Northwest Biotherapeutics Inc (QB) (NWBO) News

beartrap12,

Great work! Looked at from lots of angles and gives great rational for each look. Best wishes.

dstock07734,

Look at the Nivo numbers again. Subcutaneous Nivo had more deaths confirmed related to drug toxicity (3) vs IV (1) with only one patient difference in enrollment. We now know that two different SC versions have come out with toxicity numbers that slightly favor IV vs SC delivery. This SC adverse events trend is not favorable to patients or safety first when considering safety of IV vs SC. Best wishes.

No, the CHM meeting isn't full UK approval, it may, or may not be required, but it isn't the approval we're waiting for. I've not backed off at all, if I'm right about the 150 days starting on submission we could hear tomorrow, or very shortly thereafter. If it's 150 from preliminary validation we're a little over a month away. Nothing says the UK must take the entire 150 day period, so regardless, approval could come any day.

If it's true that no CHM meeting was required, to me that would indicate they've made up their minds and it's only a matter of doing all that's expected of them before announcing the result.

If they were notified of approval before the open tomorrow, the question might be, do they announce it immediately, or better plan how they're doing it a day, or two later. Sadly it doesn't seem to matter when they decide to announce, it will be well before the opening bell and I'll be asleep if they should schedule a webcast before the bell, typically at 5:30 my time, 8:30 in New York. Many investors on the East Coast may not be looking for such a notification. I'd love to see a company announce on Saturday or Sunday that they'll be holding a webcast before the open on Monday, that would be enough to have me set an alarm and listen to what's happening.

Regardless if it's tomorrow, or in roughly the next month, we are in for some very interesting, and hopefully very profitable, times.

Gary

A 1.5 ounce serving of bourbon contains zero grams of sugar. Straight bourbon doesn't contain added sugar during the production process. The primary ingredients of bourbon are water, corn, rye or wheat, and malted barley, which undergo fermentation, distillation, and aging. During fermentation, yeast breaks down the sugars from the mash, creating carbon dioxide and alcohol.

No evidence of anything.

Right, they won't be visiting those sites but they'll be looking at the batch records and possibly records generated at those sites to confirm the L provided in the trial is the same they'll be making commercially at Sawston/state in the MAA.

?? Running off to another country ??

UK is quite well respected .. you’re just pissed they are working with NWBO ..

Not fighting against it …

Diff is uk is working with NWBO

NOT AGAINST US

In spite of all the delays
u sure seem to be worried about an approval

U have been here for over 10 years .. free of charge 🤣🤣🤣🤣as u say …

U would not be here FREE OF CHARGE ..

BASHERS get paid by someone ..and you are getting paid !!!

It's research for researches sake without having to burden true investors with BP decisions.

>>BP does pay a large amount to the FDA in fees. But they pay even more, proportionately, to the MHRA,

Unless bourbon is low sugar and low alcohol, I shouldn’t consume any.

I may be able to wet my beak, so to speak, however I might not have the will power to stop there

We know big pharma pays the bills for our fda and majority of docs on the panel will be bought and paid for !!!
BP does pay a large amount to the FDA in fees. But they pay even more, proportionately, to the MHRA,

I find the kiddies that complain about the FDA being corrupt to be no more than those who invest in crappy bios and do not understand why their drug was not approved.

Running off to another country will not change your basic lack of understanding.

We know big pharma pays the bills for our fda and majority of docs on the panel will be bought and paid for !!!

Hence approvals elsewhere first should make the pathway more
Legit and not as corruptible …

But we know as longs nothing is a sure thing with our fda

nothing"? well that's not true, you know it.
you know all the achievements with the trail, manufacturing, patents and so on!
it all took longer than predicted but it happend!

so does approval and you are right on that point - it should have happend between 2016 and now as many (myself) believed it would and talking about in our comments- and we were wrong. blain and simple WRONG

but there always comes a time when we leave things behind, achieved goals, and an event , a release which seemingly never wiill come true CAME TRUE

(the same as i always say to friends and whoever. there comes a time after putin, after things worse, seemingly endless - seemingly no solution, enduring for so long. so we are used to it day by day, week by week. . . . . . to a point where these things are (seemingly) quite "normal" . . . . belong to the day, to the present.
but there comes a time . . . . . )

may have already occurred " in" the April CHM meeting . What else other than approval would you be referring to may have occurred "in " the meeting??You are attempting to back pedal. Surprised as that is not your style.

Hey LC, I'm sure everybody here is looking forward to a good and promising rat study from you. Got any more good ones?

What you seem to be missing is they are debating the timing of the MAA approval not the likelihood, which is considered to be very likely.

Doc, I personally don’t think the MHRA will inspect Charles River Labs' (formerly Cognate’s) or Fraunhofer’s manufacturing facilities, since they are not currently being used (or immediately planned) for initial DCVax commercial production.

