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So glad to hear that Flipper! Congratulations on beating the big C!
Yes, I saw that in your post. Very interesting and I agree, that also could be a mitigating factor that could move the treatment into a different direction, in terms of CI's.
Thanks also for that excellent and very long post. Really well done! Very clear and helpful. You've clearly put quite a great deal of work into understanding the ins and outs and I appreciate that this was not just an investment, but that you've gained great understanding through for your own health challenges and battles as well, which can only make the effort to gain this knowledge that much more important.
I hope all is well on your side and that you're fully recovered!
Thank you Flipper. That is a very helpful explanation.
I agree with you. When you look at a nanotechnology like CPXX' solution, where the lipids deliver the medicine directly to the diseased cells, it suggests to me that the CI technology may have some further evolution to be its most elegant option, ultimately. That may take some further development or cross licensing of technologies and jv development by the companies that are creating various CI treatments - to find a way to only target the cancer cells. But from where it seems we are going technologically, that seems very likely to be a possible option in the not too distant future.
I think the one challenge is where the cancer is spreading and you might want to get those early clumps of just a few cells or floating cells, here or there throughout the body. Maybe the CI treatment becomes periodic, to avoid doing too much damage, at some stage. But also, it sounds like they will have to step up their monitoring of inflation and other signs of autoimmune responses that are damaging or potentially deadly or incapacitating.
It also sounds like DCVax, having so few to no side effects, and having been pulsed with tumor cells or through the tumor, is a very practical and excellent solution, comparatively.
I suspect they will need to determine who this 1% is (maybe it's a test for a specific marker or gene), so that they can either remediate their reaction, or not put them on the treatment that can cause such a bad reaction.
I expect that the NWBO Combination Therapy project will go forward. However, those trials will also, I expect, continue to test DCVax by itself, and in various combinations, to get the best results with the lowest side effects. It's all experimental, and getting more and more data is going to advance the power and effect of these cancer therapies immensely.
Congratulations hopefulsurgonc! That's lovely news!
In that context, it's interesting to put this into perspective in terms of paying for the cost of medical care:
http://www.rferl.org/a/oldest-population/26615160.html
Japan has the oldest population in the world, with 32 % aged over 60 in 2013, while United Arab Emirates [has] the least oldest population - 0.9 percent.
Well. You do get all of your vitamins in every tasty bite!
Again, thanks for the scientific terminology clarification here in the context of the short misdirect. Very, very clear.
It was such an obvious, rhetorical flaw, seemingly intentional as I read it. And if you're (not you, RKM, just rhetorical) a short, why not throw that kind of intentional misreading into the mix?
The goal of a short, is only immediate, to make money. The emoted, false concern about "fraud", "longs" and "bad data" are just so much b.s., in the context often of efforts to confound and confuse the general public. But, if one doesn't read the shorts with an eye to their being accurate, providing identifiable quotations from identifiable articles, with LINKS provided to verify and check their posts, then the conversation will always be misleading.
Again, on this one, great clarification RKM. Much appreciated!
No quotes, with links. Lots of opinion, without quotes, but looking like it possibly could be from somewhere, filled with strong conclusions that contradict actual published papers, with data, links, tables, charts, and peer reviewed.
Hmm... not very compelling.
Really excellent and clear breakdown RKM. Thank you so much for taking the time!
Not. But thanks.
I was there. Nice summary. Let's hope the same happens here. :)
My clarification to GoodGuy was that I apologized for any misunderstanding, but he did refer to the date 11/16, in his post, rather than a range of days, starting in November. There was no intentional effort to misrepresent his post and a subsequent answer addressed this point.
Oh, and my post actually quoted the clinicaltrials.gov date, just for clarity. I do try to quote, when I can, with links. It's a good practice.
Hmm... I had not said anything to you today... interesting.
Certainly details to keep in mind. They will likely be doing lots to improve on the care would help those who were not as responsive to DCVax, and, for the other companies, their drugs. Combination therapies, as with HIV, have been an incredible advance and it looks like they will advance the cancer treatment world, going forward. Personally, I think it's a particularly good time to be observing and evaluating investments.
Very encouraging Flipper44! Thank you!
Price has been trending upward most of the day, on not much volume. If I were looking for my discount, I'd be anxious if I thought the price might rise, unexpectedly. But if I thought they were dead in the water, I'd take my time.
The key question should be, for any institutional investor: How long into November do you want to wait?
Large institutional investors know exactly what they invested in, in the first place.
