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We are on the same page! I think they are taking a unique path to approval, but they seem to be super confident and so are the co-PIs supporting them in the US and Europe. They are not worried about short term share price movement or major financing either. Perhaps Merck is assisting them behind the scenes with the strategic side of things. As long as Merck doesn't announce any double digit billion dollar acquisition, we remain in the game to get that windfall next year (with the cash they generated from Organon spin off amongst others; remember their CEO said they are going to use that cash for a major business development opportunity!)
Agreed. The bigger picture for us is they are complimentary regardless of whatever ownership structure it may be. The most important thing is it gives NWBO an inexpensive, expedient, and trustworthy facility to test flaskworks device. I wouldn’t do this at a CRL. They wouldn’t do justice as it eats into their future business.
LL inducted into Asian hall of fame! Brain cancer vaccine pioneer!
https://www.prnewswire.com/news-releases/asian-hall-of-fame-unveils-new-inductees-301379061.html
How can you not trust her to get DCVAX-L therapy approved? Buying more!
I agree. It’s not a zero-sum deal. It’s in fact complimentary!
Hi, I don’t remember her exact words but if memory serves me well this occurred last Nov during her presentation at University of Alabama Birmingham. She was responding to one of the questions after her presentation, I think, where she made a reference to the slow decision making at FDA when someone asked her about the status of DCVAX trial and what’s taking so long or something along those lines….I think she then joked around saying if she knew the trial and her most important work would take this long to get approved through the RAs she would have done something else in her career!
Again, don’t quote me on this…this is my vague recollection of her sentiments at that time….I have read quite a bit about her and followed pretty much all her interviews, talks, etc. that are out in public domain before I decided to invest over $250k in this company…few things are crystal clear - she is extremely knowledgeable and well respected in her field and a tenacious lady that won’t give up, having gone through adversities in life both professionally and personally over the years!
I don’t know if anyone has access to or recorded her talk at UAB (Nov 2020).
That’s my sense as well. It’s likely in the final review/approval stage. I expect a publication this year for sure. Very likely in Oct/Nov time frame.
Awesome! And the fact that DI is open to communicating with major shareholders is also a sign of confidence to me. If the trial had failed or results were underwhelming, I’d not engage in any one-on-one communication and simply put out pump pieces to finance before releasing data!
UK & EU accepted it last year. FDA has not been easy to convince one way or another and LL alluded to this last year, I think. My sense is a top notch peer reviewed pub, updated WHO GBM definition, and UK approvals will do the trick for FDA officials eventually as well. I think NWBO management is handling this very tactfully! And LL is fully supportive of this strategy and is persistent by nature. Won’t take no for an answer!
That’s encouraging! Can we get an article in Lancet on Oct 1? Oct-Nov would also make a lot of sense from a timing perspective given it would be about an year from data lock. We could get a series of PRs and events in the coming weeks:
1) UK manufacturing certification
2) TLD
3) Peer-reviewed publication
4) LL symposium at CNS on Oct 17
Immunotherapy for Brain Tumors: New Concepts
Sunday, October 17, 2021 - 12:45 - 4:15 pm
Directors/Moderators: E. Antonio Chiocca, Linda M. Liau
Faculty: Nduka M. Amankulor, William T. Curry, Peter E. Fecci, Amy B. Heimberger, Michael Lim, Edjah K. Nduom, Hideho Okada, Ian F. Parney
Could they possibly announce both TLD and BLA submission (to all 4 RAs) in one PR in Q4 this year? I just don’t know if they would have had sufficient time behind the scenes to put this together assuming they have been unblinded this spring. Formal peer-reviewed publication immediately follows the next day of this PR or something along those lines.
"Additionally, dendritic cell vaccines (including DCVax-L and DCVax-Direct) have shown success in treating cancer"
This is an excellent testimonial from one of the top tier cancer research centers.
https://siteman.wustl.edu/personalized-brain-tumor-treatment/
Agreed. Well articulated!
LL and KA wouldn’t be supporting the company if they didn’t trust the science, outcomes as well as folks running the company. I would trust their opinion & credibility over anyone else on this board!
