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Hi Marzan:
I did not say that Meng was given DC VAX D. I had heard---not confirmed---that she allegedly had or has cancer. I have no knowledge of the type if this allegation is true. I don't know if she underwent DC VAX therapy. I speculated that it was possible in searching for cancer therapies, she or Huawei personnel may have stumbled upon NWBO which thus led to a possible relationship and the scenario I sketched out. But this is by no means the only way that NWBO and Huawei may have gotten together.
For whatever reason they did. That is a fact. That there was a transaction between them is a fact. That the deal is a sweet heart deal seems very apparent.
Question is why Huawei? Thus my speculation.
I believe, though not a fact, that there is more under the covers than just a real estate transaction. And Huawei is dominant in China and has links into the government. If it wants to make a run in the fight against cancer, it can get what it needs in China. That market is a powerful and unparalleled launching pad. NWBO has the tech and Huawei has the market and chinese government at its back. That is all the partnering they need. Huawei does not need Astra or anybody else in the world to help them penetrate the markets. They have a world market in China. The world will come to Huawei, not the other way around. It is Huawei's dominance, influence, ties with the government and research capabilities that allows it to pursue huge markets. Cancer and immunology are potentially huge. And not just cancer......helping the immune system fight ALL diseases. If I can imagine it, and I am not that smart, certainly it is not lost on Huawei which may have stumbled upon this and became highly opportunistic after DD with NWBO and others as I mentioned in my earlier post.
Some speculate that it might have been better had big P been the "partner". But maybe this was not what LP wanted. Huawei might easily agree to let LP continue to call the shots because she knows what she is doing and Huawei will provide the leverage and support in marketing it first in China which is the strategic master key and then on to worldwide. Not much of an investment for such a huge return and geo-political influence for Huawei and the Chinese government. Not much selling to do. Government approval in China is automatic success. Obviously this will be coupled with extreme demand wrt a deadly horrible disease. There may not have been any other partner candidate and so Huawei and NWBO, without any other available or interested dance partners, decided "what the hey, why don't we dance?" And, opportunistically, that is exactly what they did. JMHO.
Depends upon who is requesting approval and the chinese government's strategic plans. You ever work in China?
Could be although NWBO does not have any valuable technology now. No proof it works. If that is so, NWBO is a very small company, no real worthwhile assets, just a promise of same(that and $3.00 will get you a ticket on the NYC subways), nobody cares. Do you need government approval for a sale of a company with no real or confirmed value? Mebbe not.
But mebbe LP moves the company lock stock and barrel to the UK on the 17 acres she retained or the leasehold and does an acquisition deal there where the laws are perhaps different. Remember, LP/LG are lawyers. They should be able to engineer a path. JMHO. But big P should now wake up. This is why the Huawei deal is so interesting from a number of aspects. Don't think it is a straight RE deal. JMHO.
The "transaction" involving Huawei appears to be perplexing especially when one considers that this was a sweet heart deal for reasons that are not apparent at first blush.
Allow me to speculate. This may be off the wall, but please indulge me.
Who is Huawei? It is a private and huge ICT company with a dominant market position in China. In summary, it is the SoftBank, Samsung, Ericsson, Nokia, ATT, Verizon, etc. of China. It is a telecoms enabler and device provider. It sells more smartphones than Apple and it is not even in the US market. Very few have ever heard of Huawei even though it has a leading advantage and dominance in 5G technology. Its annual revenues are close to $100 billion and it employs about 180,000 world wide. It sells personal computers, network switching devices, peripheral networking devices, security/surveilliance systems, software development, AI, etc. It is a fully integrated ICT company. It does have a connection into the medical/healthcare/science arena as it develops and provides specific integrative AI and networking applications for these sectors. Its connection into bio-tech is through the development of gene sequencing/testing applications. Just like a number of large ICT companies such as Samsung, Huawei is looking to branch out and enter/dominate huge and strategic world markets even though they may not be directly in its current orbit of business.
The US (Trump administration) government considers Huawei a threat due to its 5G dominance and security expertise and that as a large well funded company, the Chinese government may have engaged it in espionage activities. Of course, the tariff tiff between China and the US may easily have engendered espionage allegations swirling around the company. This could be nothing more than a politically motivated stance.
