Your end of summer timeline for regulatory submission is coming up. We will both be there to witness that unless they stop your payment flow!

He is well known to exaggerate stuff, always! He claims to speak with NWBO management often including LG (a liar) so that tells you everything you need to know! ;) His call of $80M specials revenue in 2022 was a classic.

A month or two back, I said couple of these excuses will gain traction as we approach fall.

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 is being worked on.

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. Approvals can come anytime.

FDA has nothing to with NIH. Two completely separate agencies. NIH, NSF, and many other grant agencies fund billions of dollars on biomedical research projects every year. Only a small percentage or fraction lead to something meaningful (and even that does not mean regulatory approval as quite a few continue to stay as research products forever).

Yup. I don’t expect any clarity or meaningful guidance in the August 10Q. It will be more of the same (i.e. more ambiguity and dangling of carrots!).

Another $3M payment mystery, LOL!

Very easy to address. Just update the language in their upcoming August report to say they plan to make final UK regulatory submission in Q4, 2023. Will they say that? Nope. They like to keep things vague to trap shorts! ;)

I stand by my prediction - no regulatory acceptance PR this year!

Of course, no one to blame but the management for the lack of transparency and knowingly using ambiguous language in their reports.

This narrative of keeping things vague to trap shorts is the ultimate BS they have been throwing at shareholders for a number of years. TLD & JAMA a classic example!

On the other hand, they have no problem broadcasting to the world (including the shorts) we have worked on 27 modules and 1.7 million pages!

“Let the latest Big Biz appearance be another warning sign.”

Agreed. That confirmed my belief that they are not submitting the final application this year in addition to the ambiguous language they continue to use in their reports around regulatory applications.

Why would you brag about 27 modules and 1.7 million pages but not utilize the opportunity to talk about the final submission timeline for one or two RAs if they were really close. The message ought to be really simple rather than bragging about all the pages and modules they have worked on. Who talks about such things?

If a tsunami was coming soon, there was no reason for LG to come on Big Booz show to brag about the 1.7 million pages and 27 modules. You stay quiet!

Folks are not going to fall for it again after the 2020 debacle and lies!

Agreed. No reason to be ambiguous with their language around final regulatory submission timelines if they are really close. As any reputed biotech company would do, let the market know in a simple and straight forward way. It’s a vote of confidence.

I expect the share price to gradually dip to low .40 cents as we approach fall.

Of course. In particular, DI and LG are pathological liars.

No reason to let the share price languish and continue to finance at such distressed valuation, particularly if they expected final submission and acceptance in a couple of months. Be prepared for another one or two year saga like the 2021 and 2022 TLD and publication phase we experienced.

The management could simply clear all of this by putting out a straight forward and direct statement along the lines of they will make final submission to the UK regulatory authority in Q4 2023….rather than ambiguous language like completing prerequisites, being prepared for submission, etc….

However, they won’t because they don’t plan on submitting this year.

Also, there is no hiring at NWBO. Strong indication we are at least an year out from approvals, reimbursements, etc.

As I said, there will be no submission this year, but this is another confirmation from an unbiased person!

They are waiting on some more things to line up and won’t disclose this to shareholders…just a terrible and dishonest management group! Rather, they will let their social media army provide false hope that it could be any day just like the cycle we experienced during the TLD and publication saga in 2021 and 2022…otherwise there will be a mass exodus of retail…Another year for sure, if not longer…

Good for you!

Perhaps he used his other favorite - we are working very, very hard to cross the finish line. ;)

“I never thought SP would dip this low again.”

Well, it’s likely to go even lower with no regulatory news for another month or two. Probably in low .40 or .30 range.

Did DI/LG confirm they are on 1 yard line in your hundredth phone call this week?

I wonder if LG is in the running for the oldest full time biotech executive of a publicly traded company (over $100M market cap).

LOL, well that’s par for the course! ;)

“Did you lose big on NVCR?“

—In fact, I asked couple of colleagues to not invest in it when they were considering NVCR about a year ago. I asked them to invest in NWBO instead! Although I warned them that the NWBO management’s biotech experience and execution speed (therefore dilution!) is a real risk in the near to mid term.

“Get prepared for the NWBO tsunami”
— not this year, but perhaps in 2024 if we are lucky with a partnership agreement or lawsuit settlement.

LOL, wishful thinking! Their last guidance tell us that their goal in 2023 is to work on prerequisites and be prepared for submission. Not submission per se.

And given NWBO’s execution history, we can expect a delay of a few months and therefore it’s quite likely they could potentially be in the preparation phase in Q1 2024 as well. It would be fun to speculate if they will be over 2M pages by the end of the year?

“We’re a patient bunch”

Isn’t that a prerequisite to be an investor here?

Someone said this to me once in another context which I won’t get into but I think this applies nicely in case of NWBO:

“If you are not patient, you learn to become patient. And if you are already patient, you lose your patience”. ;)

Agreed.

Agreed. This will get dragged for a long time and these MMs will fight till the end. It’s going to be an existential crisis and one or two MMs will ultimately go out of business but it will be a while. Certainly not in 2024 though.

“I have found that by ignoring him, you cannot get the private messages”

I did the same with his and one or two other aliases he may be using!

