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That is actually NOT TRUE.
Quote from the judge’s opinion regarding the allegations:
“Plaintiffs allege Defendants made false and misleading representations and omissions in thirteen statements about DCVax over the Class Period (January 13, 2014–August 21, 2015).”
Folks can read the full opinion dismissing the case here:
https://casetext.com/case/lerner-v-nw-biotherapeutics
A doctor that prescribes (for many years on end) an expensive toxic therapy he readily admits doesn’t work in unmethylated patients is a sadist, particularly when he knows it also reduces the immune system’s limited capacity to fight the tumor in unmethylated patients.
Dr. Stupp is a sadist imho
At least he’s admitted(listen all the way to the end of the video) that he prescribed/charged temodar to patients in the past even though he knew it did not work.
Apparently, despite his joke making fun of Californian and oklahoman IQs, it is Dr. Stupp that might require some help.
There are three kinds of men. The one that learns by reading. The few who learn by observation. The rest of them have to pee on the electric fence for themselves.
Avii, do you know how to treat 3rd degree coffee burns, I seemed to have spilled my mocha on myself.
No, 10/6/2021
There is a new video with Roger Stupp that was posted this weekend (recorded in October) addressing the YNF (Young Nuerosurgeon Forum).
Stupp has frequently been ridiculed on this board (as has just about every other doctor who has published GBM related data that hasn't been involved in the DCVax trial).
He reviews (for the young nuerosurgeons) his landmark 2005 paper and touches on his other research (including Optune).
I found some things interesting:
He suggested that EF14 trial may not ever have been run had it not started prior to the (negative) rGBM trial (EF11).
He disclosed a 2020 relationship with NWBO.
He offered a very good discussion on the challenges of establishing MGMT status (addresses the cut-offs and grey area between MGMT+ and MGMT-)
His mention of the Will Rogers Phenomena and the new GBM classification (I was going to post about this).
He expresses his views on historical controls and the importance of RCT's.
His critique of the German CCNU trial is interesting (but, I remind you, the MGMT+ control arm was still the same as DCVax blended MGMT+ group).
Finally, I would be interested to hear comments on his discussion of the 5 year Optune data (and if it changes your opinion on Dr. Stupp).
NWBO investors would benefit from forgoing IHUB for an hour and listening to his talk.
WFNS YNF Webinar - The Stupp Protocol with Dr. Stupp himself
nice to hear long tail survival stories
This type of attack by AV .....
The name of the company is on a bag at a medical conference. You’re really grasping at straws here, AV.
They generally don’t go after premarket promotions from small companies that end up being factually correct.
That's not DCvax, it's for a Belgium company's drug, Gliovac.
See page 6 here:
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-14-16-july-2021-meeting_en.pdf
The primary reasons Cognate was started were:
as far as I know UCLA never conducted the clinical trails for DC vaccine even if they used it
Based on these results, we intend to discuss with the FDA the transfer to us of the application on which the UCLA study was based, for the purpose of initiating a Phase II clinical trial with DCVax-Brain at several clinical sites. Because DCVax-Brain is not identical to the product used in the UCLA trial, the FDA may require us to perform Phase I clinical trials using DCVax-Brain prior to proceeding to Phase II.
1. NATURE OF WORK: The University and Sponsor will jointly develop a research program defined below and also an application for a Phase II Investigational New Drug (IND) application entitled, "AUTOLOGOUS DENDRITIC CELLS PULSED WITH AUTOLOGOUS GLIOBLASTOMA TUMOR PEPTIDES," that will be submitted by the Sponsor to the Federal Drug Administration (FDA).
Unfortunately the paper you reference in your post, “Rapid Early Tumor Progression is Prognostic in Glioblastoma Patients”, is behind a pay wall so isn’t fully available for most of us to review.
https://pubmed.ncbi.nlm.nih.gov/30973372/
One should note, however, that the snapshot in the link you provided indicated that it involved a total of 87 patients, 52% of which were (rapid early progressors) REP. That means the sample that you cite for comparison of the mOS of the unmethylated and methylated (19.6 and 34.7) is for a fairly small sampling of only 42 patients. And because of the pay wall, the link you provided prevents us from seeing what was the entry criteria for this group.
So while the consistence between the medians of these 42 methylated and unmethylated GBM patients is similar to the blended medians of the DCVax-L trial for methylated and unmethylated, it’s also a small sample without any other comparable criteria to show other than the meth status and that these patients had GBM.
Additionally, while most of us agree that medians are helpful as a comparative measure, you know full well that medians are not what the DCVax-L trial will be measuring, but rather the entire measure of the treatment arm’s overall survival, and of course, as it compares to the entire measure of overall survival of control arms in other contemporaneous, AND COMPARABLE trials.
And while you may find this type of ECT comparison objectionable, it appears that the SAB, the steering committee, the multitudes of primary investigators, Northwest management are all prepared to utilize them to file BLAs with the RAs, despite your objection.
So I’m sorry that while you may find a 25% chance of living five years or longer a meaningless metric, I am certain there are many neurosurgeons, neuro-oncologists, and GBM patients who will not agree with you.
The diagnosis of GBM offers an extremely and consistently poor prognosis (as you know), and there is a myriad of very qualified KOLs that seem to think the regulatory agencies are willing to consider this ECT comparison. And that is ultimately what counts, and not what simply doesn’t comport for you in particular.
Quote:
The DCVax trial randomized 331 out of 962 GBM patients they considered.
Ok. Seeing as the rest of your post is predicated on the above stat that you quote, where did you get your figures from?
If you can't adequately evidence the stat, then the rest of the post pretty much falls by the wayside.
Overall Survival is NOT a BS endpoint. How could someone that lost a family member to GBM say that? And why?