The connection between NWBO and Huawei may have had its origin in the fact that Huawei's founder's daughter was at least alleged to have had(or have) cancer. It is possible that through research, Huawei stumbled upon NWBO and became intrigued by the science and platform. They may have contacted and spoken at length with Linda Liau and her colleagues at UCLA in order to get a better feel for the science as well as with Dr. Bosch and Dr. Ashkans in the UK. Huawei already has two locations in the Cambridge area for Huawei Research and Technology UK and Huawei Sciences so contact with Dr. Ashkans could have been easily arranged.
The solid tumour market is huge at about $100 billion world-wide. Control and dominance in this market would confer extraordinary leverage for financial and geo-political pay-offs. Imagine the leverage Huawei AND the chinese government would have in dominating at least two major world markets: Solid tumour cancers and the ICT sector including smartphones.
This is where NWBO comes in. And the sweet heart deal worked out by NWBO and Huawei is a win-win transaction for all concerned. For NWBO, the win is obvious. For peanuts(to Huawei considering its financial largesse), Huawei gets to dip its toes in this market with virtually no risk. If the results are successful, Huawei will get to at least partner if not buy out NWBO completely. For Huawei, they could easily make an offer that would be agreeable to NWBO given their financial resources and the backing of the chinese government. If the results signal failure--no big deal. Huawei has property whose value would largely offset what they paid for it in the coming years or use it for their own expansion plans.
And....most importantly, Huawei would use the chinese brain cancer market as its launching pad. It really does not need to depend upon world markets. It could easily obtain chinese regulatory approvals and rapidly penetrate the market which is perhaps larger than all other world markets combined. It could also obtain reg approvals for other solid tumour indications. With its powerful market dominance in China it could outcompete anybody anywhere and hold governments/patients hostage to the Chinese government's purposes. It would have economies of scale no one else could muster. This would be a huge geo-political win for the chinese government and Huawei. The financial implications for NWBO are superlative if this is the true scenario behind the Sawston deal which, at first blush, looks like just a real estate deal. And doing the deal in the UK to raise money and not the US and cloaking the deal as nothing more than a real estate deal to most observers, provides cover for prying government eyes. NWBO may find itself in the catbird seat due to this deal and "force" the US government to"push" a BP or consortium thereof to BO NWBO so as to prevent foreign company/government control. These may be very interesting times if my speculation is even close.
Of course, this imagined scenario would not or should not escape the US government's notice that it may portend a clandestine and infectious advancement and infiltration of Chinese interests. Of course, the US government would probably wake up to this threat upon unblinding or later which is now under the radar screen because results have not been unveiled. Given the fact that the US government might be prone to interfere with a partnership or BO post unblinding, it may be to both NWBO's and Huawei's advantage to seal a deal before unblinding. This could be the reason to let the trial go on a bit longer, to say the 45th month mark, not necessarily for US approvals but to seal a deal with Huawei with their increased confidence as a result BEFORE any public unveiling. In the meantime, terms of agreement details could be negotiated and worked out.
I like the possibilities. JMHO.
Dr. Liau as the principal investigator needs to be circumspect. Essentially she is the inventor of DC VAX and gushing praise from her would be highly unprofessional. After all, what did professionals Dr. Hojo or Dr. Allison say about CIs(Opdivo) prior to receiving the Nobel?
I believe LL said it all when she stated that DC VAX is her greatest achievement. She would not have been the spokesman for updated info at SNO where she received an award if she did not see efficacy in a clinical environment. She is a professional and it is highly meaningful when she says that all patients seem to be living longer. That is as far as she goes prior to unblinding/approval. Further, 69 doctors signing on to the publication speaks volumes--at least to me. Dr. Ashkan, the lead PI in the UK, could not contain his enthusiasm for the vaccine. He has witnessed it in a clinical setting. He is not an idiot and backing some snake oil blended with grapefruit juice elixir. Why risk his reputation on something like this if he were not reasonably convinced about its efficacy from what he has seen?
There are certainly some physicians who are skeptical. Drs. Stupp and Fine come immediately to mind. However, and essentially, their arguments are based upon prematurely releasing blinded data where conclusions cannot be drawn, pretty much the same as Dr. Buzdar, whose earlier comments were based upon ignorance and were disingenuous. Well, duhhhhhhhhh........
I don't know about you but from what I see from all the info out there, the odds that DC VAX is efficacious at least for some sub groupings of glio are quite favourable. I would now bet on approval rather than not.
