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I have a similar feeling as well, but we will see. I did say that we were not going to get MHRA approval until Q1 at the earliest and Q2 for reimbursement approvals and that too if we are lucky. Given the history of this trial, my sense is partnership won’t happen until MHRA approvals…Meanwhile, they will continue to dilute us in the 70 cent range….
If they were close to meaningful revenue generation, we would have seen a lot of hiring activity on the commercial side many months ago. Unless a commercial partner is lined up. So again the question is are we going to see a partnership agreement soon or are we quarters away from any real revenue uptick.
Agreed. I made the same mistake during the first two pumps of not selling given all the hype and imminent buyout scenarios….It’s clear now there is no buyout in the near to mid term…We would be lucky if we get partnership this year or first half of next year on MHRA approval. Otherwise this will continue to be a long journey for retail! They haven’t made any moves on building a commercial team. Either, they are far off from building a meaningful commercial revenue stream (reimbursement negotiations & approvals) or a partner is lined up. There is no middle ground anymore.
I have been out of action on this MB lately as this is a busy time of the year at work.
And you will sell 50% again on the next pump! ;) Nothing wrong with it, just saying. You are kind of contradicting yourself with some of your statements.
Greetings from Stanford!
Yes I saw that this morning. It’s reassuring and in fact super promising. The KOLs believe!
Well said!
Aren’t you expecting a lot from a small group? ;)
The real question is at what share price the big partner come in? That’s when the max dilution will happen (around 20% as you say).
I agree. It’s kind of baked in now, unfortunately. Unless there is some compelling narrative around the data that was not highlighted during the presentations at NYAS and by KA and LL in the last few months.
Gary,
I think we are close on UK MAA application (we should have acceptance news PR this year) but I don’t believe we have made much progress on FDA BLA application. That’s my take.
Agreed. I wrote about this a few times about an year ago that you really need an in house regulatory expert to help navigate (plan ahead) and manage this ship. Otherwise you end up discovering things late in the game and in the process end up losing quite a bit of time. Outside regulatory consultants are great but their motivations, incentives, goals are quite different from someone within the company.
I have personally seen the impact of this up close, both good and bad, in medical device companies (big and small) I have worked with over the last 20 years.
“The official end of the NWBio Quiet Period. NWBio will be able to publicly and freely discuss its progress, plans and timing for DCVax-L regulatory submissions in the US, UK, Canada, Germany and the rest of the EU.”
JA does not forbid updates around regulatory submissions. They could do it now or could have done it 6-12 months ago if they wanted to. Let’s face it they haven’t updated us because there is limited progress on the applications per se given other requirements they need to fulfill first. They told us about PIP approval when progress was made. Likewise, they will tell us about commercial manufacturing approval once that comes through. Just remember - they will shout from the roof top as soon as the MAA is accepted regardless of whether the JA is out or not. And we may still be waiting for an official TLD at that point! ;)
We should get MHRA approval in the next 6 months, but let’s stay at above $2 for a week consistently, as a first hurdle. Then we will look forward to your $10 forecast through the rest of 2023! ;)
Good luck with your strategy! First things first, let’s hope our SP stays above $2 consistently for more than a week in the next 6 months. Perhaps it doesn’t matter for you since you are looking at a 2-3 year window or more, but for some of us, that will be the first test.
“A partnership is actually the next logical step to fund the company and set the conditions for a listing”
— Agree with that completely.
Do you seriously expect a partnership this year? I’d be very happy if that happens but I doubt we get partnership news before MHRA approvals.
The likely PRs we get the rest of the year will be centered around the commercial manufacturing certification & MAA acceptance, in addition to JA.
If the JA is extremely bullish and if we get Flaskworks approved for commercial use then we might get close to $2….otherwise these pieces of news are kind of baked in…at least that’s how I view it….
Let’s get to $2 and stay there for more than a couple of days! ;) We will talk then.
Fingers crossed! Although I still have my doubts we see anything meaningful this year and/or see the SP back to $2. It seems everyone is waiting to sell a portion when we get close to $2….where are the buyers going to come from?
It will be interesting to see how many C they sold in the next report.
“You made the best anti-management point of the week.“
- haha, agreed.
You still don’t understand in what circumstances those off label uses typically happen. We will not be there anytime soon. It will be a multi year process post approval, as I said.
Just read that document carefully and you will understand why!
Sorry to break your bubble but doesn’t work that way in real life! Without more data in other types of cancer, the medical doctors are not going to suggest this route to their patients. It would be premature. Plus 99% of the doctors outside neuro world has no idea what DCVAX is. And without reimbursements, it’s even more of a hard sell. We have all seen how compassionate use has gone so far.
It will be a multi year process and quite a bit of data accumulation in specific indications before the medical community gets behind even for off label use, unfortunately! Further, RA and reimbursements are a different ball game altogether.
Yup. I’d love to see a lawsuit against the likes of AF and stat news ASAP. We need to be on the offensive now to rebuild trust amongst shareholders. I think the scientific community is on our side.
Agreed. Let’s see how this month and next plays out. BB seems fairly confident we will see meaningful progress.
