I agree LP, LG et al must prove themselves in terms of building value for shareholders sooner or later. Retail shareholders don’t have the true-up option.

“Certainly the short position doesn't seem to be on the sidelines, as they anticipate Northwest won't even apply...”

They know as well that U.K. approvals are coming, but they won’t admit it. Once the UK approvals come through, they will just find something else to complain about like reimbursements, scaling the operations, investment needed, etc. And these are all valid questions and concerns. So they will likely short again if at all there is another brief spike over a dollar upon UK approval (and there is no indication of a big pharma partnership). The shorts also know that big dilution will be needed to fund existing debt and ongoing expansion in the coming months so thats another opportunity for them to slam it down. Retail alone is not going to be the answer to counter shorts in a meaningful way. It hasn’t worked so far with all these important milestones and it won’t in the coming months.

They will come up with a series of question marks over reimbursements, how fast they can scale, the investment they will need to scale, etc. It’s going to be a long, ongoing battle. Will not stop. This management has no credibility and their execution history is lethargic and patchy to say the least!

Outside the experience and credibility of a big pharma partner, how will they address these concerns? Relentless execution, but that will take years for this management to re-build trust all by themselves. JAMA & TLD didn’t do it, and MIA didn’t either.

What’s wrong in supporting the technology platform and KOLs that back the science, but not the bulk of the management that’s running the show commercially?

Like many longs, I am hoping that they make way for big pharma to take over eventually. They are not getting any younger so it’s bound to happen at some point in the next 2-3 years.

I agree with your take. Its just like CRL or other CDMO getting MIA.

All this conjecture that we may have secretly received MAA acceptance and will directly hear approval news during the summer is BS. The management will shout from the rooftop whenever the final application is accepted whether it’s via RR or not. Just like the urge LG showed when appearing on big booze show a week or two ago!

Non sense. You said the same thing about JAMA and TLD. The opposite happened. Even if there is a brief spike it will get slammed by shorts in quick order in absence of any meaningful big pharma partnership. The street does not trust this management to deliver value to shareholders. A long 15 year history demonstrates that with continuous down round of funding.

I agree. I don’t think even MAA acceptance news will move us over a $1 at this point given how long this has taken. It’s expected. MIA didn’t trigger any meaningful uptick in terms of volume even though it’s a strong indication that UK approvals are coming. In fact, JAMA, TLD, and MIA had the opposite effect on the SP.

So I continue to believe that we will need a big pharma partner announcement (depending on the structure of the deal) to change the perception and bring the much needed visibility and credibility in the coming months too see a sustainable rise in SP. FDA approval could be another game changing event given the size of the US market and rich reimbursements here but that’s at least 12-18 months away…likely longer with this management at the helm and our tight cash situation….

LOL! Moreover, he has been stuck at the 1 yard line for a couple of years while other folks within the company have been working very very very hard.

Go listen to LG at big booze show from 2020 and LP’s comments at a virtual scientific event. But there are many more instances overs the years and you already know that.

Not when they flat out lie! Pathological behavior! Similar to hedge fund social media army….

Agreed. Hedge fund social media army is just as terrible as the folks that see no fault with this management and continue to blindly support them!

Looking forward to seeing the progress the management makes with RA application(s) acceptance in the next 2 months. We will be close to the 3 year anniversary from data lock!

We will check in every 2 months to validate! Hopefully there is UK MAA acceptance PR before end of August. Not the end of the world if it doesn’t happen by then. We will check in again end of October and so on….

LOL, doesn’t suit in this context! Particularly when you don’t have any opinion on timing.

He expects UK and Canada application acceptance in August. So follow up in early September if you don’t hear any news until then.

I am hoping he is not being played by NWBO management like they did to Thermo!

That I don’t know. Hopefully things will start happening at a faster clip in late Q1/Q2 2024 when phase 2 combo study is completed.

Nicely done. However, my sense is there will be no UK approvals or any deal this year. We would be very lucky if we get MAA acceptance news in 2023. It’s likely we will be under 50 or 40 cents as we move into late Q3 or early Q4.

Great work and good luck! Watch out for all kinds of excuses you may get for why it may not be there.

