Northwest Biotherapeutics Inc (QB) (NWBO) Noticias

Bas is a genius 

I suspect there are not many things that can boost the efficacy of DC vaccine.

So now expecting more than one submission in 4 years, after LP explicitly stated she would file strategically, is bearish?


Here are the rules:

Expecting NWBO to follow through on expectations and hints is bullish talk before they start failing to do so and more delays are in the offing. During this period, questioning their track record, ability or willingness to execute on expectations or hints is bearish talk.

Expecting that NWBO to still follow through on expectations and hints is bearish once it is clear that they will not bring doing so is bearish talk. During this period (where we are now) it becomes bullish talk to gaslight shareholders and act as if NWBO never gave out those hints or expectations.

There’s nothing else to say.

I’m going back to waiting for Gadot in very late Q4 2024 might as well be Q1 2025 though with the way the Brits take their holidays it might be the latter. Have a good one.

Very good point. I am wondering what will replace BCG?

I barely agree with you on anything. But I agree with you on this one.

Merck can have a franchise deal with NWBO to adopt DCVAX as the development platform.
Seems to me LP wants to replace BCG with something else and Merck is the sole supplier of BCG in the US. It doesn't seem like LP wants to collaborate with Merck on Direct.

And if general market speculates the same and prices the share value accordingly , then they are manipulating !!!

Ahh . I see now a softctraining of masses is being started that not to expect a BLA application at all based on P3 trial 
Interesting 

Asking any reasonable question here is considered bearish or bashing 

I don't think it would be immediate. Most importantly, if Merck gains exclusivity then speculation about a buy out will lead to a higher price.

Likewise!

Would Merck only buy out DCVax-Direct and restart the clinical trial in January?

Me 2. What did i say about speculation in my last post!!!!!!

Fair enough Stonk, and I apologize for being rude in response.

It's just these applications are herculean tasks for a small team that is also doing day-to-day operations, so seeing what all NWBO was doing in parallel withe MAA is quite impressive to me.

Best and good luck to you.

Is CRL the other company that cannot produce Direct?
I missed that line in the 10-Q.

It was Cognate, now CRL, that produced Direct for the P1/2 trial in 2014/5. Cognate was also paid some to prepare to restart Direct production around 2018.

I have never heard of any other companies, nor the assertion that Cognate was not meeting spec.

I don't like it Mike, it's not natural.

I was hoping LP would touch this in last Q just to confirm what shareholders expecting. Now we have to deal with speculations from both sides. What is new in the world of NWBO!!!!!

Dam, you got me again!! How could I be so obvious!!

Fair enough! I hope there are still plans in the near future to submit to other regulators.

All I'm saying is something clearly shifted. At one point, a BLA to the FDA was definitely on the agenda. At that Lifespan conference in Rhode Island (I may be getting those details wrong - im going from memory), I specifically remember the doctor saying that he spoke with LP and that the application to the FDA was in progress or almost complete or whatever. Just not sure what happened since.

Either way, I know they're working hard on what they can control. I was simple posing a question.

Very possible Flip and I hope this is the case.

With the "individual PRs" parsed out, surely everyone who split the atom yesterday is buying with both hands today at these prices, right?

I agree. But if Merck has secured exclusivity, then we are getting bought by Merck.

Both me and the management are dead of old age before those combo trials are approved,

BO asap please.

I think it's you that been hacked dude😆

It’s not strange if you think of it as deliberate.

I think it’s becoming obvious that in the US they’re going to proceed directly to a combo application backed by MHRA approval. Why waste the FDA’s time with a monotherapy when the results of a combination are so starkly, dramatically different?

It’s also becoming clear why they stalled and obfuscated for so long. If they were to be upfront about their plans and people realised this was going to take four years longer we’d all have bolted by now and the stock would be in the teens, and therefore, likely, the company wouldn’t exist.

Unreasonable? I think so. Bearish? I don't know.

