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I do believe the news will hit when no one is expecting it. It will definitely be in Q1, just don’t know when.
Agreed. We need a big pharma with resource, reputation, and experience to scale this big in the shortest time frame possible. NWBO management knows this too and so does LL. The management is just trying to create a win-win for everyone and RA approvals would be that sweet spot when they hand the reigns over to Merck, I think.
Yup buyout soon after RA approvals. They are not growing any younger unfortunately! And they are all too smart and forward thinking to not put strategic growth plans in place for the next 3-5 years if they were going to stay independent.
LOL, folks bought fancy tote bags during Black Friday sale! No need to travel to Boston!
I agree we are close. It’s likely we get UK certification news in Dec.
I also predict we get a buyout by Merck in 2022. Merck needs this more than ever to secure their future.
A big positive in this PR is again a reference to TLD and post TLD (“ Upon announcement of the top line data ("TLD") from the Company's Phase III clinical trial of DCVax®-L for Glioblastoma brain cancer, the lender will have a….”). The constant narrative by shorts over the months that NWBO is a scam and is never going to release TLD falls flat. They have again publicly stated how important this is to the management. The shorts can put as much pressure as they want so that the NWBO management would release results prematurely and in the process piss FDA, but it ain’t happening! It will be throughly wedded by elite peer reviewers with support from FDA!
I have experienced this in the past as well whenever I put in an order of 10k or higher number of shares. Sometimes it dips below momentarily and yet doesn’t fill my order.
We have LL, KA, and the esteemed SAB on our side. Alongside our platform technology, that’s one of the biggest advantage of NWBO over CVM. In fact, no other late stage ph 3 small biotech has been able to accumulate such a stellar group of key opinion leading scientists and clinicians by their side!
I have no doubt they will get GMP certification and it’s all to our benefit. I just don’t think it will happen this month based on their PR from a couple of weeks. Could very likely happen next month though!
I agree with you. Must hand over the reigns to experienced big pharma immediately after approval. They probably already have a term sheet in place, just need to executive on approvals!
One thing is clear they (NWBO management, LL and SAB) believe they have a great shot at FDA approval now with everything we have seen emerge this year. That was probably not the case about 15 months ago because they said they would go after UK MHRA first. Or at least they would have thought the likelihood and timing of getting UK MHRA approval was better than FDA at that point.
Having said that, we forget that UK MHRA and EU approvals is going to happen, just a matter of time. With just the UK and EU approvals, we ought to be around $3-5B market cap!
In terms of our SP movement, this period reminds me of the market crash we had in Feb-March last year around early COVID cases. Folks that had the courage and vision to purchase during that dark period were the ones that made a ton of money. We are in a similar period, I think. We are close and we will turn around sharply when the news start pouring in.
I don’t think Sawston certification is happening next week, but I bought more this morning. However, they could update on the progress of Flaskworks testing any day! I think US clinical registry update would be massive and that could literally happen any day.
Can someone confirm if LL and SAB members are/were at the SNO conference in person? If they are attending virtually and not in person, it suggests they are pretty close to the final reveal and they are being extra cautious to avoid accidentally leaking at such a large and important gathering!
“FDA does come down hard on coming soon violations.”
I agree with you 100%. My 15+ year experience in medical device industry aligns with this as well.
I also agree that FDA approval will come first with everything that has come to light this year. Certainly quite a few things changed over the last 12-15 months when they said they would go after UK MHRA first…all the evidence piling up in 2021 suggests FDA is supportive and they are on course to approve this, which explains their change in strategy! Exciting times ahead! Buying more next week.
Nice and simple! On the regulatory side, one thing that is emerging in this silent period is that FDA is supporting them as well. If you would have asked this a few months back it wasn’t as evident to most folks including myself that this is the case. It’s likely they get FDA approval before UK MHRA in 2022.
Well said! She is the one of the big reason why most of us are still around. It’s also clear from DI’s recent comments that we appear to be in peer review stage. So if some of the queries are resolved soon then this could be wrapped up fairly quickly. This is why we are seeing increasing FUD by shorts. They know they don’t have much time and the good news can hit any day!!!
