Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
That’s my forecast based on the history and inexperience of this management as well as connecting various public statements they have made to their past execution history. Feel free to post your view, if you have any! JAMA Oncology article is fantastic, by the way. I just wish that would translate to approvals though.
Yes maybe in the next decade when this management has passed the baton to dynamic yet experienced crew. For now, let’s focus on approvals for GBM in 2024!
It does matter, Gary. We continue to get diluted at these prices. It’s likely we go under under 50 or 40 cents before we get any regulatory news depending on the timing. Furthermore, it’s likely we could be over 1.3B outstanding shares with almost half of preferred C shares that were authorized in Dec 2022 gone, again depending on timing. At that point upside will be muted. Perhaps it doubles from 40 to 80 cents on UK MHRA approval news in 2024 and then finally settles again at 60 or 70 cents!
This is what I see happening without big pharma partnership. The street will not see this management any differently from when they released JAMA, TLD, and MIA news. They will poke holes at managements ability to scale themselves,
investment needed to scale, reimbursement challenges in UK for subset of population, etc. Needless to say, the saga will continue! Only way to change that perception and credibility in the marketplace is to get a formidable big pharma partner on board who sees the value in our platform and broadcasts it to the world by paying a rich premium on the approved DCVAX-L for GBM indication (commercial partnership around GBM revenue sharing). This way, they do the heavy lifting on (indirect) branding building and rapid revenue generation while NWBO focuses on running additional trials for other indications with the large upfront payment they get from big pharma.
Agreed. There will always be blame game for management’s failure to convince big investors and build excitement/support despite JAMA, TLD, MIA, etc. Only management to blame because the manipulators are not going away even when MHRA approvals arrive next year. It will be the same story. The fact is that street does not trust this management group. Lack of credibility.
They are here out of altruism and don’t care about the return on investment and importantly opportunity cost.
As I stated earlier, 2023 will be another lost year. The loyal supporters would like us to buy into one of the theories detailed below while the management continues to be ambiguous and keep shareholders in the dark to avoid mass exodus for their lack of meaningful progress:
1) The focus has shifted to FDA now? UK not number one priority anymore. So need more time to line up CRL and other million BLA pages?
2) Now applying strategically via Project Orbis. All RAs at once. Need extra months.
3) Flaskworks certification given off label demand considerations!
4) Tissue agnostic approvals.
5) No MAA acceptance PR. Need to wait until final MHRA approval (in 2024?) for the big reveal!
“I have a feeling even an MHRA approval won’t result in more than the $2+ a share we attained almost 3 years ago on mere rumor of TLD.”
Exactly right. I have said this before that MHRA approval alone will not get us back to $2 anymore. Without a big pharma partner and the credibility they lend to NWBO, we are not going anywhere. 2023 will be another lost year!
As I mentioned, there will be no progress in Q3. They will create ambiguity with their statements to make investors feel like they may directly announce MHRA approvals….this way, investors are not too pissed off the rest of the year for their lack of action thinking we may get MHRA approval PR directly.
Ultimately, it wont be surprising if we find out in the first half of next year that the MAA submission just got accepted….
We are going under 50 cents again or likely under 40 cents in Q3/Q4.
Gary, CRL is not a mid to long term solution for manufacturing. You need to have your own manufacturing facilities. The risk you put yourself in relying on CDMOs once you start meaningful commercialization is immense. What if FDA finds issues with quality control during a routine audit? You are not in control of your destiny anymore. Plus CRL is not going to do this for cheap and hence NWBO’s margins will be squeezed.
That’s why all of the big pharmas including Kite (now Gilead) use their own manufacturing facilities.
I know so many companies in the med tech world that got shut down or paid hundreds of million or billions in fine because FDA found issues with quality control during their routine inspections. I live and breathe this world!
And keep in mind that manufacturing and distribution is not the end game. Although it’s the most time and resource consuming to set up, there are many other business functions a company will need to thrive. They don’t have any of that structure.
Make no mistake this company will remain a boutique operation and continue to limp along the next few years without a big pharma partner.
“They can’t appear in the mainstream media but they can appear in the Big Biz show? This looks like a proof that they don’t get exposure not because they don’t want it but nobody really take them seriously.”