Insofar as management is concerned, I am not a fan of LP and LG. I can only rate LP's management so far as D-. She has not received an F because the company/trial has not failed. But, the MC has declined over 95%, which is obviously excessive, on her watch regardless of all the excuses. She may have been a victim of circumstances but this fact is what it is. CEOs are paid to deal successfully with the circumstances at hand. Perhaps another management team could not have done any better. We don't know and it is irrelevant anyway. However, to be fair, the jury is out until results and we hopefully learn the reasons for the lack of transparency and management conduct which obviously contributed to the MC devastation at least to some degree.
I also believe that the BOD has to some extent abrogated its fiduciary duties towards all shareholders by rubber stamping the option pools for management and employees. Bonuses are for performance results. Right now, it is highly premature. We don't know results and whether management can achieve the prime objective of RA approvals. I don't mind paying out handsome bonuses for performance results. I do mind paying them out pre-maturely.
In a sense, NWBO is a little like Apple. Apple had great products and despite the abysmal management and leadership of managers like John Scully, Mike Spindler and Gil Amelio, Apple survived and was taken to new heights by Jobs and now Tim Cook. I know---I was there. So, too, with NWBO. From what I see, the product platform and strategic direction seem great. Odds are DC VAX works across a significant spectrum of glial cancers to a greater or lesser degree. For some it may be a virtual cure. For others a chronic disease that can be managed. And for still others, some additional lease on life with the hope that further improvements or combos may prolong it even more with at least good QOL. And at a reasonable price point as compared to other therapies. That's the bet I am making despite questionable management where the jury is still out. JMHO.
Or everybody is unrelated.
Could also be the other way around.
Unrelated third parties: they are unrelated to each other but may or may not be related to NWBO.
Doc:
Legally binding date? That will never happen, trust me. LP is not that stupid and any timelines she discusses will be accompanied by CYA caveats. IMHO, it is very naive to believe LP would ever make any definitive commitment. This is par for the course when management is run especially by lawyers who are always looking to limit/avoid liability. JMHO.
The only peek that counts when big money is at stake is unblinded data, regardless of how promising blended data is. If they got a peek at unblinded data, it is a reportable event. Hence not likely, otherwise NWBO would have had to announce it.
More likely is Sawston although it looks like they are having issues thus delaying any sale. They may do another mini-bridge and if Sawston falls through, they may need to unblind and get the best deal they can while doing still another dilutive bridge. JMHO.
Yes, there was. But even she said that criteria other than those related to chemo/rad type endpoints should be used for immunological approaches. She also said that all patients are living longer which may be good for the patients but not so much for our trial in lessons learned. Of course, she thinks DC VAX is efficacious and has said that a way should be found to approve it, or words to that effect.
Accordingly, she shares LP's view that the regulatory pathway is not clear and a new one should be "pioneered". However, this is an admission that the endpoints may not be met. In which case a convincing marker should be used. Thus, the long tail. The idea being that current SOC (resection- chemo/rad) treats the front end and the adjuvant DC VAX treats the back end(long tail) for a new SOC paradigm. Thus, the emphasis on a long tail home-run to confirm DC VAX's value in the new SOC paradigm. Essentially, PFS as a surrogate is not highly relevant here. Neither is mOS or even overall OS. If the long tail sufficiently covers a significant spectrum of glial cancers which are highly heterogeneous and gives hope for 1 in 3 to be alive after 36 months and 1 out of 5 to be alive after 60 months as opposed to 1 in 20, then the therapy should be approved. If the numbers are even better, that increases odds of approval. That's the pathway being pursued by NWBO, and it wants the numbers to be undeniable just in case the primary/secondary end points are not. However, it is not the usual pathway and thus a different pathway more attuned to immunological approaches is being pioneered. That is why it is a good reason to continue the trial while appeasing anxious shareholders with a data-lock statement devoid of a date in order to buy more time. We are not yet at the end. Hopefully, it will be in 2019. Stay tuned.
My premise is that big P will do nothing unless and until they get a peek under the covers. They will pay neither a high or low price or any price in-between for reasons that are obvious and which I have stated a number of times.
