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That’s classic procrastination, Gary. What if UK commercial manufacturing was approved by now and their PIP took the normal 12 month course and not 6 months? They would have been waiting for PIP approval for a few months in that case. Just shows their relaxed attitude towards things!
FDA will not accept their application until they provide proof of a certified manufacturing facility that has the capability and trained personnels to build products now. They are nowhere close even with CRL. It’s not going to be as simple as signing some papers. Doesn’t work that way!
Not disputing some of your viewpoint. The point is we will get diluted like hell before we get there. Reimbursements in UK will be resolved to a large extent for GBM indications but it will take many months. They are not building up any commercial team either and that makes it clear that they are a few quarters away from getting any meaningful commercial traction.
They have made zero progress on manufacturing in the US. Otherwise they would have shouted from the roof top line they did with Advent specials certification (not even taking about commercial certification!). Even if they go with CRL, those contracts need to be drawn, appropriate staff need to be hired by CRL, trained, and facilities need to be earmarked for at least minimal demand. Doesn’t happen in a few weeks! It will take months! And only then they can apply for FDA BLA.
Gary, they will need to include manufacturing facility info into their BLA application. FDA could audit their facility as part of the BLA review. Don’t expect FDA approvals anytime soon. We would be lucky if we get it in 2023.
I am trading on house money as well, but that’s not the point. These guys have fumbled on so many occasions and have been so slow with everything that with better management we would have seen this approved by multiple agencies by now. They are basically learning on the job and there’s no guarantee they will not fumble again.
Why was PIP only applied 6-8 months ago. Why not immediately after data lock. What did they do during the first 15 months post data lock?
They are running this as their own private outfit with no accountability and transparency. They have been hiding behind the quiet period for 2 years now and come up with ambiguous PRs, muddled strategy, and no clarity on the next steps. We are left to connect the dots. That’s not how you treat shareholders particularly when you’re ruining a pre revenue company. No wonder they can’t find big investors/partners!
Why not tie their compensation to major milestones and shareholder return?
Yes, if you consider getting diluted and our SP going lower every day a great thing!
Let’s see how the rest of the year go, but I am voting no on everything they propose at the next ASM. The BOD and management need to change. They have been BSing us all this while with their ambiguous and random PRs and statements. Can’t trust them!
Oops I didn’t mean to agree that NICE wouldn’t approve, but it will be a long drawn battle. Eventually, they will approve, but it won’t be as quick though.
Certainly it will be approved in Q1 next year, but meaningful cost reduction will take some time. Not sure Flaskworks get approved commercially anytime soon, but if it does, that could be a positive catalyst for SP.
Completely in agreement with your statements.
They will PR MAA acceptance. They will be shouting from the rooftop, just watch! They actually appear desperate, shows from their PIP approval PR. Also a strong indication that MAA acceptance is far off. If it was going to be close there was no reason to PR PIP news. No one does that! The reality is they have been playing with retail all this while with their carefully crafted (ambiguous) PRs.
By the way, LG, DI, and LP are BS artists. Remember how DI and LG told posters that publication was submitted when posters reported their calls from Jan-Feb! Ashkan’s statements today confirmed that it wasn’t submitted until after NYAS presentation at the earliest.
LP said at a virtual science conference in summer 2020 that they can’t wait to reveal the unblinded data to the community in the coming weeks.
The fact that UK reimbursement battle will take much longer and there might not be immediate path for scaling revenues quickly. And no visibility on FDA.
That is why reimbursements are not going to be an easy battle. Some poster was claiming global reimbursement approvals in 2-3 years. If a country like UK is having challenges with their NHS budget, just imagine how challenging it would be with less wealthy countries such as Spain, Portugal, Italy, Poland, etc. And not to mention they don’t have the supporters and influencers in those countries like they do in UK. In short, rest of EU reimbursement approvals are not happening in the next 2-3 years. Forget about ROW. This is why US is super important for revenues. You have more pricing power and over 50% of the global oncology therapy revenue.
The battle for freezing the tumor was interesting too. These are some of the reasons why you need to build a commercial team to help navigate some of these processes at various hospitals.
Things are not going to magically fall in place. It’s also becoming clear they don’t have any partners lined up. This is going to be a long drawn battle to scale commercially.
Ashkan was fantastic though and it’s also clear we will get MHRA approvals. But path to revenue ramp will be challenging and time consuming to say the least.