If there were no or limited evidence of other activity by their small staff, I might not find the argument unreasonable but that is demonstrably not the case.

Your post includes:
"Re-Start of the DCVax-Direct Clinical Program. As previously reported, preparations to restart clinical development of DCVax-Direct have been under way for quite a while. The Company currently anticipates that the DCVax-Direct program will be able to restart by the end of January. For the same reasons as described above in connection with the planned combination treatment trial, the Company plans to focus DCVax-Direct clinical trial designs on tumor response endpoints with potential timeframes of months rather than survival endpoints with timepoints of years. The preparations to date involve technology transfer to the U.K, development of new SOPs (Standard Operating Procedures) and regulatory documents, engineering runs and comparability testing. In addition, new development work has been carried out to develop a second version of DCVax-Direct because there is a worldwide shortage of one key ingredient of the original DCVax-Direct (an immune booster ingredient)."
* I get the impression that the immune booster with worldwide shortage is Bacille Calmette-Guérin (BCG).

* An Update on the Supply and Production of Bacille Calmette-Guérin January 18, 2023 ... Merck appears to have intentions of tripling the current manufacturing capacity to meet the anticipated BCG demand. (Merck announced a plan to construct a new TICE BCG manufacturing facility in North Carolina. But that project was anticipated to be completed by late 2025 to late 2026) https://dailynews.ascopubs.org/do/update-supply-and-production-bacille-calmette-guerin

* California biotech ImmunityBio has partnered with the Serum Institute of India in an exclusive deal to manufacture BCG globally. The arrangement aims to create “a long-term solution to chronic BCG supply shortage issues” and produce BCG “at large scale”
SII is the largest manufacturer of BCG vaccine globally, according to ImmunityBio. The Indian company has two BCG products for oncology use, one traditional BCG called Onco-BCG is already commercialized outside the U.S.
The second product, a recombinant BCG, is undergoing midstage testing in Europe. This version includes two gene modifications to improve its profile, and according to ImmunityBio, it has shown “potent immunogenicity with CD8+ and CD4+ stimulation and improved safety compared to standard BCG.”
... https://www.fiercepharma.com/manufacturing/rival-merck-monopolizes-bcg-supply-immuntybio-taps-serum-institute-new-combos

You're right, that's what I believe will be needed. I say this with the full belief that knowledgeable Drs. and patients will get combo treatment off label, and I suspect it will be very common treatment that's authorized by insurance by the time it's officially approved.

To me it's a shame that the regulators can't look at anecdotal evidence and jump ahead to an approval. Sometimes they move more quickly, but even then it takes years.

My leukemia treatment started with Gleevec after I had four or eight courses of chemo and got a catheter infection. The Dr. at City of Hope had me stay on the Gleevec, or it's second and third generation versions and not go back for the other 4 courses of chemo. I was familiar with Gleevec as I followed it many years before when the FDA approved it only 70 some patients into a much larger trial. It ended the death sentence that my form of leukemia was until its discovery. At the time I portrayed the drug as a miracle drug for the maker as remissions continued as long as patients remained on the drug. Even after stem cells I was kept on an oral chemo related to it for many years, it will be almost 10 years since I got the transplant and I only came off chemo about 2 years ago.

Frankly I don't remember any time the FDA moved faster on a product than what they did with Gleevec. I believe that all the regulators should work more dynamically and actually examine what's happening in trials during the trials if called in to do so. I'd suspect that Dr. Liau a decade or more ago could have told the authorities that they're seeing miracles if such a practice were allowed.

Gary

You may want to correct that sentence to "no announced plans for a second" filing.

While I certainly hope you're all correct, to the best of my knowledge the combo data is in early stage trials. It's impressive, I just don't know that it's sufficient to evaluate, unless there is more of a record than we're aware of.

I think you're overestimating what we're saying here.

The current combo data is not going to be submitted. Future trials combo data is what will be submitted.

