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It wouldn’t be surprising to me. They said this year so we can’t blame them if it’s not submitted until the end of the year. Then it’s just one more month for the phase 2 combo trial end date! They can submit in Q1 2024 and it won’t be too far out from when they said they would be able to file by. It looks like that’s been their master plan all along but they have been masterfully stringing us all along. You have to give them credit for this! ;)
Sshhh, that’s an excuse for the next quarter when the specials numbers are still disappointing! ;)
Correct.
If something big was in the works with a publicly traded big pharma (even a partnership or combo trial) then they would take control of the release of news and would be super careful in managing and avoiding such premature disclosures. Just doesn’t make sense.
Also the prepayment amount of $3M is peanuts so nothing big is coming even from a friendly.
It is dilution at 60 cents or thereabouts to one of their friends, fairly certain!
Its increasingly looking like approval and reimbursement in UK are not happening this year either!
It’s definitely a friendly and as usual they are dangling a carrot through their social media army. Nothing to me suggests that a big pharma partnership is happening this year. I doubt UK approval happens this year either.
I am increasingly convinced the reason they haven’t applied to any regulatory authority yet has to do with ph 2 combo data. Otherwise I can not imagine a company not being ready with everything they need to apply 30 months post data lock. Even if you have a 12-15 person team….Just doesn’t that long regardless of how lethargic and inexperienced the team is! And they will never admit to this ph 2 combo data thing because they can get in legal trouble from the shareholders for not disclosing this.
Dilution at 60 cents or less and dangling of carrot! ;)
Is the $3M prepayment another dangling of the carrot by the management? It sure doesn’t look like partnership because that is unlikely before approval (and they still haven’t applied). So it’s more likely to result in another dilution at 60 cents or thereabouts to one of their friendlies. Good use of C shares!
And some of loyal supporters expected $70-80 million in annual specials revenue last year! It’s clear our annual revenue for 2023 will be well under $10M.
More importantly, I can’t believe they still haven’t applied for UK approvals yet. It’s over 31 months since data lock now! I am not expecting an application in June either.
Agreed. Normal companies, big or small, submit it within 6-12 month from data lock!
Wow, no complain about million pages?
We will see how it plays out, Flip. Overall I agree with your thought process but I do not expect application to be submitted this month or next. This management has again not been transparent with shareholders as they have likely been holding off on the application for combo data to reach some level of maturity.
The subtle shift towards combo efficacy is occurring already! So don’t be surprised if this approval saga continue for months until phase 2 combo study is completed.
It is what it is and they knew it, so no point complaining. It’s not like NWBO is treated unfairly by RAs. It’s the same process for everyone. By the way, I have never questioned the data, product, safety profile, or KOLs backing them.
However, they haven’t been able to control what’s in their hands…. that was to be proactive with their manufacturing preparations, regulatory filings, and bringing the right partners and investors on board at the right time…30 months post data lock and not even a single approval. Can’t blame MHRA!
You won’t receive a response to this and you know why!
Engagement metric on social media gets rewarded very well. I am sure some of the big warrant holders likely value folks like her! ;)
Agreed. When she or someone starts putting timelines on social media or public domain like that, particularly around big pharma involvement, it’s an indication nothing is coming for sure. LP et al are going to be extremely careful around something like that.
Stop putting the blame on the process. Great teams do not complain and instead focus on timely execution and are transparent with their shareholders.
You will get an opportunity to load up more at a better discount later this month and next. NWBO is very generous with giving retail buyers opportunities to average down on an ongoing basis! ;)
What, you’re not averaging down? Such a fantastic opportunity! ;)
BS, no one is buying that!
Of course! And these friends will never go against this management regardless of the many fumbles, lies, and incompetence shown by this management group over the years. After all, it’s their cash cow!
While Direct continues to sit in the closet for well over a decade…..
Lol, it wouldn’t be surprising! Just like when LG commented U.K. approval imminent over 30 months ago, not realizing you need to get your manufacturing certified and PIP approved before you can even apply! ;)
Agreed!
This is what I have been saying. Hiring in such a specialized/niche medical field is not a switch you can flip. It takes at least 6-12 months and not to mention training component, process development, etc. on top of that. Demand on finance and operations side itself will be quite big even if you are scaling from a $5-7M in 2023 to $25-50M annual revenue company for 2024. They simply can not execute/fulfill anywhere close to lower end of those revenues with their current team. Forget about sales, marketing, business development, market access, quality assurance, and other critical business functions required to get there.
Or the other explanation outside partnership/buyout scenario is that they do not expect a significant uptick in sales in 2024 and that they plan to build the team gradually. Perhaps U.K. reimbursement will be limited in some way and that FDA and EU approvals are not expected for another 12-18 months. And this may be why big pharma is not interested in NWBO at this time and are taking a wait and watch approach for the next couple of years. This will be the worst case scenario for shareholders.
No, I love getting diluted and seeing my share price continue to drop, but it’s a nice opportunity to accumulate and average down while I support this inexperienced biotech management group for another decade. And I don’t care if Direct stays in the closet for another decade!
“Turns out Big Pharma brings more to the table than just a checkbook - they also bring credibility with potential investors worth its weight in gold.”
100%. The street does not trust the management team so this will be a welcome change.
