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Just shows the state of competence of this group. Such trivial task shouldn’t take more than a few minutes. Besides their website is outdated and they never cared about their digital & social media presence except a few posters that find ultimate joy in sharing such insignificant and irrelevant info!
I do not think a deal is in the works in the near term given how they are going about this. They simply lack a sense of urgency and don’t care if this takes another 18-24 months to get the regulatory approvals and commercialize fully in the US and EU….which will be 4 to 4.5 years from data lock….
Also, they do not care if retail continues to get diluted at under $1 while they work at their own pace over the next 2 years. LP ensured she has ultimate control over the next 3 years.
He appears to be a pathological liar. How can someone make a public statement in media - UK approvals imminent over 30 months ago? That was done on pressure from warrant holders so they can sell into that rally.
I don’t think DI is any different either with all the reports I have heard on this board from many posters. Although I have never spoken to either of them.
LP supporting these guys as a leader also puts a question mark on her character.
No wonder they can’t get big, credible investors on board.
One positive is they started discussions around US manufacturing. This suggests they are confident in FDA BLA acceptance. However, it’s disappointing that they waited until late last year to initiate these discussions.
Also, it’s increasingly looking like there is no partnership or buyout in the works anytime soon. If a big pharma was coming in post approvals, they would have likely wanted their manufacturing facilities to take charge rather than a contract manufacturer (particularly in the US).
I don’t think so. The likely explanation is there were major findings from the first inspection in October. And they confirm that they had to submit more documents (i.e. corrective actions) between October and February, between the first and the second inspection.
This became clear when they didn’t receive approval late last year. They have not been honest with retail shareholders while the big warrant holders have inside scoop to manipulate to their advantage. The game goes on and on!
At some point, the KOLs are going to get frustrated if there is no progress on FDA BLA application in the next quarter or two.
Unfortunately, I will have to agree with you! He tries to connect pretty much most things on the research, regulatory policies, business news, and so on to NWBO as if everything centers around the company, LOL! If that was the case, we wouldn’t be sitting here at .65 cents (with such incredible behind the scenes work and eye balls we’re generating!)
Balanced response. You forgot LG statement from Big Booze show where he said UK approvals imminent. This was within a couple of weeks of LP’s statement at that virtual conference. Anyway, I have never seen such long submission timelines from data lock either. COVID did impact most processes particularly on the human data collection and regulatory aspects, but even then the time taken is at least 12 months over what I would consider worst case scenario.
Having said that, I do expect UK approvals in Q3/Q4, and FDA in 2024.
I agree with everything you have said. I have similar experience on the neuro medical device side and went through M&A from a top 5 medical device company.
These management folks have no real experience and are not being transparent with retail shareholders. They will eventually get approvals due to the strong KOL support as well as the data (particularly around safety), but the timing is going to be way off. 29 months since data lock and no submission!
They will continue to be a boutique firm until someone partners or buys them out. Also, no commercial team building tells me they are not expecting UK approvals anytime soon.
I expect them to shout from the rooftop when they do submit or at least receive approval of one of their regulatory application. Remember the number of PRs they released around specials manufacturing! ;)
Agreed, he captures it nicely. In fact, some of us applauded the company (LP and MB in particular) when the publication finally came out. Getting support of 70 odd top neurosurgeons in a small, niche field is no mean feat. But their commercial execution, fund raising, etc has been lethargic, to say the least. It’s time they bring other experienced, energetic leaders to take charge as they have not been able to bring visibility and generate consistent returns for shareholders even when you are sitting at the cusp of approvals, having released and published stellar data!
Like your confidence, same as the specials revenue forecast for 2022! ;)
Other cancer indications also qualify! Optune and DCVAX-L are not the only game in town, LOL. GBM is a very small percentage and there is no specific quota as to X percentage of funding goes to GBM patients and so on. It’s first come first serve (including other cancer indications). Like I said, it’s entirely possible that the amount of funding left is insignificant by the time DCVAX-L gets approved. You should check the status of remaining funds with the funding source! This will provide some reassurance to the NWBO supporters and GBM patients!
He predicted $70-80M in specials revenue last year. He has little understanding around the commercial aspects of biotech companies, unfortunately. Or he is a pump. Take your pick!
I agree because big investors don’t trust this management or this management is not doing much in terms of investor presentations to build excitement. Which one is it?
Just 6-8 consecutive days of an average 10-15 million volume on the buy side per day will easily double the SP and more.
If they would have gotten MHRA application accepted by then (May 2022, which would have been 20 months since data lock) then all of this would have been noise. We are suffering because they are not executing in a timely fashion as a normal company would. Why would street trust them going forward? A well run company would have gotten FDA approvals within 18 months max. Market makers can do nothing to stop this. MMs can only manipulate the stock price swing but they can’t control the work NWBO employees put into these applications and the review by the regulatory authorities. So again the blame rests on LP and the management team.
“if it was not for the 8 venal market makers DCVax-L would be approved”
BS. All excuses for not executing in a timely fashion again! Market makers have not been stopping them from preparing and submitting their applications. They control their own destiny. Any well run company would have gotten multiple approvals and started generating tons of cash within 2.5 years of data lock. In our case, we have not had a single application acceptance in 30 months. Just tells you all need to know about this management.
I agree that’s a problem. It’s mainly a result of the lack of transparency and business ethics (stemming from NWBO management).
