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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:
The PR may be, in part, for the eyes of the judge in whose hands the MTD now lies. In addition, MHRA requires that applicats for MAA alert the MHRA 30 days in advance of anticipated filing date. Why? Perhaps so that they can alert NICE and NICE can begin their process. If NICE renews its consideration, its website will show that. So why not get out ahead and PR it?
They have no reason to. The MHRA statement is 100% clear. I can't help more than that, so I'll leave it at that.
I'm long 13+ years and as eager as anyone for success. Sometimes in their eagerness, people see what they hope to see when they read something like the new MHRA guidance on clinical trials. I get that. But these types of misreads, as they are repeated, quickly become gospel. I suggest people go to the source and read and decide for themselves what is being said.That's they only reason I decided to comment on Mav's post.
See hoffman post 626513