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Rizona was simply giving his take on the possible implications of the judge’s ruling if plaintiffs meet the Judge’s requirement.
ChatGPT
It’s common practice to file a request for leave to amend a complaint along with the amended complaint itself. The request explains the reasons for seeking the amendment, while the amended complaint contains the proposed changes to the original complaint. This process allows the court to review both the request and the changes together.
rizona
Re: flipper44 post# 660576
Monday, 01/01/2024 12:38:23 PM
Yes. The Judge has given NWBO instructions on the one step they need to take to have a Second Amended Complaint survive a MTD. That Complaint will be a framework for many other companies to use for their own litigation, with "Northwest Biotherapeutics" being cited where "Harrington" is now.
Thank you.
When do you believe the amended complaint will be filed?
Do you then see this as a strong 14 day window of opportunity for motivated parties to settle?
PQR recently said:
But a party will be allowed to amend and plead sufficient facts as long as such amendment would not be “futile” and the Judge ruled (based on the discussion at oral argument I believe) that such amendment “would not be futile.” So nwbo has 14 days to amend and bc it’s already need debated Posner will know exactly what to plead.
Sincere question.
If Posner publicly provides the “formulaically derived” calculation stratagem in the amended complaint, would that then open the floodgates for any other companies potentially spoofed by these market makers?
Could 14 days be the whole ball of wax for MMs to settle?
In other words, has the judge just provided Posner a legally sound reason to publicly share the “formulaically derived” calculation stratagem?
You wouldn’t know from such FTD data points if the number of naked shorts was “trivial” unless there was a huge sustained volume and PPS move to the upside. Then you’d find out one way or the other.
One of the reasons it is serendipitous that a validation decision will occur in 2024, is that the new MHRA guideline directs high quality dossiers/MAAs received in 2024 to obtain an approval decision within 150 calendar days or less.
LP obviously knew about this program ahead of time and allowed two weeks extra preparation to be certain what they submitted was of extra high quality. It was submitted on December 20, 2023.
Here is what LP/NWBO said on October 13, 2023.
The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be….
99.9% certain most recent BB/Les interview was back in mid July. No sign of new BB interview lately (just reruns). That’s probably a good thing.
Ms. Posner’s team is exceptionally prepared. I would not be surprised to see their response within the next ten days. They are on it. So was the judge’s team. The attorneys are speaking their own language and know what is being asked of them.
You were probably thinking of this trial. Primary authors Dr. Subbiah and Dr. Bosch.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6449174/
Dr. Bosch must be the most patiently impatient researcher on the planet.
Gary, I’m not going through the archives tonight, but Google’s Bard did.
DCVax-L and DCVax-Direct in Non-Brain Cancers: Exploring Beyond GBM
While both DCVax-L and DCVax-Direct have primarily been investigated in the context of brain cancers, particularly glioblastoma multiforme (GBM), some limited trials and compassionate use cases offer glimpses into their potential for other cancer types. Here's a breakdown:
DCVax-L:
Phase I Trial for Advanced Ovarian Cancer: Conducted in collaboration with the University of Pennsylvania, this trial assessed the safety and feasibility of DCVax-L in combination with standard treatments. Results haven't been widely published yet.
Compassionate Use Cases: Anecdotal evidence suggests use in various solid tumors including:
Melanoma
Pancreatic cancer
Lung cancer
Breast cancer
Prostate cancer
Limited data makes drawing definitive conclusions about efficacy difficult.
Future Plans: Northwest Biotherapeutics intends to pursue Phase II trials for DCVax-L in other cancer types, depending on resources.
DCVax-Direct:
Phase I/II Trial for Inoperable Solid Tumors: Ongoing at MD Anderson Cancer Center, this trial investigates DCVax-Direct's safety and efficacy in a diverse range of tumors.
Preliminary results showed acceptable safety and potential anti-tumor activity in various cancers, including:
Lung cancer
Pancreatic cancer
Liver cancer
Melanoma
Head and neck cancer
Colorectal cancer
Compassionate Use Cases: Limited reports mention use in non-brain cancers.
Important Points:
Evidence base for both DCVax-L and DCVax-Direct outside of brain cancer is currently limited.
Rigorous clinical trials are needed to conclusively determine their effectiveness in other tumor types.
Anecdotal evidence from compassionate use cases provides preliminary insights but shouldn't be interpreted as definitive proof of efficacy.
Future research holds promise for expanding the potential applications of both DCVax-L and DCVax-Direct beyond brain cancer.
