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"In this case, the cause of NWBO's PPS collapse and almost certainly failed P3 (well, P2+) trial could not possibly be caused by anything in the NWBO/Cognate ecosystem."
I was very uncomfortable with the NWBO <--> Cognate relationship for about a year and a half. But recently I think I understand what a tremendous advantage it is for NWBO to have a manufacturing company they can trust. Without that they could not maneuver in rough waters. They could be left stranded at any time. They could not force scaling to satisfy the FDA or a European agency. They could ask for it. They could even offer to pay for it or loan the money, but they could not force it. It would be out of their control.
There is not a better way to go. It is certainly possible that LP has scrwd Northwest in it's dealings with Cognate. It's possible she is planning to go bankrupt and take all the patents and run with DCVax Direct... lots of horrible things are possible, but the fact remains that being in control of both Northwest Biotherapeutics and Cognate is the best possible situation for everybody and really the only practical situation.
I personally don't care if there have been minor technical breaches in the handling of moneys as long as it does not add up to a significant amount of money. The trials and tribulations that this company has gone through with one woman at the helm is unbelievable. Whether she ultimately proves out to be a saint or a crook, she is a remarkable woman. And I am not haloing. I have just recently looked over her background again, and that is a fact.
I have rationalized the enormous moneys recently fed to Cognate as going to manufacturing development and infastructure. I know for certain that automated process development and test fixturing are unbelievably expensive. I don't know that they can account for the kind of money recently spent, but I know the $ could be an order of magnitude larger than you could imagine. I know from experience; not in this exact sector, but close enough for my personal decisions.
As to whether Linda Powers will ultimately prove to be a crook or a saint... if you want to guess now, consider the following:
* Her sister died of Leukemia when she was 7.
* Her father battled cancer multiple times and ultimately died of standard hospital stay complications while being treated for GBM.
* A few years after her father's death her life focus turned to medical. She joined the boards of about 7 different medical organizations and then ultimately became a board member, then chairman, then CEO of a company that has developed a treatment for GBM.
Compare her background, even ignoring her impressive education, to that of Saint Feuerstein, who has joined us here to help us by answering all questions about Northwest Biotherapeutics, DCVax-L, DCVax-Direct, and Linda Powers.
Yes; absolutely. Very conspicous that such negative attention continued with the cap so low at this point. Then AF started hanging out, making the attention that much more conspicous.
Continuing the negative focus at this low cap for what exact effect is not 100% clear to me. To choke NWBO as it is trying to fund... to kill it? To be able to buy in cheap if positive news comes? To force selling a percentage to the right private investors so that LP loses dominant ownership? To buy into Direct cheap if DCVax-L fails?
There is the Celldex look possibly going on... the NWBO look possibly going on (related... kind of the same) and the fact that NWBO will need funds soon. Which of these things does AF think is going to happen any day? He certainly thinks something is going to happen any day or he would not be here. I don't think it is the funding. I don't think that is sufficiently imminent. I think it is the Celldex/NWBO look.
Not sure, but I am sure AF is here to sit on NWBO's face while he waits, like a cat on a baby.
I didn't quite get your point. You are talking about an isolated (hypothetical) case. I think I was talking about statistics.
Further, one should always check the source of lemon-grass before making tea out of it. I never use lemon grass collected around the base if fire-hydrants. It may be pseudo-lemon-grass.
But both arms, right. Both arms would have this increased PFS and OS. The net effect is that the trial could take longer. No expected effect on the likelyhood of success or failure. Yet that is how many chose to spin it, including AF.
That was the crooked part in AF's response, in my view. Maybe I am wrong. But I think the most reasonable interpretation of Linda Liau's statement was that this longevity for both arms could drag out the trial.
Not only did AF broadcast to the small biocap investment world an unreasonable interpretation of what Linda Liau said, he left out some of the positive statements such as 25% of patients living beyond 5 years in the charted data with most of those still alive today, many years later.
"So you think they will go from half SD at week 8 to 85% PD by week 16 and then to <whatever % mesenchymal> CR with no treatment after PD?"
It would require only 24% of those PD actually turning out to be PsPD. You don't think that is possible?
Here is one stat on pseudo-progression timing:
http://www.ajnr.org/content/32/11/1978.full
"Pseudoprogression has been reported to occur predominantly (in almost 60% of cases) within the first 3 months after completing treatment, but it may occur from the first few weeks to 6 months after treatment."