I appreciate the gesture, BB. You know what I am talking about. ;)
Let’s see how the next month or two pans out.
Interesting, worked with couple of key neuroscience researchers at SRI too over the years. Don’t know what LANL at Stanford is unless you mean Los Alamos National Laboratory. In that case, I have worked with couple of groups at LANL in New Mexico as well.
You may have noticed that I have issues with various public statements the executive management have made particularly since summer 2020. I do support their decision to extend the trial, Flaskworks acquisition, and importantly the relationships they have maintained with KOLs and the advisory board they have put together. These are really the top names in the neurosurgery world and to be honest is the primary reason I am still invested…because I take comfort in the fact that I have been personally working for a long time with some of the neurologists and neuroscientists that work under or collaborate with these neurosurgeons that are supporting NWBO…..these guys have all been doing phenomenal work over the years….having said that, I have also realized working in this space for 20 years that science and technology alone (even with good ph 3 clinical data) will not make you successful or get you what you deserve. I have seen too many companies that remained average despite all of this because of the executive management and the team around them (muddled strategy, execution, stubborn, not learning from the past, etc). You really need experienced folks who understand this landscape to strategize and scale quickly.
In short, I firmly believe we will be better off with an experienced big pharma partner. Time is of essence.
I don’t, but we are both speculating. The fact there is no formal lawsuit makes me want to stick with my theory. The same guys have lied and BS’d about our technology, data, IP, collaboration, etc. over the years. And what worries me is that NWBO management hasn’t done anything to take an aggressive stance. At the very least, they ought to go on offensive now with the data they have as well as the support they enjoy from KOLs. And really show the retail shareholders they have their back!
I agree with your statement. I signed up and watched the presentation live as well. The reality is they botched it. They had so much time to prepare for this and yet we got screwed.
In a well run company, the board would ask serious questions around the strategy and outcome. And in some cases, top executives in charge are fired!
All speculation. SEC may have bigger fish to fry. There is no way to tell this is happening behind the scenes. Why isn’t NWBO management initiating legal proceeding and protecting the shareholders? From an outsider, it appears they are hiding something and are worried about opening a can of worms!
We have licensed technology from Peter Tass (you might want to review some of his neuromodulation work, a researcher originally from Germany). Most well respected companies in the neuro diagnostic/therapy world works with Bob Fisher. And I also personally work with Anil Rama at Stanford and his private practice in Bay Area. There are other neuroscience researchers at Stanford I work with, but what do I know!
You don’t have to convince me regarding the data. We all know data is good. The management has failed to convince the street and FDA so far. They have been sitting on this for almost 2 years. Instead they continue to dilute us at 60-70 cents.
Yes, continued dilution at low share price while they remain silent (despite sitting on good news!) is best practice, LOL.
Big booze show!? ;) that’s our business dev leader’s choice, LOL.
I agree that would mean they are excited. Just surprised that such excitement doesn’t translate to bringing big investors on board at higher valuations rather than diluting the shareholders at 60-70 cents? I’d expect they’d shout from the rooftop as they did with specials certification last year, commercial manufacturing application, and PIP approvals this summer!
Why aren’t they hiring/building a commercial team if they were close to MHRA approvals? One of these 2 reasons make the most sense: 1) they are far off from reimbursement approvals or 2) they have a big partner lined up ready to go at MHRA/reimbursement approval.
If it turns out to be number 1 then don’t you agree they have been stringing retail along by their ambiguous statements and selective quiet period over the years?
LP in her own words in front of scientific community (virtual conference) in summer 2020 - we can’t wait to share the unblinded data with the community!
LG in summer 2020 - UK approval imminent. Again, another pump.
LP at the last ASM 15-18 months ago - our top 3 priorities are TLD, TLD, TLD!
Don’t these statements bother you?
Good luck getting the next run to $2 anytime soon! I think we go in the opposite direction (towards 50 cents) over the next few months as dilutions continue. In my opinion, manufacturing news and MAA acceptance is pretty much baked in, so I don’t think we will have significant upside as a result of those PRs. If they get Flaskworks commercially certified or announce FDA BLA acceptance then things could change quickly.
Haha, try this for a change:
LG on big booze show in summer 2020: UK MHRA approval imminent.
LP at a virtual scientific meeting in summer 2020: Can’t wait to share the unblinded data with the community in the coming weeks!
LP at the ASM 15-18 months ago: Our top 3 priorities are TLD TLD TLD. LOL
DI to posters in Jan-Feb 2022: Manuscript submitted. Timing outside our control now! Ashkan says they submitted after NYAS presentation. I trust Ashkan.
We don’t need to go to PRs and statements from mid 2010s, LOL.
LOL, feel free to continue to state that NWBO plan to use Advent for their FDA BLA filing! I think everyone will find this very enlightening.
Thanks for agreeing we are a few quarters away! Such team building takes many months (and not to forget training demand on top).
By the way, they have acknowledged this need to build commercial team in their public SEC disclosures recently.
BS again. Show me where they state explicitly that they plan to use Advent for US regulatory filing?
I’d be really concerned if they state that. That would be a recipe for disaster, by the way. Good luck getting FDA to accept their BLA!