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What Dr. Platten is saying is that from the March, 2017 data, in and of itself, efficacy cannot be determined. This statement is independent of whether he has clinical experience with patients. The fact that he is not an author could mean that he does not share the enthusiasm of the authors. It does not necessarily mean that he thinks that the trial has failed. As far as he is concerned, the March 2017 data is not remarkable enough to determine and much less suggest efficacy.
It appears that Michael Platten and NWBO Mgmt/SAB have the same opinion. Based upon the info produced by the March, 2017 data collection, both parties appear to agree that efficacy of DC VAX L cannot be determined. That is the reason the trial has not been unblinded up to now and may not be for a while. Depends upon the spring 2018 refresh data.
Due to crossover confoundment and concerns about pseudo progression and the distinct possibility that PFS/OS endpoints may not have been achieved, focus is upon the long tail. In immunological approaches, long tail is the most important standard--at least that is what Linda Powers is telling us. Linda Liau appears to share similar views about the trial. Thus, it appears that all the foregoing experts are on the same page. The trial may still have a ways to go--2019 anyone?
Well, I am very critical of NWBO management. But........I cannot argue with what you say about Linda and Les knowing their family histories of cancer. I do think their silence has had a significant impact on the share price regardless of any alleged(for now as we have no clear cut determination one way or the other)manipulative conspiracies. However, we do not know the entire story and whether the decisions they have taken were reasonable considering the then existing circumstances.
There are some on this MB calling for unblinding now. However, MB posters are not experts(Flipper et al) and they do not have the resources and expertise that Linda has at her disposal, not only the SAB, but also the PIs as well as their professional statisticians who undoubtedly have a lot more info than amateur MB analysts have. Linda is not stupid. She has come this far and she is not going to do anything to screw up the approval process. Would I like to know more? Absolutely. But neither I nor any MB denizens or others not involved in this particular trial have the necessary resources, facts and predictive capabilities that NWBO management has at its disposal. As frustrated as I am, and I am sure others are as well, I give management the benefit of the doubt.
Very encouraging Gary. Glad COH is such a hospital. And GLTY.
U
I quite agree. Thank you for your explanation. The article raises many more questions than it answers and the way it is presented is quite misleading. NEJM? Go figure.
Sentiment:
Are you implying that this person who works at City of Hope and read the article was wrong in your opinion? I presume City of Hope is a hospital and that the individual is a physician?
It is highly unlikely that funding through a partnership at this stage will take place. A partner would want to get in on the cheap if it advanced funding to NWBO. Why would NWBO do any better by going into partnership with big P in raising funds as opposed to doing a toxic equity offering? Funding from a bad partnership deal is likely not gonna happen. Just like a cheap BO ain't gonna happen.
If NWBO is gonna get better financing than bleeding toxic funding by a thousand cuts, it will do a loan deal. If Sawston is not yet fully collateralized, then there will be a refi. Values have increased dramatically on the property, so a good bet is a refi. LP has to avoid toxic financing now more than ever owing to the botched pub/ASCO presentation that was supposed to raise the pps. She is under a lot of pressure and has very limited financing options. Sawston is most likely. JMHO.
What is also interesting is that mesenchymal, classical and neural are all predominantly un methylated whereas pro neural is methylated. And the pub had counted 131 patients as methylated with impressive data and derived deltas assuming historical control of 21.7 months and blended 34.7 months mOS. According to the table, it could be inferred that some significant portion are pro neural in the methylated grouping? And LL noted that mesenchymal which is predominantly unmethylated responds very well to DC VAX. All seems counterintuitive but the pub data seems to support these inferences. If true, then DCVAX does indeed work across all subgroups, both methylated and unmethylated. Hmmmmmmmmmm.
There is a 35 patient study in 2015 where there is a table showing methylated heterogeneity vis-a-vis unmethylated. I do not have the link handy but it has been mentioned a number of times on the MB. I obtained the link from one of the posts. BTW, in this article, control for the M+ group was 29 months and the blended result from the pub was 34.7 months. Based upon control of 29 months, I calculated a delta for M+ of 8.43 months. This in and of itself is a breakthrough. However, the pub listed a control of 21.7 months. In that case, Tx delta would be off the charts. We do know that mesenchymal is very mutational and possesses a high degree of heterogeneity. Further, mesenchymal is predominantly not methylated. See Abeta links. LL and RP have stated that according to what they have seen, in addition to patients living longer as a whole, mesenchymal patients, in general, respond very well to DC VAX.
