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Yeah, there is something missing from that story, but it sure sounds like Dvax in some form. I could be wrong...or right.
Maybe anticipation of the March CHM will cause some volume to come in. Unfortunately that may be negative volume (if news somehow comes out of the CHM, which I don't expect, I think it more likely to be bad news than good news). But other than that, we're just coasting, which is fine by me.
Dedugan hear you on the 2B….i was thinking 10% of the GBM market opportunity only. Why can’t this licensing model repeat for each new indication….Les specifically mentioned prostate(?) as an incoming trial to watch for and I think nwbo had finished the phase 2 for this indication
Our lead DCVax product candidate, DCVax-Prostate, is a prostate cancer treatment for which we are planning a Phase III clinical trial.
Historically vaccines have been solely prophylactic (preventative) agents as a way of preventing infectious diseases. One of the first was introduced by Edward Jenner who treated people with infectious material from patients with the mild infection of cowpox (variola vaccinae - Latin for "smallpox of the cow") to prevent the potentially fatal human Smallpox (variola). He named the process Vaccination (for obvious reasons). With the DCVax family we now have the first examples of established disease being treated by vaccination (incorrectly named from my point of view).
Unfortunately for Dr Mullholand his IPI-GLIO failed failed because the SOC arm did so well.
Overall Survival (Arm A vs B): median OS 22.7 vs 26.4 months, HR 1.223 (60% CI 0.986-1.516, p=0.431); 18 month OS 53% (60%CI 48-58%) vs 64% (56-70%).
100% certain DCVAX will be approved.
Well, Doc L asked me to reply. So here goes.
Ex, no, it doesn’t fail badly. I don’t think the censors for the first two years were discarded, what I think is they were not included in the JAMA publication because they were all part of the 99 arm and none of the 232 arm.
Other of the key points is for example the read at 12 months of 77%, because the earlier the censor effect occurs, the higher the effect. Regarding my 35% read vs. your 36% read it is your eye and word against mine and others can decide who to believe. But in any case, that 1% difference doesn’t allow for 8 or 9 censors as you mention.
As you can see from the notes below the chart, there were 81 events in the 99 patients arm. That means there were 18 patients ( 99 – 81 ) that were part of the 99 that arm, but were not PFS events. So they are censors for PFS analysis. I think that the majority if not all of those patients were censored because they were pseudoprogressors, that being initially thought to be progressors, received DCVax after pseudoprogression as part of the crossover design of the trial. As a consequence of that, these patients were not included in the 64 patients rGBM arm, because they were not real progressors when they crossed over.
That [my assertion that they would a 232vs99 win would be huge] is not a fact at all. I think it is exactly the opposite: The reality is that the less statistically significant the difference between the OS for the 232 arm and the 99 arm, the better the results for DCVax.
No update on the Court case. Expect anytime in the next week.
Flip, he already said he stopped all treatment at 6 weeks post surgery prior to receiving any DC-L.
The first sentence says '...histology consistent with glioblastoma'. The rest of the document snippet raises the issue of a possible misdiagnosis and as you said, there is no connection to NWBO's DCVAX-L or the trial.
He actually said he withdrew from the trial prior to receiving DCVax-L
You do understand that these are not pricing/payment discussions, but simply discussions about when and how the NICE process can proceed?
One would have expected to start this at least 6 months ago when NICE was calling them. But maybe NWBO knows they are in no hurry.
The real question will be where does the NICE process pick back up at.
I think there is reason for them to say another scope/matrix are needed. The previous ado not have the right indication, have incorrect statements about what is now being reviewed and is six years old.
Will they issue a new set of docs? Will those be draft or guidance? Or do they just forget that and start the meeting invite process.
Good news is that NICE is a lot more visible than RAs.
About $150k/year is list, but I guarantee you NICE is not paying nearly that much (it is already being reimbursed for HER2+ patients).
A summary of Canada's rejection of the same drug/indcation
Is there a way to get somebody to piss in the bottle for you to fake the genetic market test for HER2?
