Northwest Biotherapeutics Inc (QB) (NWBO) News

Funny coming from skibigtoe, he never has any thing new or exciting to say.

"I believed Linda powers a decade ago when she said they were on the home stretch. Only reason I think this may have a chance is Linda Liau, Robert Prins and other dedicated research physicians I have talked with les Goldman and Dave innes dozens of times and management I just no longer trust. My nwbo investment has worked it way down in value compared to other holdings so now just consider it my lottery ticket"
Completely resonate with those experiences and sentiments and 100% agree with themThey have lost all credibility with some of us . 

But they tell folks to read page number XYZ of their filing 

NWBO suing market makers and spoofing being in the Dodd Frank act can mean that Ken Griffin is facing prison time.

Should he face prison time if other flags are spoofing on the stock market? Probably not due to equivalency principle to be as dark as another state.

Technically he signed up for a position undercapitalized and even though his losses would be involuntary, they aren't currently federal. However, what if he is under brain control duress? Then the FED would maybe throw a very wealthy person in prison while leaving a solvable market up.

That is bunk to me, but a settlement makes sense if any other market makers for other flags did not spoof ever.

Giving back to Harvard is charity to the country not just the institution and it is capital well allocated.

How much should he really give if they are wealthy? And that is why Harvard went for the advertisement of if parent's sum income is under a small amount like $200k then tuition is free, but do they reject all poor because not good enough?

Gary, we both also own AVXL and they certainly go to conferences while waiting on results. Nwbo has results they can talke about.
You speak of the 25 cent mark. Well over a year ago now we were over $1 per share and at that time I was hoping we would never again see sub $1 valuation and not have to see these quote with 6 places after the decimal. Also just FYI schwab quotes the 52 week low at 0.2614 an cnbc at 22 cents so they do not just show the closing low.
I hold as many shares or more as you and just hope do not see 14 cents again - I have bought more each time but will not again. We may have similar # of shares but I have way more # to get to that # of shares as I had a very large investment as of 2015 and 90% down on those shares.
Worse I talked many others to buy this as well, many do not want to speak to me anymore
I believed Linda powers a decade ago when she said they were on the home stretch. Only reason I think this may have a chance is Linda Liau, Robert Prins and other dedicated research physicians
I have talked with les Goldman and Dave innes dozens of times and management I just no longer trust. My nwbo investment has worked it way down in value compared to other holdings so now just consider it my lottery ticket

...I'd have a lot more NWBO shares.

If I had a cent for every time Gary mentioned being invited to conferences 😁

HappyLibrarian,

Well then, semantics seems to have affected Charles River Labs’ plans too; ). Best wishes.

I think dragging their feet vs changing their plans from pedal to the metal to waiting on manufacturing is a matter of semantics.

I think that after we gain approval and get some interest LP and others will be invited to speak at a variety of Institutional and Brokerage conferences. You really don't get invited when you have nothing new or exciting to say.

Gary

HappyLibrarian,

You missed my point. Artisan is going to be used first BUT it was never going to be the longer term solution. No one has been dragging their feet trying to get to the longer term solution and Covid interfered with supply chain as did change in vendors which caused a recertification delay. I believe this all led to moving everything up towards Flaskworks soon after artisan rather than much later.
The expansion plans for Cognate before it was sold looked like initial artisan use was being planned for ahead of time but then became less tenable. There has been a pull back in profitability at Charles River Labs too recently which I believe as a guess had something to do with expansion preparedness plans for being a manufacturing partner for US demand for L needed to be put on hold as the move to a greater focus on Flaskworks for any post approval expansion took hold. So no, I don’t believe NWBO was dragging their feet but rather that plans were changed by circumstances. Best wishes.