You make it sound like that special funding was set aside with specifically NWBO in mind! For all we know, that funding is already depleted or will be depleted by the time NWBO gets approvals. There are dozens of companies that qualify. If you don’t execute in a timely fashion you lose and other companies grab it! ;)
We all know very well how speculations go when it comes to this management team. Weren’t we all speculating approvals last year? And TLD + publication the year before? And SP to be in double digits last year? LOL
Folks here said the same thing that TLD and high impact publication will change the game. And yet we are trading at .65.
Also, once approvals do come in, it doesn’t guarantee revenue. You still need to execute on the reimbursement side, market access, and many other commercial aspects. Unfortunately, street will continue to dismiss the management as they have been doing post the release of TLD and JAMA Oncology pub….
By the way, nothing they are doing on the hiring side suggests reimbursements are coming in the near term. You have to build a commercial team.
You have just heard the goal posts moved to post approval. It was TLD and publication before. Once approval, you will hear the goal posts move to revenue growth. Excuses galore!
In reality, the problem seems to be management’s lack to credibility in bringing the right investment partners and media attention. Just a quick glance at their website will give you a good sense regarding how committed they are in terms of building their brand and image in public domain.
Not really. Class III medical device approvals are quite involved. Class I and II are a bit easier to navigate but it’s still time consuming nevertheless.
It’s all excuses. If they would have executed relentlessly, all of this would have been noise at this point. The reality is they have not been able to do that and convince the investors.
A well run company would make investor presentations sharing 5 year vision, etc
Your point about company’s transparency and business ethics is spot on. There is no denying that they fail big time in those aspects. No wonder they are unable to get big, credible partner or investors on board.
However, I haven’t followed SM’s departure saga if that is indeed true. Although, I am not too concerned if he left sometimes last year. The silver lining is he stayed at least 2 years with the company and that’s really significant in these cases. Such science driven independent founders typically move on to other projects and besides don’t like being tied too much to a narrow set of commercial and regulatory objectives for too long. I have seen and experienced this a lot in medical device M&A space.
Agreed, traps new retail investors!
Fully agree. They have been playing the blame game and victim card for almost a decade now. Unethical and terrible management!
Project Orbis!!! LOL!!!
—- not just that, worldwide approvals in 3-4 years, LOL!! We are around 2.5 years since data lock and no signs of a single RA (UK) acceptance. Forget about the FDA, EU, Canada, and other major regions!
BS artist! Not sure why he’s on the payroll.
Your points are reasonable but somehow they don’t equate time = money. They never have! Calculate the impact/savings they would have had on operations, cash flow, dilution, and importantly patients lives if they didn’t have to wait on Advent. They could have advanced everything by at least 6 months, if not more.
No offense but they appear clueless and/or follow laid back academic work culture rather than a well oiled, energetic commercial outfit. Plus they treat the retail shareholders as if we are stupid. No wonder they can not get any big, credible investors onboard. They can’t fool them with their BS!
“It’s called exploiting conflicts of interest. And it’s bad for shareholders and patients alike.“
Or just bad strategic planning. Either way, management continues to damage their reputation.
This is unfortunately not going anywhere until they bring a big pharma partner on board. MIA will definitely be perceived as meh unless it’s accompanied by some other surprise such as FDA BLA news or UK regulatory approval coupled with an update on NICE timing.
Until then we will continue to get diluted at .60s.
Why they didn’t use CRL or other CDMO in UK to get MHRA approvals last year is beyond me! This way, they wouldn’t have had to wait for Advent to catch up with commercial certifications. They could have also made progress with FDA BLA application and could have gotten BLA accepted last year with CRL as a manufacturing partner.
No, they just don’t like being tied to a very narrow commercial objective when the bulk of product innovation has already been done.
They typically have a ton of new ideas and want to write fresh grants to develop that further. And they are unable to do this due to the near to mid term regulatory deliverables within the company.
Not true. It’s the other way around actually.
Flaskworks was acquired and this is quite common in the M&A sphere particularly when you acquire small science driven outfits. Founder(s) will almost always leave within a year or so to pursue new ideas as they don’t like being tied to (narrow) hard core commercial objectives.
These things happen all the time. The fact that he stayed on for almost 2 years is a big deal, I think. He is an academic and he is likely going back to pursue his passion (developing another new gadget).
The reporting is not to the company headquarters but big warrant holder offices, LOL!
Haha, and he continues on the same slippery path! ;)
He has been pumping forever! He estimated $70-80M in specials revenue last year. I don’t think we crossed $2M. I wouldn’t trust his projections!!!
He also claims he has been invested since 2006. Such a massive opportunity cost!
I agree with your perspective and I can confirm this to be the case with FDA. I have gotten multiple medical device through FDA 510k approvals. You have to provide manufacturing site address and certifications as part of your FDA application submission. Without with, the application will be deemed incomplete.
Having said that, I don’t quite understand the intricacies between specials manufacturing certification and commercial manufacturing certification as it applies to cell therapies..,.and whether specials manufacturing certifications can be used in MAA applications to get commercial manufacturing certifications in parallel.
Let’s hear about this high level process and importantly FDA approval timeline given your experience in this space!
Agreed. Ultimately, this misery will end but when is the real question. This management and board is not getting any younger (some in their 70s and 80s). Shorts are not going to give up until FDA approvals and this management has shown no real intent and strategic planning on supporting investors around some of the most important catalysts.
Hiring that new scientist/investor relations guy in Dec 2022 makes me think there is nothing concrete at this time and he was brought in to attract new investors?