Late Q3 gets worse with no regulatory news!

Agreed. When your Senior Vice President lies publicly, why would big investors trust this group with their money?

Yes, I forget the opportunity cost and extended dilution does not factor in your decision making.

Again, do have the dry powder for late Q3. There will be even better opportunity to load at lower prices.

Remind me the other countries you had in your worldwide approvals list. ;) Do you think they’ll go after worldwide approvals before/after EU reimbursements? Ohh speaking of EU reimbursements, any idea on what’s expected there?

The next few months will continue to present buying opportunities, so have some dry powder for late Q3.

LOL! How are those worldwide approvals coming along that you were posting about nearly 3 years ago?

Ohh I forget opportunity cost does not factor in your investment decision! Let’s give another 3-5 years for worldwide approvals, shall we? Japan, Israel, S Korea, and I forget all the other countries you mentioned! ;)

Haha! Unfortunately, I didn’t own enough shares at that point to care or read about NWBO on a regular basis. But folks that have invested heavily and stayed close to or over a decade with this BS are brave!

I am already fed up in my 3 year journey with this management. KOL support is the only silver lining in all of this.

Agreed. A lot of retail investors will again be disappointed when we don’t hear anything in Q3.

It’s funny how these messenger stories and patterns never get old - “I spoke with a biotech veteran or a famous lawyer or word around the campfire is XYZ (all super positive)”. How many times have these carrots been dangled in the last couple of years?

This is what I have been saying for a couple of years! Just watch out if there is no BP involvement at the end of MHRA approval. We get slammed down to near previous lows as big dilution beckons coupled with messy commercial execution. This is what shorts are anticipating and they won’t give up until a credible partner is brought on board. Easy pickings with this management!

No point arguing. These same folks were saying how the peer reviewed article and TLD were going to change the perception and potentially share price whenever those pieces were released. In fact, the opposite happened with the share price.

Before that, specials approval was hyped up as well and how that was going to change our revenue situation quickly in 2022. $20M per quarter estimates were forecasted for 2022. In fact, we are not even at $2M per quarter in mid 2023.

Nothing changes without a big pharma partner. In fact, I wouldn’t be surprised if our share price goes lower at MHRA approval if there is no partnership announcement to go along. Classic sell the news event that shorts will pounce on!

I agree with you. The shorts will pound at every little spike we may get. They know that quite a few retail folks are tired with the BS from management and slow execution, so these folks are likely to offload at the first opportunity. And that will add to the pressure.

There has been no hiring activity at NWBO so it appears that approvals and reimbursements are still a while away. And unfortunately, it doesn’t look like they have a big pharma partner lined up either.

Without a big pharma partner, we remain a boutique shop for many years to come with no credibility amongst the key investment community and shorts know that. So expect more of the same at MHRA approvals as well….just like JAMA, TLD and MIA milestones….Amidst all of this, there will be major dilution (C shares) at MHRA approval and folks wouldn’t be thrilled when that happens because it’s likely to be at a disappointing valuation!

Adding one more to the list of excuses we may hear from loyal supporters for no PR in 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!

6) We are in rolling review. So don’t expect any confirmation for months because they could be going back and forth with the regulators over some queries.

Agreed. The shorts also won’t leave as long as this management stays at the helm. Easy pickings for them!

When did Merck make this statement and where, flip? The recognition by Merck is encouraging either way.

LOL, Tuesdays actions have nothing to do with my theories, but you know that. I have been saying this for a while based on the public statements they have made and their posture over the last few weeks.

Let’s circle back in mid to late August to see where we are. Given that my theories are BS, you should have had at least MAA acceptance PR by then, if not MHRA approvals.

Here are some things to ponder until then:

Why was PIP not filed in late 2020 soon after data lock or even 2021? PIP application submission takes over 18 months?

Why was CRL or some other CDMO not used for UK? They didn’t need to wait 30 months for Advent commercial certifications. It seems they are open to using it for US application. Why not do the same for UK instead of waiting 30 months? Advent could have been added at a later stage once approvals were granted.

