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BS. FDA or MHRA will not hold up an effective therapy for GBM because of the potential tumor agnostic implications. They know it’s not practical to put massive manufacturing burden on small companies at the onset of their commercial journey. Must take baby steps. They would rather approve it for GBM which is more on an unmet need than ask them to hold off on applying until manufacturing has scaled up to a point where they can meet demand for other cancers too. Does not make any sense! They know this scenario is unlikely to play out and they will choke the company to death. That’s not what the regulators are for.
Exactly the opposite, unfortunately. They are the ONLY consultants in the world. Why aren’t other centers and doctors in UK doing this?
They will at least PR acceptance of their regulatory application. They will be shouting from the rooftop. We have quite a few examples right in front of us. We only have to go back 1-2 years ago to understand the number of PRs they sent out in connection with specials manufacturing.
Too late. LP is in charge for 2.5 more (lost and full of cheap dilution) years! However, their compensation must be tied to their performance.
It will be interesting how some of the KOLs react at SNO in November when no regulatory applications have been submitted or accepted. When Dr. Toms did that press conference in Jan 2023, he anticipated FDA approval within a year. Needless to say, they will be extremely disappointed with this management team!
All of this likely suggests that MAA submission and acceptance is going to be dragged out. I don’t expect any submission/acceptance news in Q3 or Q4. We will likely go through a big round of C share offering under 50 cents during this period.
I know. It’s crystal clear. In fact, I posted a comment along those lines couple of days ago! ;)
He has been saying that for years. Nothing new! Without big pharma partnership, they are going nowhere anytime soon. They can hardly keep the lights on and there is no way they can do justice to the business expansion goals themselves without tens of millions of dollars backing them up. And that coupled with outstanding dues, a big dilution event seems to be around the corner!
More importantly, no one wants to talk about the timing of MAA submission and acceptance. Unlikely that UK submissions happen in Q3 given this new posture from loyal supporters. Watch out for new excuses and shift in Thermo’s narrative in the next week or two.
I agree it’s coming in Q3/Q4. We will certainly be back under 50 cents as MAA application continues to get delayed.
What about Flaskworks and tissue agnostic? Was that discussed? ;)
On a serious note, there was new messaging from a few images I saw from ASCO this morning: 331 patient ph 3 trial completed….along those lines….I don’t think this message was highlighted on their booth last year except for playing KA’s ph 3 data presentation briefly on the monitors?
They are experts at keeping the lights on. So I don’t think insolvency is an issue here.
However, it seems the new narratives is that the management is going after tissue agnostic so don’t expect MAA filings any time soon. I agree we won’t go above a dollar this year except for an occasional brief spike and that too if we are lucky with the pump. They are trying hard!
The data is great. JAMA article is great and no one is disputing that. So are LL and KA. They are rockstars
However, the important point is just don’t delay a regulatory application to get approval for GBM when the shorts are attacking you non stop, you can’t raise money at the value you deserve, and importantly are struggling to keep the lights on? There is no business logic to this.
Also think about what percentage of (non-brain) surgeons and oncologists must have read JAMA article? If I am specializing in lung, bladder, and prostate cancer why do I tune in to what’s happening in the brain space when I can’t keep up with my own field? They don’t even know who LL or KA is!
I have been working in the neuro space for 20 years but I have no idea who the KOLs are in the cardiac space!
They are not applying for all solid tumors, so stop with this BS! They are only applying for GBM.
Was this conversation in a crowded bar? ;)
Manual production is not the issue for the regulatory application and approval. FDA or MHRA will not reject an application because of manual vs automated production and you know that. Pretty much all CAR-T therapies are done manually and their addressable patient base (even for a single indication) is much larger than GBM.
I will tell you this - if we’re to wait for Flaskworks, then 2024 will be a lost year too. Hopefully, they will submit an application in 2025 or later.
The management will shout from the rooftop as soon as the application is accepted. So approvals are not going to drop out of thin air all of a sudden, unfortunately. Stop dreaming, PM! ;)
Reimbursement is a whole different ball game! And that ain’t happening until mid 2024 at the earliest even if they were to submit the application next month.
You recall how many PRs they had around specials manufacturing progress! You know the history of this group. It’s more likely that we start hearing from their supporters there is this great opportunity to apply to all RAs at once or tissue agnostic or something along those lines delaying the submission by a few more months than getting regulatory approval news any time soon.
Nice, balanced perspective. I mostly agree except revenue uptick post UK approvals will be quite slow if they decide to do it themselves and not go via big pharma through some sort of licensing deal. Reimbursement will be a long hard battle and I don't think they are positioned to maximize the value on their own. Shorts will take advantage of this situation too on any spike we may see on UK approvals.
I don’t know what you call higher but it’s unlikely they will do more than a couple of million dollars per quarter this year or first half of next year without reimbursements in place. And that’s peanuts.
Total BS! Look at the specials revenue. It’s meh. Without reimbursements they remain a boutique shop.
Is he signaling that -
1) Reimbursements will take some time after approval!
2) NWBO don’t have big pharma partners lined up for licensing/sales around GBM indication and that they are going alone.
UK approval imminent by LG in summer of 2020. That was not a lie?
That would make sense. Let’s see if they update the title of the session to something other than the name of the company sponsoring it as we get closer.
Agreed. Even a 10-12 person company shouldn’t take half as long as what they have already taken to submit an application. There’s something else that they are not sharing with shareholders whether it’s combo data or who knows what! I wouldn’t be surprised if we are still waiting for submission news at SNO in November.