It's not Private Equity, so you don't get the extra rights unless you step up and privately fund, as with the current deal (though there, last version, it was a discount, no warrants). Many funds that do this, don't do that generally - they buy liquid shares on the public markets when they invest in public companies and they know the nature of those shares is that they don't come with anti-dilution clauses. It's the nature of the beast. Many funds need to be in liquid investments, not a piece of art that might be grossly undervalued, but also illiquid as an asset.
Some do buy privately and do get some warrants and other deal sweeteners - similar to what you get with private equity, yes, even when you invest in major private equity deals for major name technology companies that are still private... you can get rights like anti-dilution. Those companies, however, have some leeway on their "valuation", fervently believing (maybe confusing that with knowing) that when they go public, they will typically name a price far higher. See Uber, Snapchat, etc.
That's not the deal for tiny, already public companies that we choose to invest in or that we can invest in because many are not in the category where they get offered private deals, and when they do, they are dubious deals that VC's passed on. The table leftovers.
But public companies are a whole other deal, and they rely upon their shares to pay the bills, remain solvent and to keep investing in the creation and regulatory rollout of their products. It's the beast. They feed the beast, we get the left-overs. We buy on the secondary market, and that's the nature of that deal. We're not even funding the company, as retail investors, in most cases like NWBO, unless we got offered some allocation at the beginning of some cycle.
And, by definition, by the very nature of the process, if we secondary buyers are good at what we do, we're buying in at a DISCOUNT to the shares that were offered previously, maybe not from the initial buyer, but another subsequent buyer. Kind of like buying a car after it has already been owned. The shares I bought for these pennies, may have been issued for $12.00. Someone else may have bought them for $13, and another for $5.00, and another for .39, and you or I might be any of those buyers or a bunch of them.
So dilution, plus liquidity: That is the benefit and the price we all pay, and yes, we still can, upon success, despite the basic need for ongoing dilution, earn a larger payout than we would otherwise, if we pick our investments correctly and manage how we get into such companies - not at the top - but as cheaply as possible and as close to a liquidity event as we can. Just like private equity, you keep adding cash, it's just that you average down for public companies (as secondary buyers), rather than receiving anti-dilution clauses and having to buy up (at higher prices), to keep up. But you're still less than liquid. Liquidity has its pros and cons, including the con of having lots and lots of weak hands and speculators, shorts and day traders.
When people who don't really know what they are even discussing, and can't link to it initially, and seem hell bent on inventing "anomalies" out of thin air, it makes no sense for any serious company person to directly address those "questions".
When they give their presentations, they present the data. You can choose to believe it or try to imply it's fictional, fraudulent, amaturely mistaken, etc. But it's not rally the job of subject matter experts to rebut the fantasies of shorts who are mostly looking to manufacture uncertainty to manipulate the stock price. That just feeds the wrong people and makes them far more important than they really should be in the overall scheme of what matters.
Additionally, they never could rebut every fictitious fantasy on the bulletin boards. No company can do that, unfortunately. They would just keep coming, and on every rebuttal, they'd try to pick apart each statement, until they found something ambiguous to run off again, on a tangent. It's a vast waste of company time and money. Longs can do the job, honestly, whether you like the answers or not. Most shorts wouldn't like any answer, I suspect. It is not in their pecuniary interest to like ANY answers.
LOL, there is no "apparent anomaly". A made up one, but no apparent one. You guys didn't even know what you were measuring, from what date and how to evaluate it. It took a lot of careful effort to back you down to a particular article, and particular group of patients who did not receive DCVax initially.
If other patients did well after receiving it initially, it makes it the standard of care (SOC). And if patients that are recurrent, that have not taken it, have issues with just the vaccine, then certainly that needs to be studied, but it's not going to be the bulk of patients and it won't affect efficacy determinations, overall. I suspect, it will make combination therapies more interesting, and we already know that is their next move.
Refining the application of new technologies isn't an "anomaly" - it's just better science, with more data, and more opportunity to try new approaches to ensure each patient gets the best treatment from the get-go.
Sorry if I sounded harsh. My apologies.
I saw you refer to the 11/16 "date", which to me means you were suggesting a day, instead of a month or period or range of time, which I think is what they meant.
It certainly is possible the events have already transpired or are close, certainly.
Apologies for coming across too strongly. That was not my intention.
Actually, it looks like combination therapy is the necessary approach. Checkpoint Inhibitors, by themselves, have a limited period of efficacy, though they do have efficacy.
It would also not surprise me if, in time, there will be a variety of tools available, from CI, to DC vaccines and TCell approaches that will form the backbone, together with new chemo combination therapies, e.g. Celator's incredible nanotech enabled, targeted approach.