LP not setting a date for data-lock, giving an inordinately long process time to unblinding, declaring that there are good reasons for continuing the trial, not making full disclosure on the spring refresh, no set date on the ASM, silence on business announcements not weeks but 6 months and counting since ASCO 2018 are of great concern and thus the vacillation in the pps. November has come and gone and it appears ditto for December with empty NWBO stockings for all except LP and friends.
I am long with a significant stake but the evergreen options pool and warrant grab is disgusting. I am all for incentive compensation, but LP/LG thus far have not earned it. Rather on their watch, MC has been devastated. All they have are conspiracy excuses(where is Cofer Black in all this and the suit that was to be filed in Federal Court? Was this all rumour?) and no reasons for silence(e.g., reasons for halt and lift, etc.). And they should be rewarded with options now??????? Where is BOD oversight? What happened to their fiduciary duties to ordinary shareholders? By their passiveness and lack of backbone because they are well compensated, they only serve to add to the dilution all the while the pps linger in the doldrums. Shameful. I don't think that NWBO is very attractive unless:
1. Unblind;
2. The results are stellar and unambiguous.
Thus forget about big P for now and forever if the results are short of a home run. JMHO. Why give any money to a pig in a polk?
LP alluded to the concept that the regulatory path is unclear. Really? I beg to differ: meet the end points and the path is abundantly clear. I agree, however, that if LP does not meet trial endpoints or results are mixed and/or ambiguous, the regulatory path for her is unclear and requires "pioneering"(meaning alternative criteria agreed to by a persuaded FDA).
Accordingly, the delays and silence, considered in this context, are understandable if she has serious doubts and needs to hurl a St. Mary's long tail touch down pass. I think she wants to let the trial continue---there are good reasons for this as she says if her data, and she has much more than we do with her cohort of expert statisticians, SAB, PIs, suggests that the endpoints might be iffy. OTOH, she needs to appease the hoi polloi shareholders who fear an evergreen trial by saying they should proceed to data-lock but intentionally does not give a time-line buying her more time and extending that even more by her long drawn out collection/analysis process. Just more of the same with NWBO in a predictable pattern. Reasonable and increasingly frustrated investors see this and so does big P. Hopefully, they get Sawston done but the delay there tells me that even that is iffy and they won't net out enough money.
Given the foregoing analysis, there may be another mini-toxic bridge to a huge and toxic dilutive financing when they run out of "creative" alternatives(it will be the last one--promise) on "commitments" that unblinding will take place not later than the end of 2019 and we shareholders will be thankful for it. Trust NWBO management and by all means stay tuned. Anybody got some aspirin? I got another headache.
Hi LF:
Well OK till January sounds to me like they need to have a plan to raise cash now. January is about a month away. Not the best of circumstances I suspect.
Well, yes, I suppose saying no alternatives other than raising capital through Sawston is a bit extreme, however, I don't see other non-dilutive alternatives raising at least some moderate cash. IMHO, unblinding the trial shortly and announcing a date for data-lock is a sine qua non. Absent a peek at the unblinded results, I highly doubt any big P will come off the sidelines.
Big P stance depends very much upon the results. If mixed and ambiguous, big P will definitely not write out a big check if at all. The ambiguity wrt announcing a definitive date for data-lock and the process--is it all serial, partially parallel, etc. raises serious questions concerning just how confident LP is with looming results. Hence the almost singular focus upon the long tail. Primary and secondary end points may be in jeopardy according to her data--and she has much more than we do--and accordingly she may feel that she needs to hit long tail out of the park.She said there are good reasons to continue the trial. I think she would if finances were not such an issue. Is it enough to mitigate ambiguous results in the primary and secondary end points? Under such a scenario, how long would approval take? What would be the extent of big P interest? Is current NWBO management capable of going it alone in commercialisation? All of this weighs on investors and is not lost on big P watching silently while their prey struggles. This whole situation, continual silence, vague statements when they do release statements, failure to meet time-lines, etc., etc. provokes fear, uncertainty and the rest.
For the record, I am long. I believe in the science. But for it I would have been a different kind of long---long gone. JMHO.
Chris, forget LG. I wasted time talking to him by phone and at conferences. He is useless. He is a complete amateur when it comes to IR. His marcom strategy is non-existent. I don't know what, if any value, he brings but he is well paid with a load of options. Disgusting.
Understood. But NWBO needs cash. No big P with significant upfront w/o unblinding. They would be crazy to do so. Sawston may be the only alternative now, aside from another toxic bridge......to nowhere?
