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Who in the right mind will give $10B or $12B valuation on UK approval alone? Probably $2B market cap at the higher end on UK approval and that too if couple of big investors and some media buy into it. Otherwise it will be a repeat of what we experienced earlier where it gets slammed immediately on any brief spike we may get. If JAMA article with top 70 neurosurgeons endorsing as well as the TLD and MIA approval doesn’t bring the investor and media attention then how will UK approval change the situation? Shorts will continue to find something else to create doubt and concern. Management hasn’t shown they are be able to defend and make the right moves to support the share price.
“Approval is coming. If it is tomorrow, next week or in 6 months, it doesn’t matter.”
The same statements were made last year and our outstanding shares have grown from about 800-900M to 1.1B during that time. At this rate and considering the outstanding debt payments as well as money required to scale, we could be at 1.3 or 1.4B outstanding shares by the time we receive UK approvals in 2024. So our upside will be severely limited.….Timing is important!
They offloaded a big chunk of their position to retail when we were trading over a $1. They know we are many months away from regulatory submission and at least a couple of years away from accumulating meaningful revenue with this management at the helm. They probably also know that no big pharma wants to partner with this group so upside (if any) at regulatory approval in 2024 will be limited and short lived.
Thermo was probably played by the management again and is likely embarrassed and upset. Of course, he may have still have a significant portion invested in NWBO and wouldn’t express it publicly until he offloads more on the next pump! He was hoping that pump (or to put it nicely the upside) would come in April then May then June, but this management finds a way to disappoint one of the biggest supporter.
LP’s social media army is on the defensive. They know there will be no submission this year. So they are pointing to the loose prerequisite, application preparation and submission language LP put in the last report. And we all know how that goes with this management. They are never on time when they put formal guidance. So I wouldn’t expect anything until Q1 2024.
The rest of the year could be brutal with ongoing debt payments and dilutions while providing no indication of MAA submission. It would be interesting to check how many additional C shares they sold in the last quarter and their specials revenue when they issue the next report in August.
Here’s what he said on June 12 to my post.
hoffmann6383
Re: Maverick0408 post# 600772
Monday, 06/12/2023 5:04:42 PM
I continue to believe there will be no application submissions this summer and the narrative will shift to SNO in mid November.
I believe the opposite. Submission is happening this summer. Maybe submissions.
Thanks for agreeing what I have been saying all along. No submissions in Q3 and highly unlikely in Q4 either.
LOL. Alright, we won’t check on regulatory progress every 2 months then because management has signaled submission before end of 2023. It’s also typical for them to be delayed by a few months. So let’s not question them on submission/acceptance until Q2 2024. Fair?
Hopefully, we can at least check on share price performance every 2 months! ;)
But I have your statement captured in a photo where you said this. What changed?
Still confident in UK and Canada application acceptance by end of August?
We will check around that time to see what progress this management has made towards regulatory submission and where our share price is. And subsequently every 2 months.
LOL, that does not sound like a vote of confidence in this management.
It’s a prediction that this management is incapable of building excitement and defending the share price. It’s also a prediction that this management will have no meaningful strategy to counter shorts.
I don’t care what the pump machinery or short cabal think or say. I only care about how this management delivers return on my investment as a shareholder. And if they can’t (as shown repeatedly) they need to get out of the way!
We will check on UK application progress around end of August, as discussed!
Unfortunately, the street does not trust this management to deliver value to shareholders on an ongoing basis. We will see similar reaction to what transpired after JAMA, TLD, and MIA. Even the management is signaling they don’t expect significant uptick in commercial revenue anytime soon as they have not invested in team building, etc.
I wouldn’t be surprised if that response in 2024 would be $1! The trend is to decrease expectations by roughly 5X from the previous year.
After all, there will be great buying opportunity later this year under 40 or 30 cents. So it would still be a double or triple for those that buy it at that time! ;)
I’d say option C (everything listed in option B + share price under 60 cents!).
That’s what everyone said about high impact peer reviewed publication (JAMA) and TLD. It didn’t build excitement amongst investor community. MIA also is a strong indication UK approvals are coming, but the street did not react.
As UK approvals come through, shorts will find a way to create negative spin around reimbursement and manufacturing. They always move on to next. How will NWBO management defend itself or convince investors? They haven’t shown they are capable of doing this time and again at important milestones including in the last year or two.
Gary, how will the company achieve $5 SP without big investors on board? Forget about achieving $10, $15 share price. JAMA, TLD, and MIA should have moved us closer, but we went in the opposite direction. How about going to big biotech investor meetings and building awareness by presenting your story? Novocure was at the JPM biotech investor meeting in San Francisco earlier this year. I was there too.
It’s ultimately the failure of the management. The reality is they have been unable to build excitement amongst big investor community. That’s a big part of their job.