The cancer battle is going to be won, one new weapon at a time, and in combination and succession, as we expand the tool box.
Let's not misinform people. It's not November 16th.
It is sometime in November, in 2016, and that's just an estimate. It could go longer.
https://clinicaltrials.gov/ct2/show/NCT00045968
"Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)"
They don't have any fiduciary duty to shareholders. No one knows who they are or what their position is in regards to the shares or whether they've violated any laws. Most likely, they had freedom of speech to say whatever they want.
Merely because no one has sued them, doesn't validate what they said. You can say a lot of bs without triggering lawsuits. Lawsuits are expensive, and tracking people down is costly as well.
Nonetheless, eventually it may be revealed, and in that context, it may be revealed that there is something actionable. Why would they have taken such care to hide their identities, if they did not fear, if people knew who they were, and what they were up to, they might bring lawsuits? Surely, using the anonymity that the internet allows, rather than putting their reputations on the line, was a calculated move, shaped by potential lawsuits and liability...
And yet, not a lot of sellers, so the price was up on an otherwise down day for most biotechs...
Yes, the UK really cut off its nose to spite itself.
Excellent! Thanks RK! This is very helpful.
Thanks Flipper. This is very, very clear!
Sure, though I also think it's possible that rapid psPD would benefit, overall, if they start with DCVax-L versus patients that wait until second surgery to initiate DCVax. Again, I could be wrong on my read on that n=8 class, but I think they were not in the trial, and got DCVax later. I think they were in the info arm humanitarian trial which had 55 patients, not 19, ultimately.
Additionally, if combined with checkpoint inhibitor drugs in a combination therapy, the results might be even better. We'll have to see if the combination of DCVax plus an approved checkpoint inhibitor drug, would be a recommendation. What is the intention with DCVax-L on combination therapy?
And certainly, NWBO might want to see if such benefits would accrue to patients, based upon their combination therapy patent. It will be interesting to see how that plays out.
Sounds good. Keep up the great work! :)
Thanks RK.
I don't have the full article, so I can't review how that 2nd Cohort came into the mix, given it is in an info arm journal article. It's clear to me, that they would not be a part of Phase I because of that, and because of the kind of patients they, in fact are, which would complicate a phase I/II if they were excluded and then included.
I'll defer to you, for now, on that point. I will likely buy the article at some point, but can't do it now.
But the entire analysis is in the context of the info arm, so I agree on your take on 1) they are rapid progression patients; and 2) they did not receive DCVax initially, they were taking the comparison highest standard of care treatment up to that point.
And, given your point, that they have a 2nd surgery, at that point that the tumor has regrown and then start the DCVax, on that reoccurrence, if you add their time after that, to the time lived from the first surgery, you get a substantially longer period of life. I don't think it would make sense to count from the 2nd surgery if they had started on DCVax, and that's why I think it's more likely they are part of the info arm.
Also, as an emphasis, I think it indicates that starting with DCVax will, given such comparisons, still be the standard of care if results hold up in the Phase III trials and are comparable. There is no reason, that I can really imagine, that numbers won't be at least comparable, if not better, because the Phase III patients are not the patients excluded as rapid progressors, and therefore they should have a better prognosis from the beginning.
I'm sorry ExW, but that is a nonsensical answer.
We did not discuss a specific class of patients by their numbers. We discussed, from the beginning, a reference from an article that AVII had not CITED specifically, but had quoted from. That article, I found, and pointed to very clearly, once I figured out the issue, was from the HUMANITARIAN INFO ARM.
The article as I've said quite didactically is the only article from which the original quote can come from and those 8 patients were rGBM, and were not treated initially by DCVAX.
There is absolutely no ambiguity on this point. You can create a list of 8 patients with various reference numbers, it doesn't change that fact.
This is the quote that started it all:
"A second cohort of patients with rGBM consisted of 8 patients with recurrence following several adjuvant temozolomide treatment cycles. Median OS for these patients is 14.7 months from the time of surgery for first recurrence. The comparator for this cohort is derived from Friedman et al. (2009), who reported mOS of 8.7-9.3 months from the time of first recurrence for rGBM patients treated with Bevacizumab with or without Irinotecan"
Positing that there is ANOTHER 8 patients, when the original article you sourced your main points from was the article discussing the earliest, incomplete data from the INFO ARM, indicates again, that you are constantly trying to manufacture ambiguity wherever you can, merely to sow chaos and create a sense that there is SOMETHING UNKNOWN that is very troubling.
There is no OTHER n-8 group that has the data you referred to in your ORIGINAL POST.
As I've demonstrated, the language you quoted there originally comes from an article SPECIFICALLY discussing that group of patients that ended up in the INFO ARM, the 55.