By the way, what do you call Elon Musk then? He continues to promise Full Self Driving on Tesla cars every year. He has been saying it will be released before the end of the year since the last 5-6 years.
We wouldn’t know why did that. It’s likely their advisory board recommended that strategy. My sense is that LL knew what was coming with updated WHO definition. So they decided to hold off on the release of TLD until that was out. And utilize that time to work on a high impact publication with those WHO updates in mind? This in turn also gives them time to work on getting UK manufacturing facility certified as well as begin Flaswork testing. This way, they can provide real world evidence to the RAs they are serious about scaling manufacturing and bringing the costs of personalized therapy down. The results are going to be stellar regardless. Science as well as the blended and compassionate use data from hundreds of patients doesn’t lie. The real question will be how fast they can scale manufacturing and make it competitive in terms of pricing and yet have enough margins to thrive.
Is LL @ UCLA and KA @ Kings College London in on the scam too? They have been on record highlighting promising aspects of DCVAX-L trial as recently as May 2021. And LL highlighting SAP in her presentations in May 2021. If the trial failed, why would she risk her credibility? Same applies to KA, why would he talk so highly of DCVAX-L as his best and most exciting research work in the podcast on May 2021. They are two of the most respect neurosurgeons in the world and love what they do on the research side. NWBO is not even funding any of their research work anymore. They clearly see this as a game changing technology for the patient population.
Agreed. I went through one personally a few years ago and we had folks from the acquisition company visit us on a number of occasions as well as our KOL clinical research labs in US & Europe. We had to make several presentations to their subject matter experts and provide a ton of documents to their M&A team. They visited our production facility a few times as well. I think it was around 6 months external due diligence between their team, our team and our customers, and then another 6 months of their own internal executive/board member discussions before a PR was released that they decided to acquire our company. Those last few months in particular were the most difficult period for us because we had very limited communication from them. Although they had told us that they plan to acquire us at the price we agreed upon mid way through those final few months, the timelines (on when they would make it official) kept shifting and we were asked to keep mum and not contact them until an official PR was out. At times we were worried that there could be change of direction. Some of it may have been a negotiation tactic, but mostly it was ensuring there was no information leak as they were a publicly traded company (amongst the top 5 medical device company) and needless to say they took that very seriously.
I can’t imagine what NWBO management will be going through because our acquisition was about 20-25 times less (in dollars) than what NWBO will be acquired for.
I have been thinking about this too. Could Regeneron get into the mix now? Will Merck be more anxious than ever to get this deal done sooner given Duffy’s recent move to one of their competitors? Could there be a price war? Don’t know how much buying power Regeneron may have…they are currently close to $80B market cap…I guess Gilead is a similar market cap company and they were able to pull off a $21B (Immunomedics) & $12B (Kite) acquisitions.
Also BMY acquiring Celgene for $74B was also quite significant when the acquiring company was only around 2 times the market cap of the company they acquired.
So it seems like Regeneron would have the muscle to put in an offer in the $20-25B range too, if they get serious.
By the way, I did some research on this a while back too before investing in NWBO. LP had left Enron a couple of years before the scam broke out. Plus the folks involved were well above her pay grade. I don’t think LL or KA would have stuck around with this company for over a decade if they have had any hint of such behavior over the years. They are two of the key opinion leading clinicians and researchers in the world with the highest integrity. You don’t get there by taking short cuts or by working with scam artists! They wouldn’t stand one bit of it!
Both LL and KA have been speaking very highly of their work on DCVAX as recently as May this year. In fact, LL has been on a road show this spring showing off SAP for this trial! She believes and everyone at NWBO believes we will be successful. It’s been a long & arduous journey but game changing technology never comes easy!
Make sense. Merck’s former CEO, Frazier, has been on record in a couple of interviews (published & documented in the last year or so) stating that ph 3 biotech companies are expensive buys when he was probed about Merck’s M&A strategy. That could be directly pointing to their experience with NWBO negotiations. Basically, he spoke about their interest in looking at both ph 1 & ph 3 companies and see what makes sense both strategically and financially.
