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LOL, very good! Let’s get to $3-5B market cap in the next year or two then we will dream about one trillion! 2023 appears to be another lost year though.
Dream on! Just like your one trillion valuation.
These guys have been pumping since the stock was over $1. They appear dumbass to me.
Best strategy is to wait until you have couple of consecutive days of 10M+ shares exchanging hands. Less risk of getting diluted or wiped out! If it was easy money, why aren’t existing big investors buying in large volume at these dirt cheap prices in the open market. Who doesn’t like a quick double?
Also, combo partnership news is not coming anytime soon. It was simply another attempt to dangle a carrot just like that $3M prepayment from the previous 10Q. In fact, it’s more likely that we have big dilution under 45 cents than a combo partnership any time soon. LP and LG are liars!
“I don’t totally discount just bad or poorly managed contractors. But it’s worthwhile laying out all the possibilities for the delays.”
— Yes, totally. Lack of regulatory experience and the right regulatory personnel within the team is an area of big concern and I highlighted this a few times couple of years ago. I kind of expected bad management of these contractors (loss of time and money) once Duffy left.
It’s almost always in the best interest of the contractor to milk and stretch it as much as they can! In fact, we often work with outside regulatory consultants on our applications but that’s mainly to get advice around new rulings and some new product related guidance that we do not have much experience on (for example - evolving cyber security standards around medical devices). But we keep it to a minimum because we have been there and done that. And we generally know what questions to ask! ;)
“maybe the contingency gains were LDs from the contractors not achieving timelines?”
— I don’t know because I haven’t paid attention to what they said around contingency gains.
“Besides waiting for combo results as you suggest as one possibility, are there other there other reasons to deliberately slow play the submission that might be more commercial than regulatory in nature?”
—The other reason I have mentioned is around red tapes or bureaucracy at the MHRA. Perhaps they don’t have full buy in from all the stakeholders or a new guideline document that addresses our complex trial is in the works and NWBO’s consultants have advised them to hold off on submitting until they come online? I mean some of the UK politicians still continue to lobby and beg to the parliament around increased funding for GBM, personalized vaccines, encouraging ECA trials, etc. So that to me indicates that some sort of political blessing is still needed to get DCVAX-L approved and reimbursed all the way.
“When testing a new manufacturing device like Flaskworks, does it make sense to apply the modifications to all devices for all treatments under the Specials Program, or just a small percentage? I just can’t rap my head around why there is no Specials Revenue because Flaskworks is being optimized.”
— small percentage. But different tests will have different requirements. For instance, we do some biocompatibility tests as part of our regulatory process and there are several tests that require us to have 9 devices churned into a mixer for 3 tests; 3 for each test. We often argued why they would need 3 per test because one itself gives them enough volume to run these tests multiple times, but we have not been successful!
Having said this, all the excuses around connecting drop in specials revenue with optimizing Flaskworks is just BS by social media army. If it was true, the management would have brought attention to this point and established a link between the two specifically in their 10Q. I’d think it would be received very positively by the market that they are making meaningful progress with Flaskworks certification and that would help justify that the number of patients they treated in Q2 have not dropped (but in fact grown from previous quarter). Makes no sense why they wouldn’t highlight this in 10Q, if that was the case.
Agreed. The response to both the MAA acceptance and approval could likely be muted given how long this has already taken and the lack of faith in this management team’s ability to execute the next milestones in a timely manner.
Outside a big pharma partnership at great valuation where they take on commercialization of DCVAX-L and/or couple hundred million dollar injection on running combo trials we will remain a boutique shop. There will be some minor spikes or pumps along the way but it will obviously fall back quickly as this management is unable to bring big, credible investors on board.
The lawsuit ruling could change things and put a spotlight on us but I don’t expect MMs to be giving up as easily. There will be ton of me too cases otherwise. So this is likely to get dragged for many years.