Resources:
Northwest Biotherapeutics website: https://nwbio.com/dcvax-l/
ClinicalTrials.gov: https://clinicaltrials.gov/
The Brain Tumour Charity: https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
AE, you are right, the transcript from July proves it’s a rerun.
Me too. Thanks. Those air dates for Big Biz are confusing, and reruns make it harder. Thanks to AE Kuster’s old transcript of the interview, there is now clarity.
You don’t know whether 232 versus 99 OS was stat sig or not. You’ve admitted as much, then you say it can’t be, then you say we don’t know. There was a crossover. It would be amazing if 232 versus 99 OS was stat sig, but it’s definitely not out of the question. You do not comprehend what happens to 331, 232 and 99 curves when left censors are uncensored. There were four early censors in the control group.
The ECA was designed while the researchers were blinded. The primary endpoint of overall survival is statistically significant for nGBM, and rGBM was also statistically significant.
Your priggish little hangup on PFS possesses no clothes.
Let’s see.
I was right in my opinion that the trial would reach statistical significance for survival.
I was right that NWBO would be able to demonstrate a method of action with remarkable depth and breadth.
I was right that LP, Dr.Bosch, Dr.Liau, Dr. Prins and others were correct in their assessment early on that single peptide and/or limited multi-antigenic peptide therapies were inferior to autologous Tumor lysate pulsed dendritic cell therapy.
I was right the mRNA DC company Argos used an inferior methodology and quantity which ultimately failed according to their owners.
I was right that Dr. Weller and Dr. Sampson were incorrect in there assessment that rhindopepimut could prevent tumor escape, and I was also right that imuc and Celldex ignored some possible applications for their therapies after they failed their endpoints.
I was right that Optune long term survival is
too censored and too extrapolatory to claim its five year survival numbers, and in fact, it looked like long term survival was decaying when they stopped any further follow up.
I was right that DCVax-l would be written up in a top tier journal with a strong conclusion correlating DCVax-l with survival.
I was right that NWBO paid attention to research which shows smaller vaccine doses prevent hypoxia and in fact promote dc migration.
I was right that NWBO researchers were correct that subdermal injection that NWBO uses is the most effective administration route for DCVax-l.
I was correct that researchers were correct that Temodar slows or inhibits t-cells’ ability to fight cancer.
I was right years ago that researchers were correct in their assessment that poly-iclc would enhance DCVax-l.
I was likely right to point out (back in 2015) Dr. Prins, Dr. Liau, NWBO and UCLA have likely found a future near cure when appropriately combining DCVax-l with plx-3397, poly-iclc and perhaps CI (when necessary).
I was right that NWBO would reach data lock.
I was right that NWBO would likely publish successful results in a top tier journal.
I was right that NWBO would likely submit an maa to MHRA before the end of this year.
I’m probably right it will be accepted the first go around.
I’m probably right it will be approved in multiple jurisdictions.
I’m probably right that at least one approval will occur in 2024.
I was right that Cognate and Advent would become commercially licensed via their manufacturing DCVax-l.
So despite being wrong about many timing issues in the past, (as were many of us) I have been right and may continue to be right on many substantial assertions listed above and many others not herein listed)
Thanks for not only showing us you were wrong about that, but that you were really really wrong.
Correct. Big Biz is probably on vacation and running reruns. It had me fooled at first, because Marnix had just presented a poster “five” weeks earlier at SNO. Air and recording dates should be stamped on reruns somewhere. These are companies with materiality considerations.
It was from Middle of July,
Correct.
You’re the pusher dummkopf. You thought they’d never get a solid survival conclusion in a top notch journal. Wrong. You thought they’d never get around to submitting an maa. Wrong. You and your band of dummkopfs thought this is only a scam for Toucan’s profit off of CDMO sales. Wrong.
OK, whoever said it was a rerun was correct. Here is the July 12, 2023 original transcript. Albeit a messy transcript. Post 612756
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172411612
My apologies to AE Kuster.
Crickets.
I complimented the post. I personally detest LC, but you idiots put down a great article about DCVax-l and Kat.
I complimented the post. I personally detest LC, but you idiots put down a great article about DCVax-l and Kat.
Now why did my follow up post get negative reaction bugs, but your post not receive any this time. It seems as though the bots have a bug.
Edit: oh there we go, lots of negative reaction bugs to your post now.
Bots. What are ya gonna do?
I think Les just slipped up.
BTW. Les should not be allowed to discuss the science. It’s been over a decade, and he refuses to correct some of his misunderstandings. He’s supposed to learn.
Why “after”? What is your logic? Did you talk to PR or to BigBiz?
