Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
So, what happens when shareholders come and find out that there is no room at the inn? Why delay the ASM for the stated reason that it should give enough time to shareholders to plan their trip to attend? For example, if I planned to attend, I would be traveling from Japan. How do you think I would feel if, sorry, we cannot shoe horn you in because the conference room is too small. How about others? Wouldn't you have doubts about the sincerity of the invitation to.....please y'all come now, its gonna be an interesting hoe-down...only to be turned away at the door? If you have doubts about the sincerity of the invitation, wouldn't you likewise have doubts about "interesting"? Another bait and switch perhaps?
Sorry, Flip, I don't agree with you. Venue matters because of the PR issued by NWBO. JMHO.
I think that is bad news for reasons already stated in a previous post. Hope it is not true. Would make me question the very interesting/very exciting characterisation and the credibility of the PR invitation to all shareholders. That is unless they polled all shareholders and found out that not so many will attend.
Doc
Then how do you explain the classification in the intro to the iHub message board which classifies pro neural as M+ and MES as M-? Is that abstract wrong???
Further, isn't M+ longer lived? Isn't this due to interference with the cellular repair mechanism thus conferring longer survival? MES was considered highly aggressive in earlier studies by Liau and Prins, however due to its immunogenicity(more residual T-cells and less immunosuppressive micro-tumour environment), DC VAX L showed impressive results. What percent of MES is M+? What other molecular sub-groups are M+? Pro neural? If so, then how do you account for Prins' statement that the vaccine had little to no effect upon pro neural? He mentioned nothing about its association with M+ or whether it was G-cimp, etc.
BTW, the above referenced classification abstract is rather recent---February, 2018. I have raised these issues previously. Best wishes
Flipper44:
Venue does matter. The PR stated that the April 18th date was selected to give shareholders sufficient time to make plans to attend the ASM which should be an interesting meeting. The unmistakable implication is that:
1. Management thinks the meeting is important, and;
2. As many shareholders as possible should plan to attend. That's the reason for the almost 2 month lead-time.
If management, as in prior years, holds the ASM in its counsel's conference room, the invitation to shareholders and time granted were not really sincere but rather hollow and lame excuses to delay the ASM. Further, it would cast doubts about just how "interesting" the meeting should be. Rather, the venue, along with the proxy materials, should support the invitation to all shareholders and the importance of the meeting which "should be interesting." It has really nothing to do with "control" but rather with credibility. Do they mean what they say? In the past, management's promises and timelines have rarely if ever been met. Management has underscored the April 18/ASM event. They could have rather just announced that the meeting would be held on April 18 at their lawyer's address as in past years, period, if it were just a consideration of control. Rather, the clear implication of the PR and its invitation is to enlist shareholder support and that "we are all in it together, management and shareholders." It is a strong indication that management is turning over a new leaf and will finally share something interesting with its fellow shareholders.
In fact, though, one could argue that the PR really broke with NWBO's thus far strategy of keeping the nefarious forces guessing and then springing a trap. The PR now gives these forces somewhat of a heads up in that something will happen--interesting--on April 18 but the trap could be set at any time before that. Why not silence as usual and continue the enigma and speculation? Why say anything at all like "interesting"? Why explicitly exhort shareholders to attend rather than just announcing the ASM and signing off by saying...hope to see you there, Love and kisses, Linda and Les? It may be that any focus on the nefarious forces has finally taken a back seat. Good results are what will ultimately defeat these forces.
Another point is that NWBO is sure to have one more financing prior to the May 2, 2020 D-2 warrant expiration. Trust me, you can take that to the bank. The timing of the raise will depend upon urgency for funds. One would expect that a raise should take place after the ASM after the revelation of something very interesting/very exciting. However, if NWBO can't wait that long, the raise may take place shortly. It would not make much sense to raise funds, say, 10 days before the ASM. That would indicate poor fiscal planning and a plausible indication that perhaps nothing interesting at all will happen at the ASM. However, if a raise happens early next week, it could be argued that NWBO just could not wait and urgently needed the funds. The market appears to be expecting imminent funding and thus the recent tanking of the SP into the teens again. Hopefully, the SP takes the hit now and subsequently, without the financing overhang, a rebuilding of the SP leading into the ASM can take place and thereafter continued upward momentum due to the interesting result at the ASM.
