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Always stunned me that NWBO never ran a solo L trial to prove it could stand alone.
>>Although current therapies provide 5-year overall survival of approximately 95%, patients who receive chemotherapy often have multiple relapses or progressions and worsening of functional decline, including visual impairment and hypothalamic dysfunction. In addition, radiation is associated with the risk of long-term neurologic and cognitive impairments and is therefore generally reserved for older patients after less toxic treatments have been exhausted.
https://www.nejm.org/doi/full/10.1056/NEJMoa2303815
Much of the "vaccine" for the Plll was produced by Cognate so they'll want to see the facility. Cognate was sold years ago by LP and others.
Calling that Dabrafenib / Trametinib article FUD should be an embarrassment to even the worst pumpers here. It provides a lot of information specific to what gets approved and why. You "Investors" have been 100% denied any L cost analysis figures thanks to zero analyst coverage and no quarterly cc's. You'd best get up to speed.
Blah blah blah...BioHarm. Nemesis is far more right than wrong on this.
>>Clinicians estimate that the BRAF V600E mutation affects 15-20% of paediatric low-grade gliomas and between five and 10% of paediatric high-grade gliomas. (1,2).
"I’m able to just take tablets twice a day and go to the hospital every few months, rather than be in hospital to have chemotherapy. I’ve been able to start secondary school with my friends and go to pretty much all my lessons. I’ve also been able to be at home, rather than staying in hospital for treatment, and carry on my hobbies such as majorette.”
https://www.thebraintumourcharity.org/news/treatment-news/dabrafenib-and-trametinib-approved-to-treat-childhood-gliomas/
Finally someone gets it!!!
Precisely. That's the first issue an analyst would tackle on a quarterly cc.
Hilarious you'd all ignore this one.
No. I've already posted where that wasn't the case. But continue to ignore the my posts and remain handicapped.
NIH just told us to expect cancer vaccines in the UK within five years so there's a way to go.
That might explain the 9 year 10 month delay.
"Children and teenagers with an aggressive form of brain cancer set to benefit after NICE recommends new life-extending drug combination treatment"
>>Clinical trials show the new treatment stalls the tumour growth in people with LGG for an average of more than two years – three times longer than current drugs.
“NICE is determined to get the best care to patients fast and ensure value for the taxpayer. This recommendation follows the licensing of both treatments for this type of cancer within the last three months.”
https://www.nice.org.uk/News/Article/children-and-teenagers-with-an-aggressive-form-of-brain-cancer-set-to-benefit-after-nice-recommends-new-life-extending-drug-combination-treatment
Agree. It's strange to me that over all these years the quarterlies never mentioned working closely with MHRA. Some here tried to fool us by saying MHRA approved the externals when they never did according to quarterly reports. Only when MHRA approved externals for PIP was it assumed MHRA were good with the old Plll changes. But that was never confirmed in writing or voiced by the voiceless CEO.
On another note, I find it odd that this new report has little to no comments on NICE.
You'll notice they still haven't started PIP trials. They had five years to consult with oncologist.
Impossible to take seriously especially with living cell science. Either MHRA isn't bothering because they know it's going nowhere or they finally accepted the application in March with some back and forth, IMO.
Didn't you hear? Advent will handle everything! And, while doing their own work with other non DC products. Had to be that way because LP took the whopping $1.5M grant from local government. Eye rolls.
That may be the case but my post was imagining that they actually have something. And, if that were true, the company requires a veteran CFO with a long list of financial and analyst contacts. A real non diluting deal maker with a track record to dig them out of this hole. But it never seems to come.
The trial was conceived in 2007 or whenever. The idea that GBM SOC survival figures wouldn't at least have crept up is ludicrous. Also take into account the selection criteria favored longer survival. I for one am really surprised JAMA let it go.
Smart. Just ignore it. Hey, I know! It's now a "Franchise model" so they don't need all that commercializing stuffy. LOL. Eye rolls.
It's always been. Nothing ever changes with this "management". That's the best reason for thinking this is all yet another retail mirage designed to raise more cash. Forget about hiring for commercial success they haven't even hired a damn CFO!
You see!...A typical unapologetic-obnoxious-non learning post by the usual cast. These disciples worship only one unseen figure.
Let's just call it "Acceptance" like LC always said here was required. The real question is why they failed to report it??
>>Validation Confirmed (March 7, 2024): This is essentially a reaffirmation of the application's status. It suggests that any additional required clarifications or minor adjustments following the initial validation have been satisfactorily addressed. This step confirms readiness for the comprehensive review process but does not usually affect the start of the 150-day clock.