- that’s exactly right. And none of the big pharmas take this management seriously too. No big pharma involvement or partnership coming anytime soon either because they have no credibility!
It’s likely they have been BSing the likes of Thermo too with April-May-June showers! Can’t believe he continues to support this inept team.
LG is a liar!
My comment was around commercialization/licensing partnership for GBM indication. If NWBO goes alone, we will not achieve meaningful revenue for many years and shorts will continue to slam the stock. A big pharma partnership fast tracks commercial journey and importantly brings credibility, which NWBO desperately needs.
Dr Bosch and Navid Malik (unsung hero) from UK.
Agreed. You can already hear management army countering how going alone is the right move and that big pharma brings nothing but a checkbook, which is lame. Not only do they not have cash and capacity to grow quickly, they also have no commercial structure within the team as well as necessary experience to take it to the next level. A few more years of mediocrity and nothingburgers coming.
BS. Most of the folks are over retirement age and have no idea what they are doing. Can’t even put together a single application in almost 3 years. Continuous down round of investment over the last 15 years. False statements via PR and bad expectation management over and over again. The list goes on!
Very simple, none of the big media wants to talk to them. They are a joke of a team with bad history!
It’s also becoming clear that nothing is lined up in terms of partnership. No reason to promote on a show like big Booz otherwise. They are struggling to attract big investors at higher valuations too! Slow dilution will continue.
Ohh no, look at the background, so unprofessional!
They have no problem going to Big booz show. What does that tell us? Big media doesn’t want to talk to them or they are not trying hard enough.
Also, if they had a partner lined up there is no reason to go out there and promote particularly if the approvals were coming soon. Likely indicates nothing in the works from a partnership perspective either. Signs of desperation. Slow dilution will continue.
They are going after UK because they seem to have strong support there. Overall, I agree with your take.
From a purely commercial perspective you go after US first, which is 10X revenue potential than UK and about 50% of the global market. Plus FDA is more efficient and it’s much faster to resolve reimbursements including higher value for your product in the US than any other country.
Unfortunately, some folks remain stuck on past glory (JAMA article) and refuse to acknowledge and learn the complex commercial biotech landscape.
Angel investors ain’t helping our situation anymore. They are for early stage investing.
NWBO will remain a boutique shop until they bring a big pharma partner. Even an approval without a big pharma partner will not move the needle in terms of sustained SP rise with this team. If we are lucky we may get a short term spike for a few days post approval and then shorts will slam it down…. This group is not capable of scaling themselves and they will end up diluting hundreds of millions of shares in the process and importantly take multiple years with angel investors to get anywhere!
When is it?
Not peer reviewed. The street does not trust NWBO management. Whereas the street trust other companies that offer personalized therapy for cancer indications.
Wrong comparison. If NWBO wants to be great it needs to be compared with all the highly successful companies. Not Dendreon that ultimately failed! Name any 20B or higher market cap company that took this long to apply from data lock.
LOL, say that to folks who have been for more than 10 years! Worst thing to say to investors anyway.
Nice change of topic though. ;)
Integrity? Go back and listen to LG’s comment from Big booz show about 3 years ago. UK approval imminent. Didn’t he know there are so many prerequisites that take at least a year or more before you can even apply?
If you can not build a roadmap for approvals and path to leadership by sharing go to market strategy and revenue projections to investors then why would investors attach a higher valuation to the company or put their hard earned money in the company?
Marketing is what regulators frown on. Not investor presentations.
You are being quite generous. They have had 3 years to prepare.
You got to remember that she also said at a scientific conference in summer 2020 they can’t wait to release phase 3 data to the community in the coming weeks. That took 2 years. What do you expect from this group?
You can already sense from the defensive positioning of the supporters nothing is coming anytime soon. At least not in Q3.
The only things we will hear are excuses for not filing and how shorts are damaging the company. And yet folks that hold 90% of the shares support management as opportunity cost and accountability are not super important to these folks!
It doesn’t matter because they will continue to come up with all sort of BS stories. It’s the job of LP et al to instill confidence in existing investors and bring new credible investors on board at much higher valuations. If they can’t do this then hand it over to big pharma or young, dynamic leaders who can do justice. We aren’t here for charity!