Nwbo clearly does not put a priority on updating their website. Also do not go to conferences to make sure more people know about the product. I assume they will have the display at asco. It is my hope that we are not still waiting on mhra decision by then but nothing surprises me anymore. Just glad I am diversified

If what you say is true then the fact that company was deliberately dragging its feet and had no good faith intention of using artisan first for commercialization should reasonably be regarded as material information that would impact the share price if known (as opposed to speculated about).

martyDg,

Do you really think it has taken almost 10 years from last patient enrolled just to get artisan manufacturing and L approved?; ). They needed a bigger boat and they built it. Now it’s being readied for sea worthiness testing. Feel free to believe whatever you like but the way I see it everything hinges on being able to produce the product affordably for health care providers while profitable for NWBO. I also believe that discussions have taken place around the desire that the volume NWBO and regulators would like to eventually see is attainable with a workable scale up model which partnerships or licensing deals, ie franchises, could help with. Just mentioning franchises covers the potential as long as there is a cost effective model being worked on which can be replicated. No need to get personal just because you don’t see it that way or you are struggling with the timing issue. I think they are far enough along to get the green lights expected with approval; ). Best wishes.

Could I have been a week premature in saying we'll not go below a quarter, time will tell. It's nice to close above today, perhaps it's just the start of good things to come.

Gary

flipper44,

Correct!; ). Best wishes.

Haha.... "I am long and I am spewing how pissed off I am today because we finally broke out of the water-boarding trading pattern we have been stuck in for the last 10 months, so I am here on a Friday night to tell you all how mad I am.... hahaha

learningcurve2020,

That should have been done many years ago but “the process” interferes with good and bad treatments alike for the sake of the status quo and not for the benefit of terminally ill patients. Your point holds especially true for L in rGBM for which there is basically no question that reduced to no chemo rad is needed in many older patients to receive benefit. Your post makes it seem like this is finally sinking in for you; ). Best wishes.

Sorry Jack, you're off base and misdirected.

If you mean one pissed investor you are absolutely right.

Casting doubt, with any evidence? Makes it clear who you are.

"Flipper, along with some specialized lab freezers the only thing one would need is a procedure room with a comfortable chair."
and a machine that goes "bing"

I believe she's screwed this up to the point where second mouse gets the cheese.

Yup…Still up there!

DCVax® – L Phase III for GBM Brain Cancer
Status: Enrollment Completed in 2015
For a complete listing of clinical trial sites, details, and contact information please Click Here.

Our lead product is DCVax-L for Glioblastoma multiforme (“GBM”), the most lethal form of primary brain cancer. We have completed two Phase I/II trials and are now well under way with a large Phase III trial, as described below.

With full standard of care treatment for GBM today, including surgery, radiation and chemotherapy, the median time from surgery to remove the initial tumor to the time of tumor recurrence is just 6.9 months, and median survival is just 14.6 months. There has been very little improvement in clinical outcomes for GBM patients in the last 30 years. The incidence of GBM appears to be on the rise, for unknown reasons, and there is an urgent need for new and better treatments.

The best chance L ever had was as a stand alone therapy without chemorad to offset the cost and payment complexity while moving away from the grueling therapies. Unfortunately LP couldn’t get that job done. This all assumes L shows actual efficacy, of course.

manibiotech,

Increasing quality life years is good news, waiting on submission to get closer to Flaskworks reduced costs is the bad news. The two will likely come together at some informal or formal validation point that provides a submission time that works for all concerns. If both sides are motivated enough this will happen sooner rather than later; ). Best wishes.

The one should be a given...or you're doing something wrong. ;)

Flipper, along with some specialized lab freezers the only thing one would need is a procedure room with a comfortable chair.

Procedure rooms are positive and have a higher air turn over as described below.

ASHRAE Standard 170, "Ventilation of Health Care Facilities," is indeed the key standard for ventilation requirements in healthcare settings. While it may not explicitly have a section labeled "leukapheresis unit," it does provide the framework for appropriate ventilation in areas where procedures involving blood and potentially vulnerable patients are performed.
Here's how ASHRAE 170 applies:
* General Healthcare Requirements:
* ASHRAE 170 sets standards for air changes per hour (ACH), filtration, and pressure relationships in various healthcare spaces.
* Leukapheresis procedures, because they involve blood handling and patient vulnerability, would fall under the general requirements for procedure rooms or similar spaces where infection control is crucial.
* Procedure Room Considerations:
* Depending on the specific leukapheresis procedure and the patient's condition, the ventilation requirements might align with those for procedure rooms that require careful control of airborne contaminants.
* This could involve HEPA filtration and positive pressure to protect the patient.
* Infection Control:
* A key aspect of ASHRAE 170 is minimizing the risk of airborne infections. Leukapheresis, like other procedures involving blood, requires a clean environment. Therefore, the standard's guidelines on filtration and air changes are highly relevant.