“At this point things might only change when NWBO has earnings with which to actually a P/E ratio. If we have real and meaningful revenues rolling in the door and the price is still low then that would be manipulation.“
I am fairly certain that investors will be disappointed with 2024 revenue if they decide to handle sales, marketing, and distribution between NWBO and Advent teams. On the other hand, if a big pharma partner comes on board to accelerate sales, market access, etc then that’s a different story.
PM, I suspect even after UK approvals everyone will be complaining when share price is still languishing well under a dollar. I am not sure if anything will change until they bring a big pharma partner.
It wouldn't be surprising if the shorts go after again on any spike we get at MHRA approval if there is no partnership news on the heels of it right away. There has been no hiring and the right team building and they know that they will disappoint investors with their 2024 commercial revenue and beyond if they decide to handle sales, marketing, distribution by themselves.
Plus this tight credit market is going to make it really challenging to raise funds at reasonable valuation.
One of these scenarios ought to explain their behavior and actions:
1) The UK approvals are not coming soon. Therefore no hiring activity to accelerate the ramp up on NWBO side.
2) UK approvals around end of summer/early fall.
a) But they expect sales in 2024 to be fairly modest and therefore don’t see a need to add more people in 2023 to prepare for that growth.
OR
b) Sales/distribution/marketing/business development is licensed to a big pharma in some sort of partnership agreement immediately post UK approval. And this new partner company may be preparing behind the scenes.
While I am hoping that 2b is the most logical explanation, my bet is on 2a now given the history of this management, positioning by their social media army lately, and how our share price has been declining!
Agreed on all front.
Right, but if none of the three (buyout, partnership or licensing) occur within a reasonable time frame following MAA approval then what does that tell you? ;)
It’s not about who knows what. Show me one company in biotech space that can handle more than $20-25M in annual revenue with less than 20-25 people (outside manufacturing)? Companies cannot function this way and you know this!
Kite was around 700 employees when they got acquired by Gilead for $11-12B, and they were still waiting for their first approvals.
Haha, you said it! ;)
This question will either be dodged or not answered.
One of the important pieces to the puzzle is why aren’t they hiring folks if U.K. approvals were within 6 months? Will there be a licensing deal? There is no proper organization structure within NWBO. And these functions can not be filled overnight.
One of two possibilities:
1) A big pharma comes in as a partner for GBM sales.
2) NWBO will handle sales & business activities but they expect the uptick to be slow (more like a hockey stick) and hence they will build sales, marketing, product management, business development, operations, finance, quality, etc. over time. Not counting manufacturing, supply chain, logistics, etc as that will be dealt by Advent.
Not sure how the company can really deliver without people in these key business functions. So option 1 looks the most likely to me, but you never know with this team!
Your concerns are spot on! However, it’s not just about communication here. Even if they were transparent and open in their communication with the shareholders, this company will struggle because they can not execute in a reasonable time frame or make the right strategic moves at the right time.
MAA acceptance will happen in 2023, but share price wouldn’t have a significant impact when that happens. Folks will still be complaining about OTC and manipulation!
“I believe we'll have the rest of 2023 to accumulate shares at depressed prices.“
Agreed! Hopefully 2024 will be different.
But accumulating in between $1 and $2 must not feel good now? Assuming you are not selling and only accumulating!
How about those ever changing milestones and timelines? Want another 3-4 years to get to worldwide approvals milestone? Let’s forget about reimbursements for now!
Still expect project orbis?
LOL. You don’t do that when you pay $10-20 billion or more. The key M&A folks and/or executives including CEO could get in serious trouble.
You make an earnest attempt to scale the therapy for a couple of years by building a solid team, investing in scaling technology + manufacturing, and initiating a few combo trials. If combo trials are not successful and/or they continue to experience challenges scaling up or they continue to face resistance from hospitals and neurosurgeons/patients in terms of adoption, and do not see a path to profitability even after throwing resources and the right people that’s when they make the difficult decision to shut down a business. Not otherwise!
No one is questioning the product, it effectiveness, its safety profile, combo potential and above all the KOLs supporting the ph 3 results and science. But there are many ph 3 successful trials and FDA approved products in healthcare that failed to capitalize over the years and remain a boutique shop or disappear because of lethargic execution and not making the right strategic moves at the right time.
If you care so much for the patients, why wouldn’t you want the management to pass the baton on to big pharma that can scale this very quickly rather than the snails pace at which this team is moving.
Lol, opportunity cost does not mean anything to you but for some investors it does. The can kicking and excuses will continue, just wait and watch!
BS. Nothing will change with MAA acceptance either. It’s been over 30 months since data lock and we have instead moved in the opposite direction from $2.5 to under 50 cents during that period despite TLD, JAMA, and MIA milestones. The reality is management is unable to build excitement or convince big investors to come on board and importantly convince the street that we ought to be valued at $3-5B market cap now. You can blame it on manipulators, OTC, etc but that situation ain’t changing at MAA acceptance either as the manipulators are not leaving and will continue to plant misleading narratives going forward. Everyone expected them to give up at TLD and JAMA. That didn’t happen. Then folks expected them to give up at MIA. That didn’t happen either!
Once the MAA approval happens and we are still sitting at under a dollar the long narrative likely shifts toward combo trials and FDA approval as the next big catalyst that will move the SP in a big way and so on. While the dilution continues!
Forget about LP or executive management. Why aren’t the likes of Thermo, Bigger, etc buying millions when a big catalyst is expected soon and an easy 5X return?
Retail is being sucked again by the army! It’s looking like this MAA submission is going to get dragged on for a few months.