Sorry, my bad. Can you believe the ignorance displayed by some of these disciples? Wow.
Guess you missed all the articles I've posted here stating the real figure these days is closer to 10%. Posted a Nature piece just today saying so. That 5% figure NWBO used is outdated.
Did you see anything at all like this in tonight's filing?
>>U.S. Commercial Preparation
Geron has now completed onboarding its commercial team, with the buildout of the full sales organization in April. Other commercial preparations for the U.S. are ongoing and on target, including enhancing and/or establishing company processes and systems to support an expected commercial launch, refining market research in TD LR-MDS, and engaging in marketing, commercial access, payer, and reimbursement preparatory efforts.
What's huge? It's good shareholders finally get word that MHRA accepted the application for review but I wouldn't call it "Huge". "Huge" would be a real money / development partner instead of running on fumes with a Going Concern warning and convertible deals.
Yes, another post about proper governance so what's new? The idea that an ASM would suffice to brief investors on commercial plans / payment issues is laughable.
PS- All those who berated me for suggesting MHRA did not approve the application a day / week after submittal, you can apologize to me in the morning. LOL
If approval actually occurs there should be an immediate conference call not a damn ASM!
January 24th -MHRA confirms all components / modules are accounted for.
March 7th -MHRA confirms that all data is in order and ACCEPTS the application for review. IMO
>>On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed.
A long time. But why even go through the process if the MHRA already knows the trial data / results didn't pass muster?
>>As is typical, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company will announce the results when the regulatory review and decision - making about the MAA is complete.
Preparations for Regulatory Inspections. As anticipated in the Company’s prior reports, preparations for regulatory inspections associated with the MAA have continued to be a major focus of the Company’s activities this year to date. The Company has continued working intensively with teams of expert consultants in both the U.S. and U.K. on these preparations, and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies. It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.
Pediatric Glioma Clinical Trials. The Company continued its discussions with physicians about the two planned trials of DCVax - L for pediatric gliomas. The arrangements for the trials have not yet been finalized.
Disciples here fought me hard that none of this Acceptance (They call it validation) nonsense was necessary. Why the company failed to PR it is a head scratcher.
Perhaps a fallback should Advent/Sawston be sold??
>>What is the point of continuing to pay for London? Supposedly the Sawston facility is much larger. Why does LP not disclose what is going on?
Interested to see state of True up case and how it's connected to their new retroactive packages. Also if they actually use the word "Accepted" on the application submittal to MHRA. Also any reverse split language.
And what do you think they'll find?
Wow! So many fibs and inaccuracies. Seems so irresponsible.
8 out of a 100 vs. 13 out of a 100. NICE will see right through that. Even if they believe it they'll say $300,000 a piece for 87 out of 100 who won't see any real benefit. Perhaps they'll allow for some small identifiable subset but that won't help shareholders.
>>what you fail to say is it's roughly a 50% increase in the numbers that make it to 5 years.
10% increase of 50 out of a hundred is a lot better than 10% of 8 out of 100.
>>The FDA has often approved drugs that permit 10% of the patients to live longer, we're talking 50% living longer and many others who lived less than 5 years still living longer than with SOC treatment.
I'm not ignoring it but NICE will. It's an old trial not powered for OS. Sounds like it could be a promising combo that requires a real Pll.
>>Of course you completely ignore that adding Poly-ICLC or other therapeutics should move that 5% to over 50%, but only if used with DCVax-L. I grant the evidence is only from a small trial, but it's none the less very definitive.
It'll take years of coordination before Eden ever shows any costs savings. And, even if NICE authorizes payment for a small subset, Eden will be pretty much useless.
>>Approval will mean nothing if the vaccine can't be produced in the needed commercial quantities, so I also believe it won't be that long before the EDEN Unit is approved so that sort of production is possible without years of constructing and certifying tiny clean rooms for manual production of the vaccine.
Don't forget about the True-up suit. I do wonder if the Chancellor considers those options and warrants current value?? Anyone know how that works?
You should also include the fact that many warrants should've gone to zero by now but for the extensions.
>>BTW, despite the bogus post by one long, most shares are not being issued for warrant conversions. This has been shown in all recent 10Qs. We will see again in a day or so.
Why would NICE pay hundreds of thousands for a possible 5% advancement in five year survival while still needing SOC and with 87/100 patients having no ‘meaningful’ benefit from its use, and with no pediatric data or stunning animal data?
>>According to different research data, the 5-year survival rate of GBM is approximately 5–10%.
https://www.nature.com/articles/s41598-024-61515-3