And you are trying to say one instance they are the INFO ARM, then changing your post to say otherwise, is merely rhetorical back and forth to maintain the sense that there is some real issue here that you are resolving that others are not seeing.
It's nonsense. You're muddled and you're trying to muddle everyone else.
Again, back to my original link, quoting the article from which your original quotation comes:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126164799
That text you quoted, in your original post, would be in quotations if it was from other articles about the Phase I/II patients. Also, that research is dated, because it doesn't include the total 55 patients in the info arm.
These were patients who were NEVER included and did not receive DCVAX at the beginning. Your complete lack of consistency here is truly breathtaking.
This was the reason why I pointed out, at the very beginning, that you needed to include your links, to avoid confusion. By not including them, at the beginning, you can keep going back and forth as to which patients and which research to which you are referring, with great ambiguity always as a tool. And even when you point specifically, it's the WRONG research, because you're trying to avoid the obvious real observation that you are discussing patients that did NOT RECEIVE DCVAX from the beginning, but only upon reoccurrence. They instead had only received surgery and chemo. So if they had recurrence at 8 months and you are saying they lived only to 11 months, that's hardly a bad thing for DCVAX. Though I do think there is ambiguity in the labeling and you're further playing with that ambiguity to make it seem like there is ambiguity, not in the INFO ARM, but now suggesting, even though you're wrong, in the Phase I/II arms. And again, the FDA would have sussed out such obvious, pre-school errors as you believe you've found in an abstract only of preliminary Info Arm data (not Phase I/II data).
Great short work. Bad logic and bad analysis. Ultimately, this kind of nonsense fails and creates more interest with traders. It's very transparent.
Not that I am addressing your question to RKM, but . . . question:
You just argued to me AVII77, in a previous post, that the n-8 patients were NOT from the Info Arm 55, but from Phase I/II. Which is it?
I was clear, they were from the Info Arm... you said they were not, in your reply to me.
You're going all over the place my friend.
As I said these patients you are referring to were NOT treated by DCVax initially. Their re-occurrence of the disease is what triggered their being invited into the humanitarian trial. Therefore, while I believe there is some ambiguity in the labeling of certain charts and descriptors in the relevant studies, because it would make no sense to me to measure their response to DCVax from the time of their initial surgery when they did not have DCVax.... You would not then have a date when or if their DCVax had commenced and if they had had one two or more or fewer treatments.
The details rather show, I think quite obviously, that patients that received DCVax, from the beginning, had the best results, and that is DESPITE including these patients who did not receive DCVax from the beginning
In my opinion, that would set the standard of care for GBM, I believe, as DCVax. Other patients, who were included, whether we agree on the measure and how it was derived, the report clearly states there was overall improvement, across the two cohorts:
Results and conclusion
The results obtained in two cohorts of patients with rGBM suggest that treatment with autologous DC pulsed with autologous tumour cell lysate can extend survival by 5 months or more.
That is not correct. The 8 rGBM come from the second Phase I/II trial.
And, Ex just offered you the correct link
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3568250/#SD2
(It is within Supplement 3)
My apologies. You are correct and I misread your post.
I'm very sorry to have misunderstood you. Thank you for your kind note back.
You're completely wrong. I gave you the abstract from which your EXACT quotation comes. I did not link to that article, I linked to the abstract. And that article is about Phase I/II. However your quotes, which you are discussing, involves patients who did NOT QUALIFY for the Phase I/II trial. They were not in that data. They are in the article below linked.
That's why I've come to the conclusion that you are not talking about anything for which you have any expertise. PERIOD.
http://www.ejcancer.com/article/S0959-8049(15)00060-X/abstract?cc=y=
https://www.researchgate.net/publication/276494898_ITOC2_-_017_Prolonged_survival_for_patients_with_recurrent_glioblastoma_multiforme_who_are_treated_with_tumour_lysate-pulsed_autologous_dendritic_cells
The ABOVE Abstract says:
"A second cohort of patients with rGBM consisted of 8 patients with recurrence following several adjuvant temozolomide treatment cycles. Median OS for these patients is 14.7 months from the time of surgery for first recurrence. The comparator for this cohort is derived from Friedman et al. (2009), who reported mOS of 8.7-9.3 months from the time of first recurrence for rGBM patients treated with Bevacizumab with or without Irinotecan"
That's the article I've been linking to...
My response was here: My post’s link http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126164799
I quoted your original points and discussion in my link above to keep this focused and people can reference and fact check between this post and that post and the original post.