Either way, it is critical, in terms of credibility, that LP delivers an "interesting" result at the ASM. As I have speculated in previous posts, the most interesting outcome leading to and at the ASM is top line data. Without it, as the gateway to other "interesting" things, nothing of real interest will emerge and the ASM, as in years past, will be a disappointment, indeed a discouragement. Even though LP and her minions may have effective control, she cannot risk the ire of fellow shareholders/internal support. This is management's last chance to restore credibility internally and externally to the marketplace.
Accordingly, the very strong implication of the PR is to do just that. To do otherwise, would fly in the face of the words of the PR. Yes, as lawyers, they could easily "parse" these words as carefully chosen, but the real implication is that once again, shareholders have been led on and then duped. I believe that management understands this, and certainly Dave Innes does having once been on the outside. Parsing won't cut it and maintain any credibility.
After all is said and done, I am cautiously optimistic that NWBO management will deliver. JMHO.
As I have said before, the only "interesting"(company PR announcing ASM), "very interesting with PRs"(shareholder telecon with LG) and "very exciting and very interesting"(another shareholder conversation with LG) relates to TLD. Absent TLD, there won't be any announcements involving BP or RA regulatory status updates. NWBO will not announce timelines for TLD and announcing "data lock" is anti-climatic especially on April 18th and could not be classified as "very interesting". Accordingly, anything short of announcing TLD between now and the ASM is not "interesting" because TLD is the gateway to all of this. No one will believe that all will be revealed at ASCO kicking the can yet further down the road from the ASM.
The PR was definitely signed off by management as a whole and not just by Dave Innes. The company was not compelled to issue this kind of a PR which is definitely "leading on" investors. They did it voluntarily. In essence, the company is saying that they have information that should be of interest(very interesting/very exciting according to LG) and that it is important enough that management is giving shareholders enough time to make plans to attend what should be an important event. If the meeting is not interesting, then shareholders will be disappointed again and will feel duped......and probably for the last time. It seems very obvious to me that NWBO management has drawn a line under April 18th and thus they have to deliver. They cannot disappoint yet once again. If they do, they will have absolutely zero credibility which will greatly and negatively affect their ability to raise funds and continuing significant support from shareholders among other things. A disappointing ASM will sour many investors and even engender threats of revolt. NWBO is certainly not planning to do a shuck n' jive at this ASM. It would be suicide IMHO.
In order to feel secure in issuing such a confident sounding PR(I really don't think it can be interpreted otherwise). I think the tea leaves suggest that the company already has data locked and even unblinded the trial and are using the time up to the ASM to put together TLD in its "undeniable" form. If there were bad news, they would need to announce it relatively immediately. If it is positive, they would have more leeway and the results would be very interesting/very exciting. Mediocre results certainly would not be. The revelation of TLD could happen at any time but more than likely near or on the eve of the ASM. It certainly would keep the shorts guessing and believing that once again, NWBO will disappoint, thus preserving the opportunity to catch them with their pants down.
In short, the PR, short and sweet, augurs IMHO very favourable news wrt to TLD which essentially is the only thing thing that is very interesting/exciting in and of itself and without which as a gateway nothing else could be interesting either.
If the results are as positive as longs believe them to be and meet the "undeniable" test as LG has averred in the past(continue the trial until results are undeniable), I believe the share price will take care of itself. I believe that corona virus or any other exogenous events will have little to no impact upon placing a lid upon the share price. BP, patients, doctors and the markets will quickly realise the dawning of a new medical paradigm that will have a significant impact upon, at the very least, a deadly and agonising disease that is one of the most difficult cancers to treat if not all solid tumours and has severely limited alternatives. I believe BP, in self interest, will pursue NWBO aggressively depending, of course, upon the quality of results.
IMHO, the PR announcing the ASM seems to be a very strong hint that NWBO has the goods which will be revealed between now and the ASM. If not, I cannot imagine what else could be "interesting" enough to take up valuable investor time in attending the ASM. I don't see that anything else exciting or interesting---for investors---could be revealed unless TLD is announced. Enough with kicking the can any further down the road. Death and suffering do not take a holiday. JMHO.