I think, but I’m not sure if the MHRA is like the FDA, in that they will generally schedule a pre-license or pre-approval inspection of the intended commercial manufacturing facility after the midpoint in the review process, and request to view all phases of the production operations for the selected product under review in the marketing application.

Shutting down operations of a GMP facility for construction, maintenance, cleaning, and disinfection is complex, but routine, and would not effect anything unless a significant change to the plant and equipment occurs, which would usually require requalification. (except that a pre-approval inspection obviously could not be scheduled during the shutdown)

ski, are you asking if I think the UK inspectors need to look at the manufacturing sites used for the clinical trial, since only Sawston is indicated for commercial manufacturing at this time?

If so, my answer is no, it shouldn’t be necessary as long as there were no potential red flags raised during the review of the clinical trial patient records or manufacturing records from those sites that were sampled. However, that may not be the case, and not all inspectors/regulators are equally thorough, or think the same. Generally, the first marketing application and regulatory review for a new drug, or molecular entity, is more thorough and takes longer than subsequent marketing applications for additional use of an already approved drug. (since the appropriate nonclinical and manufacturing data may have already been reviewed by the Agency in the initial application)

Visits to potentially obsolete manufacturing sites is certainly one area of the 150-day accelerated review process that could, and probably will be cut to expedite the review from the standard timeline. As additional commercial manufacturing sites are added, they may be inspected at that time.

The bashers move their goalpost more than anyone we’ve ever seen.

That’s hilarious given that most NWBO investors here speculate continuously as to the likely timing of the MAA approval , which, of course, the presumptive date of which, has taken a bit of a setback lately ☝️😳

Right ATLnsider, as you indicate, in the UCLA combination studies with DCVax-L, the poly-ICLC is administered separately as an adjuvant. However, in the early studies with DCVax-Direct, it was used in the manufacturing process, which increased the potency. (poly I:C, or its derivative, poly-ICLC is included in the Direct patents, and the more recent hyperactive patents)

NW Bio Receives U.S. Patent On Broad Processes For Producing More Potent Dendritic Cells
Next Generation Technology Already In DCVax®-Direct; Will Be Applicable To All DCVax® Products

Building upon the pure immature dendritic cells, NW Bio's patented methods develop mature and activated dendritic cells that are far more potent than dendritic cells produced in the standard way.  For example, NW Bio's dendritic cells produce as much as 10X or more the amount of signaling compounds which are key to mobilizing other active agents of the immune system, such as T cells (which infiltrate and attack tumors) and B cells (which produce antibodies).

NW Bio is already using these next generation methods for producing more potent dendritic cells in its production of DCVax-Direct.  The same patented methods for activating dendritic cells were also used in the pre-clinical animal studies with DCVax-Direct.  In those studies, injection of these potent dendritic cells into some of the tumors in each of the animals resulted in complete clearance of all tumors (both the tumors injected with DCVax-Direct and the tumors not injected) in 80-100% of the animals in the various studies, indicating a system-wide immune response.
  ?
Going forward, NW Bio's now patented methods of producing more potent dendritic cells will also enable development of the next generation of NW Bio's other two product lines:  DCVax-L and DCVax-Prostate.  The current DCVax-L and DCVax-Prostate products have already delivered striking results in clinical trials to date, extending the time to tumor recurrence and the patients' survival time by 1-1/2 to 2 years or more, with a substantial portion of patients going far beyond that.  Incorporating NW Bio's patented methods for more potent dendritic cells will enable production of enhanced versions of these DCVax-L and DCVax-Prostate products.

https://www.prnewswire.com/news-releases/nw-bio-receives-us-patent-on-broad-processes-for-producing-more-potent-dendritic-cells-198760831.html


For DCVax-L, Northwest Bio uses the most common method of culturing PBMC’s to generate dendritic cells, which relies on the monocytes adhering to the bottom surface of the polystyrene culture vessel in a medium of granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin 4 (IL-4), which induces differentiation into dendritic cells, and activates them.

I believe this increased-potency knowledge was gained in the DCVax-Direct studies because they were attempting to overcome the tumor’s defenses by delaying the activation and maturation of the dendritic cells, which wasn’t possible using culture flasks that are used to produce DCVax-L, so they attempted culturing the monocytes in suspension, in a bagged system without IL-4, using only GM-CSF, and then various other mediums to optimize and activate the dendritic cells, including poly I:C.

Northwest Bio stated that they intended to use this higher potency method across all product lines for the next generation of DCVax, but the Flaskworks’ eden system uses a polystyrene culture cartridge (similar to the well plates used in manual culturing protocols) which the monocytes adhere to, so I’ve not seen evidence that they’ve actually changed the manufacturing method for the next generation of DCVax-L. I believe the method of combining poly-ICLC with DCVax-L requires separate (nearly simultaneous) injections to produce the more potent effect in vivo.