I consider the people that you mentioned (Flipper and Senti) to be experts in the trial and they both are convinced of the success of the trial.
Gary,
DCVax is being tested in the maintenance setting.
Remember Stimuvax? That too was tested in the maintenance setting.
Like DCVax, Stimuvax trial patients were randomized after completion of their chemorad. Remember the Stimuvax START trial? All patients randomized had to be non-progressing. Don't you remember looking at this, in depth? Remember all those arguments with people citing NSCLC Trials w/o consideration for the fact the those trials didn't screen for progression after chemorad?
This is a very similar situation.
Nothing wrong with that approach, it's done in many indications. What's wrong is comparing apples to oranges.
Links to your statements please. Need to learn how to buttress your arguments. Otherwise they will just be opinions. I read posts from people who I consider to be experts here. I suggest you don't whitewash investors here with opinions that have no references.
Are you familiar with the term ‘red herring’?
General population data is irrelevant when similar trial (i.e., similar entrance and exclusion criteria) placebo data is available as contemporaneous comparison which it is.
These are all unverifiable statements and can be classified as opinions with no links. The paper by LL et al (JTM, 2018) has the table of selection criteria, and has been quoted in numerous subsequent articles by experts in the field. These articles didn't report problems in the selection criteria.
DCVax’s selection criteria is on par with all other GBM trials
AV1177, your statement is not true, you are deliberately deceiving people!!! Why???
“ The DCVax trial randomized 331 out of 962 GBM patients they considered.
The majority of those excluded were for the reason of disease progression."
What other GBM trial in the history of mankind shows approximately 20-25% of patients living 5yrs?
Patients with MGMT promotor methylation had a better OS compared with patients MGMT promotor unmethylated tumors (P =0.042): 21.7 months (95% CI: 15.6-32) versus 16.5 months (95% CI: 11.8-19.9). Kaplan-Meier for OS based on MGMT promotor methylation status and presence of REP are displayed in Figure 2. Survival based on presence of REP and MGMT was 10.2 months (95% CI: 7.1-17.6) in patients with evidence of REP and MGMT promotor unmethylated tumors; 16.5 months (95% CI: 6.4-23.5) in patients with evidence of REP and MGMT promotor methylated tumors; 19.6 months (95% CI: 15-25.1) in patients without evidence of REP and MGMT promotor unmethylated tumors, and 34.7 (95% CI: 17-57.9) months in patients without evidence of REP and MGMT promotor methylated tumors (P = 0.033)
You can't make the assumption that the arms didn't separate in this trial. Only that the trial didn't have enough patients in the control arm to do an unbiased statistical comparison because of crossover.
LL did mention in her talk at the University of Utah that it is very hard to get people into the control arm in the GBM trials. So, the case you mentioned doesn't apply here.
Got it. I downloaded the 2015 paper from JAMA. Will take a look. Thanks.
It's similar to their finding that increased compliance with optune led to increased survival in GBM - it's inherently biased as those who are feeling well are more likely to use the device.
Exactly Ex.
I struggle to understand his confusion.
The only thing I can come up with is that perhaps he thinks the FDA normally evaluates new treatments across trials; comparing one treatment from one trial with another trials treatment.
Rather than evaluating treatments within a trial (both with the exact same randomization time).
The historical comparison is for the placebo arm. Delaying the placebo arm’s, all the patients (I get that sometimes patients can’t start, they should not be in a rigorous trial), treatment for 2-3 months, per the table, in order to start the treated arm at the same time, does not make sense when a patient may have only had a partial or less resection and the patient on the treatment arm are going to get more, and especially when the patients may only have a few months to live and the difference between the arms may be only a month or so potentially. Something doesn’t add up there. Diagrams aside, I think there is some misunderstanding RE the language and what is happening when to create your impression
I just do not see how anyone carries out a trial that might, in the end, only add a little more time to the treated patient’s life span, by delaying treatment for both arms by months. Something doesn’t seem right there.
I appreciate the links. I am familiar with the FDA policy. I think you’re grasping for straws at this moment. No one knows certainly, exactly what might come up exactly with the FDA, but grasping for anything possibly that could go wrong based upon disparate examples with particular issues not present here, is probably not a good way to really say what is probable or likely.
My comments in red
So you’re saying the DCVax trial was unusually insensitive to these patients because they seem to be saying that they started treatment rapidly for both sets of patients. No, I'm not saying that at all
Re the Rindopepimut trial:
2 months is an unusually long time for patients who have potentially so little time and where trials like that might come down to the difference of a month or two. Delaying the placebo patients treatment by two months seems kind of premeditated to me if the other patients are going to get that plus more. 2 months is not at all unusual
I am just curious about the scenario and the difference in the language and exactly when each describes certain other events happening. Something seems off to me. That that trial failed seems kind of predestined if they delayed treatment that long, given the speed and nature of the disease and the possibility that the patients did not even get the cancer largely removed consistently. It just seems strange. Something seems to be off there...
Lol. You are intelligent enough to know this trial is randomized and blinded. I suspect your intention to frame it otherwise is an indirect falsehood. Moreover, in secondary endpoints, they are still comparing the arms.
Irrelevant. The DCVax-l trial is already randomized (and blinded).
You do know that NWBio got “buy-in” from all 4 RAs (UK, US, Germany & Canada) for the new endpoints?
In addition, my prior work with the FDA where trial designs and analyses were discussed suggest that the FDA does not ever "sign off" on proposed changes unless it is a formal Special Protocol Assessment conducted BEFORE the trial begins (which does not apply here). In the current situation, the best the company could hope for is a noncomittal "you can do that if you want to but we cannot promise that the advisory committee will agree."
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