As mesenchymal is not generally methylated and does not involve the MGMT genotype, it appears to be additive to methylated which in the pub accounted for 39.6% of the ITT of 331. It is about 42% of the counted M+/M- population taking into consideration the 38 who were not identified as either M= or M-.
Accordingly, and I think conservatively, DC VAX might be very effective on about 50% of nGBM in general and have some effect across other groups.
I note your point about M-. The delta of 7 months to blended from a control of 12.7(19.8 months) is very impressive and may be due in part to the presence of the mesenchymal molecular group. However, this M- group may not produce the same long tail as the M+ group because there are other strains within the M- grouping that are not as responsive. I think this is to be expected considering the complexity of the tumour morphology.
One important takeaway from the links Abeta provided, is the acknowledgement of the weakness of single/few agents therapies in treating GBM with at best rather modest results. These links also demonstrate that there has been relatively little attention paid to DC VAX and its multi-targeting approach. Of course, no mention was made of the pub blended results, as these articles may have been written prior to its release.
So, again, I think the blended pub data is very impressive and the spring refresh 2018 data may be even better especially with those "sticks" on the 2017 graphs moving along to the right. I think LP may be on her way with an unassailable case before the FDA and other RAs and assured approval. I think there is some truth to the notion that the FDA may be biased towards big P, however, if the data is even on a par with the helmet, there will be public outrage if DC VAX is not expeditiously approved. Thanks again to Abeta for the links and these articles give support for what may be inferred from the blended data in the pub. These articles also confirm control at 14.6 months mOS in general for nGBM where M- is less and M+ is more averaging out to that figure. The deltas using just blended data are impressive by themselves.
Finally, another takeaway from these articles is that PFS, as an endpoint, in these studies MAY NOT correlate to OS. FWIW and JMHO.
Thanks Abeta. Will do.
This is an unusual trial. From my standpoint, if all patients were living longer, i.e., those 86.4% who have taken the vaccine which includes crossover, and there were not sufficient curve separation, this might not be a necessarily bad thing. It might mean, as a hypothesis which can be investigated upon unblinding, that the vaccine works for both nGBM and rGBM. That would be wonderful for patients.
However, while I see the vaccine working, to some relatively minimal extent, on the cross over group, I do think we might see SS curve differentials. Both M+ and M- show impressive results but significant separation when looking at stated controls and then blended results. While I cannot understand how mesenchymal fits into the M+/M- groupings, Liau/Prins have seen from their own studies that the vaccine works well with mesenchymal because it is immunogenic and Liau further believes, with good reason, that patients seem to be living longer.
I do agree with your views on meth. It looks like a home run. This alone would be a basis for approval for a rather large sub-grouping. We also see that the vaccine works to varying degrees on all subgroups which increases the odds for blanket approval. The spring refresh 2018 should confirm and provide even stronger blended results. From what I can see, we are in a good place. I think we will most probably see unblinding toward the end of this year. I also believe we will get an update from the spring refresh and other newsworthy PRs between August and unblinding to keep the pps from collapsing. I also believe LP has relatively significant funding in place and will announce it as one of the business items she alluded to at ASCO. I think funds will come from a refi of Sawston. JMHO.
Meirluc:
Why would you give up on unmeth? From the pub data, it looks very good. The literature suggests control mOS at 12.7 months. Blended results from the pub show 19.8 months. That is a 7 month delta. Tx delta would be about 9 months. Even using Dr. Bosch's control base point of 14.6 months relating to unmeth(I don't understand why), which is the control mOS for nGBM in general, not just unmeth, the deltas are still impressive. The meth is almost double that of unmeth. No wonder 69 docs wanted to be put down as authors on the pub because this is truly impressive.