Waiting for news of the venue---Watergate Ballroom per chance?
Indeed, there are many branching universes in Everett's multiverse. Which one is real is the conundrum. Or are they all real? Courtesy of Everett's PhD advisor John Archibald Wheeler.
With unveiling, the cat will either be alive or dead. Right now, the cat is in a superposition state and is both alive and dead. Anyway, let's hope there is at least a dead cat bounce to the pps between now and the ASM where the wave function hopefully collapses with a live cat in our universe. LOL. With attribution to Erwin Shrodinger who is not, unfortunately, a shareholder in NWBO.
Wild speculation. If LP steps aside in favour of Dr. Duffy at the eleventh hour after all these years she has put in, that sends a powerful signal that the trial has either failed or the results are mediocre at best. Not much value for Dr. Duffy to shop. I doubt very much that LP will step aside at this point. That is like admitting defeat. She is not a quitter.
I don't know what "interesting" or "very interesting" means. It may be interesting but have no to negative effect on the share price, but interesting never-the-less.
Bottom line, LP/LG have come to the end of the line. What counts is TLD and "very interesting" meaning stellar results. If they have not unblinded by the time of the ASM, I am quite certain they won't announce a partnership or other collaboration.
To long suffering investors, the only thing that is very exciting/very interesting is TLD. Everything else follows that. LP and LG know this. They also know that the string has run out and they can't shuck n' jive anymore. They have drawn the line at the ASM. Big P, at this point, is not going to do anything until TLD is revealed. Everything hinges on TLD. Other than that nothing is "very interesting and exciting".
Since LP scheduled the ASM for April 18th, two months hence, so that shareholders could make plans to be present, I wonder about the venue of the meeting. Surely, it will not be held at their lawyers' conference room as in years past. If it is the latter venue, you can bet its more of the same shuck n' jive. Shareholders are in no mood to "stay tuned" anymore and I think after the ASM announcement wrt to "interesting" and wanting as many shareholders as possible attending the meeting, LP has got to produce. I think there will be great disappointment if TLD is not announced by then. It is my feeling that if TLD is not announced prior to or at the ASM, a date certain thereafter won't be announced either. Keeping true to their strategy, NWBO will not want to telegraph to nefarious forces such a date if they want to catch them with their pants down. Between now and the ASM is the time to do so if there are nefarious forces at work as LG has consistently averred. If LP disappoints yet again at the ASM, raising money will be difficult and very toxic. What credibility management had will be gone with a blown, bottom line and stay tuned ASM. No doubt, LP/LG understand this very well.
Accordingly, I feel fairly optimistic that "very interesting and exciting" means TLD and well timed PRs/filings. JMHO.
IMHO, the published guidelines already reflect the direction and thinking of the FDA. These guidelines formalise what the FDA is already using and going to apply going forward. Hence, I do not believe that NWBO plans to withhold release of TLD pending adoption.
In any event, I believe these guidelines will be adopted by the time the FDA makes an approval determination. I further believe that NWBO regards these guidelines as a kind of "insurance" for greater regulatory flexibility in dealing with issues of cross-over/confoundment and immunological approaches. I believe that the trial itself will, overall, be successful and approved on its own merits and that these guidelines are the icing on the cake. I don't think, for one minute, that NWBO believes that without these guidelines it cannot gain approval. Rather the guidelines are helpful but NWBO can deliver undeniable results as Les has explicitly stated. JMHO.
Thank you for your response. Makes a lot of sense.
Sounds very encouraging.
You also have made a very broad statement stated as a fact that the....."scientific community, particularly the glio set are salivating...." Just curious and not questioning the veracity but how do you know this? Have you taken a poll? I presume by scientific community you mean more than the 69 authors of the JTM article, the NWNO SAB and the medical centre where you work and which is a site for the trial.
No, it is you who are interpreting it that way. Les referred to the "draft" guidelines as being helpful to NWBO where cross-over would be a non-issue. He mentioned a 60 day comment period and said it was important for people to comment in support thereof. Point, period, end of conversation on that situation.
I did not find that conversation contradicting DI. I did not interpret these comments in the way you have. All I did was to report a conversation without interjecting an opinion. Some posters choose to ignore and give little to no credence or importance to these phone exchanges. With all due respect, I don't agree with you
Sentiment:
Of course I am concerned about these forces. My point, which you understand but Flipper appears not to, is that whether or not there is stat sig wrt control(including crossover)/Tx, it is a positive outcome either way. Personally, I believe that while there may be some benefit, though not significant, from late vaccination, there will still be stat sig separation. But the important point he made were wrt to those "forces". I believe he is correct to be concerned as I am.
A waste of time to argue with you. As Burger King says....have it your way.
Peace and good nite.
That is one way to look at it. However, I don't think big P's resistance would necessarily be evidenced by a commentary section. They likely operate clandestinely behind the curtain in twisting the arm of the regulator. I do agree that we should support the guidelines by thoughtful comments. JMHO.
Gee, learning what a great suggestion. But I ain't gonna call Les again, well, because Flip sex he is a liar(Aussie pronunciation for lawyer) and by extension not trustworthy. Why don't you call him and recommend directly? Takes out the middle-man. Good luck. LOL.
The ultimate cure where the cancer dies with you. Sorry if this is a bad joke but I jest could not resist. My sincere apologies.
This was said by Dr. Bosch at a September, 2018(if I am not mistaken on the year) conference in Boston. He also mentioned SoS in tandem with Bohsie.
Sez you. LOL.
Of course, you are right. We are all frustrated. Even Flip. I think he/she has gone off the rails a bit but this poster does have some valuable insights. It is a tough time for everybody who believes strongly in the science and its value as an investment and of course in the fight against cancer. Seeing the SP erode daily is no fun and as Biosect has correctly stated, this is not for everyone. While I am relatively confident in my DD and conviction, I must admit I do second guess myself upon occasion. Bottom-line, I am extremely confident in the outcome.
The fact that the FDA has come out with these guidelines demonstrates the direction they would like to go and the thinking they will use in reaching determinations. The FDA seems to be using these guidelines and may continue to do so in spite of ad hominem opposition. It just makes sense. In the end, if the FDA wants to approve, they will find a way. The guidelines indicate their current thinking going forward. NWBO does not need to wait for formal adoption of the guidelines. It is enough now. JMHO.
Hopefully, the delay in announcing the ASM is a harbinger of good things to come.
Les advocates that all those who favour the FDA guidance write in comments in support. It will help to counterbalance and hopefully outweigh big P's opposition and strategies for delay.
One interesting comment that he did make was that if the guidelines are adopted, the cross-over issue won't matter. This will help NWBO.
Seems to me that although blinded, NWBO has a real concern with this and that there may be more than a possibility that this endpoint was not statistically significant and/or the endpoint was not achieved. I had mentioned to Les that regardless of whether there were significant separation or not, it was still a win situation. In the former, good for the trial. In the latter, suggestive that in cases of rGBM even without a second resection with updated antigens, there still is efficacy, but perhaps less than would be in the case of early vaccination. Late vaccination upon recurrence would still confer some efficacious benefit and perhaps even more so with a resection. Les's response was that there are constituencies who insist upon achievement of the trial parameters even though something new and perhaps unanticipated has occurred for the good of all patients--- requiring yet another trial. Hence, the guidelines, if adopted, would aid in NWBO's quest for approval by making cross-over a non-issue. This was my understanding.
I do hope that those on the board who support NWBO write in comments and spread the word. It would be especially helpful if MB members like Iwasdiver, Hopefulsurgonc and other physicians would encourage their networks to provide supportive comments. JMHO.
As someone who has been deeply affected by GBM and might have benefitted from a much more flexible and expeditious regulatory approach, I will write a supportive comment. I encourage others to do the same. GLTA.
Did it ever occur to you that Les used our phone call as a vehicle to broadcast to the shorts NWBO's strategies/timelines as a diversion and then....surprise. After all, you said Les is a liar.
Why ask me? Why don't you ask Les? Geeeeeeeze.
You are preaching to the choir----and then there is Flipper.
These interpretations are according to you, not me.
Hi Meirluc:
I tried to report the conversation as accurately as I could. There were a number of interruptions where he answered other phone calls and he does speak rather quickly. I have not inferred anything. I just reported what I heard and quite a few MB members have taken umbrage and implying that the conversation never took place or LG could not have said that for this and that reason or Les is a liar, DI is Leslite and they are playing good cop/bad cop, manipulation, you have been handled---take your pick.
You would think that you are doing a favour to the board by sharing info and then making your own judgements rather than calling people names(hayseed) or implying that maybe the phone call was a hoax or the contents of the conversation were falsely reported.
I know that there is a lot of frustration and I sure as heck would like TLD much sooner than later and get this over. I am tired of hearing sell and move on from my wife, fellow former investors, relatives and my own broker who got me into this in the first place. I made the same move on AVNR selling at around $2/share against my better judgement and then relatively shortly thereafter, the company gets bought out at $17. Frankly, I don't know what the hold up is but I don't think it is a scam. I think management has a similar perspective as Bhosie's SA article but much more in depth due to the professionals, SAB, etc NWBO has access to. Les never brought up scam. He was responding to a statement I made where I said that some people think that by being silent, you have something to hide, a scam. He replied as I reported the gist of which is---believe what you want and he does not have to scam to make money easier and legitimately. WTF is wrong with that response? Geeeeeeeze. I am sorry I ever posted this in the first place. You can be sure I won't make that mistake again. Anyway, good luck to you.
I did not post. I sold too early. Got too impatient. Don't want to do this again with NWBO. Just like NWBO, many naysayers, doom and gloom, etc. and I made the mistake of listening to them. They won, I lost despite my DD and belief. Not gonna happen with NWBO which is different in kind from AVNR, not just degree.
Yes, I agree with your thoughts. It's pretty clear in talking with Les that there is a vendetta. He calls them "terrorists". It sounds like business AND very personal.
The idea of releasing TLD and "stupendous" news in one fell swoop surprise is to provide an overwhelming upsurge which just cannot be contained by shorting. Piecemeal release does not provide such a knock out blow. Les emphasised that big P are diametrically opposed to the new guidance. During the 60 day comment period comments supporting it need to be submitted in volume in order to drown out big P objections. Shameful and big P are showing their true colours. Keep selling drugs that are relatively ineffective so they can continue to sell them and keep the revenue stream. Disease is big P's business. Cures are anathema.
What are they and when?
Really? How do you what he means? Did you ask him?
Abeta:
Les would not provide additional info or clarification on that statement. It is not necessarily indicative that the SAP was submitted or approved. It could very well mean that NWBO was satisfied with their version, meaning draft, and that everybody including the SAB finally came together. They had many individuals working on the SAP and it was a "ginormous task" to get it accomplished where everyone on a big team agreed and accepted the draft version to be submitted to the 4 RAs. Who knows but at the very least, management was very pleased with the draft and felt that all the bases were covered. It could also mean that it was submitted and the RA review completed(with or without comment). If it is true that NWBO knows when TLD will be released, and they are not saying, then the SAP process may have been completed and TLD could come out at any time. Keep them guessing NWBO style! JMHO.
Just reporting what I heard. You make the judgement. Instead of belly-aching on the MB, which gets you nowhere, why don't you interrogate Les and make your suggestions?
That bodes well for success of DC VAX L and a long robust tail. According to the interim article on blinded results, methylated showed impressive results. Out of the ITT total population, methylated comprised about 40% and nearly 45 % of the group that could be classified(N=293). If MES does not significantly overlap methylated, and this molecular sub-group is a relatively large proportion of the GBM stage IV population ranging anywhere from 25%~48%, it may be reasonable to speculate that for at least 50% of the entire population, DC VAX L is highly efficacious. I mentioned this to Les in my telephone conversation and Les said that it gets better than that and they have found that the vaccine works across the entire spectrum. I understood Les to say that MES is separate from the methylated group. Thus it would be additive to methylated. And....MES is most aggressive with least promising outcome on current SOC. This appears to be highly encouraging. It appears entirely reasonable that DC VAX L works particularly well in these two sub-groups, M+ and MES, since in the former, DC VAX L builds upon the Temodar destruction of cellular repair mechanism and that MES is immunogenic with higher levels of T-cells to build upon and a much less suppressive tumour micro-environment allowing more time for T-cell, etc. infiltration before immune response shut down.
I did ask Les when we would get TLD. He told me that NWBO will not specify any timeline. He intimated, but did not specifically declare, that they know when TLD will be released. When I asked whether he could reveal the number of patients still alive as they had previously, he said that now, so close to TLD, they will not release piecemeal information just to mollify frustrated shareholders. They want to release "stupendous"(yes, he used that exact word) information all at once and to catch the shorts unaware. NWBO knows who they are and have amassed considerable and compelling evidence. He said releasing piecemeal good news only gives the shorts opportunities to prepare and short. Releasing "stupendous" information in one fell swoop is what they want to do and will not give any timeline guidance so as to catch them unawares. Management also does not want to run afoul of the SEC by "cherry picking" piecemeal information. Les said that we are on the 3 yard line and they are not going to fumble the ball. They have come too far to risk that so silence, no matter how frustrating it may be and regardless of the share price lack of support, is the strategy they are following until the appropriate time.
He said that the recent FDA statement is highly encouraging for NWBO and there is a 60 day comment period. According to his information, big P is fighting against policy adoption and he wants to get as many people, organisations, etc to comment in support of the guidelines. Les specifically said that if the FDA follows these guidelines, cross-over is no longer an issue. I responded by saying that it should not be an issue anyway. If separation occurs then that is good for the trial depending upon the amount of curve separation. If there is none, it is good for patients, shows powerful efficacy in recurrent GBM even without second resection. So that would be good. He agreed but said that there are forces that will strongly support the letter of the trial parameters and throw the baby out with the bathwater. I am paraphrasing here. I said that is ridiculous but he adamantly said that there are such forces that advocate such perspectives and while "you and I may think it ridiculous, it is just an opinion no matter how reasonable we think it may be." The whole thing is very complicated and frought with landmines-- political, financial and what not--and that is why they need to be meticulously careful. Silence, for now, is the best policy. I responded by saying that many investors, naysayers, etc. interpret silence as hiding something, a scam. Les responded by saying..."you can believe what you want but trust me, there are many different ways for me to make a lot more money legitimately. Why would I risk everything I have worked for to engage in a simple and stupid scam. The spotlight is on us. But if you want to believe I am engaging in a scam, the BOD are aiding and abetting it and the SAB is in on it too, go ahead."
He acknowledged that the SAP took longer than anticipated but that they are extremely pleased with the outcome. He sounded extremely confident. He said that they are going to be extremely careful and make sure everything is right, including timing, before TLD. If it takes another month or so, that is what they will do. I responded, tongue in cheek, "look take all the time you need. I want you to get it right. Rather take two months." Les said "you are close and that is all I am going to say."
There were other topics of conversation which I will keep private.
This is a report of a conversation; judge for yourselves.
Exactly, and confirms my telephone discussion with Les. No big deal and the FUDsters(Les calls them terrorists) are trying to create a mountain out of a molehill. Geeeeeze.
Why do you say that? What evidence do you have? I addressed that very question with Les Goldman in a telephone conversation reported yesterday. Nothing could be further from the truth. Unless, of course, Les is lying. His explanation contained in my post was reasonable. LL and her colleagues have conducted trials "independent" of NWBO using variants and tweaking the vaccine in order to improve its efficacy and reach over the entire spectrum of brain cancers. They are scientists. They are well funded to do research. It's what they do. NWBO supports and encourages this activity. It is nothing new and only those who want to create FUD come out with baseless comments like yours devoid of any evidence but rather unfounded opinion. That is what is sad. JMHO.
I spoke with Les Goldman today. He made clear that NWBO has nothing to do with this clinical trial. UCLA is using a DC VAX variant. Les said that UCLA--LL and RP--are scientists. UCLA is very well funded for scientific research. Throughout the conduct of the DC VAX L trial, UCLA has conducted a number of these "independent" trials--and with NWBO blessing. LL knows DC VAX works but it is not a cure. It does not work equally well across all cancer types and so, as a scientist, she is looking for answers and improving what they have so far. This clinical trial is the latest in a series of trials UCLA has conducted over the years. There is no competition or distancing away from NWBO. This trial is business as usual following a similar pattern as in prior years. These variants are "tweaks" and so far, there has not been significant progress in developing a better mouse trap. No worries as Les has declared that.."we are many years ahead of them with a potentially commercialised product." FWIW.
