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...6 or so months ago when the 6 New endpoints...
lrdpdx77,
Any relation to hansm7777 ???
Amgen’s timeline for Sotorasib...
"...It is anticipated..."
NWBO fingerprints all over this one too!
;)
Visiting family in Reno. We don't get atmospheric rivers in Wisconsin. :)
"...I believe someone already posted a link to that report...."
if I am not mistaken, that as the HTA report, not the MHRA report.
Regarding the Streeterville Capital financing described in the 03/05/21 8-K, we're set to begin $1mm/mo payments on that loan here in a couple of days.
Any ideas on where that comes from?
Orbis
Feb 16 2021 FDA grants priority review to Amgen’s Sotorasib. https://investors.amgen.com/node/30871/pdf
Sept 13 2021 “Amgen’s first-in-class medicine Lumykras (sotorasib) has become the first new cancer therapy to receive Conditional Marketing Authorisation for use1 across England, Scotland and Wales by the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.”
https://pharmafield.co.uk/pharma_news/amgens-lumykras-gains-mhra-approval-under-project-orbis/
the NWBO SAB is very very impressive
"combination phase I trial for rGBM "
The one with DCVax-L in the Active Comparator group?
"“Active control” (or “Active Comparator”) means that a known, effective treatment (as opposed to a placebo) is compared to an experimental treatment"
One definition, anyway.
LET,
"Wow... thank you"
I think you missed the point. WH specifically called our attention to the last paragraph:
“The search for effective treatment of glioblastomas in patients is still ongoing today. Immunotherapy, or treatment via recruitment of the immune system, to fight these neoplastic cells has been investigated. First encouraging results with immuno-therapeutic approaches in patients suffering from glioblastoma were obtained by Northwest Biotherapeutics using “DCVax Brain”, a cell-based vaccination approach employing patient-derived dendritic cells loaded with autologous tumor cell lysates, and by Celldex, which used a peptide from EGFRvIII for inducing antigen-specific CTL responses, which in turn correlated with prolonged median survival times compared to median survival times obtained when using standard treatment (Heimberger et al., 2006).
Flipper44,
Regarding 5-ALA-guided resection, are you suggesting that these patients receive a photodynamic therapy that a) kills tumor cells and b) causes inflammation that our optimized DC's are attracted to?
(this is my last UnScientific WildAss Guess for the day.)
Poetic. Someone should put music to that.
Maybe its a Drip !
I think the reclassification idea can be traced back to Thursday, June 7, 2018 between 2:15 and 3:00p Louisville, Ky time.
See u in a while
Publication timelines from experience
06/05/2017 - Dr. Bosch discloses at ASCO publication of interim data is "in preparation" (earliest date I can find)
04/27/2018 - Received by JTM
05/07/2018 - Accepted by JTM
05/28/2018 - Published by JTM
Granted, we don't know how many, if any, journals they attempted to publish in prior to JTM.
And that was for blinded data.
At least a year.
"interim analyses in 2017 and 2018"
I suspect the author is confused about the differences between an "interim analysis" and an "analysis of... interim data". Study investigators did not compare trial arms to each other. Study investigators did not attempt to answer the primary research question.
They were not IA's.
Thus, the question of "stopped early if the experimental drug meets the primary endpoint" isn't a question.
I've taken the liberty of editing his Bio"
"Zhiyuan Sun is a Fool since April 2020."
[EDIT: already posted in 379077]
Re: six stages of various analyses and reviews
From Oct 5 PR and May 12 PR
1. Provide access to statisticians
2. Statisticians will analyze
3. Statisticians will summarize
4. Company, PI, Steering Committee, SAB, expert panel will analyze (and be thus unblinded)
5. announce results
6. publish results
From the 10K
1. Data Validation
2. Analysis by statisticians
3. preparation of result summaries
4. review of result summaries by same parties
5. publish
6. announce (including “public announcement will follow these processes”)
ASM: present tense “reviewed and analyzed”
ASM: “It’s really important that the review process be of the highest quality.”
ASM: “results need to go through to be reviewed and analyzed in a high-quality process.”
Sounds like we are on step 4 . Quiet period is related entirely to this process while they determine the results summary is correct and complete. A target date for step 5, be it announcing or publishing is, in my opinion, by May 31.
Before we know what has hit us, it'll be $990,000.
And then, who knows?
Dr. Liau's Preface in Glioblastoma, Part II: Molecular Targets and Clinical Trials
[EDIT: Buy this eBook! https://play.google.com/store/books/details?id=nMcpEAAAQBAJ&rdid=book-nMcpEAAAQBAJ&rdot=1&source=gbs_vpt_read&pcampaignid=books_booksearch_viewport]
Get your taxable income under $81,500 (married filing jointly) and you can enjoy 0.0% long-term capital gains tax.
I see a classic Loch Ness Monster with Baby Nessy kicker pattern.
RKMatters coming out of hibernation again is the confirmation signal.
* they suggest it's troubling that executives are being compensated substantially more in 2020 compared to 2019
* they find it more troubling that since then the stock has gone up and options are worth more
* they suggest that the order of operations - grant options, announce positive news, stock appreciates - is cause for concern
* they reference the exact same tables from the Proxy Statement that AF did, making the same suggestion AF did.