Increasing number of folks may have stopped taking his Twitter commentary seriously too given the history of this poster….particularly on the legal side of our battle against the MMs where he has shared some interesting pointers…. It’s also unfortunate because folks start associating NWBO with such posters.

He is either a liar or extremely incompetent! UK approval imminent statement in 2020 reflects one of that, particularly when they didn’t submit PIP, no manufacturing certifications, and not to mention regulatory application documents. You pick!

That would be fantastic for shareholders but I doubt that’s coming anytime soon. We would be lucky to have a reputable biotech partner and leadership team in 2024 that can take over the commercial execution from this management team.

LOL, they have survived this long so I don’t know if a couple of additional quarters would result in such drastic outcome (bankruptcy). The warrant holders have made enough money to continue to support them for another rinse and repeat event in 2024?

The share price will be lower than what it is today given the dilution and added frustration but we have been seeing that over the last 12 months, so nothing new.

Of course. I said I will.

I didn’t expect that from you, but its only fair that I stop posting if there is a PR acknowledging final submission or acceptance this year.

They are knowingly keeping things vague because they are looking at first half of 2024 for final submission/acceptance of their application(s). Otherwise they could easily update the language of their reports to say we plan to submit to this (one or two) agency in Q4 or before the end of this year….but instead they say we plan to submit as soon as possible (after prerequisites are met).

This narrative of trapping shorts is just BS as we have seen over the last 3 years with TLD/JAMA execution as well.

Will you also stop posting if there is no submission/acceptance PR this year?

There will be no submission/acceptance PR this year. Will you stop posting if there is none? I sure will.

LG, as usual, lied to shareholders like his big Booz show BS in 2020. There was no reason for him to come on that show if a big catalyst was around the corner.

As I have said since a while, there will be no regulatory submission this year. Again, as I reported earlier, they are waiting on ph 2 combo study to be completed in Q1 2024, but they will never admit this.

No one slow walks a regulatory submission, particularly when your stock is languishing in 50 cent range and struggling to raise capital at appropriate valuation for years. They have been lying to shareholders all this while. Hopefully they will submit in Q1/Q2 2024, but 2023 is certainly going to be another lost year.

Gaslight skills at its finest! ;) The milestones also keep on changing.

“The publication of the JAMA paper was a binary event.“

Publication and support of KOLs is fantastic, but didn’t unlock shareholder value. In fact, we have lost value.

“By the time, you see the volume of 10m a day, it is already too late.”

Not with this stock in the near to mid term until LP et al are at the helm. Shorts have had the upper hand with this management for well over a decade, unfortunately. LP et al never fails to disappoint. Only a favorable court ruling or a big pharma partner can bring the credibility we deserve in the near to mid term. Even MAA acceptance PR may not unlock the shareholder value we deserve given how long everything takes with NWBO team. The shareholders may not fully buy into how quickly this team can execute the next phase of their journey by themselves. When you have had a pattern of not executing in a timely fashion and building unreasonable expectations for well over a decade it’s tough to rebuild that trust!

Perhaps folks are waiting on big investors to start loading and they see a volume of 10M or more shares exchanging hands in a single day for a couple of days in a row.

Do we see that this year or another lost year?

You don’t talk about taking an activist position for fun! He sees the potential but is likely worried that the management might not think outside the box or unlock full potential as has been the case so far. He probably also senses that there are no partners lined up yet. Otherwise there is no reason to bring up potential activist role and try to jeopardize what may be in the works. He could have as well said, the neoantigen database is an AI treasure trove. After the application is submitted to the MAA, we will not hesitate to increase our holding to support the management and share price, if required.

Agreed. Shows desperation and projects an even worse side of NWBO and the management. Sometimes you gotta admit there is is a problem or you made a mistake. Humility in leadership is important. Satya Nadella from Microsoft is a good example.

Les is likely exaggerating regarding the backlog and Ex on the other side. The reality will be somewhere in between, $2-3M last quarter?

If the demand has been through the roof why aren’t they recruiting couple of more specials site in the UK (from their clinical trial days)? The bottleneck is likely KCL and not Advent. And the other issue will continue to be reimbursement.

“I’m not sure he knows how to actually engage in an activist role.”

- you may be right.

“When he mentioned being an activist, it was just in the context of influencing the company to share its antigen database with other companies”

- He probably feels that management is not thinking out of the box to attract major partners? So I think he may be hinting towards striking some licensing deals, which may kill 2 birds with one stone. NWBO does have a credibility problem and such partnerships changes the perception and puts a spotlight on the company. And hopefully bring the much needed cash upfront to expand manufacturing and/or clinical trials as well as meet their debt obligations. Shorts will likely try to spin it in a negative fashion, but if the deal is lucrative and they build a strong narrative around how it adds value to both companies then it ought to be net positive.

It’s inevitable in the coming months, unfortunately.

What carrot will they dangle in the upcoming August report to stop the bleeding? And how will the markets perceive it? No one is buying the $3M carrot they dangled last. ;)

Desperation is setting in, it seems. They know they are in trouble the rest of the year with no real catalyst.

Ultimately, we ought to trade much higher than where we are but our challenge is this management. I do hope Bigger finds courage to go the activist route and can find some support, otherwise we may be seeped in mediocrity for a while! Only real hope would be a quick resolution of the lawsuit which will hopefully restore some level of credibility and start building more awareness about the company….but again, who knows how soon before the lawsuit is resolved…