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Clever Ex. Real cute. It is now abandoned 14/534158 December 2023. Not only abandoned but someone scrubbed the July 2022 document showing the survival graph from view.
The parallel ongoing combination patent 14/533,879 does not show that trial’s data yet, at least not beyond any firewall.
The 14/534158 had the same combination data as Dr. Liau’s December 5, 2022 slide from the Merck UCLA DC/CI/poly
Trial interim data. That video has also been scrubbed.
Regardless, the true IP protection will be in DCVax-l’s biologic exclusive use and data exclusive use. Which runs ten years from any approval.
Look at the combination data figure in the patent. It’s the same one Dr. Liau presented years ago. You know this. The inference is Merck UCLA and NWBO have been cooperating for quite some time.
False. Instead, it’s been talked about. NWBO uses that very DC/CI/Poly combo data in their patent application. In the
DC/Poly trial, NWBO has been a sponsor.
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I just want to make one more point on the Elios tlpo versus tlpodc phase ii disease free melanoma trial and show you how they are working like Novocure does. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10401209/
Look at the link/figure below. Now realize that based upon this, they’re saying, well since tlpo and tlpodc are essentially equal, we should do a phase iii on tlpo because we can’t really afford to keep trialing tlpodc.
But wait a minute, look at cases at risk at thirty and 36 months.🤨 By 36 months, which is what they go by in their trial “survival section,” only one, that’s right, one data point was used to get their survival number for tlpo.😬 But look, they matured the tlpodc group and let 19 cases be at risk for the 36 month analysis.
You see what they did there? They didn’t bother to build a DC manufacturing base like NWBO, so apparently they said fck it, let’s just get one good 36 month data point and call it a day, so that we don’t have to build up an industry. (They also only had six tlpo data points at 30 months)
(Note: remember the Elios trial was for melanoma)
https://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=10401209_jitc-2023-006665f02.jpg
In the Direct trial, yes. The patients starting the trial had very advanced cancers. Inoperable.
Edit:
The lion’s share are not patients near hospice, as they were in the direct trial.
Clinicaltrials.gov is flooded with easy setups and predictable falls. I wish anyone luck, but these guys (Elios) aren’t taking themselves seriously. IMO.
Seen a million of these trials. Ovarian cancer is not melanoma, and these guys (Elios) don’t play by the rules — not unlike NVCR. Terrible past randomization, and poor future design. This is a ploy. IMO.
Elios basket trial will be 100 patients with any stage of solid tumor cancer.
Open label. No randomization.
The lion’s share are not patients in hospice, as they were in the direct trial.
Elios Trial not really randomized.
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Primary News Source: Gov.UK
Some News Without Further Comment:
Update: Project Orbis
January 12, 2024
Post #661096
Stop. Just stop it Senti. You don’t know what a validation report is. You don’t know the difference between the Cambridge article and acceptance. Are you accusing Vertex of something? No. If NWBO doesn’t want to defend their PPS, that’s their thing. You have the board. I’m done posting until news.
Name one company to get in trouble for PR’ing acceptance.
BTW, Ive texted the company very recently.
You don’t run the company either.
Last time this issue was addressed to Dave, he stated if they bothered to PR PIP, why wouldn’t they PR milestones, and when asked if they’d promptly PR acceptance, he stated it’s a milestone.
Quit hating on Dave.
That wasn’t just for the IRP.
Number 1. Was for IRP
Here is number 2. Again,
It’s a potential program announced by Jeremy Hunt in March of 2023, partially funded by a 10 minion dollar infusion for matters like SWIFT and IRP.
I think the silence on (probable) validation confirmation just helps big fish who want to buy huge dips. I don’t think silence on the matter protects retail, PPS, nor does silence reduce dilution. Vertex/CRSPR were kind enough to announce submission, validation and approval.
Bard AI:
December 30, 2022. Linda Powers:
3D printed fish filet? Great, could they also print some tartar sauce?
IRP in the spotlight during 2023. “UK first” may increasingly overshadow in 2024.
Well of course the UK and drug companies mutually benefit from IRP’s efficiencies, but what regulator should companies submit their marketing application to first?
SWIFT, if and when implemented, may make that decision easier for companies with high impact technologies, like cancer vaccines.
Make no mistake about it, even though IRP is an efficient tool, when you hear U.K. regulators get truly excited, it’s lately likely due to someone mentioning CRSPR, and before that, the Covid-19 vaccine approval.
High impact therapeutics is becoming their specialty. Companies are beginning to see this. Not only that, other regulators followed the U.K. regarding those two products.
The UK now has speed of high impact approvals, first Covid vaccine, and complex high impact approval, CRSPR, as impressive trophies on their post-Brexit shelf.
Combining these two characteristics, accelerated and complex approvals is the Holy Grail. SWIFT could leapfrog other regulators’ velocity, while (possibly) applying it to an autologous vaccine for cancer could demonstrate capability to shepherd complex scaled up manufacturing and ECA data to a comprehensive approval.
For a historically respected agency, this would be an excellent way to attract more high impact therapy companies to submit in the “UK First.”
Thanks.
I read your posts on this from about November 22, 2023 forward. My own recollection was that LP stated one or two years ago some BP were starting to improve their cell manufacturing. That would be in line with your views.
Your posts since late November on manufacturing are industrious, and, one must only guess that BP is trying to keep a lid on things (camouflage their true goal), as they often do, (in order to believe your hypothesis).
I have no idea, but keep up the good work!
I’m starting to think NWBO might be a pilot participant for the proposed SWIFT program which might be able to review in 60 days (SWIFT is not formal yet, but is supposed to be ready in 2024)
I’ve given some other reasons why this is possible, including but not limited to LP’s new program proclivities, strange behavior by some better publicly informed longs, MHRA’s tendency to pilot before full implementation, the express reference to cancer vaccine applicability, etc. The list is quite long.
I think it’s possible nwbo was assigned a “special” veteran team (which is a tool SWIFT wants to incorporate), perhaps some previously worked on the CRSPR process.
I think it’s possible MHRA had an Oncology Expert Working Group advising NWBO prior to submission.
I really didn't and don't think MHRA wants DCVax-l to hit bumps once NWBO submitted their maa. Therefore setbacks, if any, were to occur before submission.
I think SWIFT, motivated by cancer vaccine type technology (“high impact”), oncology working groups and veteran special teams assigned upon submission will get this done at lightening speed.
MHRA still has some of the best and most qualified regulator professionals on the planet. Their restructuring post Brexit wasn’t going to slow the UK down for long. Now, imo, patients will soon reap the benefits.
I believe Daltrey is mostly wrong about that. Instead, if cancer is “cured,” this will allow researchers, resources and medical providers to shift and focus on remaining diseases like Alzheimers.
Good job at not understanding when they were investigating as some time leading up to and including 2017 to 2022.