My problem is with management’s lack of experience and not executing in a timely fashion. They come across as a bunch of folks that do not appreciate the value of time and seem to want to play a victim card rather than being proactive and finding solutions.
I personally don’t buy that. Only LP has an ownership stake in Advent. Why would Marnix, Les, Dave, and others in executive management support her? Wouldn’t Advisory Board as well as LL & KA terminate their relationship with the company if something like this was going behind the scenes?
Besides they all (NWBO executive management) have a ton riding on the success of NWBO with tens of millions of NWBO shares that are locked until TLD. Advent is peanuts!
Manipulation at its best coupled with emotion, psychology, and weak hands. Data will be great! UK and EU approvals are fairly certain regardless of how anyone spins it. And that alone deserves a minimum of $3-5 billion dollar market cap, I think.
LL and KA would have moved on and disconnected themselves from NWBO if they didn’t trust the management and thought this was a scam! Are they frustrated to some degree that this therapy is not brought to the patients as quickly as they would have liked? Yes, but they also realize the history of this trials and that the red tapes and bureaucracy at FDA are challenging to say the least.
Why did LL make those presentations in spring 2021, if the data wasn’t good? Why did KA spoke so highly of DCVAX-L and the outstanding OS numbers in May 2021 podcast? Both of them have consistently said this is their one of their most exciting research work to date. And that’s putting it mildly because it is LL’s most important contribution to the field. Why would Asian Hall Fame induct her this year for a seemingly failed trial and yet refer her as brain cancer vaccine neurosurgeon?
Here’s an article from him as first author about GBM. There should be an email address there if someone wants to reach out to confirm.
https://pubmed.ncbi.nlm.nih.gov/22045118/
I simply went by his name on StockTwits (Derek Johnson) and googled his name + SNO 2021, which resulted in this:
https://www.soc-neuro-onc.org/WEB/Membership/Special_Interest_Tracks_/WEB/Membership_Content/SNO_Special_Interest_Tracks_.aspx?hkey=8248bcff-bab6-49cc-991e-a0165105521a
It became clear that his interest is neuroimaging since he is listed under neuroimaging track. That’s sort of my background as well but on the research side! So I figured he is likely a Neuroradiologist or biomedical engineer. And I did a couple of searches with his name and adding neurology/neurologist/radiology and sure enough he showed up at Mayo Clinic in Rochester.
This is legit. Here’s his qualification (person that posted the photos):
Johnson, Derek R. M.D.
Mayo Clinic
Assistant Professor of Neurology
Assistant Professor of Radiology
Similar background to Dr. Tim Cloughesy at UCLA.
Why would NWBO still be promoting if the trial failed?
Agreed. Many retail investors here own a lot more than them, but I’d be curious to know if some of LP, LG friendlies are accumulating? MM’s are indeed manipulating this and it seems like a big bounce is around the corner. No one knows when the (good) news will hit us!
Agreed!
It has to be Merck. LL knows it’s been in works for the last couple of years. Probably one of the reasons she has stayed patient with NWBO management as she can trust Merck to scale this up quickly….this way, they are able to expand access to this game changing technology to patients worldwide.
Would an immediate Duffy replacement put them in a better position than they are now? Who knows we wouldn’t have to resort to all this financing and restructuring over the last few months. I’d have rather given couple of million shares as performance based stock grant to that executive. Hindsight, but this is what CEOs are paid for!
Markets could stay in bubble territory for a long period, but I’d certainly think we are closer to the end than the beginning. And at the pace they are moving, I don’t expect TLD+publication until Q2, 2022. They will continue to move timelines back every 2 months by restructuring warrants, loans, etc. to keep retail tuned in. At least there is consistency in that pattern! The other consistent theme has been COVID! ;)
I will sell half my LCID position today or tomorrow to buy more NWBO shares early next week if we get something positive at SNO over the weekend. Can’t believe that LCID could hit $100B market cap today. Already valued more than Ford & GM when they have sold less than 100 cars so far. Crazy market valuations!
