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From CHATGBT: re: Role of CHM
In the UK, the responsibilities for handling a Marketing Authorization Application (MAA) are divided between the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM).
MHRA’s Duties:
1. Initial Review and Assessment:
• The MHRA conducts a thorough review of the MAA to assess the safety, efficacy, and quality of the medicinal product. This involves evaluating clinical trial data, preclinical studies, manufacturing processes, and more.
2. Interaction with Applicants:
• The MHRA communicates with the pharmaceutical company or applicant throughout the process, providing feedback and requesting additional information if necessary.
3. Preparation of an Assessment Report:
• The MHRA prepares a detailed assessment report based on its evaluation of the application. This report includes a scientific opinion on whether the medicine should be approved.
4. Final Decision-Making:
• After considering the advice from the CHM, the MHRA makes the final decision on whether to grant or refuse the marketing authorization.
CHM’s Duties:
1. Advisory Role:
• The CHM provides expert advice to the MHRA on the safety, efficacy, and quality of the medicinal product under consideration. This is done by reviewing the assessment report prepared by the MHRA and any additional data submitted.
2. Recommendations:
• During its meetings, the CHM discusses the MAA and issues recommendations to the MHRA on whether the application should be approved, rejected, or require further information.
3. Risk-Benefit Analysis:
• The CHM conducts an independent risk-benefit analysis of the medicinal product and ensures that any potential risks are outweighed by the benefits to patients.
4. Reporting Findings:
• The CHM reports its findings and recommendations to the MHRA, which then considers these before making the final decision.
In summary, the MHRA is responsible for the technical review and regulatory decision-making, while the CHM provides expert advice and recommendations based on a thorough evaluation of the data. This collaborative process ensures that medicines approved in the UK meet the necessary standards for safety, efficacy, and quality
The subtleties noted in that post are muy interesante, as you say. While all of these smoke bombs are being detonated on social media, NWBO is maintaining course and speed while MHRA goes through the prescribed paces. I am not giving any advice to anyone else, but I bought again this week (and I never announce my purchases, I personally think it's tacky). I only say it to show that I firmly believe all is going well and according to plan and routine. If longs like myself want to get through this marathon, they have to keep their eyes on the finish line and not be tripped up by all of this FUD BS. We are almost there. Have faith.
Additionally, denial would absolutely be a material event requiring an 8k. Could this spurious rumor be among those alluded to in the recent 7.1 filing with the SEC?
I forwarded to Les Goldman.
Your argument, though ostensibly cogent, is replete with sesquipedalian verbiage and obfuscatory circumlocutions, rendering it an insidious farrago of spurious contentions. The purported perspicacity is, in fact, an artifice of prolixity, enshrouding a paucity of substantive erudition. This meretricious rhetoric, replete with grandiloquent hyperbole, is but an evanescent façade, bereft of epistemological rigor or ontological veracity. To the perspicacious interlocutor, it is manifestly evident that such an argument, though superficially impressive, is intrinsically vacuous, akin to an ignis fatuus leading the unwary astray.
ChatGBT:
It's called The Dead Horse Syndrome, and some have it worse than others. But, apparently it is going around in a certain subgroup.
Good move, Gary. Wishing you the best!
Thanks, Senti. And great post. Linda can't say what she can't say, but being very intelligent and a brilliant lawyer, she knows how to talk around her point without violating any reg. or agreement. I'm looking forward to an entire transcript to help me parse through what she said. Like many here, I've been on board for over ten years. 13 in my case. My take-away is that we are on the road to success. If it means waiting two months for validation, so be it.
Thanks Eagle
Thank you.
Is Hoffmann in the house? What did yesterday's response from defendants attempt to say?
No. Schwab and Fidelity.
Perusing the ASCO abstracts using the search word "dendritic" yielded a few results that I found paricularly interesting as they may relate to DCVax. I'll let you do the search on the ASCO site, but here are a few titles:
A slight distinction: It's my understanding from reading about the CHM on the UK.Gov site, that they act in an advisory roll only. They can recommend approval, but the approval still rests with MHRA.
From the site:
Hey Gary - I have a 15 year old hound mutt. She has large fatty cysts, according to the vet's diagnosis. They look very unsettling but don't seem to bother her. I wouldn't put her through surgery if it was recommended. I had a cat also, and he had melanoma. He had surgery, but it recurred within a few months killing him. My dog has also begun turning her nose up at her dog food and will only eat freshly made food, unless she's outside where she'll eat any old thing she finds, as long as it stinks. Then, she'll be sick in the middle of the night. So, I started the morning by poaching her chicken thighs, carrots and spinach. Today's bluebowl special.
All the best.
I wanted to follow up a conversation I posted from ChatGBT yesterday. The reason I decided to pursue this questioning is a thought I and others have had about the possible reason for the growth of the MAA to it's final size. The following picks up after a few initial questions and answers.
Q: But do the regulatory guideline of MHRA permit application for a new treatment and a new treatment +an approved adjuvant in the same MAA?
ChatGBT: The Medicines and Healthcare products Regulatory Agency (MHRA) follows the European Union regulatory framework for medicinal products. Under this framework, it is possible to include multiple indications or formulations of a medicinal product in a single Marketing Authorization Application (MAA) if they are closely related and supported by appropriate data.
The addition of an approved adjuvant to an existing treatment would typically involve additional data demonstrating the safety and efficacy of the combination product. If the combination product (in this case, DCVax-L+Poly ICLC) is considered to be a modification or extension of the original product (DCVax-L), and if the regulatory requirements for combination products are met, it may be feasible to include both in the same MAA.