Note the titles of the article I linked to, and the poster, and the exact quotation in the abstract that I linked to above. They are all there. If it were not the article and abstract, it would be a quotation with a reference to another article. This is the article. PERIOD. Either you are confused or you are intentionally confusing people. As I said earlier, you needed to include the links in your initial discussion or it becomes a discussion about nonsense.
The relevant poster covering these patients with the fuller data, is here:
http://www.nwbio.com/AACR_poster_prolonged_survival.pdf
RK agreed - it also doesn't make sense because the FDA will go through all of that data and the tables and charts and ask thorough questions if it is patently false.
It's nonsense to think that peers won't ask questions and put them to the FDA if they think those tables are fraudulent.
The notion that this is going to sail through, as if this is some BP fraud... when it's a tiny biotech that has been attacked left and right, is an incredible assumption that seems nonsensical on its face, but this kind of "analysis" on boards, then makes its way to columns by certain writers and becomes the nonsense that drives stock prices.
I think there will be thorough analysis ultimately, so no fraud is likely to pass through the FDA's review. And if they had shown that this trial was as flawed as some suggest, I think it would have been completely halted, including with ongoing patients, as fruitless. That has not been the case. Patients have continued to be treated, and I doubt very much that would have been allowed in this context if the researchers were believed to be misstating the nature of their research and including totals and averages and improper statistical measures that were so flatly wrong that they were patently obvious to people merely reading vague summaries of the earliest parts of the research, not even the full papers or complete research.
You should not misquote people. And your response isn't really to my post. Part of the problem is this bulletin board software, which is not great for this kind of a discussion.
My original post on this subject, and I've posted a number of times since, is here:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126164799
I pointed out that you guys were discussing unlinked to "analysis", for which people were demanding the links. Nowhere have I misquote the research, rather I've been pointing you to the correct sources, with LINKS that you did not provide as you discussed quotations, some of which were inaccurate and misquoted (particularly the conclusion - which you did not re-quote) and edited to not fully present the information as provided even in this less than complete research (doesn’t include the 55 patients) excerpted from an excerpt / abstract. You can’t do your analysis this way. This is incorrect and not based upon anything real.
I think you're not looking at the complete data, and I think there may be some lack of clarity as to the measurement dates for completely different classes of patients who start treatments at different points in time. I've said that elsewhere.
It’s nonsense about nonsense meant to spread nonsense. It’s either well meaning bad research, or intended to spread disinformation. Hard to know which. But it’s bad research. It’s exactly what AF excels at, with his rhetorical, unscientific analyses of various company’s research.
And your link for the data, in your reply post, is incorrect. The relevant n=8 analysis comes from a completely different article, and a completely different set of patients. It’s from the 55 who did not qualify for the Phase III trials.
The screen shots were in AV’s posts, which were the discussion that started this exchange. The data is one small table, not the PPT’s that you linked to which are gigantic.
That is funny, but get real.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=126164799
LOL.
Here is the entire paragraph from the abstract that is the subject of this thread.
Quote:
A second cohort of patients with rGBM consisted of 8 patients with recurrence following several adjuvant temozolomide treatment cycles. Median OS for these patients is 14.7 months from the time of surgery for first recurrence. The comparator for this cohort is derived from Friedman et al. (2009), who reported mOS of 8.7-9.3 months from the time of first recurrence for rGBM patients treated with Bevacizumab with or without Irinotecan.
Results and Conclusion These results suggest that treatment with DCVax-L can extend survival by 5 months or more in patients with rGBM.
The only editing and misstating is the version of the quote you post. Can you read the Rssults and Conclusions and compare to what you posted?
But I am sure all will agree with your version. Following a single click is hard.
On the raw data, I have posted the link for the cohort of 8
I have no clue what you are talking about screenshots. And it only has one cohort, because they were two completely separate trials.
Not to answer for China. I have no idea what he means.
I think you simplify what their duty is and the need to advise. Whether they suspect the trial is very successful or a complete failure, without the final data, and ability to calculate and make real whatever they may suspect, they have no duty to tell anyone anything.
We know that they have indicated they expect completion in November. Even then, they have leeway to analyze the numbers and parse them. Obvious results are often ultimately not obvious and sometimes counterintuitive. Analysis must be comprehensive to be complete and reliable. No one should just blurt out whatever they might wish or suspect or feel, to make shareholders feel like they've received the fastest answer. Additionally, again, even if they get initial numbers that might suggest one conclusion or another, it makes sense to review and analyze before moving to disclosure immediately, to be sure that what is obvious is not, in fact, wrong, and what is not obvious is not invisible and in need of careful sifting and parsing before it becomes apparent.