I don't know exactly how mesenchymal fits into the M+/M- picture. Mesenchymal, like unmeth, is very aggressive with a much shorter control mOS than M+. However, mesenchymal , like meth, is very heterogenous and mutational, whereas meth has a much longer OS prognosis like pro-neural. There may be some overlap. It also appears that mesenchymal is much less likely to be methylated. M+/M- seem to have different MOA signatures from mesenchymal relating to cellular repair mechanisms whereas mesenchymal appears to be more immunogenic since the tumour micro-environment is less immuno-suppressive thus allowing more time for the immune system to mount an attack with attendant tumour infiltration.
As you know, both Robert Prins and Linda Liau have stated that the vaccine appears to work very well with mesenchymal which comprises anywhere between 30% to 50% of nGBM. Dr. Bosch noted as have other researchers that the vaccine works across all groups--certainly to varying degrees. While I do not believe that unmeth will be more impressive than meth results, both portend to be impressive. JMHO.
She got her money on the backs of retail shareholders who paid good money for shares which were used to build up Cognate. Cognate was sold. No details but LP did not come away as an empty bag holder. She then puts this essentially free money back into NWBO at cheap pickup prices while getting a nice 10% while waiting. She also got, along with Les & company, a hefty stock bonus prior to achieving any results like reg approval. Nice work if you can get it. I don't mind getting ripped off as long as I get something. But I draw the line at being raped.
It is unfulfilled plans communicated in private to various individuals including me and the deafening silence when all of this is swept under the rug. The constant excuses that things are out of our control, sh*t happens, I did not say that, you misunderstood, these are just estimates( which they miss by years), it is the bad shorts and big P because billions are at stake,etc., etc. and all this is a solid demonstration of lack of accountability and unreliability. Management has used up all of its currency in credibility. They are untrustworthy when it comes to their shareholder constituency. Management is an albatross on what appears to be a very promising product platform. That is why the pps are in the toilet. Management has created all the FUD. All the shorts did was to take advantage of it. AF did not have to make things up. You just can't make up things like this. All the carrot dangling, deceit and appearance of self dealing. Why big shareholders like NW don't act on outrage is beyond me unless they are on the inside and know something good. It is hard to believe that they are in the dark. So I believe all signs point to revelation relatively soon. NWBO management is near the breaking point. As LP said, they are under tremendous pressure and not just wrt unblinding. At this point, results better be good......or else. LP and LG know it. They may be inept managers but they are not insane. At least that is what I keep telling myself. JMHO.
Perhaps they got a better offer. Who really knows anymore.
While I personally believe that management is one of the significant causes of market cap destruction, I do believe the science is good. As I have said in previous posts, the pub came out with very promising data. For both methylated and unmethylated broad categories. I don't know for sure but mesenchymal may be additive as it shares meth and unmethylated characteristics. So it is within the realm of possibility that DC Vax is very effective for 50% of the ITT. That is huge. I worked for a company that had super products but very stupid management. Despite management foibles, the products carried them through. I am confident that NWBO is one of those cases.
What I don't get is why large investors are not apparently upset with management and especially Les. While LP appears to have effective control, she cannot risk a significant minority shareholders' mutiny. Even LP and LG understand this. Their pub and ASCO strategies failed. They risk severe shareholder ire if they do significant toxic financing. What they probably will do is refinance the property at Sawston. Land values in that vicinity have greatly appreciated. I think the money they can get will see them through unblinding. The refi will put a floor on the pps because there will be no concern for near term toxic financing. Due to their financial situation, the 2018 data collection is it. Likely, unblinding will take place in November. They know they must prevent further market cap deterioration. That is why LP is under tremendous pressure to unblind. She cannot afford even the threat of major shareholder derivative suits. I firmly believe she is between a rock and a hard place. I think we will get news soon, probably by the end of the month or early August. Management knows that continual silence is not a very good option anymore if it ever was. They know if they keep silent until November the pps will be in single digits. They need to announce the lawsuit. They need to announce the refi. They need to share data updates. And they have to stop the stay tuned mantra. They need to stop talking privately to MB denizens and communicate like other professional companies do. CCs will do for a start. And LP needs to start being the IR person. Les is an abject failure at that and if he is so busy, where does he find the time to communicate to these anonymous ciphers? JMHO.