Why aren’t they making presentations at big biotech investor conferences? Shorts or market makers are not preventing them from making these pitches. At the very least, they ought to make sincere efforts towards that and not make excuses all the time.
It wouldn’t be surprising if we see a similar reaction to the share price at the UK approval PR like what we saw with JAMA, TLD, and MIA. Shorts will highlight issues around reimbursements, investments around manufacturing scale up, etc. Management has shown time and again that they are unable to control the narrative, build excitement, and bring big investors on board despite achieving these key milestones.
So it will be extremely difficult to build credibility, trust, and therefore meaningful support for the share price outside a big pharma partner.
I agree the SP will be well under a $1 at UK approval as well given how long this has taken. The street does not and will not trust this management with the next phase either. Only a big pharma will bring the much needed credibility.
Even a novice knows this is pure BS. Nobody would be disclosing it if true.
— Unfortunately, I will have to agree with you on this. Such inside info will be handled extremely carefully. The company could get in huge trouble if it gets leaked otherwise! Besides, if you have high confidence and trust in your source with such sensitive and positive info, then you don’t go out in public domain and start shouting from the rooftop. You keep it to yourself.
The more such narratives start emerging it becomes clear that the company is getting increasingly desperate and so are some shareholders. This just validates that nothing is coming anytime soon.
Perhaps he is in the touchdown zone now? Only that can explain his more upbeat attitude than 1 yard line comments he has been making for the last 2-3 years. ;)
No, it’s not about Flaskworks.
My view is they want to supplement their application with the ph 2 combo data to improve their chances. Or they may want to add more data points around mechanism of action than what they currently have to add to their ph 3 data given the depletion of placebo.
Gary,
Are you unknowingly suggesting that NWBO management isn’t able to build excitement amongst investor community despite being in possession of such stellar data and presentation materials?
We are both on the same side in terms of data, science, and the KOLs supporting them. Also, we are both expecting UK approvals. However, we differ in our views as to how soon we get to the regulatory approval, path taken to get there, and the management in general. Your view is that management is overly cautious and hence taking longer than normal to submit their UK application. My view is they are hiding something and are still waiting on something, which is not expected this year. My view is also that we would be so wounded by the time we get to the regulatory approval that outside a (big pharma) partner, it will be extremely challenging to move forward on our own.
The reality is they have nothing significant to report. So if they send a meaningless PR it would backfire.
And they will not be transparent with shareholders in terms of guidance because that will very likely lead to selling knowing that application submission may still be a couple of quarters away.
DI has been toying with you for a long time, unfortunately.
They are either slow walking this on purpose (for some more things to line up) or terribly incompetent. Although these guys are inexperienced and not the most skilled folks overall, I still find it extremely difficult to believe they are unable to submit an application 3 years from the data lock. No company takes this long even if you are a team of only a handful of people and/or applying/creating a brand new class of personalized therapy.
So I am leaning towards they are hiding some things and need more stuff for the application, which they don’t expect this year. Combo data/study completion? Otherwise I expect them to be in a fantastic position to submit immediately post Sawston manufacturing certification, which was 30 months from data lock. That’s a lot of time to prepare the application package for submission.
Most of these folks were saying it was the last opportunity to load under a $1 when we were trading in the 90 cent range. When we go below 50 cents, they will again encourage folks to buy saying it would be the last opportunity to load under 50 cents. Never stops!
As I have been saying, there will be no application submission/acceptance news in Q3. Only dangling of carrots (from supporters).
Per my earlier post, one of these excuses will be hyped up as we approach mid to late Q3 (in an attempt to build lofty expectations and attract more buying from retail).
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.
6) Rolling review already in the works. Approval(s) can come anytime.
Ultimately, they will PR MAA acceptance news but it won’t be in Q3. Highly unlikely in Q4 either. We could potentially be under 40 cents before that news ever comes. It will again be very disappointing for most folks in terms of the impact on SP.
The report in August will also be revealing in terms of the specials revenue and the financing (including C shares). I expect we will be under 50 cents before that August report comes out as some of the folks connected to the management sell a bit of their position to buy back at a lower price point later in the year. These guys know regulatory application submissions are still some months away!
I don’t claim to know everything or have inside information. Quite the opposite. I have never spoken with these jokers and don’t intend to.
My views are based on my extensive experience working in this neuro field for 20 years from a business development and executive strategy perspective unlike some that claim that they know everything without experiencing it from inside day in/out.
We will find out when they release their specials revenue numbers for Q2 in August. And what’s your estimate for the next quarter, Q3? We have already had specials manufacturing certification for 18 months now. How long before we incorporate additional sites other than KCL?
Yup, just like that LG comment on a public platform 3 years ago that UK approval is imminent.
