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Well, we will re-visit in September! It’s not too far.
They eventually come through. Just like the 1-yard line comment on publication and TLD that lingered for 2 years. Having said that, they have lied and have not been transparent with shareholders on multiple occasions. There’s no denying that!
As I said, the specials revenue will be less than $2M a quarter in Q2. It’s not going to scale much higher than that given that Dr. Ashkan’s team is the only group involved.
August report will be interesting.
As I said, there will be no application submission in Q3. Very unlikely in Q4 either. It’s always someone else’s fault and things are outside their control. Now the blame is put on contractors.
They are hiding some things as to why they it’s taking so long. Application paperwork certainly doesn’t take this long regardless of the size of your team and how novel and intricate the product platform is. They are waiting on some more stuff to happen before they can apply.
The more such stories get posted it becomes evident how desperate things have become. It’s an indication nothing is coming anytime soon. No reason to post such inside info and jeopardize the investment.
Agreed. This will not happen in the foreseeable future but never say never. With an influential and visionary leader like Elon Musk anything is possible (maybe one of the big pharma leaders that take on our product and big retail pharmacy leader can make this a reality in the next 5-10 years provided there are right incentives for everyone). The reality is this is a very complex situation and will need a lot of money, time, and administrative hoops to jump through to develop a scenario like this in the real world. And the other fact is that this management is not capable of bringing this change.
No disagreements around Hygro, Ex, LC, IC, and Novocure!
I am more concerned about what the management is able to do for us and controlling our narrative than worrying about competitors or shorts. I care for return on my investment with NWBO. Whether Novocure or shorts go brankrupt or thrive is immaterial to me. And in that context, we will continue to monitor our share price performance every couple of months. Another few months on top of 3 years from data lock is no big deal!
You still have no idea how this end to end process works. I’d so some reading on leukapheresis, freezing of tumor, etc. in connection with our product.
These pharmacies even if they are brought into the mix in the future will not ease the bottle neck around leukapheresis. They will mainly act as distribution centers for vaccines and places where patients can get their shots from a certified staff. Again, a lot of ground work including training, processes, etc need to be implemented and blessed by various administrators for this to become a reality. It will also be a financial battle between the hospital admin and pharmacy admin too because part of the potential revenue stream is displaced from hospital to pharmacy center. It’s not going to be easy.
On the other hand, the hospital staff will still need to be trained on leukapheresis regardless and they will need to develop their processes around this.
Will do, but I have also been living and breathing this world for 20 years now!
That’s only market access game, but who brings in new customers, helps build the process and training for new sites, marketing, finance, etc?
But you shouldn’t be worried about this scenario anyway because you expect a partner post UK approval who already has an experienced team built to handle all of this! ;)
It’s folks in the other camp like me who should be worried about this scenario because I don’t expect a partner post UK approval.
That’s the only other reasonable explanation for no hiring activity on the NWBO side. Here are the two likely scenarios:
1) NWBO handles commercialization themselves. In this case, given the lack of hiring activity it’s prudent to believe UK approval and reimbursements are at least 9 to 12 months out, if not longer.
2) A partner is lined up post approval. In this case, UK approval and reimbursements can happen sooner (and it’s even conceivable they are in a rolling review) since they have a partner lined up that has built a team already to take up commercialization of DCVAX-L for GBM indication immediately post approval.
But if a partner is not revealed at UK approval without the hiring in place then the market won’t react positively to the UK approval news as everyone expects. It could even be another sell the news event that shorts will take advantage of!
LOL, you have no idea how these things work!
Just do a simple google search and see how many Walgreens and CVS there are in the UK! ;)
“Advent are handling the MHRA MAA”
Yeah, right!
LOL. Patients and physicians should just look for a GBM cure on YouTube and simply follow that!
There are many sites that are likely not familiar with the process of correctly freezing the tumor, leukapheresis, etc. even if they may want to provide DCVAX-L as an option to their patients. Even though it’s trivial, correct processes need to be built and implemented at each site. Unless you have folks from the company actively working with each site on implementing these processes and training protocol, things don’t get done.