PM,
Please don’t trust anyone that say Flaskworks is required for regulatory approval. It’s not. As I have said, me and my team have had successful 510k (FDA) and medical device CE (Europe) certifications for class II and III products. None of them required us to guarantee a certain volume. It’s always about quality and compliance of the manufacturing facility from a production point of view.
To your question about the Flaskworks, it can and will be handled separately from the MAA. Flaskworks certification will be a process similar to MIA and that can be added at a later stage.
I never said flaws in product or manufacturing the product. In fact, MIA validates manufacturing. So there is no question regarding manufacturing and the quality!
I said maybe red tape or bureaucracy at MHRA is holding this up or combo data.
For instance, they may be getting some advice from their consultants (who are well in tune with the latest guidelines and recommendations from local regulatory bodies) suggesting to NWBO that they should wait for some more things to line up before they submit. And these could be some new guidelines that maybe forthcoming around ECA without patient level data, reimbursements, etc.
Or it could be that these consultants are advising them to wait until they can include ph 2 combo data to increase likelihood of success.
Otherwise, I don’t see a reason for them to not be in a position to apply to UK at least in April soon after MIA.
They are liars for sure. How do you justify UK approval comments from 3 years ago?
“No RA I know of has a rule that capacity must be of any size in order for the drug to be approved. For the FDA this is by law. “
I agree on this as well. Worked on several successful class II and III medical device approvals across US and Europe with our team over the years and never had to deal with volume requirements. And Class III medical device approvals are just as stringent as the one NWBO is dealing with. It’s all about quality, standards, and the compliance of the manufacturing facility.
Agreed. This is typical NWBO. Months for TLD turned to years!
If they really were confident and had intentions to submit this year, they would simply say we will be submitting the final application in the second half of this year or Q3/Q4 2023. Rather than saying say we plan to submit as soon as possible after X, Y and Z are done. And they will never say what X, Y and Z are and when they’d get done! Also, as soon as possible could be months given NWBO’s history.
The reality is everyone will know when the application is submitted and accepted. They will shout from the rooftop. Unfortunately, it ain’t happening this year given their posture and the ambiguity.
It’s likely combo data or some red tapes at the MHRA signaling them to wait until next year given the complex trial.
Approval is not going to drop out of thin air. They need to submit the application first. Fall with come and go and LP et al will still be in the final application preparation and submission phase! ;)
You should follow their LinkedIn posting. They have been exhibiting at many conferences/events in Europe and promoting their services. It’s likely they have new customers that are utilizing their facility.
Not saying that expansion has nothing to do with NWBO and the future prospects, but try to open your mind towards the fact that not everything is centered around NWBO.
“This type of validation is not revenue friendly because the vaccine produced via Flaskworks/Eden has not yet completed the tests and it would be unethical to charge patients for this treatment.”
— if they were doing this then they would be shouting from the rooftop. In fact, they would have had a statement in their 10Q along the lines of how the number of specials patients they continue to treat grew again in the quarter and that some of that data is being used for Flaskworks validation. This would have killed 2 birds with one stone and would be perceived positively by investors.
Overall, you are misunderstanding my earlier comments. LG did not convey anything negative. Quite the opposite. He was trying to pump the stock by conveying inaccurate information that they are backlogged. This would give everyone a false sense of how specials revenues were going through the roof. Just like what he did with his UK approval comments 3 years ago.
Again, there is no backlog. And this will be confirmed once again in the next quarterly report.
The low Q2 specials volume has nothing to do with Flaskworks testing or any other excuses the social media army is putting out there. LG simply lied as he has done in the past (UK approval imminent comment 3 years ago on the same show). There is no backlog.
If what you are saying is true, they could have easily clarified this in the 10Q and it would have been quite positive in fact.
You will see in the next quarters 10Q as well that Specials revenue is not going to be significant. Nowhere close to their current capacity.
Despite all the dilution, no real revenue, people still believe very strongly in what this little biotech has to offer.