One step further on conjecture about mesenchymal.
The early data for DCVax-L suggested OS beyond 5 years for 50% of mesenchymal patients. I am calling that complete response, "CR".
40% of GBM patients are mesenchymal... it's a huge sub-group.
Mesenchymal cancers exist outside of GBM. What percentage of all solid tumor cancers? 40% of all solid tumor cancers? (I don't know, asking.)
Was the half of mesenchymal GBM patients that lived past 5 years the Temador responsive part, ie methylated?
Can mesenchymal character be evaluated easily in a lab via a microscope exam of tumor biopsy/sample?
Can the methylation status be easily detected in a lab?
Are we talking about a nearly 100% CR for methylated mesenchymal GBM patients for DCVax-L?
Will that nearly 100% CR be seen for other methylated mesenchymal patients?
Is that a nearly 100% CR in nearly 20% of all solid tumor cancers in an easily identifiable subgroup using a therapy with virtually no side effects and based on results prior to a decade of intensive study in the field?
Probably not, but maybe.
Edited last post 100 times during timeout period. Even then, there was one statement remaining that should bother Pyrrhonian quite a bit.
Talking about whether the Ph1 efficacy (50% CR) for the mesenchymals in DCVax-L is being seen in Direct... thus also outside of GBM.
You have pointed out that there were no CR cases for Direct.
My claims of CR in that Ph1 DCVax-L are from data over 6 years in maturity. I think the chart went out 6 years or so and verbal follow-up was at least 2 more years. So nothing like that would be seen at this point for DCVax-Direct... but they still might see indications that such is shaping up. Now that they have markers that project efficacy, it will be interesting to see if the Mesenchymal subgroups outside of GBM appear to be headed toward big responses.
The sawed-off-shotgun approach used in the Direct trial might be particularly useful to detect such a favoring of mesenchymal. If such a picture starts to emerge it would seem likely that doctors would want to try DCVax-L or Direct on such mesenchymal cancers. The very good safety profile for DCVax-L would allow such off label use if DCVax-L gets approval, even if only for the mesenchymal subgroup of GBM. Thus the market could mushroom.
If DCVax-L proves out to show a CR in half of mesenchymal GBM patients, as Dr. Liau's described from early data (albeit typically dubious unblinded phase 1 data), then what if there is similar efficacy for other mesenchymal cancers outside of GBM?
Cancers may typically have a long tail for some small percentage of patients, but the thickness of the tail seen in the early DCVax-L P1 data is much wider than historical norms. And for the mesenchymal group, according to Linda Liau, it was nearly a 50% CR.
If that data is representative, then Northwest did the right thing to keep the Phase 2 data blinded. It is the longest part of the tail. If proving efficacy to regulators rather than investors was their priority, then they did the right thing.
Is Northwest seeing similar levels of efficacy for mesenchymal group cancers in the DCVax-Direct trial?
I am no longer an investor, I am a gambler, and I like this gamble. But I wish I had continued in the trades to support this habit... my tech career appears to be over.
I thought that the placebo's for the ICT-107 Ph2 and the DCVax-L phase 3 were very different. IMUC used un-pulsed DC's for their placebo while NWBO used white cells that contained everything but DC's... or something like that. I thought the expectation due to this difference was greater efficacy for the IMUC placebo, thus poorer comparitive results for the experimental arm.
Above regarding that single aspect of the difference in the two placebo's.
Pyrrho:
To the extent that details of the Ph1 Direct trial and trial results that are not public could help to support conclusions about efficacy... even if the publicized data is not useful, the trial would have served it's primary objective, which is to find out what to do in the next trial, if anything.
A secondary objective may have been to support funding efforts, but the primary objective would have been to figure out what to do in phase 2, or whether to do another phase 1, or nothing at all.
They went after a huge number of different cancer types. Very much a shotgun approach. Highly unusual as far as I know.
I think they would be selling the product to Northwest, not competing with Northwest.
Right now Northwest is protecting IP for some reason. Whatever the reason, it would likely weigh on LP's decision as to whether to have Northwest own that product, or start a new, small company.
I think the reason they are protection IP right now is because there is an unblinding in process, initiated by the FDA. Though the look at data was probably not for the purpose of determining futility for DCVax-L, that would be a possible outcome, however remote.