As someone who was diagnosed with GBM4 by Kings College Hospital in 2015, the DCVax-L Clinical Trial wasn’t the noble enterprise some people may think 🤔
Biosec, you are missing the point that spoofing by definition requires intent.
If you place a buy limit order with the intent to buy, and then cancel later when it does not fill, that is not spoofing.
If you place a buy limit order with no intent to buy hoping that causes other buyers to raise the bid, that is a spoof.
Intent is core to the issue.
Hi guys,
I didn't follow this thread, so I do not know why you started discussing intent, but if it is concerning the MTD, the only remaining element CM needs to improve on when they refile the complaint, is causation - not intent.
I am sorry you cannot understand the fact that being "basically" the same does not make them the same.
The manufacturing process is known to be different. And somebody once said "In this space, the process is the product"
From the combo trial pre-print
One day before each vaccination, DC were pulsed (co-cultured) with tumor lysate overnight, washed, and the final product was tested for sterility by Gram stain, mycoplasma and endotoxin testing prior to injection.
Who cares what George Baily said, he is just citing material circling around from other ignorant posters.
He is mistaken. He stated the definition of a well established use of a medicine in EU law (or EMA regs or whatnot).
An established medicine is one where the active substance has already been approved.
We are approaching the stage where settlement seems probable after MTD denial.
If Citadel Securities and its ilk are to beat this case and prevent a string of copycat suits, they will probably have to give the rest of us more of a peek ...
There was a post in winter of 2023 saying almost the exact same thing. Something like :"We (NICE) are working with NWBO and hope to update the website in the next week or so".. Reported by some poster (forget who) that had asked and received an email.
Even if this nth hand copy of an undated email is current, is it any more reliable than the previous?
I do think there is a decent chance NICE will update the webpage this month. It will just be a progress report, it will not be a NICE approval.
So what is Dr Mulholland talking about for a cure in 10 years? He talks about needing charity funds and BP drug donations. He talks about combinations of drugs used used in melanoma and blood cancers.
We know his recent IP-GLIO was charity funded with Yervoy contributed by Merck. But that failed badly, real badly. Yervoy+SOC was 22.7mOS vs SOC at 26.4mOS. Though 22.7 mOS for Yervoy+SOC does beat NWBO's ECA by 6 months (and the -L arm by 3 months).
Anyway, what is the combo he wants to push. Sounds like it will be Yervoy plus a CAR-T.
IMO, he is off the deep end if he thinks he can push through to results of a P3 (it will need a P1/2 first) in 10 years without BP cash. Though it may be he just means to the point of a P2 trial.
You missed the point that the FT writer made in that very quote.
If Citadel settles they will get a flood of copycat lawsuits. That is why they need to proceed through discovery and not settle.
Though I am happy to see the article, this is a clear violation of Financial Times copyright rules. Very likely part of the reason why certain cut and post posters get posts deleted and even banned.
March News:
90%) lawsuit amended complaint in next 2 weeks
90%) 10-K in next 2 weeks
50%) Nice update
20%) ASM Proxy
20%) Update by NWBO on MAA status
05%) Update on Flaskworks
05%) Bluebird
Did I miss anything?
DD was speaking about the phase I study, I believe. You are discussing the phase II study.
NWBO has been using Monte Carlo for derivative valuations for years. Nothing new, nor uncommon.
What happened here s somebody miss classify the 2 loans as standard, not converts, so the accounts booked took them at face value. Must have been caught at the very last moment because it could have been corrected quite fast.
Or maybe it was just convenient it was not found until the last moment.
Perhaps we finally see revenue from compassionate use.
2022 2021 2020
Change in fair value of derivative liabilities (25,821) 239,347 (435,351)
The 2021 10K got released on…….hold it…..wait……3.01.22
From BBC News:
The government will only rarely allow a ten minute rule bill to progress far enough to become law so MPs tend to use this procedure simply as a way of gaining publicity for a particular issue.
