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Doc Logic,
I am long-time long with mid-size position.
I am comfortable with the science.
I am comfortable with management.
I am comfortable with extended timeline.
I am not comfortable with the FDA, which, along with much of our government agencies, I believe to be corrupt.
Has someone previously found assurances that NWBO will get a fair hearing and the science advisory panel will not, at the last minute, be overruled by a top-level bureaucrat (who will soon resign and get a lucrative job with the big pharma company that bribed him/her to kill approval)? If you have such info could you please ease my jitters?
Sorry if this has been asked/answered previously.
Yes, and something else that could adversely affect the outcome, that I have not yet heard mentioned: corruption within the FDA; e.g. payoffs from big Pharma to kill the approval. (Remember aspartame?).
AVMXY was automatically converted to RCEL by my broker, which I think is typical for OTC holdings; i.e. I don't think there is any cause for alarm. But check with your broker if your shares have not been converted.
flipper/statistics. I was not trying to say that. I said that statistical inferences are often wrong (in my second post), and that there may be a way to improve things for small-sample studies with a new technique (in my first post). This may or may not be relevant to NWBO, depending on how the data are analyzed, and who does the analyzing. The new technique may be of help if for some reason the analyzers have some issues with the statistical techniques used for NWBO.
edwick709, I have been involved for many years in engineering science and, from your comments, believe I share a highly skeptical attitude to statistical inferences for complex systems; i.e. not likely to be credible based on small samples, many significant variables, and blithe assumptions of distribution properties.
Statistics for small samples (e.g. clinical trials) might be greatly improved, according to this new approach: https://www.sciencedaily.com/releases/2018/10/181018124937.htm
"Drawing reliable conclusions from small datasets, like those from clinical trials for rare diseases or in studies of endangered species, remains one of the trickiest obstacles in statistics."
My 2 cents about Adam F: He's only been right because he's been playing a con game, posting negative predictions about bios that have odds 1000:1 against them in the first place.
Hard to lose if you are playing the short side on bios.
However, his poor character has been proven by (1) not sticking to his game plan, where he started to believe his own PR, and he tried touting some bios on the buy side. He promptly fell flat on his face with those prediction; and (2) his overly negative and juvenile comments about his short calls. No class at all.
biosect, thank you (and ex); sounds reasonable; i.e. automated spam problem. In any event will be confirmed by Woodford end-of-month portfolio report.
Again, the "NWBO sold" post is dated 22 May, the official Woodford portfolio update is end of month; last one was obviously end of April. If the original post is incorrect, fine; but to be sure wouldl have Woodford confirmation later than 22 May.
biosect, could be; confusing. The Nasdaq post was dated 22 May; the latest portfolio posrs are end of April.
Wrong Woodford fund: that's not clear; the Nasdaq post reported the top-level holding company had sold NWBO; I think that company controls all the funds. Not clear to me what subfunds may have been affected. Not being negative to report and attempt to clarify news.
bioinfo, thanks for the nwbo link showing woodford selling. Your link (nasdaq) is more recent than the filings in the other links discussed, so it could be that Woodford has indeed sold.
Milner, whoever hired you is not getting their money's worth, imo. You at least need to be able to feign some understanding of the bio issues. All caps shouting is not a good substitute for an understanding of subtle propoaganda, as practiced by learning, Pyrr, et al.
evaluate, thanks for the drummword reminder.
Do you have any reason to doubt the authenticity of the quote?
If it is accurate, it lays to rest some major issues which seem to continuously circulate on this board. In particular, the Dr. Liau "living longer" quote was specific to DCVAX treatment, period, which is a very powerful statement, imo.
Do you really understand p values? Read this to see:
http://retractionwatch.com/2016/03/07/were-using-a-common-statistical-test-all-wrong-statisticians-want-to-fix-that/
iclight,
As I mentioned before, I used the combined (all ages) data from UCLA.
Second, you stated that a good proxy for that data would be Group 4 from the study you cited; you mentioned no qualms about age or any other factor in making that assessment. So I followed your lead in comparing the Group 4 data to the Group 3 data that you said was a good proxy for the DCVAX population.
At that point UCLA was not even in the picture. I just looked at the data you recommended from the study you cited. You used that same data to arrive at 6.5 mo MOS.
Okay, so no UCLA, and just using your data, I noticed that the estimated survival for Group 3 was way below that of actual DCVAX trial data.
In my opinion, and I say this respectfully because I do think you tried to apply some quantitative analysis to this issue, your logical error was in assuming the treatments embodied in the Group 3 reference you cited were equivalent to DCVAX treatment. They appear to be very different. You did not seem to notice this since you did not state any reservations (e.g. 40% point or other factors); you seemed to be happy with your 6.5 MOS which you apparently thought settled the issue.
Conversely, if you are now back-tracking and saying that there is no way to compare groups, I would say if it is that difficult to come up with a reasonable number, how can you come to the conclusion that DCVAX is inferior? It seems that if this issue is not analyzable then the position to be in is agnostic.