So it would be like a Dialysis clinic with separate rooms and an upgraded HVAC system. Naturally the machines are different and you would need specialized staff.

I believe this space could be an outpatient facility similar to a dialysis clinic but slightly more advanced.

If the information is already public in SEC document then it is their responsibility to get the points that they think they made on page 27 to general public and new investors . Market and investors don't owe them anything that they should decipher the message and then circulate . 

Reimbursement. The Company has evaluated and selected specialized, highly experienced consultants with whom to undertake preparations for a potential reimbursement review and evaluation process. The Company has executed the relevant contracts and is under way with the first stage of the process with the consultants. The preparations for the reimbursement process will involve several stages and include health economics and outcomes (HEO) analyses, analyses of the relevant clinical landscape, engagement with experts and stakeholders, and other steps.

Fast forward to 2025, and they still have not submitted the application for NICE reimbursement. Looks like these consultants are taking their time so they get paid more.

Yes, I already reprinted it yesterday in another post.

The problem is that this letter could have been written in the early 2000’s when this whole DCVax journey started.

There is very little here about the fact that an effective treatment is less than a year from approval etc.

Instead the letter concerns broad stuff one would do at the very beginnings of recognizing a public health problem.

Thus any deliverables that would make a difference to us are years away and thst assumes this doesn’t fall on deaf ears.

Maybe if something like this had come out in 2015 it would have had enough time left to make a difference in things like MHRA jerking us around since January 2024 because reforms would have taken hold in the 9 years since.

This is entire page 27

“Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December 31, 2023 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not rely upon on these forward-looking statements.

Overview

We are a biotechnology company focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.

Our lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM), published the results in the JAMA Oncology peer reviewed journal, and on December 20, 2023 we submitted a Marketing Authorization Application (MAA) for commercial approval in the U.K. We plan to conduct clinical trials of DCVax-L for other solid tumor cancers in the future, when resources permit. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. We plan to work on preparations for Phase II trials of DCVax-Direct as resources permit.

During the first nine months of 2024, the Company continued its progress on multiple fronts, including the following.

MAA Application and Inspections. The Company has continued to work with multiple teams of expert consultants, the trial’s CRO (contract research organization) and Advent BioServices on the MAA process. The review of the application is ongoing, and inspections are being conducted in the U.K and the U.S. Each inspection involves pre-inspection requests from the inspectors for production of extensive documents and information, weeklong onsite inspections (including review of further documents, interviews of personnel, checking of facilities and procedures, etc.), and ongoing follow-up document and information requests after the onsite inspection. The inspections cover the sponsor, the CRO, the independent experts involved in the trial (such as the independent clinical database company, independent statisticians and others), selected trial site hospitals and their pharmacies, and others. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.

Reimbursement. The Company has evaluated and selected specialized, highly experienced consultants with whom to undertake preparations for a potential reimbursement review and evaluation process. The Company has executed the relevant contracts and is under way with the first stage of the process with the consultants. The preparations for the reimbursement process will involve several stages and include health economics and outcomes (HEO) analyses, analyses of the relevant clinical landscape, engagement with experts and stakeholders, and other steps.

Collaborations: Private Clinics. As previously reported, the Company has been working over the last couple of years and during this year to develop certain clinical collaborations. These include joint efforts by the Company and Advent BioServices to establish collaborations with several private clinics in the U.K. The collaborations with private clinics are designed to achieve several goals. One goal is to establish dedicated leukapheresis units which will be available for NWBio patients at all times. This is quite important for scale-up of the numbers of patients who can be handled for NWBio’s treatments, because there is a country-wide shortage of leukapheresis capacity in the U.K.

Another goal of the clinic collaborations is to potentially be able to conduct clinical trials with these private clinics as trial sites and be able to treat compassionate use patients – patients with diverse types of solid tumors, in addition to patients with brain cancer. The joint efforts have now reached or are reaching fruition. A contract has been executed with one private clinic for a dedicated leukapheresis unit there, and the focus is now on arrangements for the medical personnel and training. A Letter of Intent has been completed with a second private clinic, and the full contract is in process, for both a dedicated leukapheresis unit and treatment of patients. Arrangements have been made with a third private clinic for treatment of patients, and the first such patient is in process.