While I certainly hope you're all correct, to the best of my knowledge the combo data is in early stage trials. It's impressive, I just don't know that it's sufficient to evaluate, unless there is more of a record than we're aware of.

I have no idea if all the data from compassionate use is catalogued somewhere and includes combo treatment, but if so, that could be convincing not only for the combinations, but also for the other solid cancers they've treated. Of course everything there happened in the UK and might only be considered by them, But if we got an expanded initial approval there, it could spread rather rapidly, but only when the the EDEN is available meet commercial production needs.

Gary

I simply don’t think nwbo will be the one filing the BLA in the U.S. I also believe it will be based on combo data past and future (plus the grandfather trials). I imagine the collaborator has seen enough combination data. I believe, hallelujah, we’ll get approved here on the current maa and start with artisan. Eden might be completed in UK by NWBO/flaskworks/Advent, or ___/flaskworks/Advent. Then Eden might be used for commercial here, combo trials and then BLAs around the world, and IRP combo maa full circle back to UK. Alternatively, the combo might first pursue maa in UK as opposed to U.S.

Flip and I in strong agreement once again. Scary times.

NoGro,

So, what per your following comment,
"Seems MHRA is sure dragging their feet on a decision. MHRA said 150 days with 60 days for the filer to respond to issues. We're already past all of the time windows MHRA publishes for their review. Not a good sign and one that NWBO seems to be hiding. Good luck folks."

https://www.timeanddate.com/date/workdays.html?d1=01&m1=01&y1=2024&d2=13&m2=11&y2=2024&ti=on&

Reality is that it is only 216 days "work" days from 1/1/24 to 11/13/24 for MHRA to complete the approval effort for NWBO and this is well within MHRA's timeline.
MHRA indicated that they were over booked. When did MHRA start working on NWBO's submission?
NWBO is not hiding anything as you opinion states and is once again worthless, IMO

I simply don’t think nwbo will be the one filing the BLA in the U.S. I also believe it will be based on combo data past and future (plus the grandfather trials). I imagine the collaborator has seen enough combination data. I believe, hallelujah, we’ll get approved here on the current maa and start with artisan. Eden might be completed in UK by NWBO/flaskworks/Advent, or ___/flaskworks/Advent. Then Eden might be used for commercial here, combo trials and then BLAs around the world, and IRP combo maa full circle back to UK. Alternatively, the combo might first pursue maa in UK as opposed to U.S.

Seems MHRA is sure dragging their feet on a decision. MHRA said 150 days with 60 days for the filer to respond to issues. We're already past all of the time windows MHRA publishes for their review. Not a good sign and one that NWBO seems to be hiding. Good luck folks.

All they can do is spin. The shorts are not even indicating approval will not take place anymore. Spin, Spin, nobody is interested, Spin.

And there's the spin. LOL

So now expecting more than one submission in 4 years, after LP explicitly stated she would file strategically, is bearish?

Cool.

Stonk, fe, captain,

We have questions...

🧐

Actually, I do find something strange. The bears repeatedly stated submitting a proper application was such a daunting task that this tiny company would never get it done. And now the questions is, "Why not another one?" Well, why not two more? Three?

How many sets of goalposts are there in the field house to bring out?

Best post of the week

Funny that the ones responsible for squeezing out their funding are asking the questions. SMH

Ain't got no dinero

Thank you. I’ll take a closer look.

I have 100% trust in LP's leadership. You can advertise your judgment to your clueless minions.

Keep FUDing... we realize it's a job. 👿☠️

Keep deflecting. No one shorting a .29 POS. You ever check the open short interest in this POS....not even .05 percent of the float. No meat on that bone. If they pump it it might be worth the short if you do that kind of thing.

Hey FUDster... better cover your shorts. A surprise is coming! 💥

Hey genius when is approval? Lmfao. So inspections are still ongoing and possibly rfi could be incoming? More delays? Can we blame an external mhra for this? Modus operandi.......