I've been reading the board posts for a lot longer, but was hoping that someone would be able to provide some good quantitative data, hence I started making a few posts. Not trying to waste anyone's time, I can always be ignored, but I do appreciate those who respond. I can tell however that you do not wish to discuss this further and I will respect your wishes.
Pyr,
Thanks for the reference, sorry if I missed it earlier.
I see we are still on somewhat different wavelengths, but that's fine, I appreciate your perspective, and I thank you for your time.
Pyr, okay, sorry about any confusion. Anyway, I hope that iclight and you both respond per my last post:
Pyr,
1. I would like to hear iclight explain [the discrepancy between the trial data he cited and the DCVAX trial data]
2. You are again using qualitative data. Show me some numbers (like iclight did, to his credit, even though the data undermined his thesis.)
Thanks
Pyr,
1. I would like to hear iclight explain, unless you are perhaps his daddy?
2. You are again using qualitative data. Show me some numbers (like iclight did, to his credit, even though the data undermined his thesis.)
Pyr,
Please see my recent post to iclight: 54105
iclight, I reviewed the data you provided: (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1871999/table/t4-neu0603p227/). Thanks; nice to see quantitative data.
You said:
"You want numbers? Check out groups 3 and 4. Group 3 is pretty close to the P3. Group 4 is the UCLA study. Both the P3 and the UCLA data include patients that would fall into groups 1 and 2 so at best we can call that a wash."
From your assumptions (Group 3 = proxy for DCVAX-L vs Group 4 = proxy for UCLA) you say further: "MOS difference of 6.5 months based on the inclusion/exclusion criteria."
But if you look at the same table, the 2-year survival estimate is 17% for Group3 (your proxy for DCVAX-L). The actual DCVAX-L data (to date) show 3-year survival for 40% of the population. This obviously does not equate to the Group 3 data. One way to explain this would be that the Group 3 data in the study you cite, although representative of the DCVAX-L population, are not representative of the actual DCVAX-L results, which appear to be substantially superior.
If I missed something, please let me know.
Thanks for your time; the link was very instructive.
iclight,
You said, "Perhaps you are shooting the messenger and not reading the message?" I don't know what you mean, but I apologize if I misinterpreted something you said or responded inappropriately.
I will review the references you provided later.
Thanks for the more detailed response.
Pyr: Well, at least you didn't say "apples to grapefruit juice."
Thank you for your response, but it is a qualitative (speculative) response (e.g. "likely represent", "perhaps"). Please note that I am understand the value of qualitative analysis, and furthermore am trying to provide respectful responses.
The idea was to try to quantify the data, which I think most would agree to be superior to qualitative speculations.
You say, "PsPD patients, just historically have a mOS of 27 months." Can you reference any recent survival graphs to support that statement?
In any event you are saying, I think, that including PsPD in the DCVAX population would pull those survival numbers down, or conversely, pulling them out of the UCLA data would pull those numbers up. If so, how much? I.e. what are the specific factors? Can you reference any recent published survival data that makes this comparison?
Mainly, however, not knowing the PsPD makeup of the UCLA data, I think you will admit that your "filter" comment equating to 36-48 months must be just a guess. Would you agree that if the PsPD contribution could be extracted from the UCLA data, then that would be a good comparative baseline?
The idea is to take these qualitative points and turn them into quantitative points that survive peer scrutiny, and to diminish the large amount of qualitative "hand waving" that often results in relying on one's belief in the reliability of the poster rather than the science.
Thanks again for your time in discussing this issue.
Pyr, I think everyone is better served by quantitative data, to the extent possible. Such data also should be analyzed conservatively.
Let's talk about DCVAX L, although the methodology would be the same for Direct.
NWBO has published data showing 3yr survival (to date, it might grow) for 40% of population.
UCLA has published data showing 2yr survival for 40% pop (or 1.7 yrs at 50% pop), using a variety of advanced therapies.
Now, to refine this rough comparison, can you provide any factors to apply to the survival numbers to account for the population differences between NWBO and UCLA?
Thanks
Pyr, you actually made my point. True, UCLA patients are not turned away even though they have a worse prognosis. Yet, with advanced care, they do better than SOC discussed on this board at length. So the advanced care more than washes out whatever deficiencies in the sample you listed, as evidenced by better UCLA survival times.
If you have some numeric values to want to discuss (e.g. survival curve data) then perhaps my estimate can be refined, or possibly refuted. But I would need to see numbers, thanks.
iclight, if you are going to criticize my work, why don't you talk to me directly?
The UCLA "universe" is a valid conservative comparison because the SOC to which DCVAX is being evaluated is likely much less than the UCLA 2 year survival (40% population) used in my estimate. In other words 2 years for the UCLA population refutes your claim that the DCVAX pop was healthier; i,e, the UCLA population benefited from advanced care, as shows up in the better survival numbers. If DCVAX is doing well against that baseline, it is doing well, indeed.
Have you ever performed any quantitative analysis? Do you understand worst case analysis methodology?
If I have missed something please show me the numbers; blithe statements like "apples to oranges" are meaningless.
iclight, you said, "Why would you try to boil this down into age group alone."