According to the pub, unmethylated MGMT aint doing so bad. The literature suggests that mOS for unmethylated SOC is 12.7 months. The blended mOS is 19.8 months. This is a delta of 7 months. For methylated MGMT, the literature suggests SOC mOS of 21.7 months (although a 35 patient study in 2015 stated about 29 months) and blended results were 34.7 months, which is a delta of 13 months. Methylated delta is about double that of unmethylated on blended results. Where does mesenchymal fit in the M+/M- category? Like methylated it is highly heterogeneous and mutational. But like unmethylated, mesenchymal is highly aggressive. Does mesenchymal overlap in these two categories? That might explain the delta in unmethylated to some extent. Seems to me that the prognosis is quite good for unmethylated and extremely encouraging for methylated which comprises at least 40% of the ITT population and 42% of the counted population taking into consideration the 38 patients who were not categorised as M+ or M-. JMHO.
I have been puzzled by whether there is some correlation between Methylated/Unmethylated(M+/M-) MGMT and Mesenchymal. I don't know and the research I have done has not indicated a clear correlation.
In the case of M+, life expectancy and SOC typically is long lasting. The 35 patient study written in 2015 cites M+ SOC at about an mOS of 29 months. If I recall correctly, the pub cited an mOS of about 22-23 months. M-, on the other hand, is more aggressive and an mOS of about 12.7 months was cited. Mesenchymal is also very aggressive and highly heterogeneous as well as mutational. Thus, mesenchymal has some characteristics of M+ but the big difference is that mesenchymal is very aggressive like M-. Mesenchymal is also characterised by mutations of NF-1(among other deletions/transcription factors). Apparently, mesenchymal is more immunogenic meaning that the tumour micro-environment is less suppressive allowing more time for increased T cells, indeed the full arsenal of the immune system, to infiltrate the tumour and attack it before the immune system turns off. That is why, it is hypothesised, that DC VAX L can work very effectively without checkpoint inhibitors because of the immunogenicity of the mesenchymal strain.
M+ is as stated above much less aggressive and more like pro-neural in that particular regard. Methylation reduces expression of MGMT and thus the cellular repair mechanism. M+, according to the publication with an N=131, was 39.6% of the entire clinical population and about 42% of the counted M+/M-population of 293 where M- N=162 taking into account the 38 patients that were not identified as either M+ or M-(or other). So a significantly large proportion of patients, of the M+ variety, appear to be responding very well to the vaccine, at least close to 40% at a minimum. It could, indeed, be a higher proportion if, in addition, mesenchymal is not fully inclusive in M+ but is rather net additive as a part of M- where the vaccine appears to have some effect. So, it may be quite possible that DC VAX L is quite effective on perhaps 50% of the clinical population. However, this may depend somewhat upon mesenchymal/M+M- correlations. JMHO.
It is quite obvious. It is a non response to the question posed in the email. The SAB member obviously does not want to be a spokesman on this matter and so he passed the buck to Linda who, in any event, as the CEO makes the final decision wrt unblinding, whether she follows advice or not.
The question I have is why would only this one SAB member, and not any others, respond to this kind of an email from unknown investors/individual(s)? SAB members have no responsibility to answer to anyone but to NWBO management. It is then up to NWBO management to communicate.........or not.
IMHO, assuming that an SAB member replied, it was a lapse of judgement, un-necessary and a complete waste of time.
DoGood:
Just an excellent response. GLTU
Cherry:
We have beaten this to death. Excuses that they are spread too thin, too many things to juggle, things fall through the cracks, etc., are all excuses. For small biotechs, that is the common environment. They obviously need a CFO. Common complaint for years. Instead of Story Partners, get good regulatory counsel on retainer. Les should spend less time talking to MB denizens and more time crafting communications and PRs. How about a web fireside chat with Les on a bi-weekly basis? That way we all get a level playing field. Let's hope we get some PR strings like Les let on. Silence, especially till November could be a killer. JMHO.