It might take the DMC and the host company to make a decision about AA or application thereof, but I think the FDA is obligated to make a call on futility if they see it. Kind of like a police officer being obligated to arrest you if he sees illegal drugs growing in your window. They may not have the right to entry to look for such, but they have the obligation to act if they see it for whatever reason.
The chances of a finding of utility may be super slim, but it would be in character for LP to go into a defensive stance however slim those chances. What to lose? What to lose would be trust in the investor base, but perhaps she just doesn't weigh that very high compared to even the slim odds of losing everything... thus the positioning of the patents during this alleged look at the data by the FDA (probably for gauging relative efficacy of Celldex's drug).
But even ICT-107 showed statistically significant PFS across the full patient population, with a significant percentage of those patients being outside of their limited antigen set. And that is also with this potential problem of un-pulsed DC's in the placebo arm appearing to show some efficacy, a problem Northwest has presumably avoided. And recall that "The ICT-107 phase II trial is a randomized, double-blind, placebo-controlled phase II study".
"Consistent with prior data presentations in December 2013 and June 2014, the results demonstrate a statistically significant progression-free survival (PFS) benefit, and a numeric overall survival (OS) benefit in ICT-107 treated patients compared to the control group. The ICT-107 treatment effect continues to be strongest in the pre-defined HLA-A2 subgroup of patients in which the MGMT methylated patients showed the largest treatment effect, with a significant PFS advantage over the control group, and continued potential for the OS advantage to move toward significance as more events occur. There were no differences in adverse events between the ICT-107 treated group and the control group."
http://investors.imuc.com/releasedetail.cfm?releaseid=883028
Further, my strong opinion is that if the FDA did insist on the crossover of DCVax-L control group patients upon progression, as Dr. Liau recently claimed, then they have to allow PFS as a primary endpoint.
Regarding stable tumor size.
I guess I undersand Pyrrho's concern about having a partially necrotic tumor; the mechanical degradation potentially allowing healthy cancer cells to float away and become mets. But, if you are going to kill the tumor you are going to have a state of mixed live and necrotic cells at some point. There is no way to avoid that, other than surgery.
Still, I would hope that the immunotherapies are better at killing single cell and small mets than the chemotherapies. The chemotherapies often rely on the cancer being more challenged than native tissue, thermally, getting oxygen, getting rid of waste and CO2, etc, all related to crowding. Single cell castaways and early mets have no such crowding. What they do have is greater surface area to volume ratios than tumors, allowing less penetrating immune components, (such as antibodies?), better access.
I know someone with lung cancer, undergoing chemo. The chemo has all tumors in a quiet state of some sort, possibly necrotic. But they can't be too certain that the tumors are dead, because they are continuing the $100K/year chemo indefinitely. I think he gets infusions every three or 4 months. There is a huge knot on his chest where he gets the infusions.
My point being that everyone is happy with the status of his cancer as stable disease. I know him because he swims laps at the same pool where I swim laps. He is a Stanford patient.
I don't think NWBO would want to partner unless they were on their knees. Though clearly, they might be on their knees at this point. On the other hand, it might be win or go home time, and a win might allow them to buy a blockade inhibitor outright, if they haven't already.
Regarding TLR Agonists: A quick Google search led me to this article:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3656332/
A quick skim of the article: There are many TLR Agonists, and you can stimulate tumor growth using them if you are not careful. Further, mice and men do not have all the same TLR Agonists, so I would argue that it is difficult to conclude with any certainty that the need for one TLR agonist for one cancer type in mice indicates the need for the same TLR Agonist, or any, for the same cancer in men, let alone all cancers.
But... I looked it up because I didn't know what it was. So thanks for bringing it up. Not saying you are wrong, just saying that it is pretty confusing, and pretty complex, at least at first glance.
I thought that a popular theory was that the halt was for a look by the FDA at DCVax efficacy to make a determination for AA on Celdex's Rintega for newly diagnosed GBM, since relative performance to DCVax-L may be part of the decision, subgroups considered of course.
Or that the PEI is taking a look to determine hospital reimbursement level, if any.
Or both.
But the conspicous point in enrollment and recruitment suggests that NW may be hoping for consideration of AA without a spend. Based on the HE reimbursement level, if any, they could estimate the likelyhood of AA with confirmatory... and the data would already be in the hands of the FDA and or PEI, so that there would be no spend by NWBO.