(not my claims, a summary of their communication)
"Don't provide any "oxygen" to AF and his crew."
Maybe I didn't think this one through.
"If you are a shareholder of Northwest Biotherapeutics, Inc. and wish to receive additional information, free of charge..."
By raising my hand to that, how am I encouraging those who are against the company?
I expressed an interest in the "INVESTIGATION". Here is why.
It's as frustrating as one of those unsolicited calls you get from "MICROSOFT SUPPORT". There seems to be no way to stop them. So one approach is to return the frustration. Answer the call, put it on mute. Tie up their phone system. Some will engage actively to make it a 30 minute phone call or more, which if scaled makes the potential benefit given the cost/inconvenience/frustration just not worth it.
So I responded. If 10% of shareholders responded once, that's 4,000 emails, phone calls, or voicemails. You don't have to complain. You don't even have to "comment" in the webform. I'll be happy just to receive their updates.
"Dose-dense" TMZ
First time I have heard the term. Googled "dose-dense" and didn't help me understand it any better.
Is there a reason LL would use "dose-dense" now?
Is SOC TMZ dose-dense?
Is dose-dense a form of off-label application of an approved therapy?
TIA
I monitor views of the Bosch 2019 ASCO video (which is displayed on the home page of nwbio.com) as a proxy for website interest/traffic.
Nothing scientific, and not even specific counts I have recorded.
But I have noticed that while in the past it used to take weeks to move the view stat by 100 views, it seemed it jumped by multiple hundreds in the last week or so alone.
agreed, and those are the percentages I had used until I compared them to the other columns. Weller's n=130 is 37% of (130+218) and the missing n=26 are not figured into the math at all...
That footnote re: Gilbert struck me as out of place. It reads in future tense and as part of a plan. I took it to have perhaps been copied from another slide deck.
Patient Characteristics versus Other RCT's
Added a column to Dr. Liau's slide 23. Behind on messages, apologies if already done.
The methylation status figures in her table totaled 100% even if "missing" was > 0, so that is what I used. Didn't see any info wrt over/under age 65 and residual disease.
Northwest Biotherapeutics Announces Name Change
FOR IMMEDIATE RELEASE
CONTACTS
Dave Innes
804-513-4758
dinnes@nebio.com
Les Goldman
240-234-0059
lgoldman@nebio.com
Northwest Biotherapeutics to become Northeast Biotherapeutics
BETHESDA, Md., April 1, 2021 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it will change its name to Northeast Biotherapeutics (“NE Bio”) to address confusion over the company’s location.
“In preparation for what we anticipate will be a several month process, the Directors have decided that Northeast more accurately describes where we are as a company”, explained Linda Powers, NE Bio CEO. “We’ve been in Bethesda for so long that frankly, we’d forgotten we needed to do this.”
The Company anticipates a smooth transition from Northwest to Northeast.
In a separate matter, The Company announced its intent to move its corporate offices to Seattle in 2022.
About Northeast Biotherapeutics
Northeast Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” This Phase III trial is now completed and locked down, with announcement of top line data expected in the coming months. The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
ccie1024 wishes everyone a Happy April Fool’s Day.
###
Brain Tumor Vaccines
J Lee, BR Uy, LM Liau
Neurosurgery Clinics, 2021
"Brain tumor vaccines * Brain tumor immunotherapy * Dendritic cell vaccines * Peptide vaccines"
https://www.neurosurgery.theclinics.com/article/S1042-3680(21)00003-6/fulltext#secsectitle0010
Glioblastoma: Molecular Mechanisms and Clinical Trials
LM Liau, Guest Editor
Neurosurgery Clinics, 2021
From the Preface:
"Cutting-edge and comprehensive, this issue aims to bring together many of the important and emerging advances in our understanding of glioblastoma and illustrates in powerful detail some of the new applications for translating new scientific knowledge in the field to novel clinical trials."
Retrospective Classification of IDH status in Gliomas
Liau, Ellingson, et al.
https://cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-021-00396-5
"Unsupervised clustered features have revealed voxel-wise imaging associations, and may improve the understanding of the priority of multiparametric imaging features for classifying IDH mutation status, which may help predict molecular status before surgery."
Temozolomide chronotherapy in patients with glioblastoma: a retrospective single institute study
Temozolomide chronotherapy in patients with glioblastoma: a retrospective single institute study
The advantage of morning TMZ was even more pronounced among the subsets of patients who were ... enrolled in the
DCVax-L trial (N=15, median OS=2.32 vs. 1.03 years, P=0.041...
Women in Neurosurgery
Neurosurgeons in 2020: the impact of gender on neurosurgical training, family planning, and workplace culture
Thum, Liau, et al.
"The effect of all the radiation to the brain..."
This could be a reference to the many interventions Matt has had throughout his battle.
"brain cancer survivor/11 surgeries/ 2 rounds Radiation/ 6 Wks temador #glioblastoma / still fighting!"
There are UCLA contacts listed in the clinicaltrials.gov page - you could contact them with your question.
But please don't bother Matt or his wife. This is a very personal matter for them.