Jack, I really think DC VAX has promise. When I came upon this company and its approach to GBM, indeed all solid tumor cancers and perhaps as a new paradigm in treating all diseases, I was excited and invested. Management looked great on paper and my early interactions with them were fine. But management has since been largely disappointing. Perhaps you can agree on that. The real heroes here are Linda Liau and her collaborator Robert Prins, Alan Boynton and Marnix Bosch. Linda is to be commended, not for her CEO skills, but for her vision and financial support of the company. But she is out of her depth as a professional CEO well versed and experienced in NWBO-like ventures. I think you may also agree that her side kick Les adds little value, even though he is reputed to work hard, and may largely be counter productive. He has sabotaged his own credibility by stating plans to MB denizens but never delivering. And when pressed, he goes off on a tangent haranguing nefarious forces and "billions at stake." He is a very poor communicator, does not listen and belittles points of view different from his. Lack of credibility and respect is a killer in business. As I said ad nauseum, the environment NWBO finds itself in is what it is. It is up to them to meet and beat the challenge. That is what they have been paid to do. Rather, Les incessantly complains how hard it is with these vultures constantly circling around. This is part of the biotech jungle. Experienced bio tech managements know this and deal with it. Many bios fail because management can't meet the challenge. However, I think that the science will ultimately triumph in this particular case.
However, I no longer believe that this investment is the promised land as I once did. But I think there is a good chance the investment will pay off. I will admit, though, that I fell in love with the science and that clouded my view of the overall situation. But I am still here if lightening strikes. I think the promise of the platform still outweighs the foibles of management. That is why I am still here. Good luck to you. Hope we make out alright.
Well, bully for you.
Well excuse me! Sorry I put a bit of a dent in your fragile feelings.
As to a CFO, I think money is better spent there than on an SVP who can't lawyer very well. IMO, these bumps as you call them are a serious indication of incompetence and gross negligence. Biotechs that fail invariably have poor management even though they may have stellar promising products. Credibility is built by management in doing what they say they are going to do. Les spends a lot of time talking to MB members and telling them all sorts of things. I have repeated these undeliverables ad nauseum. You may disagree, and we will have to agree to disagree, but management is largely incompetent. Their strategy of silence has worked negative wonders on the pps. With all the shares, options, convertible loans, etc. management can easily endure more toxic dilution as it is not nearly as toxic to them as it is on long suffering longs.
Debating this further with you is a waste of my time. Have a nice day.
Making a mistake is one thing but lying about it to cover up is another. Not saying that Les lied. But no correctional PR kinda lends weight to a goof and attempted cover up. Even if he did not lie, and I hope he did not, leaving an ambiguous perception about it is very suspicious. Appears Les knew this weekend. JMHO.
Did Les lie to those individuals who called him over the weekend for an explanation of what is going on with the pinkies? Hmmmmmmmmmmmmmmm. If he did, very bad and foolish move.
I disagree. The failure is NOT minor. And it confirms a pattern of management missteps that have contributed as much and likely more than the conspiring naked/MM/hedgie cohort assigned by Les to take the blame for the devastation of the share price and the toxic financings. If that is lawyer Les' best argument, well, I would prefer AF representing me. Incidentally, where is the promised lawsuit or has that been misfiled too?
Jack, bottom-line, management is incompetent period. No waffle there. The science is promising, mainly for MGMT methylated. This is about 40% of the patient population in this trial. I don't know whether mesenchymal is part of the MGMT methylated population and if it is to what extent. Both seem to work with different pathways. Mesenchymal involves NF(nuclear factor). Mesenchymal presents a less suppressive micro-tumour environment. Thus more immunogenic. MGMT methylated promoter implies less MGMT expression thus disabling the cellular repair mechanism. So you may have a trial population of maybe 45% susceptible to DC VAX and the rest not so much to any significant effect. From my calculations I think the mOS delta is about 7 to 8 months. Overall, perhaps 4 to 5 months delta in mOS. We don't know about PFS but it appears there is trouble there with some analysis still to come. The long tail will be coming from the roughly 45% population. I think it will be approved and spring refresh hopefully has better numbers. JMHO.
I agree that most longs will not sell on this gross negligence. They are making the same bet I am. The science overrules poor management. Saw this with Apple with Spindler and Amelio before Jobs came in.
But management has severely contributed to the devastation of value of NWBO by their strategy of silence. That a Poly Sci major can spank two lawyers with ease is embarrassing. That they don't have a more enlightened approach as opposed to saying nothing is inexplicable. So you may ask--what can they say?