Thanks, LF, for your conjecture. I doubt very much that the SEC inquiry is the hold-up. Frankly, it is very small potatoes after all this time. If it were serious, we would have known sometime ago.
Your conjecture is interesting, but as I have stated, now ad nauseum, no significant up-front monies without knowing what is under the covers. So late in the game and upon the relative eve of unblinding, all players are on the sidelines. Now, LP is damned if she discounts(suspected dump) or damned if she holds fast to value(too expensive without unblinding confirmation). The inflection point is unblinding. Anybody advancing significant $$$ is gonna ask.....do you have the goods or not and show LP their Missouri driver's license(all smart players are from Missouri don'cha know?).
Maybe the players for Sawston know that NWBO is in dire straits and needs money. They do DD, don't they? So the delay is related to what NWBO needs cash wise. And with the mortgages as you say, they won't get significant net cash to carry them over. So, now we know why the silence and lack of announcements for business deals. The 10-Q may be legit if a bit disingenuous. As I have long averred, NWBO is between a rock and a hard place. Major dilution now and for certain a shareholders' revolt.
What can LP do given these circumstances? She needs to unblind and quickly. She has run out of time. What she will do is structure yet another short term bridge to get to unblinding which I think will come early next year. The results will tell the tale(or better, the tail). She has come to the end of the noose. She needs to act before the trap door opens. Then I think she can do a deal quickly. I think big P told her....gimmee a call when you got something and then we can talk....
So maybe a little net cash out of Sawston and another mini-bridge before unblinding. Hope unblinding happens before or no later than on Valentine's Day. JMHO.
OK my friend, what do you think the deal or deals are? JMHO, but I sincerely doubt any licensing, JV , BO or other deal for significant alternative financing. Well, I guess NWBO can raise significant alternative financing(i.e., alternative to LP and Bigger) by doing some creative stock sales to some vultures but it will be toxic. I don't think LP wants to go that route and risk a shareholder revolt, especially not after the option pool and warrant grabs.
Yeah, I wouldn't sell Sawston either.....but if you are between a rock and a hard place......?
Yore move podner.
There is a difference here. NWBO trial results are relatively near. LP will not agree to a cheap buyout. BP will not pay her price without unblinding, you can take that to the bank. As I have said before----if LP agrees to a cheap price, BP will think something smells funny. So they won't buy, even with a discount. Right now with the results relatively around the corner, big P is on the sidelines. What deals are LP talking about? Most likely a Sawston sale/leaseback. But something is holding it up.Hmmmmmmm... Is there yet another toxic mini-financing on the way. How many warrants will LP take this time? How about Mr. Bigger to agree not to trigger his 4 month walkout? I dunno 'bout you, but I am not feeling too merry or jolly right now. JMHO.
Yes, that is the problem. And the deafening silence. And the toxic bridge loans and enrichment. It may be a jolly time of year for LP. Retail S/Hs? Not so much. I expect an empty stocking from Santa Powers this Christmas, same as last Christmas. :(
I disagree. No BP will pay $10B for unblinded data. And LP would never discount from $20B to $10B. Even if she did, why would a BP trust that the unblinded data is snuff for approval. Rather they would suspect a dump.
The deal smells like a property sale/lease back to me. But why the delay? It has been half a year!
I would be very careful here. It is by no means a lock. It looks like we have a long tail, but what is its composition? Why are these patients alive so long? What is the MOA? What about the primary and secondary endpoints? Have they been met? Are they stat significant? If not, would the FDA grant approvals based only on the long tail? Medical device approvals are different than drug approvals. If the results are mixed but maybe approvable, how long would approval take? With mixed but good, not stellar overall results, where do the pps go? The science may be good, but NWBO as an investment???
I am very cautiously optimistic based on the blended data and LL SNO update but this is still very high risk. NWBO's lack of transparency is also very troubling. It is encouraging that they may go to data lock sooner rather than later but exactly when? The multi-month process prior to unblinding is also concerning. Knowing NWBO, this could drag on until late 2019 at the earliest. And all the while silence and perhaps additional toxic financings.