Can’t hide behind evil shorts narrative for years. And it won’t get easy! Build shareholder value or perish is the mantra!
Still committed to end of August for one RA submission? ;)
I wonder what excuse will be used by loyal supporters when there is no submission this summer (say 3 months from now or mid September):
1) The focus has shifted to FDA now? UK not number one priority anymore. So need more time to line up CRL and other million BLA pages?
2) Now applying strategically via Project Orbis. All RAs at once. Need extra months.
3) Flaskworks certification given off label demand considerations!
4) Tissue agnostic approvals.
Anything else?
But you can always pass it on to your kids and grand kids (even though your rate of return may ultimately be lower than inflation over the years provided you’re still in green).
That’s great! Perhaps he should urge the team to submit the applications ASAP. He will be 79 and 80 in no time. And who knows we may still be waiting for approvals then! Certainly didn’t look like it would take that long when he was 75 and the data was locked.
LOL! Who is NWBO’s CSO and how old is she/he? ;)
Agreed. As I said, they will shout from the rooftop whenever the application is accepted. And our clock will start from that point on. In case of FDA, we will be assigned a PDUFA date about 6 months out once the BLA is accepted.
No reason not to PR that. Shorts and manipulators can do nothing at that stage in terms of influencing the decision making process of the regulators. So all this crap about keeping it hidden from shorts because they can influence regulators and what not is BS.
I continue to believe there will be no application submissions this summer and the narrative will shift to SNO in mid November. Why didn’t Dr. Bosch accept Q&A at ASCO? He didn’t want to respond to difficult question(s) around RAs because it’s entirely possible they are not that close to submitting yet. At least that’s the impression you get from the defensive positioning. If the application was already submitted or they were really close to submission, you’d want to invite such questions and respond positively (while staying within the boundaries of the regulators).
This statement is with respect to low grade glioma with some other drug.
I’d encourage you to post such statement or video in the context of DCVAX from her or anyone at UCLA (if you can find something like that). We will be over a $1 in a heartbeat!
The real question is why aren’t they (UCLA folks) saying the same thing for DCVAX L approval? Likely because the application hasn’t been submitted and they don’t know which direction FDA will go once the application is submitted.
If a big pharma partner is not lined up at MHRA approval, we will get manipulated/shorted on any spike we get. They (shorts) know there will be fairly big dilution along the way and importantly this team will not be able to scale the revenue quickly. It will take years! No hiring on NWBO commercial side yet.
And that will very likely move to Q1/Q2 2024. Remember what they said about TLD initially in 2020 and how long it took them to finally reveal!
They have methodically slow walked this to line up with study completion of ph 2 combo trial (Q1 2024). Meanwhile, they will keep retail engaged with some carrot stick(s) between now and then! Tissue agnostic, Flaskworks, MAA applied secretly and we will only hear once everything is finally approved, all RAs together via Project Orbis, etc are a few that may be in play! ;)
Hopefully the confidence thing will resolve itself in the coming months. We will circle back on August 10 or September 10! Your pick?
LOL, you are not showing any confidence in this management! ;)
Should we do Sept 10 rather? Every 3 months? ;)
Let’s circle back every 2 months to see if we get MAA acceptance news or not. Next check in regarding non sensical prediction on August 10! The MAA acceptance milestone ought to be in the bag for this stellar management group by then!
I agree with you. Dead money in 2023. Although the supporters are trying their best to pump!
The management themselves have said we plan to be strategic and be prepared to file by the end of this year. And going by their excellent execution history, it’s likely the applications get pushed out to first half of next year because they have repeatedly shown that they are unable to meet even their own most conservative timelines.
Also, notice that Advent folks are going out to quite a few cell and gene therapy conferences to promote their services. They are looking for new clients! So something to keep in mind and not correlate their expansion to NWBO alone.
Agreed. They will shout from the rooftop when it’s accepted. It’s likely they will not PR submission but they will PR acceptance.
All this speculation and hope that approvals will drop out of thin air one day ain’t happening. Doesn’t work that way. We will find out when the application is accepted.
However, given the history of this management and the various statements in public domain, I don’t expect anything in Q2 or Q3.