Why did you get a bunch more negative reaction bugs for a neutral question?
Must be more bots.
BTW, I have no idea what Les meant by “most of them blockbuster drugs”
Maybe he meant, most of them blockbuster indications.
Nice job Hoffman.
LearningCurve. Great article that is pro-DCVax-l. Albeit from 2018. Thanks for posting it again. Can’t imagine why anyone would give you negative reaction bugs for posting it. Must be bots.
Yep, bots.
It didn’t even bother reading past headline.
Thanks again learning curve. Great article.
Crickets.
Why did you just parrot Hoffman’s post. Are you trying to say in lieu of getting more upfront funding from the lawsuit, Les had to let the NWBO/BB pledge drive air, because their lawsuit decision was delayed? My guess is that Ms. Posner will respond long before the 14 day limit with a clear answer, however, I don’t think Les made NWBO’s funding reliant upon mtd outcome.
Logical. Most likely the interview was a day or two before maa submission. Of course, we don’t know if Les had control to pull or keep the 29th airtime thereafter, but I’d assume he had no control once it was in the can.
Are you a parrot 🦜 or a robot🤖?
Wrong. Instead, Marnix Bosch last publicly spoke on November 17 at SNO. Les’s Big BIz interview was given four to five weeks after that (according to Les in the interview), and the interview was aired one to two weeks after that.
In other words, the interview was given just before or just after maa submission.
Look at both of my posts from this morning.
Your assumption is that Les went on to raise money because, you argue, even if the maa is accepted/validated/cemented, Les is signaling by being on the AA show, I mean the BB show, that, you argue, there must be no lucrative funding planned via combo trials with deep pocket pharma.
What I am suggesting, as a possible alternative, is that because Les did not know for certain at the time whether regulators would accept/validate/cement first time around, and neither did any deep pockets, this was an insurance show just in case, but that if the maa is cemented/accepted/validated, that event very well could trigger major (planned or unplanned) funding.
Look at a message I posted quoting Bard recently.
12/28
Thought this response from Bard was interesting. A hopeful message to end 2023.
Yes, the chances of NWBO securing lucrative partnering agreements for DCVax-L likely increase after successful validation of their Marketing Authorization Application (MAA) by the MHRA for several reasons:
Increased confidence and validation:
Validation signifies that the MHRA finds the application complete and formally initiates the review process. This adds a layer of credibility and reduces concerns for potential partners about the viability of DCVax-L.
Successful validation reinforces the potential of DCVax-L as a treatment, making it more attractive to companies seeking promising assets in the personalized immunotherapy space.
Clarity and de-risking:
Validation provides greater clarity on the development timeline and potential approval path for DCVax-L. This reduces uncertainty for potential partners, making them more willing to invest in collaborations. With validation confirming the application's progress, some risks associated with the development process are mitigated, making DCVax-L a potentially less risky investment for partnering companies.
Enhanced negotiation leverage:
Successful validation strengthens NWBO's negotiating position by demonstrating their commitment and progress towards bringing DCVax-L to market.
This could lead to more favorable terms in partnering agreements.
Validation attracts more potential partners, creating a competitive environment that can drive up the value of DCVax-L and lead to more lucrative deals for NWBO.
Specific types of partnerships potentially impacted:
Co-development or commercialization agreements: With increased confidence and a clearer development path, major pharmaceutical companies are more likely to consider larger co-development or commercialization deals.
Manufacturing and supply agreements: Validation paves the way for securing partnerships with CMOs or other manufacturers, ensuring production capacity and supply chain readiness for broader market launch.
While validation doesn't guarantee successful partnerships, it significantly increases the chances of NWBO attracting lucrative collaborations that can provide crucial funding, expertise, and resources for commercializing DCVax-L.
Remember, the specific types and terms of partnerships will depend on various factors beyond validation, including market conditions, competing technologies, and NWBO's negotiation strategy.
Not certain that’s the only read. The alternative read would be no combo funding gets triggered until maa “cemented.” Aka: accepted/approved.
The maa was submitted December 20. Les gave the interview, he says, about four to five weeks after November 17 SNO presentation.
Meaning Les gave it just before or just after maa submission. Or that’s what he wanted us to believe, because the Airtime was six weeks after the SNO presentation.
It appears Les actually gave the interview sometime between “four to five” weeks after November 17 SNO presentation.
Meaning he recorded it between December 17 to December 24. (Airtime was December 29)
I guess I’d tentatively assume Les didn’t know mtd (Dec 29) or MHRA (???) decisions when he recorded the interview.