Quite a separation in years between the group of Gonzales(won Forest Hills in 1949), Rod Laver(Calendar Grand Slams in 1962-1969), John Newcomb(late 60s and 1970s)---and Fred Perry(1930s and a peer of Don Budge). Never saw Fred Perry play but did catch all the others and was in the Forest Hills Pavillion watching the Laver-Roche final in 1969 which Laver won in 4 sets to clinch his second calendar grand slam. Gonzales was the best of them all and in his prime nobody could beat him including Kramer, Trabert and Lew Hoad who came close to winning a calendar grand slam only to lose to Ken Rosewall in the 1957 final at Forest Hills . Tony Roche was a peer of Newcomb's and would have been great but for his elbow troubles which caused him to retire prematurely. Roy Emerson won 12 grand slam singles titles only because the tough competition, i.e., Laver, were pros at the time and could not play in shamature events.
What motivation do LP and LG have to engage in a scam? Especially at their age? They are both very wealthy. There are much easier ways for them to make money and legitimately rather than risk everything to engage in a scam especially with the spotlight upon them.
There is a prestigious SAB and at least 69 supporters. Are Drs. LL and Ashkans in on the scam?
Did LP/LG pull the wool over some pretty smart people including Judges? What did the SEC find after all these years?
I suppose anything is possible and they are insane with greed. However, the probability is certainly nil. It makes no sense. I think the science is solid and legitimate. Apparently, some very smart professionals think so too.
It may be entertaining to engage in statistical masturbation on the MB, but there is no one on this board who is credible and a professional statistician--at least as far as I am aware. I am certain that LP/LG have some PhDs and very experienced statisticians who do this for a living and who they pay very well. NWBO has been extremely careful when dealing with the regulators. It is relatively easy for an agency to issue the dreaded CRL letter unless the data and the way it is presented is undeniable. Since they have orphan status, I am certain that NWBO and the RAs have had continuing discussions and "guidance".
Furthermore, I don't agree that NCVR is a scam either. Obviously, the data is not as rich as data from the DC VAX L trial. The bar for Optune approval was lower considering the intractability of the disease and the fact that there was no significant progress since 2005. Better surgical techniques/SOC may have added some little time. Patients deserve a viable alternative to a helmet and the blinded results from the DC VAX L trial look at least as good as the Optune Tx. Unless there is something that is terribly out of kilter at this stage, I think it is fair to say that the odds favour approval and hopefully relatively expeditiously.
Scams? I think that is nonsense. JMHO.
Doc:
Thanks for responding. Again, my point, to summarise, was that in either case, it should be a win-win situation:
1. Case 1: Late vaccination, absent resection, for cross-overs does not confer benefit or it is at most de minimus. Good for trial as a comparison arm and should for all intents and purposes mirror placebo/SOC.
2. Case 2: Same as above, but benefit shown and separation of curves blurred/non-significant. Not good for trial but good for patients where even though later vaccination upon occurrence and few if any resections, the vaccine is still relatively effective. The later vaccination would have perhaps been even more effective had a new sample through a resection been obtained. This may be especially so if the recurrent cancer is the most aggressive kind, which appears to be the case in recurrence, and has morphed into MES where LL/RP have found the the vaccine to be especially effective given that MES is more "immunogenic".
Thus, it would be a win-win in either case and I would argue that one could not ignore the benefits of a case 2 scenario. Having said that, I do agree that case 1 may be more likely and depending upon your perspective, rather disappointing although rather suspected. JMHO.
Doc:
I tend to agree that the crossovers in this trial probably did not benefit except perhaps to a minor degree. However, suppose that there is more than minimal benefit to the crossovers. While it may not be good for the trial it would suggest the very broad and powerful efficacy of DC VAX L extending to recurrent GBM despite the fact that very few crossover patients had a second resection. This would be a good thing.