Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
True, however he did get the effective notions across in layman’s terms that can be processed by the general public.
He also plainly stated that drugs that have proven ineffective against a cancer on their own could potentially contribute to efficacy in combination with DCVax!
It was more like 14 other solid tumor cancers.
For GBM they wouldn’t need much of a sales team as the world will beat a path to the treatment given its breakthrough only game in town (the world actually) status offering the best chance to extend survival.
Les mentioned there’s a backlog and waiting list for the UK specials program access to treatment already pre approval.
Hiring and scaling to handle the increasing volume of production will likely be the limiting factor if any.
Check out the Sawston hiring efforts!
Dealing with regulatory compliance is always a challenge as well but limiting production facilities should help keep things under control.
I beg to differ.
The phase 3 trial in effect was also a trial of the entities and steps and distribution of treating over 300 patients in four countries.
The actual administration of the vaccine is easy, like a flu shot as long as the low temperature facilities are available as they were for the trial.
The tumor is obtained by the neurosurgeon and frozen just as in the trial. The tumor is shipped to Sawston (or another certified facility such as CRL in Memphis if re-engaged) and the most sensitive part of the process is where is the leukapheresis(sp?) performed? Les implied that might be best done closer to the production facility due to timing/aging of dendritic cells maturation.
So for GBM it is plausible for nwbo to go it alone imo.
Nothing was said about drawing things out assuming the rolling review would likely take less time overall than waiting to submit the whole thing and then getting feedback that would require rework all at once.
The rolling review might be loosely thought of like modern software platform delivery where you provide iterations along the way so the users could get up to speed and provide feedback sooner. The whole platform is supposed to reach “completion” sooner or at least more on target from a user perspective.
Getting back to your assertions, I don’t see that patients are getting treatment any later with a rolling submission. If anything it could be sooner.
Thanks Gary!
Ponder this possibility:
Would DI stating MAA submittal will be PR-ed be accurate if the process allowed a rolling submission that could be near simultaneously submitted and accepted by the MHRA?
Has this scenario been ruled out by facts yet?
Some of us bought them all, although I was dumb not to load up at 14 cents, picking up most shares between 25-50 cents.
But things were a lot dicier then in the midst of no completed and successful phase3 trial and various attacks and vulture financing with serious concern of insolvency.
Much, much better now!!!
Patients with low-grade glioma (LGG) may soon have a new treatment option following groundbreaking results from INDIGO, a global, randomized, double-blinded phase 3 trial studying a novel targeted drug called vorasidenib. MindMatters shares what this emerging drug is and how it could transform the future of treatment.
If it’s true that Dr Liau dropped out of the ABTA event, could it be related to this news from ABTA?
Here are three things you should know:
1. Vorasidenib specifically targets IDH mutations.
The IDH1 and IDH2 mutations are found in 80 percent of LGG and 20 percent of diffuse gliomas—the most common cancerous brain tumors among adults. LGG mainly affects young adults in their 30s and 40s.
While they’re considered low-grade tumors, LGG may still grow/progress and require unique treatment because of the IDH mutation. The standard of care is typically surgery followed by chemo or radiation therapy, which can be toxic to other areas of the brain and cause harsh, long-term side effects.
Vorasidenib is an oral penetrant inhibitor that can bypass the blood-brain barrier and thus, deliver a more potent drug. It specifically targets the IDH enzyme, which can effectively hinder the growth and progression of the tumor, setting it apart from traditional therapies.
Led by Dr. Ingo K. Mellinghoff of the Memorial Sloan-Kettering Cancer Center, trial participants took vorasidenib (or a placebo) by mouth daily in 28-day cycles. The 331 participating patients had no prior treatment besides surgery.
2. Patients who took vorasidenib went much longer without tumor progression.
Results published in the New England Journal of Medicine in June showed that patients who received the drug saw a 61 percent reduction in their risk of disease progression—a median average of 27.7 months of progression-free survival, compared to 11.1 months in the placebo group.
In turn, vorasidenib helped to increase the time to next intervention (TTNI)–the timeframe before patients need additional treatment, like chemo and/or radiation. About 83 percent of patients who took the drug did not need further treatment at the trial’s two-year mark—compared to 17.4 months in the placebo group.
Overall, the drug was received well, and patients reported only minor side effects.
Smitty,
At one time LP had structured things so that a takeover of nwbo would not get everything needed. As I think I remember the IP was being held such that it wasn’t completely owned by nwbo and manufacturing was a non public company, as I think it still is with Advent although it used to be Cognate.
Could be different now but LP is expert at M&A and I’d bet she has hostile takeover threat covered.
Is that Occums(?) Razor?
Approximately $180M if memory serves me correctly. Senti and Flipper can keep us honest!
Woodford held long after $12. I bought some of those $12+ shares and averaged down afterwards.
White night mentions always make me think of Nights in White Satin. Go figure.
Ooops, Woodford
It wasn’t Woodford who sold the nwbo shares. He was already separated from the funds company. The new funds management liquidated the positions.
I think Woodward was like the rest of us longs, believing the potential and waiting for it to be realized. Imo Woodward was involved in the unsolicited attempt to shake up or gain control of nwbo.
