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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.
...yawn...
In actuality, what difference would a PR on application acceptance/validation make? Look at what news of the application itself did for pps. We know that eventually, whether it's on the first go or at a subsequent time, the application will be accepted by MHRA. What we really need is news of either a combo trial, JV, or denial of the MTD to potentially move pps up before the main event of approval. And, I believe that even the denial of the MTD won't do much for the price, though it would lead to needed cash for the company.
Thank you. Schedule: Tuesday, November 14, 2023 at 10:30AM in Courtroom 9A, United States Courthouse, 500 Pearl Street, New York, New York 10007
An order was added to the court docket today. Sorry if this has been discussed here already. But, does anyone have access to PACER?
Absolutely.
Can the judge deny the Oral and MTD simultaneously, theoretically? Is there a timeframe in which the judge has to respond to the request for oral hearing? TIA.
The MHRA deadline is today, 9/25, not 9/28.
MHRA meeting schedule
Nobody expects the Spanish Inquisition [on a Friday].
A git gebenscht Jahr!
georgebailey - Interesting reasoning. The deadline, as you know, is 9/25, Monday. That day happens to be Yom Kippur. What effect, if any, that may have on the day's trading may be a consideration regarding a decision to PR Monday. Fridays are generally not considered the time to PR great news. So, IMO, we may be less than a week away from MAA submission announcement. Should be an interesting week.
Don't believe it. It's all AI -- Actual Ignorance -- responding.
"but first things first." Absolutely. The myriad of 'first things' that have been required to get this far are largely unknown, and there aren't many among us who've actually enjoyed the time that it taken for these careful and calculated preparations to me made, just as very few people get as excited about watching the preparation of this as they do about watching the final result:
The road from bench to approval
I find it noteworthy that LP has gone from speaking of combination trials to combination treatments. IMO, Linda chooses her words extremely carefully. Being months away from approval, would a combo trial even be necessary for DCVax with the exceptional safety profile that it's demonstrated? Experts will correct me if I'm mistaken, I'm certain, but upon approval couldn't clinicians combine treatment with DCVax with another approved treatment of their choice with the patient's consent?
Thanks, amazing.
JTORENCE: Please quote me in entirety: