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in principle, I am uncertain about that.
You cannot simultaneously have the link and the information it contains. You can either have the link but not the information or the information but not the link. In the latter case, you can't use the link to get the information. Don't ask me why. As Niels Bohr once said.....anyone who says he understands quantum physics does not understand it. Richard Feynman said roughly the same thing years later, but he played the bongo drums so what does he know?
Respectfully,
U, an uncertain quantum physicist :0
Nice analysis. So would I. GLTU
Different words, same page.
Thank you Bio. Good luck to all of us. But my gut tells me it is not a question of luck but future fact!
My hypothesis is that the 23.1 month blended mOS from surgery as compared to the 15-17 months SOC from surgery is rather modest at first blush---20.1 months from randomisation and I would assume that you would need to subtract from the 15-17 months from surgery SOC marker to get to a randomised apples to apples comparison. The delta roughly remains the same even though the measuring stakes have changed. Anyway, this blended mOS does not tell the whole story.
From the blended data, we have seen the blended mOS results on methylated MGMT. In fact, it appears even in the case of unmethylated MGMT, that this blended mOS is quite striking in addition to methylated. I don't know to what extent MGMT+ and - correlate with mesenchymal but the expression of MGMT and mesenchymal appears to be different. One has to do with the on/off cellular repair switch and the other with the extent of the micro-tumour suppressive environment or how immunogenic the particular classification may be. Mesenchymal and MGMT may be additive and/or overlapping to some extent. It also appears that the vaccine may work to some extent on other classifications including classical(EGRFviii--there is some correlation seen with methylated MGMT) and the other two classifications, although I think the vaccine effect there is rather de minimis. This overall subgrouping is rather large and could be 40%-50% of the clinical pool of patients. You would think that this overall grouping would have a significantly more robust mOS than the blended mOS. And as Dr. Ashkans confirmed, DC VAX works across all groups[to varying degrees].
However, weighing down on this more robust mOS is the "placebo" arm composed of non-X and Xovers. Any extension of the X-overs would be relatively minor, I would surmise. Pure placebo and the population with little to no effect would also weigh heavily on the blended mOS in addition to X-overs. Thus, what appears to be a modest overall blended mOS, may really mean that the vaccine works extremely well in some subgroups but not so well in others and further, that it does not work very well for the X-overs(late treatment). In this regard, very few of the X-overs, I believe only three as reported by a MB poster, had resections. And recurrent GBM may manifest itself as a very aggressive mesenchymal strain(which is susceptible to DC VAX), extensive mutation from the original tumour(s)and with greater tumour load all these factors severely mitigating a significant positive effect on survival. Further, in these circumstances, one would expect to see some separation between the two arms.
As I explained in a previous post and at the risk of being repetitive, top line results just by the numbers may not be too meaningful by themselves. Good clear commentary will go a long way to prevent twisting what is good news into bad. I believe the spring refresh will not only confirm but overall will improve upon the already striking data we have seen in the publication.
Thus, I would conclude that the chances of success and ultimate approval by RAs are very encouraging. I also think that big P will see this and break ranks. This is digital. Either big or zero. I believe there are good odds for big. LP, and indeed all longs, may be able to go to a bigger home after all is said and done. Go big or go home indeed. JMHO.
Of course he has. His practice is certainly not limited to patients associated with the trial. Dr. Ashkans is both a respected researcher and clinician as is Dr. Liau. His expertise is made available to patients in need both in and outside of the trial.
A lot my friend. He is in the live clinical world. He sees what goes on with patients every day. What he has to say is important. So what is the meaning of your question? He may be blind to trial results but he is not blind to what he sees on a daily basis.
Could not agree more.
Of course, one would agree that there are other explanations and perhaps mine is a bit disingenuous. I do not mean to necessarily convey the idea that NWBO has failed in the overall trial---just perhaps in the primary and secondary endpoints. Perhaps the results are nothing to write home about and it represents a quandary in analysis and communication to investors and the market at large. Allow me to explain.
I am going to speculate but here is what I think is going on. From what we know, not necessarily with certainty but with fairly good odds, DC VAX appears to work over all sub groups of nGBM to varying degrees. I would guess that DC VAX works very well for mesenchymal and methylated MGMT. I do not know what the correlation is between Mesenchymal and MGMT is but I would guess, as a whole, that this broad grouping comprises about 30%-40% of the clinical trial pool. I would posit that approximately 2/3rds are in the early TX group and the balance in pure placebo and the X-over groups.
Mesenchymal(NF) and methylated MGMT may express themselves in different ways. Mesenchymal is immunogenic meaning that the micro tumour environment is less suppressive and therefore more responsive to Temodar and DC VAX. The methylation promoter associated with MGMT interferes with the cellular repair mechanism. DC VAX appears to work well with this overall group.
In addition, there is some correlation between classical(EGFRviii) and methylated MGMT. The efficacy, to some extent, might be significant for a portion of patients in this group. Wrt to the other two groups, pro-neural and neural, there may be little to no effect and it is thought that some small selected pro-neural group may respond to the vaccine. However, wrt to these latter two groups, I would surmise that the efficacy is relatively de minimis.
Accordingly, I think that, overall, about 40% of the patient pool would respond very well to DC VAX. As to the balance, DC VAX may have relatively less to no effect at all.
Thus, the rather modest blinded mOS of 23.1 months from surgery and not randomisation, in and of itself, does not tell the whole story. It could very well mean that the vaccine works quite well in a relatively large sub-set but not so well for the balance. The long tail that we see developing pertains to the groupings where the vaccine is quite effective. And LP is continuing the trial to ensure plateauing and a dramatic slowing of the eventing rate. I believe that she is quite correct that the most important factor in evaluating immunological approaches is the tail. If it is quite significant and for a relatively large sub-group, this may serve to assure broad approval, leaving it up to doctors and their patients to decide whether to take the vaccine as part of their therapy rather than leaving it up to regulatory fiat.
With respect to PFS, we are all in the dark, as no data has been revealed even though we have reached the so-called trigger event back in February, 2017. Perhaps due to pseudo-progression confoundment, which LP has stated, if I recall correctly, was not an issue, the data has not been available simply due to the need for further analysis. However, the foregoing may well indicate that there is nothing to write home about with respect to the PFS end point. Further analysis may be needed to ascertain whether PFS extension is seen in some groups versus others and to what extent. In addition, while PFS eventing extension may not be significant, slowing progression dramatically after eventing as the immunological approach begins to take hold in time may possibly be happening. That is a good thing. We won't know until all the fine analysis takes place after unblinding.
Certainly, we would have been more comfortable with a blinded mOS of, say, 28 or 30 months versus 23 months. Perhaps the mOS will shift more to the right with the spring refresh. If it does, I think it will shift in 1/10ths of months rather than a month or two. I don't think there will be significant improvement.
Accordingly, unless top line numbers are remarkable for the trial as a whole, their revelation may not be meaningful without explanation. If the numbers show, for example, that they are overall marginal, their publication could give a completely misguided perception and Wall Street, with its limited attention span and understanding, turn what is good news into bad. Therefore, LP and company need to be very careful in their analysis, presentation and how they communicate to the market at large. This may be why LP is banking on a home run tail. It neutralises and significantly overcomes what may seem to be negative but is rather good news with proper explanation.
Finally, I have to believe that the 2018 spring refresh is it. LP, due to financial, investor and competitive pressures, surely realises that the trial cannot continue with more expense and now largely diminishing, if no, returns. LP understands that NWBO is a commercial and not research institution at this point. There is little if anything to be gained with yet another data collection and indeterminate continuation of the trial. It is time for data lock. JMHO.
With all due respect, LP knows with a good amount of certainty where NWBO stands with the trial. She has a very good idea as to whether the trial met the primary and secondary end points.
After all, she has engaged professional statisticians, has PIs and the SAB, all giving her input. They have more data than anyone except those running the trial. She knows whether or not NWBO has met the primary and secondary endpoints by now.
I believe that NWBO knows that either it is an extremely close call or that they failed. LP has stressed the importance, almost to the exclusion of these end points, of a long and fat tail. This is what investors should be looking for she has continually emphasised. It appears that in order to win reg approvals, broad support from the medical community and insurance coverage, she requires a home run here. They are trying to wring out as much tail as they can and I think LP knows that the spring refresh is her last stand. She won't say it in order to be able to play for time for a miracle hail mary touch down pass. If she delays beyond spring refresh 2018 and goes for a fall and/or 2019 data collection or drags her feet on the current refresh, you know the trial is in trouble. This appears to me to be the reason for all the silence and shifting the responsibility for prolonging the trial on the SAB. JMHO
Agreed.
About the recent loan. It looks rather bullish but.............
First, LP's pub and ASCO presentation did not do the trick in sustaining a rise in the pps. Investors were expecting more than a dog and pony show on what we already knew from the pub and the lack of spring refresh updates which Les had told a number of investors including myself would happen at ASCO. No string of PRs either before or reasonably after ASCO. Carrot dangling on business matters that would be announced in coming weeks. Well, at least one has been announced wrt to the loan.
LP had little choice but to raise funding in this manner since her pps expectations were dashed and she did not wish to risk the ire of large investors, already p*ssed by the incomplete presentation and lack of timely follow on news, by still another piecemeal dilutive toxic financing deal.
So she was able to negotiate a loan deal. Interest is steep when taking into account the discount but the 18 month term appears bullish.
Anyway, what is strange, at least to me, is why the lender did not either demand or failed to get convertible rights. After all, in reviewing the financial history in their DD, the lender must have known that LP made convertible loans to the company. Why not them as well? In order to convince the lender to loan money and for an 18 month term, LP had to open the kimono to convince them. If the revelations were bullish enough to entice this loan, they would have been enticing enough to require a convertible loan by the lender. The lenders are not well known. It is not as though LP had lenders all lined up begging to give her a loan.
So one would presume she had some leverage. When it came to conversion rights, which probably would have come up during the negotiations, she drew the line and told them no-- take it or leave it. Maybe she played guts ball and if the lender balked, she would have advanced the money herself, as a last resort, perhaps on the same T&Cs so as to avoid accusations of self dealing. However, the lender would never advance money no matter what the return if he were not reasonably certain that he could get his money back with interest. Especially considering a term of 18 months. So, all in all, this looks bullish. JMHO.
Les and Linda are more on the hook than anyone else?
Perhaps but let's see. Both get a very nice salary; nice bonus options with sizable volume so as to ameliorate the effects of dilution or R/S down the road; Linda has a nice deal with respect to the convertible Bs. She gets a nice 10% per annum while she waits; let's not forget that she got some recompense upon the sale of Cognate which NWBO shareholders helped build up; she has effective control and can pretty much do as she pleases; in addition to Les' salary, his wife Sue is also on the payroll to the tune of $ 180K per year.
Yes, they are on the hook, a golden hook without achieving success yet.
Screw Wall Street you say? Unfortunately, the market has a lot to do with the success or failure of our investment. Rather, Les/Linda ought to be more transparent and lift the veil of silence which has devaluated the investment perhaps as much as anything else. In any event, results are what count. Wall Street will fall in line if they are stellar. In the meantime with no news and a looming fund raising, Wall Street will once again take NWBO to the woodshed and long suffering investors with it. JMHO.
Indeed these are uncertain times. However, we can't be sure that saying something rather than nothing will at least ameliorate downward pressure on the pps. We now know for sure that silence was a failed strategy. And it served to dig a deep hole from which ii is very difficult to emerge. Let's hope that it is not a black hole.
There are things that management can do. For starters, get those damned PRs out. Commencement of lawsuit, clean bill of health on 90 day investigation, timeline for announcement of spring refresh data, clear articulation of what they are looking for to trigger data lock and unblinding. These will do for a start. Announcement that there will be ccs and/or biweekly web fireside chats with Les/Linda will begin the march toward transparency and improved communications. You have to start somewhere rather than throwing up your hands and thinking...we are damned if we do and damned if we don't. You have to break the log jam somehow. And you don't need to do so by prematurely engaging a PR firm to do this. It is simple enough that even Les and Linda can do it. Wall Street hates uncertainty. That is a lesson that should have become ingrained in Les/Linda's minds. Steps taken to lessen the uncertainty will go a long way to restore some semblance of credibility. Of course, with stellar top line, these concerns should rapidly evaporate. For now, do something that will change a losing game. Delay in revealing spring refresh data is a killer. And of course, Linda should stand by her statements of announcing business matters soon. The clock is running. Hopefully the announcement is not yet another toxic financing. Peace.
Rootjim:
I am pretty certain that there are no deals or discussions taking place now wrt partnerships and upfront money or even less likely a BO.
LP has come this far. She is not going to do a deal for pennies on the dollar. Big P has known this for a long time. They are not gonna cough up big bucks predicated upon the pub. It is not hardly enough to go for AA based upon year old data. Big P is not going to buy a pig in a polk. They are gonna wait until top line at least before making any move. Expectations that a PR firm will be funneling deals to NWBO and that Les will be busy analyzing and negotiating the best one of many is just plain a fantasy. Les knows this too so you can bet he is not waiting by the phone for a Saturday night date. Without at least top line, nobody is interested except some wishful longs wanting to accelerate their investment return. Forget PR firms and pre mature options awards. Don't count your chickens before they are hatched.
You don't need a PR firm and an SVP sitting by the phone waiting for a deal that ain't a gonna call, at least for now. Why waste the money? NWBO needs every toxic cent it can get. A PR firm is an amenity that NWBO can ill afford now. Instead of spending inordinate time responding to all manner of MB denizens, Les will certainly have enough time for deals as, if and when they may come. But I am afraid that this is not imminent, not without top line at the very least. How good it may be is open to debate. It may be just a mixed bag. Stay tuned.
Thanks for the response. I do not want to belabor the point. IMHO, right now, there are a lot of maybes. What the company needs is more communication and transparency. The silence breeds huge uncertainty and speculation runs wild. The shorts have a field day and use NWBO as a punching bag because it is committed to silence. If they cannot reveal something, at least communicate that these things have not been swept under the rug and forgotten. Most of us longs have heard many statements made by Les that never came to fruition and when confronted with this, he responds by saying he was misunderstood or he never said it. What happened to the string of PRs that we're going to take place in the January timeframe several years ago. Nothing, nada and silence at the other end of the phone. Les' response? Well, sh*t happens. With NWBO it seems that a lot of sh*t happens and instead of being cleaned up, finds its way under the rug. Where are the string of PRs that were supposed to happen prior to ASCO? After ASCO? What happened to the follow up update that was supposed to be revealed at ASCO? Les said it would happen. Is he really clueless about what is going on? Or will he fall back on the well worn refrain that sh*t happens and stay tuned?
The things we investors are looking for is communication and if they cannot directly answer for reasons known only to themselves say so and offer some explanation as to why. Silence breeds huge distrust. The perceptions created by possible self dealing and "hiding something" have significantly affected the company and its valuations. Maybes and supposed good reasons are no longer satisfactory. Stay tuned and indeterminate continuation of the trial invites suspicion. I am not in the least persuaded by MB statistical analysts. NWBO has, for sure, experts helping them out. They know a LOT more than we do. Just as likely is that they are pretty sure they failed the primary/secondary end points but are hoping that trial continuation will lead to a Hail Mary long tail touch down pass. Do they have good news now? Probably they really don't know. It is entirely likely that it is a mixed bag--but they won't know until unblinding. Hiring a PR firm now with all this uncertainty is premature. You and other "defenders of the faith" have not convinced me. I stand by my criticisms of management. I strongly feel that they are not deserving of any rewards unless and until results warrant them. It is premature. Ditto for a PR firm. JMHO.
Doc, your point about having a more polished CEO and PR strategy taking money and due to limited resources sourced significantly through financial toxicity, the company channeled these limited resources to bring the company to a successful regulatory goal is exactly the point I am trying to make. Engaging a PR firm now makes little sense: Limited resources. The company already has a biz development guy, IR advocate and spokesman. And to boot, he is a silver tongued lawyer. The company, at this point, cannot afford both an SVP AND an expensive PR firm. As, if and when they cross the regulatory goal line and achieve a higher value, then engaging a PR firm may make sense. And....management's PR firm choices in the past exhibited poor judgement. What makes anyone think that this choice is any better? Right now, bottom line, a PR firm is very premature. They need to change their underlying management style which has given grist to the naysayers' attack upon "inept" management. It is not only the naysayers who advance this view but also thoughtful longs that have forgiven management many times and now, frustrated, have become fed up. A PR firm won't fix this underlying issue. Management has to do it without the insulating layer of a beltway consultant.
And what are we to make wrt advance rewards to management and employees for yet to be realised results? Cant they wait? Or are the results interminably delayed because the data is immature, or that they have failed the primary and secondary endpoints and so their only option is to continue the trial in hopes of a long tail grand slam because they are afraid of sinister big P forces behind the workings of the FDA affecting approval decisions? Further toxic dilutions then await and shareholders would then not be well disposed to agree to these advanced rewards; so better to do so now, at the 4/27 SM, while the getting is good and the publication carrot still dangling in the wind. And the grants are sizeable especially with no results but just unfulfilled promising conclusions.
Doc, with all due respect, I think we have given management the great benefit of the doubt. It is now time for transparency. For example, has management received a clean bill of health as a result of the 90 day investigation that has now been veiled for not 90 but 900 days? Why can't we know what was behind the hold? It's been lifted right? The FDA has not embargoed NWBO from saying anything about it? Or, when will we see the results of the spring refresh? I could go on and on but the silence and lack of transparency has gone on too long. Hiring a PR firm will not fix the underlying perception of management as lacking in credibility and reliability. Management has created its own perception and, importantly, it is not attractive to Wall Street. Lack of positive news due to uncertainties with the indeterminate length of the trial and Linda's stay tuned mantra will continue to weigh on the pps. Finally, as, if and when there is positive news, the pps will recoup itself and again rise to current levels. A five bagger from a nickel is not a very attractive investment story to say the least. It's time for management to change its style and begin communicating--and not through message boards. Instead of being an apologist for management and giving them the impression that all is hunky dory in paradise, which is a disfavour to all shareholders, it's time for a wake up call. Otherwise supporters and investors won't stay tuned for long and will undoubtedly change to another channel. JMHO.
I mostly agree with what you say. However, management is very ineffective in its communications or lack thereof. Lack of transparency and silence in the face of attacks and spankings by a poly sci major have been a major factor in destroying the credibility and market value of the company. It is management's responsibility to protect value. The fact is they haven't and excuses to the contrary that they dealt with unprecedented nefarious forces, blah, blah, blah fall on my deaf ears. They are in the game. It presents challenges. Nothing is easy. Up to management to figure a way out. JMHO.
Why doesn't NWBO management tell "well told stories' to their shareholders?
Kab, if I did not know any better I would think that you were polking fun at me.
I have put up with management miscues up to now only because I believe we have a winner with the science. Thank God for people like LL, RP, KA and MB. LP must be commended in part for keeping this together up to now and hopefully bringing us to the regulatory grail despite her and LG's mishaps. But she and LG take a lot of the blame for devastating the market cap. Frankly, I don't see the value that LG brings. He is her loyal pit bull and I suppose that is valuable to her but certainly not to the shareholders.
JMHO. The coming business matters hopefully to be announced in the coming weeks may possibly show LG's worth and resurrect his credibility. Isn't he supposed to be the SVP for biz development? Hate to borrow a shop worn refrain but.....stay tuned.
In response:
1. I am from Missouri, the show me state. If and when results, then you get the reward and not before. Shareholders should not have to pay for a pig in the polk.
2. Nothing of real moment for a PR firm now. Investors are looking for results, not marketing hype and stay tuned trivia. Hiring a PR firm now is premature, expensive and redundant. For better or worse, our Senior VP of Business Development and IR has the job. He is paid enough and perhaps over, spending a lot of time responding to MB individuals and making statements that never turn out. Transparency on behalf of all investors is preferable. How about some ccs or weekly fireside web chats with Les? :)
Long on the science, short on the management.
Gee, Rootjim, I thought that all you laid out was Les Goldman's job. Hmmmmmmm, isn't he supposed to be the Senior VP of Business Development(and Investor Relations)? Didn't he line up and do business deals when he was a senior partner at Skadden Arps? Didn't he work with Donald Trump on an acquisition of some vineyard in Virginia. Seems to me he has the background, experience and position description at NWBO for doing all that you describe. And isn't he well paid for it? He and his wife Sue together pull down over half a million in base salary, not to mention stock bonuses. And now, on top of all that, poor Les needs the assistance of some Beltway consultant which probably does not have near the experience, expertise and contacts Les is supposed to have while having worked in Washington, DC all these years? Really?
But maybe you have a point after all. Perhaps it may be a good idea to replace Les with the PR firm instead. If they can do all that Les is supposed to do by virtue of his job description and is more economical to boot, I am not against the idea at all. But PR firm plus Les? No, I'm sorry it does not compute. As a shareholder I don't want to have to pay for both through further dilution of my investment interest. One will have to go. And maybe it should be Les. After all, he never met a deadline that he promised or didn't like. JMHO.
As I have posted previously, I am betting that the science behind DC VAX prevails and it becomes approved by regulatory authorities, of which the FDA is most important IMO, in the not too distant future.
And I am betting that management miscues are significantly out leveraged by the degree of success of DC VAX. However, recent management actions are discouraging.
They have hired a PR firm. Why now? These firms are very expensive. NWBO is not in a financial position to burn cash in this manner, at least at the present time. It is premature.
Just the same as the very dilutive stock bonuses were to both management and employees prior to achieving the regulatory approval goal. As a share owner, I don't mind such bonuses as long as they are well deserved. If NWBO is upon the eve of unblinding the trial, why award bonuses before such time? Why can't they wait at least until unblinding so that we can all assess the probability of approvals predicated upon the data presented? Unless of course, unblinding is not a relatively near term event and may indeed be pushed out until sometime in 2019. If so, further toxic dilutions will take place but the size of these awards will be such that NWBO management and employees will be somewhat insulated against dilutive effects unlike most retail shareholders. Larger investors should not be happy either.
What is the point of engaging a PR firm now? It now provides an expensive insulating layer between management and the stakeholders. Rather, what is required are simple PR actions that are obvious and do not require the questionable expertise of a PR firm, especially this one assuming it has orchestrated the ASCO presentation. What stakeholders are looking for, and had expected based upon Les' "promises" that this would happen at ASCO, is UPDATED data on more than year old data, which management felt was not "mature" enough then for data lock. Rather than just stating that they "hope" to provide business matter information in the coming weeks(this is a term of art meaning perhaps but it depends...on X, Y or Z and in any event not any time soon) and make a Jerry Lewis MS telethon like plea for help---obviously financial---LP could have also explained why the update was not available and a timeline by which it would be revealed. But no, nothing but crickets. The testimonials of patients were heart warming but hardly scientific where data is the priority and the most important basis for the assessment of efficacy. Emotional testimonies from patients and Dr. Ashkans plus nothing really new in Bosch's presentation which he ripped through due to the absence of sufficient time without a dollop of mention of updates did not give investors much comfort. Thus the pps reaction was certainly not unexpected. If the PR firm did not realise this and management did not either by having approved the content of the overall presentation recommended by them, this is tantamount to burning thousand dollar bills on a clueless consultant as well as suffering a tanking of the pps in the process. Surely the point of the publication and ASCO was to provide enough promising material so as to sustainably raise the pps in view of the need for further funding in the relatively very near term. The coming business revelations were perceived as nothing more than carrot dangling due to a lack of follow up on the article and its update or at least explanation as to when we may see it.
Management's awkwardness in articulation and resulting silence because they are"damned if we do and damned if we don't" caused in significant part, IMHO, the devastation in market cap value. That a political science major can run rings around a Harvard law school magna cum laude grad and a former senior partner of a white shoe Wall Street law firm is inexplicable and shameful. Bringing on a PR firm now is like closing the barn door after the horse has run out. The PR firms they selected back in the day were useless reflecting on their poor judgement choices. Why is the current choice any different?
Bottom line is that they don't need a new PR firm. They need more transparency. They need more communication to shareholders by ccs, etc. rather than Les' responding to MB denizens at all hours of the night and making selective "promises" that he never delivers on.
IMHO, a PR firm cannot be successful in rebuilding respect and credibility of management. They need to do this themselves. If they believe that they have an overwhelming mandate from shareholders in continuing their style of management from the April 27th SM, they are more than naive and it spells trouble down the road. Large investors are definitely not pleased with the overall conference and continued silence. Stay tuned is no longer an option. While the unblinding pressure may be excruciating,
the transparency pressure is even more so. A PR firm won't fix that. JMHO.
Hi JR:
What was it about the data that you did not think was so great? Even considering the blended data as though it were Tx--after all, over 86% took the vaccine--you think it was not all that good? Gee, JR, quite a few medical experts think it may represent a break through and said so, despite all the cautionary disclaimers which are normal for yet to be approved drugs.
While you may not think much of SOS--he is after all a shameful shill for NWBO-- from his analysis of the data, he thought it was quite remarkable. He said so too. Can you show me contra-opinions from real experts? AF, Ex, Turtle, AVII and Phyrr don't count. I am listening.........While other hard headed longs don't like the helping hands extended by good samaritans like Ex, et al who tirelessly and generously try to point out the foolishness of our ways, I am willing to take hold of these charitable volunteers' grasping fingers in order to save me from me.
Just curious, but what is your background? I must be missing something. Maybe it is just me but I thought the data in the article was remarkably promising. Wrong descriptive perhaps? And I guess all these so-called experts aren't to be trusted because they have vested interests including Drs Liau and Ashkans. Never thought of that.
If you think, as I do, that management largely sucks, and you additionally feel that the data is not so great, but rather ho hum promising, I don't see with that equation that you should hold. You don't have the promise of the product significantly outweighing the incompetence of management. JMHO, but why don't you sell and move on? Management is in the toilet, the data is unremarkable---with that perspective I would sell and ride another investment recoupment horse. Why wait for the trial to be unblinded and be disappointed? There are many potential investments out there. Good luck and please let us know how you are making out.
Best,
U
Hank, my answer is what it is. Sorry that it is not acceptable to you. GL.
Hello Hank.
Well known naysayers? Such as who? AF, Ex, AVII, Turtle? Professional and well-known medical experts are they?
I do not claim to be an expert. I am not in the neuro-oncology field. I presume you are not either. Accordingly, it is not unreasonable to depend, as part of DD, upon the experience and knowledge of those who are expert and not upon some MB naysayers who have no skin in the game or are otherwise disgruntled due to management mishaps and attempt to take their frustrations out on the science.
It matters that there are 69 respected authors and other medical experts who believe that the data portends great hope and may be truly a breakthrough in the management of this thus far intransigent disease. Dr. Ashkans, who is a very well respected researcher and clinician in a top teaching hospital in the UK, believes that these results are remarkable and is obviously clamouring for the vaccine's wide spread availability while expressing an obligatory cautious disclaimer as any professional would be prone to do, MD Anderson's Dr. Buzdar notwithstanding. I am not going to single all of them out and name them. No doubt you have read news reports and know who they are. To my knowledge, and I have not thus far heard or seen otherwise, no professional oncologist or researcher has said otherwise. If you have such comments, please enlighten me. While he has his critics and is portrayed by some as a shill for NWBO, SOS believes the data presented is truly remarkable and may portend to be an important breakthrough. There is no comparison between him and AF or any other naysayer on the MB. His research is professional, dispassionate and very careful. He does not throw out cavalier claims of grapefruit juice and is very circumspect in his analysis and conclusions. People who I do follow on the MBs and respect greatly, and who are professionals working in the field such as Hopefulsurgeon, believe the results to be remarkable.
Finally, I believe that the data presented in the article and walked through by Dr. Bosch at ASCO, is self evident and speaks for itself. If you can't or don't want to see it, then we will have to agree to disagree. To me, there is no point in further debate. You, of course, are free to believe what you want. I am not here to convince you otherwise. I am not your investment advisor. I'll leave it at.....there are no certain things other than death and taxes.
Insofar as my "holdings" are concerned, they are objectively substantial. They are greater than 100,000 shares. Other than that, it is none of your business. In conclusion, I think you agree with me on management. My gut feeling is that you have serious doubts about the vaccine and you are looking for someone to sway you one way or the other. If so, I think that NWBO is not an investment for you. JMHO. Anyway, good luck whatever you decide.
Let me be very clear on my position.
First, I am a long and have been for several years. I hold a considerable position, have averaged down and participated in the convertible offerings as an accredited investor. I have a lot of skin in the game and can afford it. I know both Linda and Les and have met them several times.
There are two basic considerations for my investment here: the product and management. Up to the release of the publication, I was seriously considering selling my entire position and investing what proceeds I recovered elsewhere. I was extremely unhappy with management and with little news wrt to the product, I lost considerable confidence there too. You don't need to ride the same horse in order to recoup your investment.
Where am I now? The publication, though delayed and in a relatively low impact journal, presents remarkable data. Even considering the blended results as though they were treatment, I am greatly encouraged. I think the 2018 spring refresh will present even better results on top of what is already truly remarkable data. I can understand why there are 69 authors. I am not going to debate the implications of the results because as far as I am concerned I am convinced since the data speaks for itself. IMHO, naysayers are in denial. To me, the question is no longer whether DC VAX L will be approved but rather when. This depends upon a number of factors not the least of which is when the trial is concluded and the approval path(s) decided and pursued. Plus, of course, the time which the various regulators take in order to reach an approval decision.
I am further convinced that there will be great demand by patients and physicians. There are at least 68 of them who, in addition to Dr. Ashkans, are clamouring for the vaccine. With the more recent revelations about the toxicity of CIs and hyper-progression, there is no doubt that big P around the world will come knocking if only in an attempt to salvage their products. It is inevitable that at least one of big P will break ranks whether in China, Japan, Europe or the US, etc., in an attempt to control the solid tumour market. I firmly believe with the data in hand that this vaccine represents a new paradigm in the treatment of disease.
Management is a completely different story. LP is to be commended for being a visionary and steadfastly keeping the company going throughout this never ending trial. However, besides her vision and steadfastness, is she a good CEO? No, I don't think so. She lacks charisma, the aura of leadership as well as clear communication skills. I can say candidly that LP is a rather poor presenter and while English is a second language to Dr. Bosch, he runs rings around Linda as a presenter. A number of her actions were/are controversial and her judgement questionable. From what I have seen and heard from my meetings with her, she is perhaps not the greatest negotiator.
The inexplicable silence and contradictions which I have laid out in previous posts and which I am not going to repeat here have caused considerable damage to the value of the company.
Les is Linda's pit bull but unfortunately he provides a disservice to her. He says many things but he almost never delivers. His negotiating style is to outshout his opposition and change the direction of the debate. He never responds to a direct question. He never makes the other side feel that he gained anything but rather comes away brow beaten and frustrated. The end result is that no one really wants to talk to him, although he is, as a positive point, available whereas Linda is mostly not. Alton Boynton has said of Les that he is a good man and he means well...I leave it to you to come to your own conclusions.
The ASCO presentation was a huge missed opportunity. And certainly served as a jab to the FDA in a none too subtle push for approval. Whereas before, NWBO management remained silent for fear that anything they said might upset and prejudice the FDA against them. However, is this really true? Not at all, IMHO. A fellow investor, concerned about the silence attending the hold, called the FDA and asked whether NWBO was embargoed from talking about the hold. The FDA responded by saying absolutely not and that it was up to NWBO, and they were free to do so, to provide information about the hold. It was not up to the FDA. Anyway, this whole thing is inexplicable.
And silence caused great damage. AF, a political science major, who obviously knows next to nothing about the science, ran rings around a Harvard law magna cum laude and US government trade negotiator and a former senior partner of a top tier Wall Street law firm. Made them afraid to take him on. Caused them to retreat when he spanked them. Needless to say, he caused great damage.
The constant references to malevolent forces conspiring against NWBO by Les and the 100s of millions of naked short shares that he alleged were served up in an attempt to divert attention from management's own shortcomings. If this is so well known by Les and Linda, WTF did they do about it? Hire Cofer Black and pay him a nice bonus for what? Where is the announcement of the lawsuit that Les said was going to be revealed before ASCO? Well, these "business matters" were thought to be better delayed so as not to distract from the ASCO presentation at the industry theatre. What happen to Les' promise that updated information was going to be revealed as well at the ASCO presentation? This was not even mentioned among the delayed announcements that Linda "hoped" would be made in the coming weeks.
What happened to the company investigation to be concluded in 60-90 days? We are over 900 days now.
String of PRs that will blow the shorts out of the water and raise the pps so that we can finance upon better terms? Where have we heard all that before? Contradictions, unmet deadlines, inexplicable silence, a stay tuned mantra, questionable judgement and what appeared as self dealing transactions, SEC investigations, etc., etc.--inept management certainly and significantly contributed to the devastation in company value. It is this ineptness that surely enabled the degree of the shorts' success.
There was another company with a break through product platform that survived poor management. This was Apple before Steve Jobs returned and rescued the company. His predecessors were the three stooges: John Scully, Mike Spindler and Gil Amelio. Similar to NWBO. Breakthrough product platform but with two stooges leading the company. My bet is that LP/LG's amateurish management will be largely offset by the inevitability of the new paradigm product platform. One can hope that history repeats itself.
Lest MB members believe that I am not with the NWBO program, allow me to chant the company slogan: stay tuned.
Perhaps so. We do not know whether this pertains to NWBO's situation. However, I strongly believe that management's lack of transparency, inept marcom, failure to deliver, etc. has significantly contributed to the devastation of the value of the company. It is they who are largely responsible for turning good value into bad. I am sorry, but good management is aware of these conspiracies and should know how to handle them. That is why they get the big bucks/bonuses. We as investors expect results and not excuses and conspiracies. If there are, where is the long awaited lawsuit? What is the conclusion of the company investigation? What is the reason for the complete and utter silence? Why no cc's? Why limit questions at meetings to one question with little chance for follow up? Why has "NWBO" become a code for "stay tuned"? What are they so afraid of?
Les has said to me, specifically, that the end goal is to get approval. They do not want to be on the wrong side of the FDA. They do not want to incur FDA ill-will by appearing to try to influence the FDA and its independence from the court of public opinion. Make sense? Then why publish a pub and then have a presentation at ASCO by bringing on DC VAX patients who appeal to the emotion of public opinion? That does not appear as a vehicle in trying to push the FDA into an approval decision? If I were the FDA, I sure would think that it does. All the years in silence in service to being on the right side of the FDA perhaps dashed by this "put-up" conference. If Les really believed what he originally said, you would think that NWBO would lean on the side of caution. Better would have been to devote the presentation to the expansion of the article and its UPDATED DATA. The emotional appeal of patients and a doctor pleading for this vaccine's availability can certainly be interpreted as a non too subtle elbow in the FDA's ribs. Seems contradictory to me unless NWBO management is waking up to the fact that hardball needs to be played. And that Les can play his vaunted "trump" card(pun intended). We can only hope that NWBO management knows what it is doing. Stay tuned.
Oh Puleeeeeeze. Let's stop this silly discussion on what is meant by "few","several", "some", "handful", etc.
What about a "peer reviewed major publication" and publishing takes 6-9 months? They turn around within a month on the JTM. Crickets and we are all left to wonder and speculate.
What about the 90 day investigation conducted by the company?
What about the string of PRs Les said would becoming out in January a few years ago? How about the string of PRs leading up to the ASCO conference?
What about an announcement on the lawsuit against the manipulators that Les has been promising as one of the string of 4-5 PRs to several investors including myself?
What about the follow up at ASCO on the refresh data promised by Les to several investors including myself? Why no word as to when it will become available and communicated as an update?
What about the announcement of having reached 233 OS events which Les said was a material event? Again, he said this to several investors including me.
What about the wishy-washy statement by LP that " we HOPE to announce "business matters" within a few weeks? Another carrot dangling in an attempt to salve investors' disappointment at ASCO? Is one of these "business matters" another raise? If the presentation were geared to generate excitement on Wall Street, as one of the publication's objectives undoubtedly was, it had the obvious opposite effect. LP had a stellar chance to build excitement and raise the pps for what is sure to be yet another fund raising, now no doubt upon toxic terms. No wonder several large investors that I know are frankly pissed. And with good reason. She blew a major opportunity and again wasted money on a large booth with only depressed pps to show for it.
I could go on, on and on, on the over promises and undelivereds. On telephone discussions with Les, the conversation is always steered to nefarious forces and huge naked shorting. These forces are the ones responsible for the pps tanking. It has nothing to do with management lack of transparency. Just check all the material on the website Les exasperatingly declares at the end of a long winded and vitriolic telephone lecture. No, it is never the fault of management and there are good reasons for the "lack of transparency"..... just think about it and if you can't figure it out, I can't help you paraphrasing Les. Well obviously these materials have not gotten the message across to enough investors/Wall Street. Don't blame it on the investors. If what you have ain't working, change a losing game. Insofar as management is concerned, it is every body else's fault and not their's. That a poly-si major can run rings around a magna cum laude Harvard law graduate and a former senior partner of Sadden Arps is just inexplicable.
Bottom line, I believe that NWBO has done more to hurt themselves and their investors through their "turtle-like" withdrawal and excuses wrt transparency and failures to deliver. Les has never met a deadline that he liked. I believe in the science and I believe we are sitting on a pot of gold. Management ineptness is resulting more in turning treasure into fool's gold. Unfortunately, we are stuck with LP/LG and will never reach full potential as an investment. Unless, of course, they wakeup and start communicating. What are the odds of that before we go to single digits? Then, ultimately, approvals will result in the pps once again reaching current levels after successive toxic dilutions.
Sorry to vent. I am a long suffering long who is excited by the promise of this science, but highly disappointed in amateur hour management.
SPECULATIONS:
How many patients remain alive, what is the break down and what are the implications?
As of a year ago, Dr. Bosch indicated that there were a little more than 100 patients alive. Upon information and belief, the more precise number is 109 patients that were alive as of the 2017 spring refresh. Dr. Bosch also stated that the eventing rate was about 2 per month. It most probably has slowed down below that rate. If we assume this eventing rate, the number of patients still alive would be 85.
Assuming that mesenchymal accounts for about 40% of the trial population, we can estimate the breakdowns among mesenchymal/non-mesenchymal among the Tx, Xover and non-Xover groupings. Mesenchymal alone has been estimated to constitute between 30% and 50% of all stage IV glios. The mesenchymal grouping alone at 40% is likely to be conservative.
Applying the 40%, there are 132 mesenchymal patients out of a total of 331. The non-mesenchymal number of patients is then 199. The spread among three groups, Tx, Xover and non-Xover is as follows:
Tx: 88 mesenchymal(M) and 133 non-mesenchymal(NM). NM is further broken down between pro-neural(P) and non-proneural(NP). P is estimated to account for about 13%. Thus the breakdown is 28P and 105NP. Total Tx is 221 patients. Of the 88M, 55% are estimated to be alive as of spring refresh 2018 or 48 patients. Of the 133 P and NP patients, roughly 15% are expected to be alive or about 20 patients. Total Tx alive are 68 patients which comprises 31% of the total Tx group and 20.5% of the total of 331 patients.
Xover: 44 M and 33 NM. It is estimated that approximately 25% of M are still alive or 11 patients. It is estimated that 10% of the NM are still alive or 3 patients. Total Xover patients alive are 14 and this constitutes about 18% of the total Xover group and about 4% of the total of 331 patients.
Non-Xover: out of a total of 33 patients that did not cross over, about 10% or 3 patients are still alive and are probably all pro-neural out of a total of 15 such patients in that group. It is assumed that none of the pro-neutrals in this group crossed over.
Therefore: total patients alive are Tx(68) + Xover(14) + non-Xover(3)= 85 patients. Of the treated group--early plus late--of 82, this constitutes about 25% of the total of 331 patients and about 28% of the early plus late treated grouping of 298 patients.
In my earlier post where my mathematical model used a blended mOS of 23 months, a Tx of 25 months was estimated. With the foregoing breakdown of mesenchymal patients, mesenchymal Tx is estimated to be approximately 32 months. If the blended mOS moves further to the right as a result of 2018 data refresh, the numbers could be even better..
All IMHO.
I agree with most of your comments. However, the issue with Les/Linda has always been their inability to communicate properly even when they do. Obviously I am aware that there may be good reasons for why they do not address reasons for the hold and its lifting, etc., etc. However, as you point out they can do a much better job of communicating of where they are and the status of certain issues that they know have been long pending and outstanding.
Linda's alluding to a possible fall data collection is a case in point. In a MB exchange with BearTrap, I addressed this issue. I won't belabour it here but the point is that you never really know where Les and Linda stand. The constant railing about nefarious forces by Les every time I call him gets old and appears as an attempt to obfuscate issues as an excuse for lack of transparency. I know that others who have spoken with Les have encountered similar soliloquies. It gets old real fast.
Where is the publication? A response by Linda saying it's out of their hands is completely disingenuous. And her statements on time lines are clearly contradictory. It is certainly reasonable to surmise that the publication contains nothing earth shattering but is promising so stay tuned, yada, yada, yada. If the blinded data were that good, that "interesting", trust me, a top tier journal would pounce on it. We are talking about the "king of cancers" where little progress has been made in a fearsome fast killing disease with unacceptable alternatives. The best you can do is Temodar, Avastin, a helmet? Puhleeeeeze. I am certain that if, for example, blended mOS were 27-28 months and we are three times what Optune was at the same stage, the NEJM, Lancet, et al would be falling all over themselves to get the scoop. The apologia that I read on this MB and Linda's excuses on that "damned" publication are completely unconvincing. Rather, they engender doubts about how really good and "interesting" the data is. It might appeal to the medical community but not necessarily to the investing public at large/Wall Street. And the latter are very important if NWBO management wants to reach one of its objectives in releasing the publication in the first place---raising the pps. After the vote, how do you think investors would feel with another raise at today's closing price? Further, Les told a number of people including myself that the pub would be released shortly--within a week-- after the vote on April 27th. Here we are a month later and? Crickets. And don't get me started on the 90 days investigation fiasco. WTF has Cofer been doing to merit his bonus shares? There is a lot simmering to a boil and investors' patience and good will, large and small, are wearing thin. If Les and Linda believe they have a lengthy get out of jail card, they have a very weird sense of judgement.
Longfellow, I think you mean well and I follow your posts among a very few others. But it is time for NWBO management to produce. Bottom line, if NWBO is going to have the pub released, get it done NOW. No more "its out of our hands" excuses. And, the contents had better be compelling. Any less than that, management is not only shooting itself in the foot but also in the head. If they decide not to release because the data by now is stale, fine, but then tell us what they are gonna do without equivocation. They gotta deliver on top line at least before the end of this year if not sooner. I am sure other shareholders will join me in exclaiming enough is enough.
I try :)
Thank you Longfellow for your reply. It is quite late where I live and so I will try and respond to you tomorrow. Take care.
Cheers
BearTrap, thanks for the kind thought.
You did clarify, to some extent, Linda's comment by giving the contextual background. However, you cannot get a straight answer from either Linda or Les. Your statement that she did not take it off the table, implies that it is a possibility and that depending upon spring refresh 2018, they will make a decision on whether further data collection takes place. From your report, I take it as a "maybe but we hope not due to expense, delay, etc." That is different from a clear and decisive response that does not equivocate such as...the spring refresh is it. We are going to collect all the data and proceed to data lock. There will be no fall data collection... This is a clear message. This has always been the problem with Les and Linda and their lawyer like conditioned responses. You never really know where they stand.
Thanks for attending the special shareholders' meeting and reporting to the board. It is much appreciated.
Longfellow, good post. So why doesn't LP just say so. It is not betraying any confidences, but saying why they continue with the trial. That would allay much of the speculation and pushing for unblinding this trial prematurely. Complete silence is not the answer. Unfulfilled deliveries, e.g., 90 day investigation, publication, etc. do not engender support. They got their vote, their bonus shares, so where is the payback in a little communication? Les told a number of investors, first the vote and then shortly thereafter the pub. Its been a month and just crickets.
At least you spelled ignore correctly. There's that.
JRIII, you misunderstand my explanation wrt the publication or lack thereof.
I am, in effect, saying it is their fault. I believe that Bosch spoke out of turn concerning the pub. Linda confirmed this when she expressed dissatisfaction that it had been mentioned. They also knew the data points and their level of comfortability with them. The publication news was out of the bag. It took on a life of its own. No doubt, rather than playing it down, they certainly used it as a carrot, giving potential investors a peek under an NDA. The data was artfully "sold" by management, in all probability LG, in convincing fashion to gain investors and thus needed funding.
They realised the possible difference in reactions by the medical community familiar with these things and ordinary investors/WallStreet. As it turns out, the revelations of the blinded article were not so ground breaking as to compel a top line prestigious journal to publish at all or, much more, expeditiously. And...as time went on, the data became even more dated and presumably possessed less impact. Certainly not enough to engender a sustained rise in the share price. In fact, the less than groundbreaking data, where expectations were extremely high, could conceivably cause disappointment and actually tank the pps, an outcome clearly at odds with their initial objective. Thus it is quite conceivable that they did not push for publication. In fact, they may have, indeed, changed their minds about publication of less than groundbreaking data which is rather stale by now because it serves no useful purpose anymore and may, in fact, become a liability. So we may now never see a publication. As I said, an excuse is available. Blame it on the journal. Too much time has passed. Including 2018 refresh data would essentially constitute a de novo submission. No timeline would be set as it is "out of their hands." If there is any explanation by management, it would likely be.....Gee, Sh*t happens. That damn journal. It's too late. By the time an updated article is vetted and published, it will be time for top line data. Wouldn't that be preferable, they would say. Publication gone. Swept under the rug. In the dustbin of history. Time is bought once again.
While it may not be a ruse and be entirely innocent, investors would be sour and demand that the SEC specifically investigate possible manipulation by NWBO management in order to inveigle investor funding. And this veiled threat would be a good thing. NWBO can ill afford such accusations and threats now. They are between a rock and a hard place. The trade off may well be that a pub will not be forthcoming after all, but top line will be announced relatively soon. The spring refresh 2018 would be the final data collection and data lock would be forthcoming with top line data announcement in the late summer/early fall time frame. I think that this is a distinct possibility. The only other possibility which I think is less likely is that a pub with very compelling data comes out shortly. But the delay and silence would be inexplicable. My speculation herein above sounds more likely, at least to me. Either way, I think we get information soon. Silence is no longer golden.