It’s extremely likely that LP asked for double digit billion dollar figure even around late 2019 (when Duffy joined the company) and Merck decided to wait until ph 3 data was officially unblinded and perhaps approved by RAs? This would ensure there is minimal to no risk even if that meant LP’s asking price was going to be 5-10 billion more than what they may have discussed in 2019. They could justify this to all stakeholders involved.
Agreed. Management is super confident and connecting all the dots! It’s going to be a fun next few weeks/months!
It seems you are getting increasingly anxious every day more so than even some of the longs with a very short term outlook. Regardless of how much you shout from the rooftop and try to create panic with the same story, no one here or the management will fall for it. They will release the TLD when we have a top notch peer reviewed publication ready. And I am sure you guys will pivot and try to come up with another silly argument to attack the management then! LP and the team has endured enough over the years but they are well prepared this time, so watch out when a series of back-to-back news come out later this year. Who knows a buyout news comes close enough as well to trap the shorts! ;) They seemed to be super confident, but that doesn’t appear to be the case with you repeating the same thing over and over again!
Also, renewed focus on patents to me point to a buyout in 2022. Buyer wants to ensure the technology is well protected if they are going to pay anywhere close to $20B. Plus the confidence and discipline of NWBO top management during this quiet period when they have good news in their hands is also telling. There are just too many signs that point in this direction.
LL is not distancing herself. In fact, it's quite the opposite, if you take time to study her presentations over the last year or so in particular. She is taking full charge in terms of garnering support and convincing her clinical and research colleagues + FDA regarding their SAP. She is tenacious by nature and won't give up until we secure FDA approval in 2022! By the way, UK MHRA and EU approvals are in the bag, just a matter of time!
You should also read about her life's journey and some of the interview's she has given over the last few years. It's obvious this is her most important work and she is extremely proud of it. She also has a business degree from UCLA and is fully aware of the stock manipulation NWBO had to endure over the years. Her favorite movie - the big short! ;)
She has also spoken openly about how women leaders have had to struggle a lot more to be recognized for their work. On the corporate side, her inspiration is Meg Whitman (former CEO of ebay). I am sure she is rooting for LP to succeed!
Agreed. There are a bunch of European and Asian companies that are traded on OTC in a similar fashion. Some with market cap in hundreds of billions of dollars. Look at SFTBY, BAESY, TCEHY, SBRCY, etc. They are all heavy weights and well respected in their respective countries and abroad. One of the companies from China (Tencent) is valued at over $600B market cap.
One of my friends who also enjoy technical analysis messaged me earlier today along the same lines you post here. We’re heading much higher in September!
I just expected Merck to keep him for at least an year or so post acquisition since he had the inside scoop and could have been tapped for planing and navigation pre/post acquisition. But Poor man made a good point that his boss retired earlier this year and that may have resulted in him moving on as well. Hopefully someone higher up at Merck has also been championing the buyout given that Duffy and his boss are not with Merck anymore!
Good point!
Agreed. Many signs point in that direction. Although I am a bit surprised Kevin Duffy is now working for Regeneron since last 4 months. It would be interesting if he comes back after NWBO acquisition. Or could Regeneron come in play?
“So Maverick, using this background does that mean we can expect NWBO to be acquired in early 2022 or after fall 2022. When did/does that clock start ticking?“
— it’s hard to say what’s going on behind the scenes. If they haven’t shared data with Merck yet (under NDA), it’s more likely for this acquisition to go through in the second half of 2022 than the first half.
Merck spin off of Organon couple of months ago and subsequent statement by their new CEO that they plan to put that cash ($9B) to work on a new business development opportunity gives some hope that it will happen sooner than later….but it’s a bit of speculation at this point...
It certainly can be done alone with the truly game changing technology they have, but will need a significant investment over the course of their journey to scale in a timely fashion. Also, they will likely need to bring in external top management talent to help them achieve this dream. On the other hand, the age of their current management team gives a strong impression that they are setting it up for a buyout in the next year or so.