Maybe NW had some say in when the look took place, and made sure they were at this convenient level of enrollment and recruitment, just in case they decide to apply for AA based on the HE reimbursement level.
Silly record indeed. I would never be so petty.
Thanks. I should have seen that.
"233 OS Events"?
Did they change the definition of events? Sorry if I am missing the point Pyrrhonian, but I wanted to rehash the issue anyway for my benefit. PFS vs OS for events.
The original definition was progression / "tumor recurrence" or death. I don't see a change to that definition in the PR about the changes to the trial in August of 2014. Here is that section of that PR below:
----------------------------------
BETHESDA, Md., August 11, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced an update about the Company’s Phase III clinical trial of DCVax®-L for Glioblastoma multiforme (GBM) brain cancer in conjunction with the Company’s separate announcement today about certain changes to the Phase III trial. The update from the Company reported that the trial is progressing on track, and that 55 patients who were not eligible to enroll in the trial due to unusually rapid tumor recurrence were included in a compassionate use “Information Arm” and are showing encouraging survival times.
The Phase III trial is enrolling patients at over 50 trial sites in the US and a number of sites in the UK and Germany, and is progressing in accordance with industry norms. The current trial plan involves enrollment of 312 total patients in the trial, and counting 110 “events” of tumor recurrence or patient death, from among these 312 patients to determine whether the primary endpoint of the trial is met. As announced separately today, the Company is modifying its trial plan so that it will enroll 348 total patients, and will count 248 “events” from among these 348 total patients to determine whether the primary endpoint of the trial is met. So, the number of “events” counted in the statistical analysis will increase from 110 to 248, but the total enrollment in the trial will only increase from 312 to 348.
Thank you Jack.
Anybody know what year Linda Powers was born? I need that to paint a picture of interest to the longs.
I can't find this information anywhere.
AVII77: Allowing that the FDA insisted on crossover after progression in the DCVax-L trial is aknowledging that they accepted PFS as a primary endpoint, period. Either that, or they are crooks, and you can't start with that as a premise. Or perhaps that is your premise. My vague recollection from reading your posts in IV is that you are very familiar with the FDA. Perhaps you have some inside info here.
Are you saying that you think PFS will not be good enough for approval, even for the mesenchymal group, or are you saying that the FDA will not ultimately accept PFS as the primary endpoint?
"A few of theStreet's articles," H2R: Please forward list to Joe Biden. Really.
No, at least not as I remember it, though "Red Acre" strikes a bell. But I remember it being distributed by "FierceBiotech" and more in the style of Phase V, though not as long an article.
What does ihub list for Reefrad's start date.
Reefrad was frightened by the article and posted, for the first time, to ask what people thought of it.
But no criminal charges mentioned. Of course. So they will just keep doing it because in the end, it is profitable even with a fine every leap blue moon.
Sentiment: There was a mini Phase V article published by FierceBiotech about 18 months to 2 years ago. I'm not certain but I think it was also anonymous. There have been many damaging articles that have been anonymous, but this one was special, deeply damaging like Phase V. Cross checks to the Phase V might be useful to Cofer Black et al.
I was not able to locate that article, but I do remember that a day or two after it was published, Reefrad joined the board, and posted his first post, which was about that article. At least I think it was his first post. So I think you could locate the article through iHub records. I can't because I am an iHub freeloader.
If you do want to send the article info to NWBIO / Les / Cofer Black, and can't find the article, let me know. I can look further to see if I cut an pasted it somewhere.
£65,000 British Pounds (not French Francs as I thought) is quite a bit of money for the proton therapy. Currently $89,000 USD. It does sound like it was worth it in that case, but it also sounds very expensive.
So, back to finding a way to produce those proton accelerators more cheaply.
I saw a project years ago where they combined a particle accelerator, or accelerator array with a very powerful / high resolution "supercon" MRI. They use both often I am sure, but here the two were built as one unit so the patient did not have to be moved to do the treament after doing the MRI scan. I don't know what became of that project. It was in southern California somewhere. I think Irvine.
In retrospect, you can't have an MRI mag field in place while you shoot protons at something. That would make the protons path curve. So... not sure exactly what the arrangement was. There are MRI magnets that can be turned on and off, but even the residual field might be an issue if not super repeatable.