27
”

Not sure why some keep on fabricating situations or events :- Company has not submitted evidence when they could have - company just recently hired consultants to start working on economic modeling to help submit evidence - company has said they will start with artisan method - NICE has rejected reimbursement of some of the medicines right after MHRA approval , as recently as few months ago. So NWBO needs to make sure their proposal doesn't get rejected .

It's really that simple based on actual facts available as above . One can speculate all one wants without any concrete facts divulged by the company .

Like it or not, the safe bet is that what we see is what we get when it comes to upcoming events short of a buyout, a revenue-generating partnership or licensing with up-front-revenues.

Beyond those things, with NWBO black swans are possible but they are pretty much always had for shareholders and harbingers of more delay.

Maybe this time will be different.

KevGee59 It would also be nice to get laid tonight, but my gut says I am not gonna get either.

It’s got nothing to do with multitasking. Advent’s group could do it quickly if LP wanted it. The problem, IMO, is the data is nebulous and the cost is too great, so she’s slow walking the process to build a CDMO or two.

It would be nice to get MTD decision tonight.

Flip D Innes told me the other day to read over pg 27 of the 10q

Leukapheresis. Does the last 10Q tell us something we didn’t figure out?

Maybe.

By September 30, 2024 they were planning/contracting to have three dedicated leukapheresis units total - one at each of three clinics.

Someone can correct me if I’m wrong, but I’m thinking, together, the three units could handle six to nine Leukapheresis per day total/combined.

2190 to 3285 Leukapheresis patients per year
max capacity.

This exceeds the 1200 or so patients the artisan method can handle by itself, so perhaps they are anticipating high volume for the comparability testing, and/or they are preparing for Eden coming on line commercially relatively soon after artisan starts.

I understand that NICE can't finish the appraisal DCVax-L without approval, but hearing from NICE that the company hasn't submitted evidence to get the process rolling is a different story. Why on earth doesn't management want to submit it? What the heck are they waiting for? Their actions are literally one step at a time. Literally going to start NICE submission after MAA approval where they can do this now while waiting for approval results. This management doesn't know the word multi-tasking. And DI said LP needs a raise and bonuses. GTFOH! SMFH.

Not sure why some keep on fabricating situations or events :- Company has not submitted evidence when they could have - company just recently hired consultants to start working on economic modeling to help submit evidence - company has said they will start with artisan method - NICE has rejected reimbursement of some of the medicines right after MHRA approval , as recently as few months ago. So NWBO needs to make sure their proposal doesn't get rejected . 
It's really that simple based on actual facts available as above . One can speculate all one wants without any concrete facts divulged by the company .  

You have been saying it could be approved any day for over a year now.

Maybe you such just start posting "any year" instead.

Again,

Not what LP stated. Instead, when approved for marketing, manufacturing will start with artisan.

Comparability tests in parallel for (commercial version of) Eden will occur.

Then, after certification, full transition to Eden process.

We might see Approval before we see the 10-K

So now, everything revolves around Flashworks—waiting for Flashworks before filing the BLA with the FDA, and now waiting for Flashworks before filing for reimbursement with NICE. What a nice conspiracy theory. So, what happened to the FDA being in communication with NWBO? What happened to NICE being in communication with NWBO? Excuses after excuses. Sorry, but who are you fooling? Fool!

Another vote for "waiting in Eden".

We will see the 10-K update on that in a bit over a week.

Not what LP stated. Instead, when approved for marketing, manufacturing will start with artisan.

Comparability tests in parallel for (commercial version of) Eden will occur.

Then, after certification, full transition to Eden process.

🤫🤐🤫🤐🤫🤐🤫🤐🤫🤐🤫🤐. Let me sell my 45k shares then they can drop it sub 20c.

It’s positive that NWBO’s Management and NICE have been working together. The huge wild card is are they going to evaluate the manual method of production or the Flaskworks method. Two totally different methods of production. My guess is, when we see approval we will see it with Flaskworks and that is why Advent received the second inspection that was not due. We will see.

still believe this is happening. Q1 will pass us by and we will see sub 20c