neuroscience world that hiring talented folks with relevant experience in this domain is quite challenging and time consuming....in case, they wish to stay independent, it's already too late to see any meaningful revenue traction in 2023 and you can sticky this post for that! So in short, in absence of a buyout, we will remain a boutique shop and not be able to scale meaningfully in 2023 and the markets will punish us whether you like it or not. Perhaps management is not thinking that far ahead because they are strapped on resources? How about voiding the true up and using that to fund ongoing operations to scale up quickly?
By the way, what about all the missed deadlines with publication and TLD based on their official PRs in 2020? Did they not anticipate the challenges when they said months and we are now years? LG saying UK approvals imminent on big booze show in the summer of 2020. Again, either incompetence (or put it across nicely inexperience!) or BS.
I am not even going back to their missed statements from mid 2010s when they were talking about data lock and results soon, etc. What does that indicate or were they BSing us? There seems to be some sort of pattern
I have said all along no MHRA approval until Q1 2023 at best. And no reimbursements until Q2 2023. Again, these are best case scenarios and things may slip if commercial production certification gets delayed due to non compliance and back and forth with the auditors.
Time and again, we have seen that this management is not proactive and lack the experience and foresight. I don’t see an aggressive go-to market strategy/plan from this team! As a consequence, we will remain a boutique shop even after approvals and reimbursements. We really need a major partner or buyout that can take the reins away from this group. If one of these scenarios do not occur soon, I’d be quite concerned.
More excuses! No one to blame but the management, they are in charge of running the show.
You can deflect all the blame you want on small retail investors like me (who believe in the science and the KOL supporting the technology) but for once ping the management to convince the street with their strategy and meaningful actions! This way, none of this external noise will matter….unless you are happy with where we are currently trading at!
Or are you suggesting that’s not their job?
So what you’re suggesting is we deserve to be at $600-700M market cap valuation now and not a couple of billion dollars when we are sitting on breakthrough ph 3 data? Why did the management try to halt on May 10 then? You also seem to indicate that the events at NYAS and ASCO were done for a specific purpose, but SP appreciation or value creation wasn’t one of them. With that logic, we ought to be skeptical with future SNO presentations and such? Anyway, I disagree with these excuses, but I am not going to argue any further.
I expect another pump before the publication. There will always be evil forces trying to take advantage of the situation and perhaps we shouldn’t rely on much support from management again…it’s too much to ask the management to put their big boy pants on and defend the retail shareholders!
Anyway, if they can’t convince the street on the value they are delivering then investors will sell again on the next pump.
It’s important to understand this as an investor to future proof our investment. Otherwise, how can we trust them to not fumble again? It’s happened quite a few times in the last 10 years and it’s concerning. We are a pre revenue biotech company and these things matter a lot more than a company that has hundreds of million in annual revenue to fall back on. The street will continue to have a hard time believing in our story with such missteps and the can will be kicked further down the road (in terms of retail seeing any meaningful and sustainable SP appreciation any time soon).
We have been exploring Alzheimer’s Dementia lately. They will make for good participants in our future study, I think….
I wonder if they will be similar in magnitude to a serious of compassionate use approval PRs we saw last year!? We did generate about $1M in revenue from compassionate use this year! ;)
LOL, there will be no true up and no BS, that much I can promise. ;)
Yes, they will dangle a carrot to get us to vote on share count raise. They are running this as their own private company and it’s unfortunate that retail is not asking for any accountability. Just ridiculous!
PM, I am not so sure about their deal making prowess give the excessive dilution we have endured over the years. We will find out in the next month or two how preferred C gets handled. They had an opportunity to get some issued around $2 range a couple of months ago, but they decided to offer at .60s to some of their friends last month!
How strategic of this management to dilute us at .60s and .70s when they had an opportunity around $2 range a couple of months ago!