“LP's on the expressway now”
—- LOL. LP is either scared of the expressway or she has no idea what you are taking about. Sshhh, please make sure she and the rest of the management team doesn’t hear this! It’s likely they will develop cardiac issues!
So close to approvals and no movement towards building a commercial team! You start building a commercial team many months in advance in preparation of a blockbuster product launch. Tells me everything I need to know.
I agree with your take. Who knows they might PR they needed to take care of one more thing before they could apply for MHRA. That’s how they have been playing with retail all this time.
When no MAA acceptance news is PR’d over the next few weeks and into early November, folks will start speculating that management decided not to PR MAA acceptance news and we will get MHRA approval news directly before the end of the year!
If it was short covering we would be moving higher. But the opposite is happening.
Any well run company would have had FDA approval within 12-18 months of data lock. We don’t even know if they have applied for any regulatory applications. At least they didn’t until late August when they PR’d PIP approval. We are not going to see any regulatory approvals this year. It’s quite possible that retail will learn of another thing that NWBO team needed to accomplish before they could apply for MAA in the next month or two!
They have been playing with retail all this while by hiding behind their quiet period strategy and lack of clear communication.
We have all been waiting for this to happen for the last 2 years, particularly after a poster shares the conversation with DI and LG on this message board, but hasn’t happened yet. Wishful thinking though!
“Oh, I have never seen anybody bother to disclose a PIP though”
I hate to agree with you, but good point. Smells desperation to some degree as they want to sell more C shares. Another reason why I believe we do not have any major near term catalysts on horizon. Otherwise there is no point in PRing it, if MAA was going to be accepted anytime soon! Like you say, no company does a PR (or pump) on PIP news!!!
This is a bit similar to the series of PRs (hype) we saw last year (summer & fall) around manufacturing certification for specials program. Less than $2M in specials (compassionate use) revenue in the last 9 months since approval!
No worries. I am just pointing to the history and that typically gives a great clue into their behavior!
A lot of folks before you have relayed info from him and LG. All turned out to be false! They are experts at kicking the can.
It’s clear we are going to go lower with all the pump machine working overtime trying to get retail to buy more. Importantly, major dilution is coming!
If a major news was coming in the next few weeks or month(s) then big investors would have been buying more here and we wouldn’t be trading at under 70 cents.
You can come up with all sorts of excuses - pre-revenue, short attacks, etc but the buck stops with the management. If they can’t manage and control the narrative they ought to make room for more experienced and dynamic executive team. No one else is going to come to the rescue and things won’t magically turn around.
Just a simple thing like web presence (as simple as website) says a lot about their attitude and commitment for this business. It doesn’t matter what (billion dollar) business you are running but if you can’t even get that in order that says a lot about this team.
Elon never got his company delisted to OTC land. The history of this management gives us a lot of clue as to what to expect going forward. Some things never change!
Look at their damn website for that matter. Doesn’t take a genius or too much resources to fix that. Just goes to show their attitude and commitment towards this business.
All excuses will now start pouring in!
You said 2-3 years and hence I commented that the last milestone of regulatory approvals and reimbursements from rest of EU and rest of the world is a pipe dream with this management within that time frame. I just wouldn’t create those false hopes for folks that are new and don’t have much experience in this space.
If you continue to stretch your timelines then anything is possible!
We are talking about personalized vaccine manufacturing and not patient beds or real estate!
You ought to work with the local regulators, governments, bureaucrats, etc. They can’t even get a UK manufacturing facility certified commercially yet and it’s been 3-4 years of hard work. You better extrapolate that!
I will miss your Project Orbis and rest of world approval and global reimbursement narratives! ;)
LOL, global reimbursements! They took multiple years to build a small manufacturing facility in UK that is still waiting on commercial certification. Wonder how many years it will take to build global production capacity that is certified by various regulatory bodies around the world, LOL!
Good for you. Keep some cash on the side, you will need it to average down as dilutions take full effect!
If we don’t have a major partner at MHRA approval then I don’t know what to say other than good luck to everyone that hangs on!
I agree with your perspective.
Overall, I think we get commercial manufacturing certified in UK as well as MAA acceptance news before the end of the year, but MHRA approval will likely be in Q1 2023 at the earliest. And reimbursement approvals in UK will be Q2 2023 (best case scenario).
Points 7 & 8 regarding $20 SP will not happen for the foreseeable future. Forget about 2023 & 2024.