What’s surprising is likes of LL continuing to support NWBO team. That’s really the saving grace!
I have been to CNS conference many times. This is looking more like an industry sponsored symposium. Likely NWBO paying for the 10 minute slot. You will notice that most sessions seem to have title as the name of the medical device company. And the person presenting is the surgeon closely linked to the company’s clinical trial (as a PI or co PI) or innovation.
I know two of the surgeons presenting during that symposium. Just like Dr. Ashkan, Dr Sameer Sheth has been doing phenomenal work with Parkinson’s and movement disorders patients.
CNS is primarily a conference attracting medical device companies such as Medtronic, Zimmer, Stryker, etc. I haven’t seen any big pharma there except maybe Merck once or twice, if I remember correctly. It’s a bit strange that NWBO is using this conference to talk about personalized immunotherapy (provided it’s sponsored by NWBO). Either way, it’s great that LL continues to support NWBO.
I think there is confusion with timelines: 32 months since data lock and not a single RA submission. You may be able to clear some fog if you consult with LG who made a public statement that UK approval was imminent about 3 years ago. Or if LG continues to BS then approach DI. He’s been at the 1 yard line for a couple of years too…
Haha, wouldn’t be the first time. Tissue agnostic application seems to be a good excuse! Why not?
What is nonsense - LP and LG lied to shareholders in 2020?
BS. So many car-T therapy applications have been successfully submitted in less than a year….as far back as 2017 when this was being done for the very first time…5-6 years later NWBO takes over 3 times longer to apply! But you already know this!
No other reason to support/tolerate the lies!
It’s unfortunate that a few folks that control 90% of the shares tolerate the pathological lying behavior of LP, LG, and DI. And why is that? Could it be because they are fed inside information to pump and dump, and then rinse and repeat every year?
Are you kidding me - that’s a gift and likely a strategy by LP et al? The shareholders are being consistently given an opportunity to load at bargain basement price.
However, one thing is clear over 90% of the shareholders agree that LP, LG, and DI are a bunch of liars. One only has to go back to their public statements from summer 2020.
No one is asking you to sell. You can continue to buy as many shares as you like. And if you are patient, you might as well be able to buy under 50 cents in Q3. Another gift from spoofers and MMs! Keeps on giving!
LOL, solid tumors. How about getting approval across US and UK for one indication? 32 months since data lock is not enough to submit one application.
Agreed. For those of us deeply involved in this space, they are a joke! No one takes this long to submit an application. Consultants are there to provide guidance and not write/complete the application on your behalf.
It’s also becoming clear that no major pharma wants to get involved and work with this inept team. There will be no partnership even after UK approval. So folks looking for a $2 exit in the next 6-12 months will be disappointed as we’ll remain under a dollar while the slow dilution continues….with the debt payments and ongoing cash requirement, they would have exhausted the C shares in 2024…all under a dollar!
Now excuses are made to justify being on OTC, LOL! How about holding off on regulatory submissions for another year or two so that the Flaskworks technology has the opportunity to mature further? This along with ph 2 combo data will create a perfect storm! ;)
I agree. They should have used CRL or other local CDMOs to begin with and they wouldn’t have had to wait 30 months for commercial manufacturing certification and all the resources deployed during this period. They could have saved 18 months!
Very likely they wanted the combo data to mature because their consultants or perhaps regulatory agencies may have indicated that it would increase their approval chances given the lack of proper control arm. Hence they slowed things down on purpose by going with Advent from a strategic perspective.
At this point, if they fail to get approvals retail will sue the hell out of them.
“So the state of play is the company will need to raise additional capital. And if it’s the usual suspects, then shareholders can expect more highly expensive and highly dilutive penny stock financing — paging Mr. Fife, please come to the counter to pick up your hot mess sandwich.”
— I agree. It’s likely they continue diluting slowly to their friends to avoid mass exodus of existing retail investors. They don’t want retail to lose hope that a big partnership is just around the corner!
Overall, they are experts at keeping the lights on so there will be no insolvency. But there will be gradual erosion of shareholder equity and value as we move into Q3 and Q4.
“something very good (i.e. MAA submission) could occur during that time interval.”
— highly unlikely
“lack of expectations that good events will happen within a certain timeframe does not prevent them from unexpectedly popping up.“
— with the history of this management group it’s again highly unlikely. They typically surprise you the other way around where they fail to meet even their own most conservative expectations! ;)
Gary,
MAA wouldn’t do much to the stock price except for a brief spike (couple of days and that too if we are lucky), but ultimately we will still be trading well under a dollar. Only a big pharma partnership news or FDA BLA surprise would get us close to $2.
The street doesn’t trust this management to do justice if they go alone. Everyone is expecting MAA submission/acceptance later this year so it’s not a surprise anymore and nothing will change in terms of attracting big credible investors…..the fact that NWBO is an OTC stock is not going away…plus shorts will not stop creating fear, just like JAMA, TLD, & MIA. Only a big pharma involvement and/or FDA BLA acceptance will change this!
Good post. Unfortunately, I don’t expect anything next month! Meanwhile, silent period and speculation will continue as usual.
None of these countries or 99% of the patients in these countries have money to pay for such treatments. Let’s get it approved in US and UK.
When they bring big pharma on board. The street does not trust this management group to execute and build shareholder value on an aggressive and consistent basis. Until then the slow dilution at 60 cents (and likely lower in Q3) will continue!