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Today you didn’t deny being Michonne, and Michonne was Pyrr.
Yeah, but I was Raven Seldon* on a different site, many years ago.
You are Pyrr, Michonne and inquirig on this site. In obvious violation of TOS.
(*Can’t wait for season 3)
Thanks for the riveting entomology, Michonne. 🙄
Mr. Junorama stating August.
I should have highlighted Dr. Ashkan’s work and effort as well. Perhaps I’ll redraft this in a few days.
I was talking about the DD that followed. It is a helpful reminder and reassuring.
How’d you two get back on the same page so fast? Great DD insights, btw.
Lest we forget. Dr. Coley’s advances were buried for well over half a century. Later, so were Ruth and John Graham’s lysate vaccine work for cervical cancer.
When we look back years from now regarding how doctors Liau, Prins (& UCLA researchers), along with NWBO’s Boynton, Bosch and CEO Powers kept DCVax technology from disappearing off the radar, I think some things will start to make more sense.
From starting with the safest, least aggressive, least threatening and broadest spectrum DC therapy, to Dr. Liau’s tireless continuing educational grand rounds and global conference appearances, to Dr. Bosch’s nearly annual updates at ASCO’s Industry Expert Theater, linking UCLA’s/NWBO’s /Advent’s/Flaskwork’s research breakthroughs/developments, and his unending patent expansion, to Dr. Prins (and other UCLA researchers), continually optimizing and documenting the foundational scientific basis for DCVax, to Linda Powers working with regulators and establishing a path to manufacturing scale up with Cognate, Advent and Flaskworks; these giants, plus many others, worked all this time to keep DCVax technology ** from suffering Dr. Coley’s and Doctors’ Graham’s works’ back-burner fate.
Watching history in real time, as an investor, is a roller coaster ride and a lesson in patience, but it has also been quite something to witness these pioneers, day in and day out, grabbing their lunch boxes and working to bring the world a beginning to the end of cancer.
(** Not to mention the future combination and DC advancements NWBO/UCLA are developing.)
I think there are rules against pure profit from compassionate care, but that would mean I’d have to look it up again. Then there is the trap of looking like you are marketing if you start booking sales. Then there would be less flexibility with working with poor and rich patients on a sliding scale before some other forms of reimbursement.
As I’ve been saying for a few years (or more), to me, they would have “say” if acquired as a wholly owned subsidiary.
I didn’t say she did. BTW, confident is spelled with an e.
Money can be extracted from lawsuits moving successfully through a process and increasing reward chances. Just saying, I’m hoping that does not play into regulatory timing.
I’m encouraged Ms. Posner asked that pleadings for the MTD conclude by early May, even though the judge ended up giving defendants a little more time. And that’s all I have to say about that.
U might check your math.
That’s not how it’s played. Watch the Deer Hunter. Or don’t. It’s gruesome. You couldn’t pay me to watch it again.
Allow me to suggest the following edits:
DCVAX-L MAA TRACKER
104 days from SUBMISSION
104 to 90 days from VALIDATION
Days to DECISION
0 to 60 days for 150 day assessment (no RFI)
61 to 120 days for 210 (150 + 60) day assessment (with RFI)
121 to 180 days for 270 (210 + 60) day assessment (with RFI)
BTW, the window is wider if clock off time (one to sixty days) occurs and/or validation confirmation didn’t happen until a couple weeks after submission. Still, I’m hoping things go much faster.
BTW, the MHRA approved DCVax-l for compassionate use about a decade ago. You are thinking about Sawston’s license to manufacture for compassionate, which happened about two years ago. Prior to that, it was made exclusively in London for compassionate.
My primary concern is that they not let the MM lawsuit somehow guide the regulatory timing, but I obviously have no say on that, and I hope they don’t either. I found it encouraging that Ms. Posner was asking for MTD pleadings to be done by early May, (even though the judge went to mid-June), I say without explanation.
I think the standard is lower there with compassionate, but I don’t disagree. Perhaps what is more telling is that LP finally pulled the trigger on submitting an MAA for regulatory inspection. LP would not have done that without minimizing risks from every conceivable angle and some level of educated assurances from former regulators who are consultants. IMO, even continuing trial maturation, which no one really thinks about anymore, likely buttresses DCVax-l’s prospects.
Wondering if we might see some PIP trial initiations soon and/or another NICE update.
It’s starting to look like, because time moves on, that Mike is probably right. Sawston will commercialize/initiate ahead of Eden, but others will commercialize when Eden is ready, and Sawston will then make the switch.
World peace would be nice.
It seems like the timing, by now, would have led everyone but Sawston planning to start with Eden, or whatever the commercial version will be called.
Not sure. The preprint is already out, but perhaps a final print means more to the scientific and investing community. Hard to know. You might ask someone like John Carroll at Endpoint News, even though I’m not a fan, he’d probably give you a fair read on that.
I think you meant narcissistic psychopaths. “Mentally ill” is too general and can include such common things as depression or anxiety.
Edit: rGBM
Car-T study: Ok, finally, by the way, the authors concede that the reason Car-T likely failed in that patient is that tumors 9, 10, 11, etc, did not have cancer cells with the antigen the car-t was targeting.
In other words, in one of the 75% GBM patients, in a 65 patient trial*, tumor escape occurred within 7.5 months of car-t treatment initiation, two months of which included a complete response (in five tumors) before treatment failure via tumor escape.