That is the challenge. Instead of minging about conspiracies, dark pools, naked shorts and all the rest---well that is the environment. That is management's challenge. That is why the get paid the compensation they do. Its their challenge and problem. Where I come from is that if you can't meet the challenge, get out of the way for someone else who can. Les is inept and Linda is just as bad for keeping him on. The big issue is lack of any credibility. It is shot to h*ll. Tough to do business in these circumstances. Wall Street hates lack of credibility. Sorry, he and his wife Sue have exhausted their welcome. If they are cashiered, good riddance. They are not worth the bucks.JMHO.
Non admission of error is not absence of commission of error. Silence only aggravates the wrong. Bad move by management.JMHO
You are eternally optimistic. This latest "pink" episode has confirmed to me that this management is incompetent. I would think that neither Linda nor Les have any credibility with anyone save the "head in the sand" apologists. As regulatory counsel how can you fail to file important forms? This is gross negligence with consequential valuation damages. No PR either. Just unbelievable. We may need a change of management to restore credibility. At the very least, Les has none. Not a guy you would want to do business with. Maybe one of the reasons for such toxic financings. Lack of credibility will kill you every time.
When I first invested, loved the science but never thought management could be like this. Really unbelievable. My bet is that the science will ultimately out leverage bad management. JMHO.
Cherry:
This is not a small oversight or miss. Les may or may not have been involved. But legal counsel were. This miss constitutes gross negligence on legal counsel's part. Of course, LP is ultimately responsible.
Further, as SVP of IR, Les should have cleared up any misunderstandings through a PR before much damage could be done to the pps. For example, ......"ooooops we goofed and did not file the required form. Will fix immediately. Investigating misstep and will advise end of week at the latest..."
Why no PR Les? Some team. Gross legal negligence and p*ss poor IR. I don't know about you, but I think Les has zero credibility. He could f**k up a wet dream. Shame as the science seems promising. JMHO.
There is no waffle in my post my friend. Management is clearly incompetent. A downgrade like this and the SVP and de facto second in command does not know about it? Gimme a break. You apologists don't know when to come in out of the rain. Haven't you had enough of all these failures to deliver? String of PRs? Lawsuit? Business matters unless the loan, toxic equity raise and pinkie downgrade is what Linda had in mind. What happened to spring refresh 2018 which was to be presented at ASCO? Les said this to a number of people including me. I could go on and on. No Jack, we have waited too long not to shoot and put management out of its misery. No news on Monday, and what apologia will you bleat next? JMHO.
The BOD is useless. They have zero oversight and should be sued for breach of fiduciary duties towards the shareholders in whose interests they are bound to act. They get a payday by doing nothing and allowing LP to do whatever she wants. Les is a liability. For a lawyer, he has made too many slip-ups. He is not up to the job of SVP, business development and IR. And his wife Sue pulling down $180K a year and guess what we are paying for this farce in dilutions. Good riddance to both of them. Management is really a disgrace. What a shame and the science appears promising. But perhaps not promising enough to nullify really incompetent management. JMHO
Some investors already talked to Les this weekend. He claims he knows nothing about it. Transfer to the pinks appears to be a fact. If Les did not know about it, he is either out of the loop which is highly doubtful, or he is lying which is more probable and if he is this is a really dumb move for a lawyer, or there has been some mistake which again is highly improbable. Again, it is highly improbable that going to the pinkies is somehow part of an elaborate plan to catch the shorts. That's right, when things go bad its never management, it is the bad bad shorts or other conspiracy theories woven by that master story teller Les. Recently, he has apologised to a number of investors for making optimistic guidelines for certain company actions like, for example, the string of PRs, etc. In making such "apologies" these are tantamount to admissions against interest. For a lawyer, this is a dum dum. You begin to wonder about management's overall business judgements and whether they are hiding something. It is all about perceptions and they are clearly wasting money on the PR firm who must be advising them. So far, not impressive.
Moving to the pinks because it is a cheaper exchange is nonsense. The difference in expense is de minimis. There has to be another reason. Non-compliance? Doubt it. They are current in filings. What then????!!!
Moving off the BB is material information. LP/LG need to come clean. If they remain silent, the pps will get slaughtered as this move, whether initiated by NWBO or the BB exchange, is inexplicable. Continued silence now is deadly. If there is continued silence, I think large investors will no longer be supportive despite LP control. Could be some consideration of shareholder lawsuits being filed if this isn't explained quickly. Just like other things. Recent loan, then, on its heels, a small but toxic equity financing. Huh???