News about business transactions which were planned to be announced within several weeks after ASCO, 2018 have not been announced going on 6 months!? I can almost guarantee that there are no licensing, JV, BO or other negotiations going on without unblinding. As I said before, LP is going for broke. The implication is that unveiling is to occur relatively soon. A buyer, partner, licensee would be very wary if now, LP would sell out cheaply---wouldn't pass the smell test. No one will pay close to LP's asking price for a pig in the polk. So, what's left? Sawston? If so, what is taking so long? A bidding competition as some have suggested on this board? I doubt it. The delay is very concerning and LP had to go to yet another toxic financing, albeit small, to tide her over. Is it a bridge to nowhere?
Many questions without many answers and the "stay tuned" mantra. My view is that the science is promising. NWBO management? Different story. Overall, NWBO is very high risk. JMHO.
Define "small" reverse split. It is essentially meaningless if it is not enough to place NWBO on NASDAQ. If no deal, you can bet the stock tanks. If the deal is good enough then you may not need a R/S. R/S just give shorts more altitude to short. Shorts love R/S!
My belief is that there is no deal with big P or any other big player for sizeable money unless it is coupled with unblinding. There will be no big up front money without a peek under the covers. If they are working on a deal it will be contingent on what is seen when unblinded. It can be structured as a walk-away if basic data is unsatisfactory and laddered to specific results and milestones. No unblinded data at this stage, no deal.
I think the negotiations have to do with Sawston. That's all there is. Unfortunately. JMHO.
My experience tells me that R/S are bad news. I think particularly in this case regardless of how good the data is, the MMs still will have influence to drive the price down. I think the R/S is a bad, bad idea, especially since I went through one. No thank you. JMHO.
Nope, won't happen without unblinding. You may then see a structured deal. At this stage in the game with relative around the corner data lock, top-line, etc., any big deal with significant up front money will require unblinding. JMHO.
We are in agreement. If a deal is in the making:
1. Unblind;
2. Data is good.
However, I doubt very much any such deal is in the making. Rather, there are parallel discussions with unrelated entities for substantial alternate financing via the Sawston property as most likely. However, once that asset is sold, they have no other cushion except homerun data---IF they have it.
I agree that data is mature enough. I believe that they can produce top line relatively quickly. Going to ASCO as a proper venue for announcement is a dodge. If LP does not announce data lock soon and we don't get top line latest by March 2019, Houston, we have a problem...JMHO
I agree with you. Count me in!!!
I don't know about you, but prior to unblinding I would never pay LP's asking price. She goes big or goes home. No discounts. Even if offered, it would be suspicious. Parting with a lot of money makes a potential buyer ever more wary. Discounting in advance of unblinding would be looked upon as a possible salvage dump.
As a business man, I don't buy a pig in a polk in these circumstances without pulling back the covers. Neither will big P. Would rather wait for unblinding and then do a deal if the numbers are good. That's why I think any deal will necessarily involve unblinding and soon. LP needs cash. More bridged toxic financing is over. No choice but to unblind to complete a deal. JMHO.
There will not be significant financing completed without unblinding. I do not believe anybody would agree to provide significant financing unless it were highly toxic and highly dilutive with a significant discount to market with horrendous warrant coverage. I don't believe LP is going that route. Rather, I believe a significant deal will go hand-in-hand with unblinding, assuming the data is good.
LP is bridging now but she cannot continue indefinitely. The string has about run out. In order to bring in even relatively non-toxic significant financing, a partner or investor will want to see unblinded data. LP has stated that there are good reasons to continue the trial. She would like to let it run some more but she is under tremendous money pressures. She needs a deal and in order to get it, she has to unblind.
I believe that IF there is a deal, and it should come about shortly to avoid another bridge thus frustrating even supportive investors like Bigger, there has to be unblinding. It should happen soon. JMHO.
NWBO is between a rock and a hard place. Why would BP make any investment now? Not. Simply because LP's asking price is too high. Remember LP's statement that "all BP brings to the table is a check book."
IMHO, LP does not want to deal or sell out on the cheap. She is confident in what she has. So, it is a trade-off between cheap deals with BP which greatly impacts future value and toxic financing. She has opted to go the toxic financing route because she thinks net-net that is a better alternative than a cheap BP sell out on a JV, licensing , BO, etc., deal. After all is said and done, if this is successful, as she is obviously confident that it will be, the MC will take care of itself and nullify all these toxic financings and current MC. BP is waiting too.
LP is going for broke and she is confident from what she knows with the complement of experts she has at hand: SAB, PIs, professional statisticians, etc. She must believe the odds are heavily weighted in her favour. LL has not distanced herself from NWBO as she delivered the 2018 spring refresh data highlights at SNO. All indications are that DC VAX is effective, more or less, across the glioblastoma spectrum.
It is too late for LP to backtrack and discount her very likely high price to entice BP. If she did so, BP would smell a rat and surmise that LP wants to unload and salvage something before unveiling. So, prior to unblinding and top-line revelation, there is no deal. No BP would step up now without seeing unblinded data unless they were persuaded by the data and info LP has short of unblinding. My view is that BP won't bite without seeing unblinded data. JMHO.
Your points are largely irrelevant and an apples to oranges comparison.
LP was raising funds to keep the organisation going. Toxic financing was what she employed. In this case, "investors" had a good deal with very little risk: advance cash and in exchange get shares at a deep discount with warrants attached. There was no lock up. So these investors turned around, dumped the shares very likely at a profit plus obtained free warrants just in case NWBO was successful. This was a reasonably safe bet and money maker.
BP, as I said, would not pay big money for a pig in a polk. Especially when LP was not willing to sell at a significant discount pre-unblinding. In fact, if she were willing to do so, BP would be very suspicious and reckon that the discount was a carrot to allow LP to unload. So, BP would be unwilling to buy at a significant discount and certainly was not willing to pay an un-discounted high price, without results.
The bottom line is that no one, now, is going to BO NWBO pre-unblinding--discount or no. Too much risk. In the former case, risk vs. reward was much superior. JMHO.
Trust me, but there will be no sale before unblinding at the very least. LP would NEVER offer NWBO at a discount before unblinding. Further, no one in their right mind would buy now at a discount. If the results are so good, a potential buyer would want to know.....why sell now at a significant discount when portended good results will be unfolded relatively soon? Unless, of course, LP has doubts that this is not the home run she thinks and wants to unload.... That much of a sucker, the prospective buyer ain't.
No one will buy at the high price LP undoubtedly would entertain in a BO prior to unblinding. Buy now, buy after results......no discounts...same, same. LP would not offer one and a buyer would not take it because something would likely be rotten in Bethesda.
LP likely knows what she has got. She has a LOT more info than the rest of us and beaucoup professional experts advising her. SNO pretty much nailed it. With the high price she would undoubtedly be asking, BP will only write a check upon confirmation. JMHO.
So the source of info is you. But you don't want to admit it. Rather you want to masquerade the perception that the "source" is authentic and has factual non public information which is another way of stating inside info.
Look Dude, I sent screen shots of your postings to NWBO. It is up to them to do what they will. As I am a lawyer, I can assure you your posts are actionable.
You are a foolish individual. That much is evident. I guess the defence is that the posts are so ridiculous, no one would find them credible and act on them anyway.
BS. You know all about the company both public and non-public and assert this knowledge as facts. Now you are backtracking. Fancy footwork. LOL
Doesn't make too much sense. If it were that simple why didn't NWBO do this earlier? Less effect on the pps and not so many investor questions/uncertainty if lifted relatively quickly. Did Linda lie when she said turning good news into bad? Halt was not necessarily a bad thing?
OK, I'll play:
why was screening halted and then reinstated? Why did it take so long?
Blended M+ mOS was 34.7 months blended. What is Tx? What is the delta?
Blended M- was 19.8 months blended. What is Tx? What is the delta?
Do you know sub group data such as mesenchymal?
How many patients now alive?
How many patients lived at 36 months or greater? What is breakdown of Tx/control?
What is mOS of cross-overs?
How about non-crossovers(I think N is about 46)?
TIA and glad you feel like sharing for the heck of it. As good a reason as any.
Regards,
U
Seems to be a trenchant hypothesis. Assuming a 2:1 ratio between Tx and control up to 300 patients, control would be at 99 and Tx at 201. Then the final tally as per the article is 232 in Tx while 99 for control remains the same as opposed to 221/110.
If we are to believe the JTM, the hypothesis is pretty close to factual. If so, this appears quite positive for the trial. Just say'n. And I am a pretty skeptical SOB. LOL.
Regards,
U
You state that the final 31 patients were enrolled in the Tx arm as if it were a fact. Is it?