I didn't; I used the combined overall samples.
The subgroups were sorted by age, but that was not what I used.
The UCLA overall data show 40% of patients survive about 2 years compared to 3 years for L at same 40% point. Direct is also better.
This is the only quantitative estimate I have seen on this board, and I will argue that 1 quantitative estimate is better than the dozens of the qualitative arguments I see continuously on this board, as entertaining and sometimes informative that they may be.
dogood, yes, just trying not to cherry pick, so I used the larger sample size. (I employ a "worst case" methodology that uses data that are biased a bit negative to the chance of success. This helps prevent skeptical challenges, and if the result is still favorable, this also means that the actual results will typically be much better than estimated.)
dogood, thank you for pointing out my error.
"27 of 39 patients are still alive at up to 18 months after first injection," or ~70%.
Not sure where I got my original number of 40%.
Comparing this to the UCLA GBM baseline, the correct number at 70% is about 14 mos, as compared to 18 mos for Direct.
Not as impressive as L, but still positive.
So now I am a cautious bull on both L and Direct.
iclight,
Your comments are not worth anything to me unless you care to explain your reasoning.
OK, I see; thanks for the clarification.
From the Direct P1 data to date, the 40% population survival at 18 months is not impressive compared to the UCLA baseline of 40% population of 24 mos. Although the UCLA data is only for GBM, it would seem that this would be a conservative baseline, since other cancers may have better outcomes (if you know otherwise please correct me). Again, this is very rough, but it is quantitative using available data.
If the P1 survival continues to extend out to 24mo or more, then over time Direct will look better. But this does not seem likely to me based on typical survival graphs. So at this point I am cautiously bullish on L and bearish on Direct.
RK, you said: "AND none of us know if they have decent results from survival lines on a graph."
I'm not sure how you can say that. Those are objective data and can can be compared to the UCLA baseline survival data.
Not perfect, but at least its a rough quantitative estimate as opposed to a lot of the what-of speculation that consumes this board.
Here's a rough and conservative quantitative DCVAX-L assessment using data from the recent Phaciliate presentation, as compared to UCLA average survival data (patients treated since 2009; see http://www.neurooncology.ucla.edu/Performance/GlioblastomaMultiforme.aspx).
This comparison is conservative because the UCLA data includes treatment which likely is much better than SOC.
From the Phacilitate data, 40% of the DCVAX patients have reached about 3 years or more survival. By comparison, from the UCLA data, 40% of the total population only reached 2 years. (Within the UCLA subgroups, only the 18-34 year group did better, with 40% reaching ~ 3.5 to 4 years.)
Hopeful (and AVII and longfellow), it seems that it might be possible to quantify the probability of DCVAX success, which would make moot many of these qualitative arguments.
On http://www.neurooncology.ucla.edu/Performance/GlioblastomaMultiforme.aspx
UCLA presents its lifetime data for several groups receiving UCLS treatment, starting in 2009. We can take the longest-life group, and compare it to a similar lifetime graph that can be extracted from the latest NWBO presentation, which would yield a conservative evaluation of DCVAX.
Does anyone disagree?
Sturm: All good points imo. And a true journalist would have noted and written about the impact of Liau's presentation back in October. To write about it now is illogical from a journalism viewpoint.
Adam, you previously claimed to be a journalist, but you have now admitted a "bear thesis." It might be worthwhile for you to review the following requirement, particularly the last sentence, from the Journalists Ethics Code:
"When publishing materials on a medical topic it is necessary to avoid anything that can cause hope of rapid recovery which is ungrounded or inappropriate to the present condition of the sick person. On the other hand, one-sided critical publications on the perspectives of curing the illnesses, on which contradictory points of views have been expressed, should not develop in sick people the feeling of uncertainty and thus undermine a possible success of therapy."
Adam,
I should have included that I had previously asked you specifically if you were compensated by outside entities for your articles, with the expectation that they expected you to impact the NWBO share price, to which you responded, "no."
I apologize for the omission.
I am long NWBO and appreciate reading both sides of the debate.
Although you make interesting points, and I do appreciate your background, my view is that, overall, there are many positives to this story which you tend to ignore.
In any event I am a cautious long, and welcome your further comments.
TC_Trader, if AF is not an "analyst," I stand corrected. However, it doesn't really matter what label a person has; if they misrepresent the facts for the purpose of influencing a share price, that person is engaged in securities fraud.
Papa, I agree that corruption is a very serious problem today. It is particularly tragic when it delays potentially effective treatments; I hope such is not adversely affecting you or loved ones. Hopefully with enough complaints to the SEC, FDA, and representatives, something will be done. And, I would add, the FDA should stick to SAFETY only, and let doctors and patients decide on efficacy, based on published data.
Papa, it is securities fraud for an analyst to provide misleading information. However, since AF seems to carefully structure his negative articles, and since they do not appear to contain outright lies, it might be difficult to prove fraud based on the articles alone. But if it can be shown that he is being compensated by others to influence the stock, then he, in my view, has a very serious problem.