As Ringo says, peace and love!
Speaking of Ringo, doesn’t he look amazing for his age?
He must be doing something right! Maybe just doing what he enjoys with people he enjoys?
True dat Doc
There’s a fine line between humor and hurtfulness, and the line is personal, different for different people.
I hesitated when I posted however I took the chance that the nwbo shorts were the intended recipient of displeasure of their behaviors, not their physical characteristics. My parents generation of immigrants from Italy were mostly under 5’7” in height and many were giants in character.
Where’s Randy Newman when you need him
Short people….,,
Is that the dosing requirement?
If it is then it may face practical resistance on the part of potential patients imo.
Also it would have been an unnecessary diversion of valuable resources and funds that could provide a circus for AF and the cabal, and the cabal is the head of the stinking fish.
Fabrications and deceptions
Approval opens up sales and insurance coverage, and provides the assurance that DCVax is legitimate and by extension nwbo is legitimate!
The previous milestones are steps along the way to approval!
I’ve held on to Abbvie through the 37% decline and now question pulling the trigger every trading day despite recommendations to hold for their new drugs to pick up the slack.
It’s hard to make up for blockbusters that go off the patent cliff, and not without temporary hard comparisons while the pipeline reaches levels to compensate.
Therefore if I were such a BP I would be very interested in a way to not only extend the patent protection but enhance current markets and open new markets for the same blockbuster drug, especially if the deal would come with ownership of the new (DCVAX) broad cancer treatment platform!!!
For example, apparently keytruda has not shown the incredible promise against GBM that it promises in combination with DCVAX L !!!
DCVax L will be approved in the UK this year or I will stop posting on this message board!
So shall it be written, so shall it be done.
As Mr Wonderful says, hai chi hua hua you are smart and you’re speaking my language!!!
Great post and clarity of message!
I stay up into the wee hours EST to check Bloomberg European and CNBC out of the UK for the breaking news of MHRA approval.
One of these days Alice, to the moon!!!
Wow, you flushed out and recycled all the old debunked trash again!
Not wasting any of my time with the same old garbage so don’t bother, unless someone else wants to waste their time, but not I.
Gary,
I’m not a doctor nor biologist, however I would think the antigen targets should be either unique to the malady or foreign, in order to avoid autoimmune responses.
PM,
It’s been obvious you’re highly intelligent, clever, and witty.
However suggesting that nwbo management ineptitude is the reason for delaying submission of the MAA application is not logical imo.
We don’t even know if the application submittal process has begun, and given statements that teams of expert contractors were working on the application, what basis other than passage of time would prompt such a pessimistic assessment?
The track record is of accomplishment albeit taking longer than WE expected without the benefit of all the facts and advice.
Yo Happy,
So I guess a law suit with a top notch law firm against 6 or 7 parties alleging spoofing with 5 years of actual evidential data and a defendant essentially admitting to spoofing and trying to use AF-made-us-do-it as rationale, all that leads to a conclusion that spoofing isn’t real in your opinion?????
I rest my case!
Not a true long imo
But enough energy wasted countering the mercenaries!
DCVax works and that’s what matters most!
Thanks, I value your sound opinion!
They are related by coordination, the yellow journalism, the negative narratives on the message boards, and the trading shenanigans.
Gee, isn’t that a conspiracy to illegally manipulate a stock?
Sounds like a RICO case, and that’s not suave!
Well I’d continue the back and forth but I’m trying to do something more useful, namely watching Revenge of the Nerds!!!
You must be aware of the law suit alleging spoofing on the part of more than a handful of trading entities, nes pas?
As someone long ago said, “You pays your money, you takes your choice.”
I’m sticking with my choice, you of course have every right to do you, and we’ll deal with the consequences.
The spoofing and other shenanigans grip on the share price will be broken and like a phoenix the sp will soar, imho!
My friends, what is more logical?
A. Various assertions of managerial and functional malfeasance and incompetency at nwbo, punctuated by claims of impending financial insolvency, or
B. Determination to bring a new platform against the scourge of cancer come hell or high water:
+ successful phase 1
+ successful phase 2
+ successful phase 3 multi everything
+ successful JAMA Onc peer rvwd paper
+ successful manufacturing MIA
+ successful PIP approved in UK
+ successful specials program in UK
+ extraordinary combo indications
+ can approved MAA be denied?
I’m thinking B, how about you?
Yes, you could say the white night rescues the dencel in distress
What a shame these high ranking leaders in England don’t appreciate they are about to approve a superior treatment that can deliver on the promises now, not 2030!
So frustrating! Let’s hope political face saving doesn’t get in the way of dcvax approval and widespread adoption.
It’s also disconcerting that a dumb sh_t layman like me grasps the inherent superiority of dcvax while world leaders go on superficial awareness and the Covid glow of mRNA despite targeting a relatively small subset of antigens and poor immune memory characteristics.
As Adam Sandler stated on board the first class section of the plane to Vegas in The Wedding Singer, “Billy Idol gets it!”
Any feedback from the BNOS Dr Bosch presentation today???