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Agreed there are enforcement mechanisms written into the law. The reality is there is no consistent enforcement. There are numerous other examples of entries that have not been updated recently (whether in violation or not).
I can’t be certain it was a consideration, since there have been no press releases stating the reason(s) for not updating ( :) ).
Wasn’t there a legal action against them at one time that they accepted a default judgement in rather than wasting limited resources defending themselves?
Thats how I see their prioritization of the issue. Calculated risk taking. What gets us *over that dang goal line, and does updating a public database have anything to do with it?
After all, there are only, what, 14 of them?
Not updating a website for endpoints was not unusual behavior. Prior to May 2022 the web page had not been updated since 2016. For almost 6 years it estimated the primary completion date to be in the past.
Updating a website was never a primary concern of the company until the information was used to successfully attack them. Combined with the unfortunate slide that focused too much attention to the PFS results, it allowed the naysayers to connect the dots.
Cobra making grapefruit juice.
Hard to not cheer for an “eat me” flag.
I think there would have to be a reason - they’re so careful with what they otherwise say.
Could be to stave off a lawsuit compelling the ASM. Just long enough for their response to the court to be “ok, scheduled it” and have that work with the rest of the more important needle-threading.
Started watching Squid Game on NFLX last night to see what all the fuss was about.
From that I can say green light is good!!! Red light, bad.
“blocked her on Twitter, which seems an odd thing“
Not really. I muted her long ago as I thought the quality of her posts were less than I wanted in twitter.
I don’t think that shows bias. I’ve muted others too for the same reason.
Conspiracy: debunked!!
NORTHWEST BIOTHERAPEUTICS CONFIRMS CEO SIGHTING
Bethesda, Md., September 9, 2022 - Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that several of its employees confirm having eyes on President and Chief Executive Officer, Principal Executive Officer, and Principal Financial and Accounting Officer Linda F. Powers.
“The rumors of my disappearance have been greatly exaggerated”, would be the statement of Ms. Powers if she was inclined to provide one. “Some may be relieved to see my name adjacent to words surrounded by quotation marks. That is not unplanned.”
"November, Flipper44 ;)" she would have added.
Reports that Ms. Powers was singing with perfect pitch Donna Summer’s “She Works Hard For The Money” could not be confirmed.
About Northwest Biotherapeutics
Northwest 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 has been completed and top line data was presented by a key investigator at a recent scientific meeting. The Company also plans to pursue development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and plans to prepare for Phase II trials as resources permit. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
And since RT and Temodar are not being used in the trial, they are no longer SOC?
“Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy.”
That’s how SOC is traditionally used in my experience.
Another dimension of efficacy, perhaps. I might have missed it, but there is still the Brem comment that has not been answered.
And the secondary endpoints. What if after all that work and analysis and debate on ECA’s, they were not necessary after all???
IHubber: “Hey Dave, what’s taking so long?”
DI: “One of our RAs requires a Pediatric Investigation Plan. We are working very hard on it.”
IHubber: “Hey iHub, we gotta do a PIP. It takes 12 months for MHRA to Approve it, and we haven’t even submitted it to them yet!”
IHub: “A PIP? That’s gonna take ANOTHER THREE YEARS!”
IHub: “Do we even have the money for that?”
IHub: “Where are we going to get the money for that?!?!”
IHub: “Four years?? It’ll take NWBO eight!”
IHub: “Dilution! Reverse split!!! Pitchforks!!! Torches!”
SP: <gazillion eye rolls !!!>
DI: “GOOD GREIF!!!!!!”
they expect to reach statistical significance
There’s a sort of one note feel to all of your postings.
Someone issued a call for creative predictions as to what the *-dencel name could be.
goesToTenDencel
I won some at 1.85 before May the 10th and have a crapton between 1.00 and 1.75 from back when I was happy to raise my cost basis of under .50. :)
holdencel
Abbreviation for “Hold for dear life. Then sell.”
heldencel for a criminal slant
adamencel
"You miss 1005 of the shots…
What? No INN speculation???