The publication strategy fell apart. One of its goals was to raise the pps for better financing. No follow up or timeline for 2018 spring refresh. NOTHING said at ASCO about it. What happened to the string of PRs? What happened to the business matters? Are the toxic financings, loan, demotion to pinkies the string of announcements LP alluded to? What happened to the big lawsuit that Les told a number of investors including me was going to be announced? First it was going to be announced before ASCO. Then the excuse that management was advised that after ASCO would be better. Nothing, nada and we are all surprised over the weekend that we are now on the pinkies. Weeks have now gone to a month. And.....our stalwart Senior VP, a lawyer himself, claims he doesn't know anything about it???????????????
There are a number of apologists here for management. Even for these diehard apologists, the bloom should now be off the rose. Thus far, though I have roundly criticised management primarily for their communications or better, lack thereof, but given them the benefit of the doubt, I am beginning to sense that something smells rotten. If management does not come clean Monday morning or very shortly thereafter, a coalition of large(and smaller) investors should demand answers, perhaps under threat of a shareholders' lawsuit.
This whole sorry saga is a disgrace. Management either has something to hide or is just plain incompetent. Les knows nothing---c'mon give us a f**k**g break. JMHO.
I think the answer, either way, is a win-win. If crossovers are living longer as well, but perhaps not as long as the early Tx, that is a good thing in any event even though there would possibly be de minimis curve separation. If it does not work, may be good for the trial but not so good for patients even though we know that there were only 3 resections, etc., etc. and the crossover population is not the same as the early Tx population.
As I said, certainly not now.
Let's look at this logically.
LP has at her disposal expert statisticians, a well respected SAB and PIs. LP is privy to more information than just about anyone else except those involved in the trial. She has expert advice from Dr. Bosch, who I am sure, talks to Dr. Liau. Odds are that LP has a pretty good idea whether the trial will be successful enough for approval and with spring refresh 2018, she is unfolding data to largely confirm the odds of success. She has done all she can to sufficiently de-risk the trial to assure success at some level. Particularly with respect to methylated MGMT and mesenchymal. Dr. Ashkans, as well as others, has stated that the vaccine works, to varying degrees, across all sub groups. The odds are, at least insofar as the PIs who signed off on the article, NWBO management, as well as other insiders are concerned that the vaccine works and should be made available to patients. However nothing is guaranteed except death and taxes(and perhaps delays by NWBO). Results and approvals are what count.
Big Pharma knows all this. It is pretty obvious. They also are certain that LP is not going to sell out cheaply. If, for example, LP were to agree to a BO of $1Billion, BP would be extremely suspicious. If the prospects for DC VAX are so great and it has the potential for a sea change paradigm in the treatment of solid cancers, indeed all disease, at least in NWBO's view, why sell it for $1Billion? They would suspect a "dump" as we all would. So it is pretty obvious that BP would not touch it for $1Billion. They are also convinced that LP is not going to sell out before approval at a substantial discount. This, again, would be very suspicious. Accordingly, BP is not interested in any BO or partnership requiring an expensive investment until approval or what looks like to be odds in favour of approval in order to get the jump on other competing BP. It makes little sense to make a lowball offer that would certainly be rejected but would legitimatise NWBO and raise the pps, which would be counterproductive to BP now anyway.
Bottom-line, BP knows that they bring a check book to the table. But why pay the same price before approval when for about the same relative price they get the assurance of approval. For now, the price is just too high for BP without approval. You can be sure that BP is interested and is watching closely. DC VAX can help market their products in a combo cocktail. BP are not unmindful of the serious disadvantages of their therapies. They know the potential and size of the market if DC VAX obtains approval. NWBO has gone this far. They are definitely not gonna sell on the cheap now. They can't. No one will buy for the reasons stated above. So it is very true what LP has said....Go big or go home... There is no other way; it is digital. Zero or..........? JMHO.
Let's hope that management is capable of more than good intentions, otherwise we all are on the road to Hades. Hade to tell ya.
The road to hell is paved with good intentions.
I believe the science will prevail despite poor management. That is the bet I am making. I would like to see a BO. I don't believe this management is capable of successfully executing commercialisation.