Continued: Car-t case study article.
Senti, in the Car-t trial you are analyzing, when they say “all” tumors regressed (starting day 133), they were not talking about tumors 1, 2 or 3, I think. They believe those sites remained stable after 100% resection.
They are counting tumor stabilization to extend their 7.5 month “dramatic” response claim.
That makes this paragraph by them a bit disingenuous, because it lumps in stabilization with tumor response.
While I understand your conservative times, if, and that’s a big if, no RFI, then there is no rule saying the MHRA has to wait 70 days. Given they would not need to review a response to an RFI in that situation, the deliberation is much much shorter than it would otherwise be, which might mean a great deal shorter than 70 days.
That said, we do not know if there was no RFI.
Senti, another reflection about your analysis on the Car-T trial:
Because there are so many “tumors”, I’d think it would be worth having your own graphic timeline of when you believe “tumors” one through twelve appear in juxtaposition to surgery and treatments, along with when the reported complete response starts and ends on which “tumors.”
In your timeline, you should also include when the patient deceased.
The article’s masking technique is really atrocious, but it also somehow makes the reader feel like it is their own fault for being confused, and therefore no one speaks up. Until you figured out the false narrative.
If one could rank the deception level by tumor however, I’d say “tumors” four and five were their biggest timeline deceptions.
For what it’s worth, I think you are spot on correct.
Personally, I’m still not convinced that # 4,5,6,7 or 8 were all tumors. They could have been those weird transient nodules, which is sometimes a side effect of Car-t.
Anyway, now we know, if my memory is correct, that the patient did not live more than 18 months after he started treatment.
Because they did not take a new MRI until day 231, those new tumors 9,10, etc, would have been growing for months.
The author, the Journal and the peer review people need to withdraw the article and re-publish. Their timeline for partial/complete response, if any, is way too long. Instead, two months, tops.
Edit: SRD is 10.6% at risk at five years. For DCVax-l
MRD is 10.9% at risk at five years for DCVax-l
Long term survival is where the impact is expected to be highest with cancer vaccine therapy.
You’ll also notice it appears significant residual disease (where I logically assume most mesenchymal are) will surpass minimum residual disease by year six.
This would not be the case with SOC therapy. It would be the opposite, and by a much wider margin.
(And of course SOC SRD OS would be less than half that by that time, essentially zero)
Continued: And of course SOC OS would be less than half that by that time.
SRD is 10.9% at risk at five years. For DCVax-l
MRD is 10.6% at risk at five years for DCVax-l
Long term survival is where the impact is expected to be highest with cancer vaccine therapy.
You’ll also notice it appears significant residual disease (where I logically assume most mesenchymal are) will surpass minimum residual disease by year six.
This would not be the case with SOC therapy. It would be the opposite, and by a much wider margin.
#dcvax $nwbo #gbm
— Peter Davis (@peter_brit) March 31, 2024
As Vivek Subbiah, MD continues his important work promoting Tissue-Agnostic therapies in precision medicine, from a previous conference he attended at the SABCS in Dec 2023, some incredible highlights are quoted below:-
Tumor-agnostic therapies advance… https://t.co/HC1ZxuN5tv
Thank you. I will read more about it. One might conjecture the starting material for “SEC” analysis might vary from tumor lysate, blood, lymph and their immune constituents, and that changes over time, for instance, after targeting many antigens and what remaining and new cancer adaptations appear will be known on a real time basis.
Doesn’t matter who thought of it first.
My thought was/is one short course of tmz, maybe four weeks, (because otherwise tmz inhibits t-cells & other immune cells) when tumor has/had methylated mgmt, followed by a normal course of DCVax-l therapy, followed by DCVax-l maintainance boosters.
With unmethylated mgmt, maybe no TMZ, and receive DCVax-l therapy, followed by DCVax-l maintainance boosters.
Of course there are many more things they are hoping to incorporate with DCVax-l, like add poly-iclc, plx3397 and perhaps CI.
I think even Dr. Stupp has come around to not necessarily giving tmz to unmethylated patients.
JMHO.
There are other types of IP including biologic exclusivity which protects a biologic from biosimilars for ten years from the date it is approved. If you think that’s not enough, there is data exclusivity, which prevents other companies from using DCVax trial data to prove safety and efficacy. On top of that, DCVax-Direct has patents on method B+ out to 2036. Additionally, DCVax-l + checkpoint inhibitor is patented in several places, including Europe out to 2036.
Residual disease in the DCVax-l trial.
Remember, the easier tumors to resect are not the ones DCVax-l works best on. Instead, mesenchymal tumors are more infiltrative and tend to spread out in various directions. Mesenchymal tumors are probably why there are so many partial resections in the DCVax-l trial.
That’s in part confirmed, imho, by the NYAS DCVax slide deck, because, for overall survival at five years, DCVax-l proved statistically superior to the external control arm in treating patients with significant residual disease.
Equally important, but under appreciated, overall survival at five years for DCVax-l treating patients with significant residual disease, was equal to DCVax-l treating minimum residual disease patients. Both have essentially 13% five year survival, and both have almost 11% patients at risk — at five years.
This then logically disproves EX’s assertion that DCVax-l did not really beat the external significant residual control arm, because the treatment arm supposedly had better resections.