—you are arguing with the wrong person. Folks certainly believe in the technology platform and the KOLs supporting them. And I am one of them. But for me that does not translate to the management (except MB), their ethics, their biotech experience, their execution, etc.
Almost 500M diluted in the last 3 years and 7 months. And another big dilution is around the corner. It’s rinse and repeat!
Or indirectly by big warrant holders! ;)
If you compare it to other promising biotech firms at similar stage coupled with TAM for GBM then I think we ought to be at at least $3B market cap (once UK application is submitted/accepted and some guidance on other applications)….but then NWBO does not trade like other promising biotech firms…in fact, we ought to be closer to $2B market cap or more right now….you can blame it on MMs, hedge funds, etc…but I also put a lot of blame on the management as they are unable to execute quickly, build the trust, excitement, and importantly bring the right partners/investors on board….not to forget the history of this management where they have done nothing but lost investor money over the last 15 years!
If more of the same continues, the response on MAA submission/acceptance PR could be muted just like TLD and JAMA.
Regardless, I think we will be well under a $1 at MAA acceptance. It’s likely we are in the low .40 or high .30 cent range before we get any news. And a double from there in the best case scenario will put us at about .80 cents or thereabouts and then it could move down towards .50 cent range again with more waiting game.
I am 100% certain the application is not waiting for Flaskworks device. And none of the regulatory agencies require automated or semi automated manufacturing for approvals.
Having said that, I don’t believe they will need to run a new trial with Flaskworks to get the device approved. The Flaskworks device will just need to meet certain standards and produce some test results demonstrating they meet these standards (not that they may apply in this case but as an example - biocompatibility, disinfection/sterilization, etc). They will need to create additional SOPs around these processes and so on. Then they go through a similar audit process (by the regulatory body) like the MIA. My experience over the years has been in the Class II and III medical devices, so I am not quite sure what standards apply in such cases, but you get the idea….
The regulatory agencies are fairly accommodating in terms of volume ramp up, particularly for such novel treatments. They are there to bring safe and efficacious treatments to the patients as quickly as possible and not create additional roadblocks. They care about the quality and compliance of the manufacturing facility rather than the volume!
“Possibly. I’m a firm believer that NWBO is technically ready to apply but is stalling for something. There is just no other explanation for this delay”
— this is what I have been saying for a while. An application simply doesn’t take this long and why wouldn’t you apply immediately post MIA in March/April time frame? They have had 30 months post data lock at that point.
Did you get a chance to check with LG what his Specials backlog comment meant? Or his lying behavior doesn’t bother you?
Haha. Won’t be surprising if others take a similar strategy or he does it again at the expiration of the current contract..
Either way, he is officially on ignore list as of this morning!
Excellent. I should post here more often then!
Please also ask your buddies as well as convince Thermo, Marzan, and his minions to buy a boat load in the open market. When can we see 10M+ volume day for a couple of days in a row?
I’d be happy if it happens sooner, but I don’t expect it. The longs are tired and will offload at the earliest opportunity. There is no major institutional support and this management’s track record coupled with OTC will not change that situation. So even if it happens in the coming months, it will again be extremely short lived as the previous 3 attempts since late 2020.
LOL, why would anyone need validation from a well known paid pumper? You are going on ignore just like your colleague Hoffman and his aliases!
Although I have to give it to you that you are typically not as aggressive and obnoxious as your other colleagues.
Ask the management to execute aggressively and not lie and dangle carrots. Everything will take care of itself!
“Big numbers but I doubt Specials would get so much. You need insurance or government paying. Not many can afford $200K even to give a loved one ten years extra because it is still not a certainty.”
Agreed. Specials was never going to get there. Not even close. I don’t know what he was thinking and whether he can be trusted with some of these projections. Anyway, that and subsequent attempts to pump during the spring didn’t work! ;)
I agree. It ain’t happening anytime soon. Even if it happens in 2024 in the best case scenario, it will be very short lived as this management comes with extremely poor track (governance and execution) record and simply does not inspire the investor community.