I'm talking about a PR for approval, not the occurrence of the CHM meeting. I've not seen any company announce that the meeting occurred.

Gary

Sometimes an end run is better than running up the middle.

Approval from the US FDA is a goal. It’s just not the first one.

There is a process to getting approvals in our FDA is very corrupt as you know since you work for the enemy that’s why we are going to get it approved in Europe the UK Canada then our FDA won’t be able to deny it when it’s already available elsewhere they would look like the incompetent fools that they areif they did attempt to deny it

Your boss is probably already shitting his trousers.

Update – May 2024

“Stable appearance”.

Joel’s April brain scan continues to show stable post treatment appearance. It is such a relief and extraordinary news.
🫶
The DCVax® Platform For All Solid Tumor Cancers
💪$nwbo #glioblastoma #CancerVaccine

https://t.co/GQxd4PuHRU— rj (@sharpie510) May 19, 2024

The interim analysis data certainly does.

It’s equally ineffective though.

You know how many longs have said that and have left the board because this trial still hasn’t submitted a BLA to the FDA?

Guaranteed approval in 2016-2024 and still nothing.

The bashers move their goalpost more than anyone we’ve ever seen. That’s why we know they’re not here for the right reasons and they should all be just ignored. I would invite LC to the shareholder meeting. I’ll even pay his way there and back if he brings me his receipt, he can even sit right next to me and ask questions to his heart, but him and all his friends are cowards

Elsie that’s hilarious. All your things that would never happen. Oh look they won’t get approval approvals on deck

No they are not.

I myself participated in over 30 clinical trials.

Now it all makes sense !!☝️😳🥴🧟‍♂️

Nemisses. you are trully the dumbest and most corup payed shill

Let me help you..
Nemesis, . you are truly are the dumbest and most corrupt paid shill ever !

It took many more years than normal.

-NWBIO will never data lock

According to their own website the trial is still ongoing. LOL. It took twenty years to run with still unknown reaction from regulators for changing the design to an external control.

-They will never finish the trial

Dragged out for years. Data isn't solid.

-They will never release results

I admit JAMA surprised me. Thought it'd be that Italian journal they reported in previously. The JAMA pub hasn't gone without controversy, however. Also JAMA notes only Bosch responsible for the data.

-They will never get published

They did but only after tiny MHRA umbilical cord was cut from EMA. And, management was rewarded handsomely for submittal but not approval. We'll see in the fall.

-They will never apply for approvals

Boiler room boy is to put emojis on all negative posts and then login with his other aliases and do the same emojis. Pathetic.

No- it’s a constantly shifting FUD narrative he and others like him are paid to continue to push, in hopes of influencing new board viewers.

Just look at all the arguments they’ve had to give up, as they move on to the next- there’s only a few more arguments available, and each is more feeble than the last.

-NWBIO will never data lock
-They will never finish the trial
-They will never release results
-They will never get published
-They will never apply for approvals

I ask you the simplest question to define "Lots" from your initial statement but you could not do it.

lol denial .. your just tired of getting slammed with every stupid comment u make ..

and u get paid by the response

BASHERS never block people

Thats what I thought too - you’re a paid short. You don’t care about patients and their families. Tell them they will not only save money but also not be able to enroll in a free trial in the future. You can do a lot of good there, LC!

Tell that to patients families too. Start with one, LC!

Your time and energy better spent there. You will also save their families a lot of money!

You're in total denial. I'm going to have to ignore you. Sorry.

They have not wasted time ..

U and your friends have delayed them at every turn

But it appears to be for the better for current shareholders .. yes there is a legacy of skeleton shareholders along the way .. thanks to u n your bash bros

Yep, that's what I thought. It's too embarrassing to think about.

LOL. One trial redo or required confirmatory and you've got a half dozen treatments for GBM in the race. And, at the pace this crew moves they'll be overtaken - Already being overtaken with so much time wasted.

>>pretend like they are a threat to DC VAX.

Take baby steps and start with one or two.

Yes
It explains I have far more basis than you do …

Paid for a year of college
Provided an additional job and career connections
Got published as a coauthor !!

Far more credentialed in the business than u could ever dream to be …


How are those hot pockets your eating for lunch today in moms basement. ..

U still stealing internet ??

That would explain a lot.

>>I myself participated in over 30 clinical trials. You actually get compensated for them.

It’s a shame you’ve done everything in your power to prevent patience from receiving DC VAX over the years just think of all the lives that could’ve been spared and you’ve been championing the cause for DC VAX rather than being an impediment to its approval you’re on the wrong side of that legacy