Ok, I’ll start.
juiceofthegrapefruitdencel
Pronounced juice-of-the-GRAPEfruit-dencel
ccie
“We are in a quiet period.”
How long has the quiet period been in duration? What is the precedent for one of this length?
But maybe when NWBO gets there I'll buy one that removes several of those steps
Yes, with a light blue (?Cambridge?) blouse and hairstyle unchnged from way back. Only thing is that, like me, she's a little chubbier in the face than the "official portrait".
watching for updates there too… :)
TOTAL DYSFUNCTION[color=red][/color].
ZERO[color=red][/color]
You just bricked my iPhone…
2019: PR’d 30 May for a 3 Jun (I think) ASCO presentation. pR June 4 with “highlights”.
Content (slides and video) made available on Nwbio.com fairly quickly thereafter. I suspect the video depends on getting it from ASCO unless they are allowed to record.
“We got the TLD… There may be more…”
If they had top-lined some jaw-dropping results with the footnote of “we met 2 endpoints also” it may have been much easier for the scientific community to question the motives.
If they top-line meeting the endpoints and subsequently elaborate on some jaw-dropping observations as the real headliner, I think it might be better received by those who matter most.
That said, I have no idea what I am doing.
ccie
“1) when does the AACR issue a retraction?,”
Get over it. Move on.
I’ve been wondering about the blogger’s “…will NOT contain any new data/results…” tweet on 5/9.
Were journalists privvied to prelease information, and did the blogger violate the confidentiality that comes with that???
Websites that send their readership to Stat news and the Feuerstein piece for revenue:
https://www.google.com/search?q=%22after+years+of+delays+and+excuses%2C+Northwest+Biotherapeutics+finally+disclosed+on+Tuesday+the+final%22&rlz=1CDGOYI_enUS977US977&oq=%22after+years+of+delays+and+excuses%2C+Northwest+Biotherapeutics+finally+disclosed+on+Tuesday+the+final%22&aqs=chrome..69i57.2534j0j7&hl=en-US&sourceid=chrome-mobile&ie=UTF-8
Perhaps a reference to Industry Theatre.
NWBO with trial investigators, or statisticians, or third-party imaging experts who assessed progression, consultants (Stupp), etc.
Cancer Connect article also removed even after their twitter account defended themselves against those who would pump the stock.
https://news.cancerconnect.com/.amp/brain-cancer/dcvax-l-for-glioblastoma
Thank you also to @cancer_connect who appears to have taken down their updated article on the DCVax-L(TM) Phase III trial results at the New York Academy of Sciences. $NWBO
— 6brooks (@6brooks) May 18, 2022
STAT@ASCO: with “Cancer’s Gatekeeper” Richard Pazdur.
Suggested topics @matthewherper of @STAT might cover with Pazdur of @FDAOncology at their #ASCO2022
— 6brooks (@6brooks) May 18, 2022
Event.
* Real World Evidence
* External Control Arms
* Endpoint selection before unblinding
* Phase III Glioblastoma Trials
* Media Integrity$NWBOhttps://t.co/t8he2tLSjg
It has. Let’s move on. :)
If a study can show
* PFS, the current standard in measuring cancer trial efficacy (done)
* why it does not apply to immunotherapy, and
* what *confirmed PFS (results that omit pseudo-progression) is
Another <gasp!> will be heard, around the world, then “they did it right!”
We heard results. We didn’t hear all of the results. And we certainly did not hear the company release top-line data.
Pioneering. Sod-busting. Homesteading.
Agreed, Doc!
And here are the others. :)
The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
The third secondary endpoint, PFS, is progression-free survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
The fifth secondary objective is tumor response compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
Thank you, LET. I needed this. In a big way.
Yeah, I had come across him in earlier research, aside from the fact that he co-authored the First Results journal submission. Thought I could shortcut a backtrack.
Paul Mulholland —> University College London Hospitals —> UCLH.
Anyone recall the video where someone said “UCLH” and it sounded a lot like “UCLA” ???