These are all signs of a bigger plan to time the various pre requisites to line up with phase 2 combo study completion date. Or are we to assume they are just terribly inept with limited to no organization, planning, and multi tasking skills? Which one is it?

They have had over 30 months to prepare for this. If they didn’t submit their application post MIA approval within a couple of weeks (in April) then I am fairly certain they are waiting on ph 2 combo study to be completed and there will be no submissions this year.

They will keep shareholders hooked via their messengers with reasons such as tissue agnostic, Project Orbis, FDA first, Flaskworks, etc. All pointing to needing more time to submit and how it can be a game changer. But all of this is a cover to allow completion of ph 2 combo study. In the end, we will find out that they only applied to the UK and for GBM indication only once the ph 2 combo study is completed in 2024. And it will be quite disappointing.

Of course, the other remote possibility is that they already submitted the application in April and we may get approval news directly in the coming weeks (in July?). Even if I were to trust this theory (which is next to impossible), the longer this drags on into mid-to-late Q3 it becomes evident that nothing is submitted and that there is no intention to apply this year because they are waiting on ph 2 combo data. The reality is it simply does not take this long to prepare and submit an application regardless of the inexperience and bench strength you have within the team. And all these excuses about waiting on tissue agnostic, FDA first, Project Orbis etc is just crap.

You will likely lower those expectations in Q3/Q4 and may take a dollar for an exit in 2024!

It’s coming in Q3. Be prepared.

LOL, that’s a bit too much! But hey there will be another great buying opportunity before the Holidays. ;P

You are right. They may not announce submission, but application acceptance will be PR’d. In fact, they will shout from the rooftop when that happens! In case of FDA, a PDUFA date is given about 6 months out.

Why would you knowingly sell shares at bargain basement prices when you have an excellent opportunity to build credibility and support with acceptance news. They didn’t shy away from reporting progress on specials manufacturing progress with multiple PRs in 2021. LG wouldn’t go to big Booz show if they didn’t care about building awareness and support.

They will try to create some ambiguity and mystery around direct approval news to keep shareholders on the hook. Ultimately, we will get UK acceptance news PR. Hopefully it comes sooner than later, but I don’t expect it in Q3. In fact, my prediction is Q1/Q2 2024 after the phase 2 combo study is completed.

Many loyal supporters said the same thing for TLD and JAMA, but it’s ok to live in denial. It went from 1.2 to 60 cents.

It’s likely we go back to 40 cents or lower in the second half of this year before we get any regulatory news. Again, you are welcome to live in denial. Depending on the timing, we are also likely to be around 1.3B outstanding shares before we get UK approval news as dilution accelerates in the coming months due to debts and ongoing operation costs.

So if we are lucky, we double at UK approval to 80 or 90 cents and ultimately shorts slam it down to 60 or 70 cents in subsequent weeks with lack of execution on commercial front. In essence, UK approvals won’t provide the return everyone is expecting for folks who have bought in 60 or 70 cent range. And folks who bought it over a dollar last year will continue to remain in red!

However, a big pharma partner can change the market perception and bring experience, energy and rigor to the fold. That’s where things can change quickly to our benefit. Otherwise, it will be more of the same. The same group who weren’t able to convince the street on the value of DCVAX-L with JAMA, TLD and MIA won’t be able to make any meaningful impact with MHRA approvals either. In my view, UK approval is expected and priced in with this group at the helm given how long this has taken.

Not sure about this week or next, but we will see 50 and likely 40 cents in Q3 for sure. And slow dilution will continue.

That’s my realistic forecast and I have given my reasons. If you have any opinion on timing, feel free to counter.

I am sure a lot of folks back in 2021 wouldn’t have taken mid 2023 without UK approval as realistic either. In fact, LG expected UK approvals in 2021 but that was his fancy! ;)

“Publication of the JAMA paper is a watershed.”

— It’s indeed great to have the support of 70 odd top neurosurgeons in the world. No mean feat!

“Using the pattern extracted from a sequence of past events before the JAMA paper to predict what is going to happen next is not wise.”

— when those patterns have repeated over and over again from the same set of people in the past, it would not be prudent to ignore! In fact, it would be foolish.