They are doing nothing in terms of building a commercial team. Either they see themselves as remaining a boutique shop for a while or a major partnership is inked and it’s just a question of getting one RA to approve before announcing the deal. If this partnership doesn’t come at MHRA approval, then we are being set up for another major disappointment as management has not been working behind the scenes to build a commercial team in preparation for the product launch. Shows their lack of confidence and they will end up wasting another few quarters!
Gary, I have been in this for 7 odd years now. I am a bit fortunate that I sold a little over 50% of my personal investment in NWBO this spring. I am playing with house money at this point and yet I am frustrated given the opportunity cost during these years. I can’t imagine what it must be like for folks that bought a ton 8-9 years ago when NWBO was trading over $5. They got diluted like hell.
I am convinced that 2023 will be disappointing from a revenue perspective. So we ain’t going anywhere for a while unless there is a major partnership announcement soon and that seems unlikely at the rate they are diluting us.
We would be lucky if we get a pump this year. It will likely be next year when we are close to UK approvals. We will likely get slammed in the near term due to dilution and overall market dynamics. I’d be happy if we move in the positive direction though.
Nice, I have been in NVDIA and TSLA for a very long time as well. The management there didn’t have a history of BSing like what we have. They didn’t get delisted from a major exchange. They stayed compliant throughout their struggles and didn’t blame shorts and played victim card when they were struggling. They didn’t shy away from communicating with the investors and street about their vision. In our case, it almost appears that they are hiding something by staying in this so called quiet period (2 years since data lock) and not going all out to convince investors and street.
And you know as well as I do that techs and biotechs are very different. Biotech are regulated and hence the valuations don’t fly as high and as quickly as techs. You have got to run trials, convince regulatory authorities, work on reimbursement with various governments, etc.
Why dilute when you are so close to major catalysts except to keep the lights on?
The more they dilute us at this price, it becomes evident that the management themselves are not confident in any near term catalysts moving our market value and share price in an upwards trajectory. Otherwise they wouldn’t be diluting us at these levels except to keep the lights on.
Forget about buyout or partnership in the near term!
Let’s see how much more they dilute us in the coming weeks.
Then we wouldn’t be sitting here at 70 cents. He ought to be buying shit load here if we are so under valued and good news was coming. I’d get my billionaire friends join the party too. Either he is manipulating the SP or isn’t buying. Market doesn’t lie!
LOL, why isn’t he investing more if it was so obvious and close? It’s all a game.
I agree with you. It’s done to benefit a narrow group of investors while poor retail gets sucked!
The PRs and statements at conferences in the last 10 odd years give us enough evidence that they have been BSing us, no?
From official statements in mid 2010s saying data lock coming soon to presentation by LP to scientific community in summer of 2020 at a virtual meeting that we will be unblinding in the coming weeks to LG’s appearance on big booze show in summer 2020 saying UK approval imminent….what additional proof do you need?
They have not been able to tackle the shorts for over 10 years now. They know what was coming and yet botched May 10. Given their repeated failures, no guarantee it won’t happen again. You could argue this is done to benefit a narrow set of investors to pump and dump, suck more retail.
Why are they hiding behind the quiet period for 2 years post data lock when they ought to be going out there convincing the street as to the real value of our platform, particularly with the stellar ph 3 data. Something smells fishy? Give me example of one successful biotech company that has taken this strategy? Importantly, why would you dilute the company at such low share price when you are in possession of such great data for months now and approvals that are imminent? The investors ought to be dancing on our tunes to invest in us!
It’s a 10 minute slot so it will be a nothing burger. If it was something massive, exciting & different then they would have given her more time and an important slot. I’d actually be happy if we don’t get taken down after SNO like NYAS.
And yet here we are trading at .71. I am assuming you believe we are fairly valued at this stage?
In the last 2 years since data lock we have lost 30% percent or more in SP and market cap value. On the other hand, Tesla appreciated by over 100% and Merck by over 20% during the same period.
I am fairly certain the same pattern which we have seen on 3 different occasions in the last 2 years will repeat itself where we will see a momentary spike to $1.80 - $2 range around the next set of PRs before going back to under $1. I wonder who that’s benefitting? Let’s see if the management is able to convince the street so we stay above $2 for good. Is that too ambitious or too much to ask from this management team? Or will new set of excuses come pouring in when the same pattern repeats?