This is also why I think time is of time essence for NWBO. We are pretty much in a bubble territory and could get tremendous lift off if we time this right - TLD+publication+conference+marketing+social media. Otherwise I worry we will only score a field goal instead of touch down once the psychology changes and risk appetite goes down!
So Regeneron executives now know this is in works too!
Interesting take and that explains why NWBO team is struggling a bit. At the same time, they seemed to be relaxed with how things are moving along because they have Merck deal in their back pocket. Although I’d expect some timelines in the agreement to get regulatory approvals accomplished!
On a serious note, what’s your opinion on Duffy jumping ship to Regeneron? Is that deliberate or Merck doesn’t care?
I respectfully disagree. If the science is as convincing as we all believe (plus the esteemed SAB and LL on your side) it wouldn’t be hard to attract the right talent if you’re seriously committed to filling that position, particularly this close to ph 3 approvals. These big pharma executives know they could strike really big with a promising biotech that have blockbuster technology…with the stock options and exit strategy!
About Duffy comment from DI, I’d take it with a grain of salt.
No doubt. It’s strange they didn’t hire anyone to replace Duffy after he left. We really need someone like him to help us navigate. Perhaps the Merck team has access to data (NDA) and are helping them behind the scenes?
I hope you’re right! The slow progress still bugs me with UK certification, dealings with CROs and ultimately TLD+publication. It would have moved faster if Merck was facilitating behind the scenes, I think!
Either way, this would make a great movie one day!
I don’t think it’s that. Perhaps ego or incompetence? They feel like they can get this accomplished on their own with the help of SAB & external consultants. In all of this, they probably underestimate the challenges. The complexity of this decade long trial adds to this, unfortunately. Not sure if you can fully trust the outside consultants to do this job for you when no one within the company has experience navigating around even relatively easy to moderate FDA drug approvals. How do you evaluate their performance? You have no real experience to fall back on for comparison? In essence, you’re blindly trusting these CROs. They may be taking NWBO management for a ride, who knows!
I don’t know why they don’t have a chief medical/regulatory officer on their team who has experience dealing with CROs and regulatory agencies. Unfortunately, the NWBO team have limited insight into who the right folks are and how to deal with them. Don’t understand their strategy. They continue to lose time and there is no end in sight! Unless Merck is working behind the scenes, which seems more and more unlikely given the slow progress.
The SAB and LL is not going to be able to provide meaningful input or for that matter have much experience/insight into this either. They have been in academia all their life!
That seems most likely given their pace!
If nothing happens at SNO, our next catalyst will be MHRA certification in Q1 unfortunately. They continue to make COVID excuses. I had my company’s audit done by British Standards institute (BSI) in a timely fashion couple of months ago. I know a couple of other medical device outfits that had no issues with such audits either. Also, there aren’t any major issues getting to university hospitals in US or Europe anymore and conducting research with neurosurgery patients. In fact, we were at UCLA neurosurgery twice for research visits with their patients over the last 2-3 months. Same for some sites in Boston, Amsterdam, etc. No restrictions!
I agree, they have been dangling this carrot.
I do not expect TLD, publication or MHRA certification this year. MHRA certification will be in Q1, 2022. TLD+publication in Q2, 2022. Meanwhile, they will continue to dangle carrots and blame COVID for their incompetence!
I don’t think that’s the case. Don’t you think LL would have spoken about this or urged the company to reveal the data if it had failed? She just got inducted in Asian hall of fame, predominantly for her brain cancer vaccine work. The results are bound to be stellar. Even the shorts agree now that the data is going to be great! ;) Just don’t trust the management to execute in a timely fashion given their lack of experience. Such a shame!
“The new language on all the delays is troubling to me. They added more detail on all the delays, but no clarity as to where we are now? Have things started moving again? Why, after all the delays, can’t they tell us more?”
Agreed. If this language is new then that’s concerning to me. I work with neurologists & neurosurgeons in my day job, and elective surgeries have opened up since a while. Research activities with these patients have also been active for the last few months. Makes me wonder if they have even submitted their first draft of the publication? Again, shows the lack of urgency and experience in handling such situations similar to the UK certification.