Thanks Smokey. I think today is the last day to buy shares in the 50s. Dave Innes refers to the SEC filings as the Bible and so we can expect some clues today.
Odd, the version from the actual preprint says:
This study was funded in part by the National Institutes of Health NIH/NCI grant (R01CA123396), the UCLA SPORE in Brain Cancer (P50CA211015), NIH National Center for Advancing Translational Science - UCLA CTSI (UL1TR001881), the Parker Institute for Cancer Immunotherapy, and the Brain Tumor Funder’s Collaborative. Mass cytometry was performed in the UCLA Jonsson Comprehensive Cancer Center (JCCC) Flow Cytometry Core Facility that is supported by NIH award P30 CA016042. W.H is supported by the NIH/NCI grant (1R01CA236910), Jonsson Comprehensive Cancer Center, , and the Parker Institute for Cancer Immunotherapy at UCLA. L.S. was supported by a Career Enhancement Program award from the UCLA SPORE in Brain Cancer. A.L. was supported by the UCLA Tumor Immunology Training Grant (USHHS Ruth L. Kirschstein Institutional National Research Service Award # T32 CA009120). L.D is supported by grant from Parker Institute for Cancer Immunotherapy at UCLA and a postdoctoral fellowship from National Cancer Center.
Their market cap has dropped substantially. I imagine they are non accelerated if they want and we may not get 10K this month.
Public float has to be less than $700 mil which it is now….
We haven't even made it to spring yet Ex, slow down.
But Fall is just a few months away in Linda (P) time.
As it drags into fall it will be more like paying chicken against a turtle.
Phase 2 is after the clock-off period "if needed", according to the MHRA guidelines for 150 day assessments.
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required.
Yes, Dave said that they would PR acceptance. However, it has since been pretty heavily researched and confirmed that companies very rarely PR the acceptance/validation of an MAA.
Sure, 1B naked shares short. I will call BS.
Problem is this. Naked shorts (FTDs) are shares that have not been delivered to the DTC (which books most all US stock transactions). DTC knows the shares have not been delivered to them. They are legally required to report this. And the semi-monthly reports show almost no NWBO FTDs,.
The theory that DTC is complicit is insane. It is not DTC that would be looking to make a profit on the short transaction, it is the party that sold. But the DTC woulkd be on the hook for a failure, and also would be committing a massive securities fraud in not reporting.
So plenty of reason to call BS on the theory. And the reason to support it? Nothing. Not a single piece of real evidence that the open FTD balance is more than the few thousand on average (with occasional days when it pops as high as a million or so only to be delivered shortly.
P.S.: Single-stoick, I know I am abusing the language here on "naked", but sometime easier to go with the flow than continually fighting it.
I see you are spinning this crap again,.
NWBO was forced to put out a retraction just a week later saying how some may have been confused by the first PR to think that the -L was actually available. Really? Was it the lawsuit or the SEC letter that caused LP to react?
How confused was Nevid Malik who was all over the place pumping the "first commercially approved oncology vaccine", and patients flocking from all over Europe to get it?
How many shares did he manage to sell to fools who bought in at a price that has no chance to even be seen again? Sure, some got money back by the lawsuit, but NWBO was to broke to really cough up much so the settlement was minor.
I like the way LP never keeps much cash in NWBO. Makes lawsuits kind of pointless.
Advent books the revenues because this is not a regular drug sale. It is under the Specials Program and Advent is effectively serving the role of a compound pharmacy in the UK, putting together a treatment that is ordered. There is no “royalty”. There is only fee for services in terms of NWBO and Advent. The fees are in their contracts, but the revenues are ultimately NWBO’s revenues and Advent will get some fee for services. However, there are baseline costs for licensing the facility, managing it and staffing it. It would be similar for their previous CDMO, Cognate, but much more up front costs because it would be at Cognate’s own facilities and it would require allocation of lines that otherwise would go to manufacturing other drugs.