Good stuff Jack. I'm surprised that it is seen as big news, but glad to see it. Proton beams have been used for a very long time as far as I know. I'm sure Reefrad knows.
Sounds like less free-radicals generated. I would think those free radicals are likely responsible for most of the damage to the immune system as well as the heart, lungs, and GI tract mentioned in the article. You have to wonder how much adoption of such in treating GBM might improve outcomes. That of course is your point.
Not sure what the French-Frank to US-Dollar exchange rate is, but at 65K Franks it does sound expensive. Volume production of the accelerators. That would bring the cost down. Would love to be part of that effort, though I am probably too old at this point. Worked in a physics group for an MRI company for 5 years. More similar to this technology than it sounds. Precision magnetics and low frequency electronics for one thing. They need M.D. / Ph.D. Larry R. Miller. He's the best on the planet, yet affordable because he is not a player. He's honest. Not a quality sought in the Silicon Valley where he resides.
I remember thirty years ago learning about an effect where accelerated particles interact with material more as they slow, so that you can set depth. I don't remember the name of the effect.
The protons accelerated near the speed of light become more massive than the protons in the patient's hydrogen. This mis-match in mass results in a poor transfer of energy to the patient's peripheral tissue. But a small amount of energy does transfer even initially, so the protons do slow, and lose mass. Once they have slowed to the point that they are close to the mass of the resting protons, they begin to transfer energy very efficiently. So there is a steep curve of density of energy deposited with depth. They can set the depth at which most of the energy gets deposited by adjusting the proton energy. Big advantage.
If you have seen the toys where two steel balls hanging by strings smack into each other fully transferring all motion/momentum/energy with each impact, you have seen the principal behind this effect. The basic momentum and energy equations constrain the result of the impact to work that way if the impact is inelastic. Just F=MA and E=.5MV^2 are enough to force the solution. Just add relativity and you have this radiation energy deposition at depth effect.
But again, I don't think it's really new. Will have to hope Reefrad pipes in on that.
"Leukapheresis is a laboratory procedure in which white blood cells are separated from a sample of blood. It is a specific type of apheresis, the more general term for separating out one particular constituent of blood and returning the remainder to the circulation."
Wiki Pedia
So the only issue is the targeted component(s).
How much blood do they draw, typically, and what percent of the total blood is that, typically? That would tell you the max % reduction in targeted components. It may not be a very large percentage.
Are the DC's cultured in vitro to increase numbers as well as to bring them to the right maturity? I think so, but I don't remember for certain. Hopefully somebody knows the answer to these questions.
Good to hear. Makes sense. No way IMUC would make the same mistake twice. Bodes well for NWBO. I agree.
Glad to hear it. What about PBMC's. I hope they don't have efficacy.
Are they able to collect and or grow more PBMC based "vaccine" than DC based?
Discussions about off-the-shelf-immunotherapies often lack details that are key to determining the true efficacy across-the-board.
In this case, how many patients did they screen to select cancers that expressed the right antigen? Maybe no screaning specific to the antigen... or maybe thousands to find the 20 that they tested. Big difference in the usefullness of the therapy.
Price does matter, and off-the-shelf therapies are much cheaper. I understand the concerns that big pharma, the insurance companies, and their biaches have regarding price not being a consideration for approval of autologous therapies. But they need to open a discussion about that issue, not mislead people about the true usefullness of the alternatives.
So what about patients in the control group? If they run out of placebo do the use the real deal? Or... is there more placebo generated than true vaccine... and if so why? They use real DC's either way.
Never mind.
I don't see how they could have done better in selecting new board members. Huge positives in my view. Mr. Black's first task should be to figure out why $NWBO dropped on the announcement... and all other positive announcements in recent history.
"Which labels are disorienting?"
Confused not disoriented. Dizzy maybe but not due to the labels.
Ie, 10-4... group 10? I thought the first numbers related to the trial (trial phase sort of). But since they had a phase 1 then a phase 1-2, that there might be 3 or 4 groups... but 10 groups?
-------------------------------------------------------------
Classical Patients
1-5 2 PFS = 7.8 months OS = 10.1 months
10-4 PFS = 4 years OS = 4 years and 3 months
Proneural patients
5-5 PFS = 7.5 months OS = 2 years and 10 months
5-3 PFS = 5 years and 9 months OS = 7 years and 2 months
Mesenchymal Patients
1-6 OS = 4 years and 1 month (Still Alive in 2011)
1-2 PFS = 4 years and 10 months OS = 7 years and 8 months (Still Alive in 2011)
1-3 OS = 8 years and 6 months (Still Alive in 2011)
5-4 OS = 5 years and 10 months (Still alive in 2011)
10-5 PFS = 5.6 months and OS = 13.4 months
10-6 PFS = 2 years and 2 months and OS = 3 years and 1 month.