The FDA is most probably in the pockets of big P. There is little doubt that the FDA is biased towards big P. Not surprising. This is obviously not lost on NWBO. To wit, LG's statement on April 27, 2018 to the effect that the trial will continue until the results are undeniable(one way or the other). There is no middle ground. If the results are undeniably successful, the FDA will not filibuster or otherwise attempt to thwart DC VAX L. In effect, the FDA will tell big P....."look it's undeniable, We can't rail road it guys. If you are worried, buy them out. You have the money. $10-$20 billion is pocket change to you, but we have no real choice but to approve. You're on your own". To make this virtual conversation happen, the results need to be undeniable---a homerun or two. LP will not settle for less. These are the practical regulatory realities. The trial will go on until LP is sure(one way or the other). Ranting and raving by the shareholder peanut gallery will not change that. JMHO.
Thank you. You are one of the few posters who I greatly respect and am appreciative of your response. Good luck to you and to us all---patients and investors.
Respectfully,
U
We really do not know what LL meant. I believe you are incorrect when you claim that she referred to early enrollees versus late enrollees. Rather she was referring to early vaccinations versus later vaccinations as a result to crossovers upon eventing and comparing the two. In fact, it may be that there is no significant separation which is good for patients but not so good for the trial.
When she said that patients are living longer than expected, what does this mean? Does it also refer to the non-crossovers? Perhaps as an overall group, patients are living longer than expected but this could also include the non-crossovers which are about 14% or about 46 patients. She would not know about these patients. And what is she comparing this expectation to? The usual 15-17 months mOS? She probably did not mean long tail or 36 months at the time she made the statement. WRT to M+, the comparator was 21.7 months mOS and blended was 34.7 months. Looks good with the comparator chosen for the article. But......there are studies that have SOC at 29 months or even 34 months. Are these outliers? We have unconfirmed ideas what comparators will be chosen and those selected will be extremely important to success or failure of the trial.
So, you can now see that long tail/36 months is extremely important and the reason why LP and the SAB are dragging the trial out:
1. Most probably, due to pseudo-progression, I believe that even with adjudication, the primary end-point of the trial will be missed. Does this threaten success if other sign posts are positive? In my opinion, no. Firstly, OS is the gold standard and PFS is used as a surrogate. By now, NWBO has enough data for OS and long tail. What is more important is the "distance" between progression eventing and OS. Secondly, even though there may be earlier PFS eventing than expected, it may be that as the vaccine effects begin to take hold even after progression eventing, the rate of progression is slowed and in some cases, perhaps to zero. So, failure in the PFS primary end-point is not a killer to trial success. But it certainly is a concern, especially if other markers are not significantly positive.
2. WRT to OS, it appears that this is more promising especially when you look at bended numbers both for M-(19.8 months) and M+(34.7 months). So, paraphrasing the words of Dr. Ashkans, the vaccine appears to help across all groups to a greater or lesser degree. Much more so wrt to M+ than M-. However, success is largely dependent upon the comparator used. If it is a combination of crossovers plus non-crossovers as control, there may be confoundment and extended survival. We just don't know. Further, there are studies that show control to exceed the commonly referred to the overall 15-17 months more commonly quoted. The success in M+ which appears to be made up of predominantly pro-neural seems to contradict Dr. Prins'/LL's earlier findings that pro-neural seems little or not affected at all by the vaccine and chemo/rad due to its being less immunogenic than say mesenchymal which is found in M- and was found to be a better responder to the vaccine in earlier studies. So, in summary, there are question marks wrt to OS as the secondary end-point.
3. Thus, one can easily understand the focus on 36 months and long tail out to 60 months and beyond. LP stressed, in so many words, that this is the new gold standard for immunological therapies like DC VAX L and that this is the criterion that investors should be focused upon. If 1 and 2 above are not successful, mixed or ambiguous, 36 months/long tail need to be home runs. These probably need to be in any event. There is no second chance. Once they unblind, they either hit it out of the park or it is over. Forget D. They want it to be undeniable(note LG remark on April 27, 2018) on at least the 36/longtail not only for reg approvals but for QALY/ insurance purposes as well---and not to mention relatively quick reg approvals. A lot is at stake here. It is digital. There is no in between. Thus, the odds may be that the trial drags out beyond November and into next year. Neither good for investors(more dilution, uncertainty and pps devastation) nor patients(obvious if it works). November is a critical month. Can LP/LG hide an accounting at the ASM assuming they don't delay it indeterminately? JMHO.