They are BS artists! You got the same treatment like the other guys that spoke to them before you.
The specials revenue will not be more than $2M from Q2. You will find out in August.
Also, there will be no regulatory application submission and acceptance in Q3.
So where will the upside come from? In fact, it will be the opposite. Slow dilution will continue and we will be under 50 or 40 cents by end of Q3.
Sure, it will grow some, but it will never scale beyond a few million per quarter.
Firstly, the main bottleneck currently is KCL even if they had sufficient demand. It’s the only site doing leukapheresis for DCVAX-L compassionate use and they can only handle so many GBM patients per month. Why aren’t other UK trial sites participating in the specials program?
Secondly, how many patients will pay $200k out of pocket?
Thirdly, what percentage of neurosurgeons outside the ph 3 trial are deeply familiar with DCVAX-L results and not attached to other technology platform or trials?
Specials revenue will never exceed more than a couple of million per quarter. And the company simply can not survive on that.
Doc,
Two of the patients have recently reported that leukapheresis is only done at Kings College in London. They had to travel overnight to London (one of them was from Bristol, UK, and another from Ireland, I think) to have the 4-5 hour process done. Also, one of them reported that she will have to return to London again once the vaccine injections are ready.
I will guarantee you that the Q2 specials revenue is going to be $2M or thereabouts at the max.
See below a link to an update from the patient based out of Bristol on June 23, 2023:
https://www.gofundme.com/f/funding-for-tracy
Agreed. Q3 will come and go and excuses will keep piling up.
I wrote about these excuses a few weeks back. Some of this will likely trend as we move into late Q3.
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. They want to trap shorts!
6) Rolling review already in the works. Approvals can come anytime.
As discussed, we will check in every 2 months on the RA progress, Dr. Bala.
Hopefully you can show me the PR that their application is accepted around end of August. If that doesn’t happen, we will revisit end of October.
Do you also disagree on the specials revenue forecast? If so, we will check on that in the next report too. There’s no way Dr. Ashkan is able to see more than a handful of GBM patients per month. So that’s the big bottleneck for specials revenue even if there are a few patients that are willing to pay out of pocket.
There is no capacity crunch at Sawston. You have heard from couple of patients recently that Kings College London is the only center handling DCVAX-L therapy on specials program for patients at this time. So the gating factor is KCL and Dr. Ashkan. He can only see so many GBM patients per month (in single digits).
You will see in the next report that specials revenue will be disappointing (likely less than $2M per quarter).
Manufacturing shouldn’t be an excuse anymore for not submitting the regulatory application for UK. In all likelihood, there are other reasons why they have been holding up the submission and we will never know the reason until one day in 2024 when we get a PR from them indicating that the MAA has finally been accepted.
I wouldn’t fall for it. They always use the shorts excuse to suit their narrative. If an approval was expected in the coming weeks, there was no reason for LG to show up on that Big Booze show recently as it’s contradictory to their quiet and conservative communication strategy. That was just weird!
Very likely, LP had a word with LG after that show aired and decided not to do a follow up episode which was expected last week?
I agree it’s a tough balance but you don’t lie like that.
I don’t think he was asked about U.K. approval timing on that big Booz show and even if he was asked, you can always deflect saying we are super excited to bring this therapy to the patients and we will update shareholders as we make progress with the regulatory applications….or something along those lines….That was obviously done to benefit some of his/their friends, who sold during that pump!
You trust them a little too much! I don’t given their repeated past. I do believe we will receive UK approval, but I don’t expect it this year. It’s extremely likely they won’t even submit this year given their statements and how the social media army is positioning. They are hiding some things from us that’s preventing submissions and we will never know what that is. No reason to be conservative and defensive otherwise.
Ultimately, everything will fall in place but it will be 2024 then.
I agree with your LG comment though.
Of course, they have been on 1 yard line and working very very very hard for 3 years now. There will be no submission and therefore acceptance news in Q3.
Whether it’s LG, DI, or whoever else, they will not give any material info. Whenever these messages start appearing saying they spoke with the management and now have full confidence in their investment and that big news is around the corner, that’s an indication that nothing is coming anytime soon. Just shows desperation from the management where they are using these tactics to manage retail frustration by dangling some carrots via posters.
We have seen this pattern so many times in the past few years!
Again, Q3 will be another frustrating quarter for retail.
“Also got a little more color on the compassionate use side of things that are truly remarkable. He let me know in a polite but direct kind of way things are proceeding as they envisioned.”
Such BS! If they envisioned U.K. approval 3 to 4 years post data lock they shouldn’t have lied on a public platform 3 years ago saying it was imminent.
Also, I am confident their compassionate revenue is no more than $2M per quarter in Q2. That too will be a stretch, but we will find out in their next report!