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.
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
It won't matter.
>>In addition, the endpoint against which the data is measured must be acceptable to the regulatory authorities, and the statistical analysis plan for how the data will be evaluated must also be acceptable to the regulatory authorities. The statistical analysis plan that we submitted to regulators for the Phase III trial embodies a different primary endpoint and secondary endpoint than did the original Protocol for the trial. Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design, which allowed all of the patients in the trial to cross over to DCVax-L treatment after tumor recurrence (while remaining blinded as to which treatment they received before tumor recurrence). The statistical analysis plan uses external control patients rather than within-study controls. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach.
Dopey. In the 10k Sawston is simply described as a "Facility" and not a CMO or any other that would indicate a stand alone business. It's basically a place for CDMO's to rent.
>>When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients.
>>All of the development activities and licensing for the Sawston facility have been carried out or managed by Advent BioServices, who is also the contract operator of the facility.
>>We will need to enter into new contractual agreements for manufacturing at our Sawston, U.K. facility and new agreements for commercial production in any locations. We may encounter difficulties reaching such agreements, or the terms of such agreements may not be favorable.
You need only look at Geron in real time to understand what and what not "management" should be doing.
I found shareholder's Sawston website.
https://www.adventbio.uk
I'm sure donations to UCLA are pouring in.
To most investors it would.
Where's the Sawston facility website?
LOL. Have you ever seen in writing Sawston referred to as a CMO?
"Why would anyone care?"
Then why does Advent do the patient contact and billing? We all saw the form.
Guru says...Meh!
Unfortunately the Pll is from 2014 and wasn't outright powered for OS, and there were only a few GBM patients.
GuruGary...LOL. Are you talking about the 2010 gen, 2016 gen, 2020 gen, or 2024 newcomers?
>>I'm of the belief that most of the longs are largely satisfied with the positions they've built.
Your share value is being eaten away by an endless supply of authorized. RS on the way.
This should be stickied but instead it won't even be acknowledged.
"Bashers" are actually skeptics who've predicted and presided over a disastrous loss to retail's personal wealth.
I remember in an old interview with LL she said how she wished one day there'd be a "One stop shop" for DC production. I think LP made her wish come true and LL made LP's wish come true with Cognate and Advent.
LOL. Are you not watching the mounting count that Captain keeps postings or do you think that's just business as usual? Can't make it up.
You can be certain the shares are pouring into the outstanding count.
You're all full of crap, IMO.
We haven't seen one patient come forward saying as much, so I really doubt it. I guess docs could administer it in secret but not sure MHRA could keep that a secret. My guess is it's only being done at UCLA
You'll notice the pumps are topping at a lower and lower share price. Likely a good reason for that. RS and a new trial.
Excellent research. But read between the lines and it's very unlikely MHRA will approve L based on the Plll. Not even a peep about NWBO in that PR. Had LP managed her shareholder's company right this research whould've been NWBO's not UCLA's.
So much time lost.
>>While this association was statistically significant and suggests a potential link between this treatment and improved survival rates, the study was not originally designed to measure survival rates of this treatment. As such, the authors emphasized the need for caution regarding true clinical benefits of this combination treatment.
I could see MHRA / NICE perhaps working with L to provide some subset after another trial.
>>This means we could test patients for this specific immune response, and if it’s strong, we know they are likely to respond well to the combined TLR agonist and dendritic cell vaccine therapy.”
!!!!! It is as LC has always said.
>>For DCVax with PolyICLC regulators could simply require a confirmation trial post approval
The UCLA Pll was not powered for anything but signal seeking.
Yet nobody here will ever simply post the email/ screen shot.
Has it? I missed it somehow. I thought it was more than a bit??
>>If they lose, they have to return them, which reduces our dilution a bit. IMO
Really, this has been discussed ad nauseum here.
Any word on the true up suit? Ignore it as you wish but It's incredibly important to common shareholders.
I watched PPHM investors cling to hope for twenty five years only to find through discovery there never really was much of a plan.
It does feel that way doesn't it? Who is in control of this ship?
"Happy trails!"
All good questions. You must've gotten some good sleep last night.
Hey, whatever happened to Mercidensel or whatever they're calling it?
Exactly. And now looking for funds to support Polly.
So here's what you do Sentiment, you write the company that LL told you herself and just want it confirmed by them. Post the reply here please. See how easy. Save everyone thousands of posts.