I can tell you from my personal experience in medical device space that such acquisitions take a long time to get the necessary support and approvals in place. My previous company was acquired by one of the top 5 medical device companies and it almost took them around 9 months to get everything in place on their side after their M&A team decided they wanted to acquire us. I was involved in this M&A activity from our company’s side, helping them with their due diligence (such as scheduling meetings with KOLs that used our equipment in US & Europe, regulatory docs, patent, product questions, etc). By the way, our company was acquired for around $100M. So I can’t imagine the hoops they will have to jump through for an acquisition in the range of $20B.
Who knows we may see more and more small biotech companies take this approach in the future with NWBO leading the way! Just like how Tesla changed the car market for the foreseeable future. I can not think of any mass production car company before Tesla that took 6 months to an year to deliver cars to their customers, but Tesla prevailed and became the most successful car company in the world. In fact, many new car companies are now adopting this business model and following in the footsteps of Tesla. Disrupting companies with game changing technology are often the first ones to chart a new unconventional course!
What’s your take on the data from 2018 publication?
Agreed. They are going nuts that LP and NWBO advisory team has taken this route. They are not in control anymore and it seems they are way more concerned than even some of the longs with short time horizon!
There is also only one Tesla and one Apple, by the way. They changed the whole experience and the way we buy cars and smart phones. None of their competitors and in fact the whole industry did anything remotely close to what they do over the last few decades. They faced a ton of challenges early on in their journey and there were a ton of skeptics! If it were up to you, these companies are fraud and do not deserve to be successful?
Regardless of what you say, they are the most successful companies in the world as well as the future of their respective sector. More often than not, you take an unconventional path to disrupt and become world leader! Sometimes it takes multiple years for community at large to acknowledge and appreciate the game changing impact such companies have on the society.
Look at what is happening to Cassava (SAVA) stock. They announced positive ph 3 data recently for their Alzheimer’s drug, and one of the analyst (likely a short) is questioning data integrity. They lost more than 50% of their market cap (shaved around $2.6B of their market cap) last week. Overall, the stock had been up around 7X since the beginning of this year until a week ago.
I commend LP and the whole advisory team to take this brave step of going with top notch peer reviewed paper in parallel with TLD announcement. My confidence in the top management grows with ever passing day. I am sure it’s tough as hell to remain quiet and disciplined when you have great results, but they are doing what’s best to get DCVAX-L approved by all 4 RAs. A group of investors with short term outlook are anxious, but the management is doing the right thing. In essence, getting a publication & manufacturing facility ready before TLD doesn’t really impact the overall timing of getting the regulatory approvals and ultimately access to therapy for the patients. This strategy will minimize distraction once these PRs come out. Shorts simply hate this as they’ve never dealt with such approach before!
Agreed. Both LL and KA are rockstars and continue to believe this is their important and exciting work to date. All signs point to approvals by 4 RAs. Just a matter of time and getting all the ducks in a row!
I expect a 3X jump around the release of TLD/publication if they are released in parallel or a day or two from each other. We’d have compressed what would typically be a one year cycle/lead time to within one or two days between those events. So I’d think we ought to at least jump by 3 times within a couple of days. Additionally, if the results are phenomenal and we get a ton of media attention, who knows where we could be!
Thanks for sharing this! This talk again highlights the support towards NWBO trial and direction the field is moving towards! Loud and clear!
It also seems to me that most of the delay that we have been facing is likely due to external data access and some of the queries around it rather than ours. Although LL charted these plots during her presentations in May, I suspect they may end up using a subset of those for comparison….and all of that process is probably taking longer than expected? Either way, I expect TLD/publication around end of October, if not sooner.
Good one, those would be really informative!
Wouldn’t it be great if she received Nobel price for this work!? In a very small way, a lot of long time investors/supporters become part of this journey too!
Agreed. She has certainly seen the data and is super positive it’s going to get approved by all 4 RAs. I mean we knew that during her presentations in May as well, but this solidifies it further (no more doubts!). Moreover, today’s comments also point to her bullish take on the scale up of manufacturing and pretty much everything progressing in a timely fashion going forward. If she would have thought we were still over an year away from FDA approval, I am not sure she would have responded in that fashion.