Forget about the other group of sites that are either not familiar with the technology or have competing interest where they are running other clinical trials, etc. How do they bring them on board given the resistance, competing interest or lack of awareness?
Remind me how many sites are handling specials other than Dr. Ashkan at KCL?
Who handles sales, marketing, business development, finance, operations, etc. The business is not going to come looking for them from outside the trial sites. In the clinical world, things don’t move as quickly unless you bring awareness and help nudge the hospital admins to adopt a new technology. Of course, they can remain a boutique shop and survive with their existing team but then the street will only value them accordingly. That just gives clue to the street as to how they are thinking about revenue expansion.
Also, how about training programs for non trial sites?
We will also know by their hiring activity. There is nothing on NWBO side. We are many months out. Approvals certainly not happening this year.
If you look at US population, it’s roughly 14k GBM v/s 40k TNBC.
I don’t believe Citadel et al will give up easily. Many me too cases are bound to spring up otherwise. This will go the distance and well into the next presidential cycle.
Still over 2-3X addressable market size than GBM.
Laura Posner in her interview recently specifically stated we are still quite early in this case. And she said this last month, 6 months into the battle. So let that sink in.
I will check again in late August to see if we have any update on MAA submission/acceptance.
No kidding! Are you suggesting that we should wait another few years for the lawsuit to settle in our favor before expecting fair valuation or return on investment? If so, we should not expect things to change at UK approvals because MMs are going to do their thing anyway, just like JAMA, TLD, and MIA. They will always find something to complain about and create fear and uncertainty.
You seem to indicate it’s not LP’s job to bring big investors, build excitement around our story, and importantly deliver return on our investment. She can not take responsibility of our share price until we win the lawsuit. And if the lawsuit doesn’t go anywhere in the next few years, then the remaining retail folks that don’t believe in the management can also sell their shares as the ones before them.
By the way, breast cancer is 10x the addressable market size than GBM, but you already knew this.
In fact, I will talk to you when we get to $2 and stay there for a couple of weeks consecutively. When do you think we achieve that big milestone? Or do we just magically jump to $200 share price in early 2030s? Everyone’s favorite LP and LG would have long retired before then as well!
JAMA is great, but that resulted in a 50% price reduction over the next 7 odd months! The management is unable to convince the street and bring the much needed visibility and credibility they deserve. It will be a repeat with UK approvals in 2024.
If we go by their 15-17 year history, it’s likely that number is true but with a negative sign before. From ~ $1,000 to .57 cents now.
I have to agree with you on this. There are some on this board that are proud of accumulating every day without selling as far back as almost 10 years ago. LP got them good! On the other hand AAPL, TSLA, NVDIA, MSFT, etc. and pretty much the whole market went bonkers during that period. Anywhere between 1000 to 10,000% or higher during that period.
If you bought your NWBO shares over 25-30 cents then you made a bad choice, unfortunately. Longs that bought in the $3-4 range or higher around 7-8 years ago are stupid for not having enough dry powder to average down when it dipped under 20 cents. Only they are to blame and not the management. Management gave them a nice opportunity to load!
I agree with you. They messed up the release of TLD and JAMA article. This narrative of releasing a series of back-to-back events, trapping shorts, and quiet period was just BS. They just use these excuses to shield themselves.
If the management had the chops and the network, we would have seen it in full flow around JAMA and TLD PRs to build excitement and support for higher share price. Why would you knowingly let the SP languish and make financing increasingly difficult? Again all excuses and it’s an indication of what we might potentially see with UK approvals as well.
Does that give him the permission to lie whenever he wants to other shareholders in order to benefit the one he raised those dollars from?
So LG never made that comment about UK approval in 2020?
So you agree LG is both a liar and an embarrassment to the team?
Agreed, but no LG please! He is both a liar as well as an embarrassment.
Agreed. It applies both ways, folks that gaslight and pump as well as short mafia. It’s the naive retail and patients that suffer in all of this.