However, it's important to note that each case is assessed individually, and the MHRA evaluates applications based on the specific characteristics of the products and the supporting data provided. Therefore, Northwest Biotherapeutics would need to ensure that they provide comprehensive data supporting both the original treatment and the combination with the adjuvant, and they should consult with regulatory experts to determine the most appropriate regulatory strategy for their products.
Q: Would MHRA permit additional data from a study outside and separate from the clinical trial data for DCVax-l? For example, UCLA has Phase 2 data for DCVax-L and Ploy ICLC combined which showed efficacy.
ChatGBT: The MHRA typically accepts data from clinical trials conducted outside of the European Union (EU) when evaluating Marketing Authorization Applications (MAAs), provided that the data meet certain criteria and standards. These criteria include:
Quality and Reliability: The data should be generated from well-designed and well-conducted clinical trials, following Good Clinical Practice (GCP) guidelines, regardless of the trial location.
Relevance: The data should be relevant to the population, indications, and objectives outlined in the MAA. This means that the patient population, treatment regimen, and endpoints assessed should align with the proposed use of the product in the EU.
Consistency: The data should be consistent with the overall body of evidence supporting the safety and efficacy of the product. This includes data from other clinical trials, preclinical studies, and any other relevant sources.
In the case of DCVax-L combined with Poly ICLC, if there are Phase 2 data from a study conducted outside of the EU, such as the one conducted at UCLA, demonstrating efficacy, these data could potentially be included in the MAA submitted to the MHRA. However, it would be crucial for Northwest Biotherapeutics to ensure that the data meet the MHRA's standards for quality, relevance, and consistency.
Northwest Biotherapeutics would need to provide detailed information about the study, including its design, conduct, and results, as part of the MAA submission. Additionally, they may need to provide additional analyses or explanations to address any differences between the study conducted at UCLA and the requirements or expectations of the MHRA.
From my friend ChatGBT:
The ignore option is a lovely thing, especially once you have a take on who's useful to read and who's noise.
dstock: I just have to chime in on this, because your statement really raises questions about your reasoning ability and DD. Singlestock said he was long 11 years. I happen to be long 13. You presumed that he loaded up in the teens. Do you know that even before the last r/s the pps was not in the teens? 11 years ago, in 2013, the low of the year was 3.10. After reading your presumption, I took the rest of your post with a big grain of salt.
That may very will be so. I’ve been long 13+ years, so I’m hardened to all this. But, i wonder what you guess the pps will do in the interim?
Thank you for the input. Perhaps NWBO/UCLA might share some advances with Poly IcLc, for example. And, Dr. Bosch's Experts Theater delivery is not known to all in the community, I'm sure. And, is any discussion about cancer vaccines complete without mention of DCVax? Are there many more important cancer vaccines at this point?
NYAS Frontiers in Cancer Immunotherapy 2024. May 21 - 23. NYAS
George Zavoico is on the Scientific Organizing Committee and the only NWBO mention. NWBO Listed as Academy Friend. Curious, given one of the topics will be Cancer Vaccines.
Skitahoe - I wish you all the best.
The filmmaker, Mark Faulk @faulkingtruth says he's 90% sure he'll be covering spoofing and $NWBO in his upcoming docuseries.#dcvax #glioblastoma #CitadelScandal #CancerResearch #CancerMoonshot @POTUS @FLOTUS @NIHDirector @NCIDirector @FT @JoeMillerJr @maddow @CNN
— rj (@sharpie510) March 23, 2024
👏👏👏👏👏👏 https://t.co/8dq196clFI
Chiugray - While I hope you and ATL are right, I have a feeling you're not. There are two other upcoming treatments on that list, DOC1021 and NXL-OO4, and like DCVAx, their indication is listed as Brain Cancer - malignant glioma; AA and glioblastoma (GBM). I think this is a bucket category of sorts for any brain tumor treatment. I may be wrong but, 1) We haven't heard this anywhere else; and 2) What are the odds of three treatments on that list with identical indications?
Any thoughts? NICE met with NWBO in early February, one month ago, regarding next steps,. Does NICE normally take a month to update the timeline? Why did they updated now?
The question I’ve had is: how long will the assessment and price negotiations take? This guidance seems to suggest that the NICE decision may not be that long after marketing approval
I agree
Thanks, Doc. I recall the same thing. I'm curious because next week could be extremely significant to those who know, IMO. I do not think NICE would waste time and waste all of the interested parties' time assessing a product that wasn't going to be approved. The only glitch might be, and I truly don't expect this to happen, that NICE deem DCVAX too expensive. It may be pricey, but not relative to other treatments.
Ducks seem to be coming into a row. The Parliament Bill, the End Brain Cancer Initiative PR, NICE initiating it's review process, etc.
Here's hoping. Cheers.
Question for the board (FUDsters need not respond, you're on ignore): Does MHRA kickstarting the NICE evaluation imply MHRA intend to approve? If we see movement on the NICE site next week, would that be major news? Yes, NICE would still have to issue a favorable Guidance, I know.
Loving this.
takes two to entangle
Yes, my mistake.
Thanks!
Do you have a link? I don't find it on courtlistener. TIA.
142 is Exhibit A for the defendants. A report from Prof Milgrom that they cited in their arguments but didn't provde. The judge noted that they hadn't provided it, so here it is.