I'm not understanding the way you are labeling the data. What I remember from Linda Liau's recent presentation is that there was no apparent benefit in the early data for DCVax-L with the Proneural patients, though the number of proneural was very low, so the statistical significance was very low.
She says this at about 25:10, along with a slide charting the same.
You weren't responding to me, but picking up on the thread;
Makes sense to me. Not that I actually know the procedures;
but steroids to control inflammation in an emergency would need to be part of the side-effect response arsenal. And if such use is metered to only pull back inflammation to this side of scary, then there might be little reduction in immunotherapy efficacy. Regardless, responding to excessive pressure would almost certainly be the priority.
Based on Linda Liau's recent presentation, it looks like issues of heavy inflammation for pseudoprogressives are gone by about 4 months. At least in one example that she displayed.
"Researchers should use pigs rather than mice for such studies... "
My understanding is that large animal studies are difficult due to the large space needed, and other scaled care requirements. But maybe such would be the answer to the difficult situation that would result if patients all received genetic tumor typing before selecting therapies.
Such might results in patients never selecting trials where their genetics was shown unfavorable in, ie phase 1 analysis. Pigs would not get a vote in their trial selection. Unless or until Charlotte spilled the beans.
Currently, mice strains are bred or otherwise developed to yield desired tumor types. I wonder if there would possibly be enough naturally occuring GBM like tumors in pigs to avoid having to do such. If so, diagnosis would still be required, seeming unlikely given the amount of care pigs currently get on pig ranches.
What about dogs? Not as close to humans genetically as pigs, but much closer than mice? At least with dogs there is the potential for large numbers of desired cancers being diagnosed by vets. If non-sacrificial dog patients are useful, I am sure many owners would allow their dogs into trials if it meant a possibility of curing a likely fatal cancer. Probably not nearly as many dog owners would allow their dogs into trials if they were ultimately sacrificial.
As for pigs owned on breeding farms... for a few bucks I think you could have any sick pig with absolutey no restrictions on what you do to it. Maybe that is part of the advantage of pigs:
https://www.change.org/p/tell-tyson-to-stop-torturing-pigs?alert_id=nCWYedCMwz_erVVxnrQvF&utm_campaign=41719&utm_medium=email&utm_source=action_alert
Thanks. Stopping steroids 10 days before leukophoresis means stopping long before DC administration... so not an issue regarding DCVax-L. I see.
Corrected/better version of my last post:
Isn't AVII the one that brings up the FDA's broad look at the ITT population? Maybe "Intent to Treat" is not a good name for that group. The information arm patients are treated with DCVax-L. One must assume that doesn't happen accidentally; that there is an "Intent to Treat" prior to treatment, in spite of the fact that they are not part of the trial.
If a large number of mesenchymal patients were filtered into the information arm, as AVII argues, then what would AVII say about the health of the information arm patients being considered by the FDA?
If analysis that includes the information arm shows a 90% CR for patients that are both mesenchymal and respond to temozolomide... and that subgroup constitutes a large percentage of GBM patients, ie 30%... then how could the FDA ignore that?
I remember watching a video of a presentation by a senior FDA member about 18 months or so ago where the official said that the FDA can and will grant early marketing authorization with required confirmatory trials, for outstanding results shown in very small trials, even without controls, for indications that have no current effective therapies. He said as small as a dozen patients, then corrected himself, and said even a much smaller numbers of patients.
Although I have not been able to find that presentation in recent searches, at least one other poster, more credible than myself, remembered seeing it too.
That presentation may have been the FDA's appeasing of the public after the "Dallas Buyer's Club" gained so much attention. I believe the timing was about right. Maybe the FDA back-peddled and deleted all traces of the presentation from the internet after the furvor died down... but it is hard to forget the presentation, and hard not to wonder why the efficacy I describe above, if shown in the DCVax-Trials for mesenchymal patients that respond to temozolomide (tumor shows methylated MGMT promoter), would not beg such an early marketing approval.