The one below from March was not promotional? Or did you fall into LG’s backlog trap? ;)
“Just a few calcs on possible revenue from Specials:
20 patients/mo * GBP 150k * 12 mo/yr = GBP 36M/yr
50 patients/mo * GBP 150k * 12 mo/yr = GBP 90M/yr”
Thermo, you were probably not too pleased with their Q2 specials revenue? Below your commentary from this Spring.
“I think the Specials program is
generating material revenue for NW and expanding Sawston will not only increase that opportunity but make a rapid commercial launch possible.
Just a few calcs on possible revenue from Specials:
20 patients/mo * GBP 150k * 12 mo/yr = GBP 36M/yr
50 patients/mo * GBP 150k * 12 mo/yr = GBP 90M/yr”
Regulatory submission/acceptance news in unlikely this year.
They are trying to pump with the combo narrative and everything else but the street is not buying it. Seems like they are unable to convince big investors given their checkered history.
How did the months of waiting for TLD turn out? Do you call that incompetence, lying or exaggeration or some other term to soften the blow?
No one is questioning the lawsuit and all the manipulation that has happened. But that doesn’t give them a free pass to BS shareholders.
LG should be fired!
Better question is last 3 years. Probably sold a lot during the last 3 years and I don’t blame him. Why not take advantage of the nice rally we had seen in 2020, 2021 and even 2022 before May 10.
All speculation and BS by a paid pumper!
When did she start raising funds? That will give you an indication of when she must have talked to a physician about DCVAX-L.
Again, all of these indicators point to at least one year wait if not longer.
No point responding to paid pumpers. It’s so obvious and they will never admit it. Just like they will never admit that LG lied again last month that they are backlogged.
Makes you question their statements around combo discussions in the 10Q. Are they lying/exaggerating there as well just as months turned to years around TLD release?
They have always been good with dangling the 🥕 and also know how to survive in these situations.
We will see how the rest of the quarter plays out.
I agree, but I wouldn’t hold my breath on anything to materialize this quarter or even this year. How many times have we seen them make these statements in official PRs and then change their direction or months turning to years?
LG continues to lie about the specials backlog…makes you wonder if they are BSing about these discussions around combo trials…it’s unlikely, but given their history what’s stopping them from removing that statement in one of the subsequent 10Qs saying the discussions didn’t pan out as expected and hence decided not to proceed?
Someone should ask LG. Refraad, Hoffman, or Iwasdiver will be best equipped.
1) KOL support. I personally have been working in the neurology (medical device) world for 20 years. I know first hand how influential some of these neurosurgeons are and how niche of a community this is. For example, I have followed Dr. Ashkan’s work with PD over many years. He is arguably an even bigger rockstar in that space. Also, I know one medical doctor in Chicago that was involved in DCVAX-L ph 3 trial at their center (helping with coordination during the last couple of years). I will leave it at that.
2) I am hoping that big pharma comes along as a partner at a higher valuation in a year or so.
3) Age of the management. You would think they would want to cash out in a couple of years, if not sooner. I have been personally involved in an M&A where our former company was acquired by one of the top 10 medical device companies. I visited couple of our KOL sites along with the M&A team as part of their DD process. Also, I was part of the executive team and fairly close to the founders. So I have a decent understanding of how these things play out and some of the triggers.
4) Playing on house money. Although opportunity cost applies on house money too!
Nevertheless it’s painful to see how this management treats the shareholders. Ethics of the management, sketchy history over the years, and the pumpers they deploy is what concerns me a lot because it’s extremely difficult to put any trust. So 2 & 3 is a bit of a gamble.
You probably haven’t been in the stock long enough to connect the dots with the sketchy history of this management when they put out such vague timelines/statements.
LG in particular has a rich history of lying. The fact that LP and others tolerate it reflects very poorly.
But you can continue to live in the bubble.
Agreed. It’s an indication it’s not happening this year!