The same rules apply to management too. Although I don’t know what to call LG’s statement on Big Booz show from 3 years ago that UK approval was imminent. A lie or embarrassment?
Haha. I figured LP would have a word with LG after I saw the first interview. That was so embarrassing! I’d be curious how the clinical and research community react at the upcoming SNO conference in mid November if there is no submission by then. The KOL support is the only silver lining there is to our misery. And if that recedes due to lack of meaningful progress from the management, then it would make the adoption journey as well as regulator support (outside UK) even more challenging.
Dr. Toms in that January 2023 media announcement (video) hinted towards potential approvals within a year or so. And there is no visibility on the manufacturing agreement with CRL in the US yet.
Agreed. It’s pretty much priced in now and there is no surprise element.
Outside a big pharma partner nothing is going to change our situation significantly for another year or two in terms of share price.
Hope is not a strategy. Why they don’t go to major biotech investor conferences such as JPM, RESI, etc is beyond me. There is no visibility amongst investor or media community except Big Booze show, which is a joke! Just look at their website, for example. Shows the attitude of this team!
Finally, there will be blame game as always for management’s inability to bring big investors or big pharma that buy into the story, but no accountability of the management team.
Nope, but you did keep on saying for more than a year how JAMA and TLD was going to change our situation with bring the much needed coverage and relief to the share price. What happened there?
And do you expect MAA acceptance in the next 2 months? I say no.
Just wait until we approach September and there is no update. Any guesses where we might be trading? No hiring activity on the NWBO side is a strong indication nothing has been submitted and they don’t expect approvals well into 2024.
That’s what everyone said of the high impact publication (JAMA) 12-18 months before its publication as to how that was going to be a game changer. The same hype was created around specials manufacturing approvals in Dec 2021 and then MIA in March 2023. The reality is Dr. Ashkan and his team at KCL is the only group handling specials patients.
AF and shorts will not stop at UK approval. And given the rich history it’s highly likely NWBO management will be lame ducks again. They have not been able to defend or control the narrative and build shareholder value.
Let’s check the share price around end of August. That will bring it closer to 3 years post data lock. That’s not days, weeks or months. We will monitor it every 2 months the rest of the year and check the progress. With weak hands gone, there should only be upside from here on!
It’s unfortunate your top 2-3 milestones have taken over 2 years and resulted in opposite price action. Will be lose another 2-3 years for the next 2 milestones and yet end up with a lower share price than today?
Well, the silver lining for you is you never run out of dry powder! That puts you in a good position to purchase more shares at a lower price later this year and next.
They get in legal trouble if they start marketing or promoting before approvals. But I hear your larger point. Sales, marketing, business development and market access are critical functions they will need to have on their team to grow. The neurosurgeons/sites outside the ph 3 trial will need to be recruited, trained, and infrastructure set up with the hospital admin to establish business activity. The lack of hiring activity tells us we are still many months out from approval. Probably close to an year. Otherwise we would start seeing job postings.
Keep in mind, it’s only Dr. Ashkan’s group at KCL working on specials program currently.
“The markets are forward-looking, and so am I. I am a patient investor who is focused on the DCVax science and data, and its long-term potential.”
Are you sure with this management? JAMA, TLD, and MIA resulted in opposite reaction.
We understand that opportunity cost does not factor in your investment decision, but the forward looking statement gets tired in connection with this management team.
To be taken seriously, I’d start by putting some timelines including info on market access for each of the major markets (US, UK, Canada and EU). I’d also remove worldwide approvals! I told this to you about 1 or 2 years ago and how even EU was going to be extremely challenging for this team in terms of reimbursements. It’s just not a good utilization of their resources over the next few years.
You have been saying this for 2-3 years now, but let’s get UK and US approvals for GBM indication in 2024. Hopefully, we will be at a $1 with UK approval in 2024 and stay there. Then we will dream about FDA around end of 2024 or 2025. We will reach 1.6B OS by then. Forget about EU approvals/reimbursements and tissue agnostic. This management will not be around if and when they start planning for those milestones.