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Agreed. I would add that the make-up of the long tail is important as well.
Thank you and Amen. GLTU, patients and longs.
I have been very critical of management in the past, particularly wrt transparency. I once asked LG specifically about silence concerning the reason for the halt after it had been lifted. He responded rather generically that things are not that simple and that there are very good reasons. End of discussion. I have considered the following about management since it has been there where I have had my doubts. I think the science is solid and compelling and I believe TLD will confirm this. I have less doubts where the science is concerned.
1. Linda and Les are not stupid people. Like all of us, they have made mistakes but even then I believe their choices were well thought out. Without being in their shoes and knowing what they know, I have suspended judgement and if the trial is successful, that is all that matters now.
2. It is possible that this is a scam. However, the probability of it being so is nil. Les has said that working on this is a "labor of love" and that there are many easier ways to make money. He could have continued at Skadan Arps or gone on his own. He could have retired by now and he has made a lot of money over the years to fund a wonderful retirement life. Why go through the trouble of scamming to make money and expose yourself to criminality at his stage in life? Ditto for Linda. Their financial position at their current stage in life is more than enough. So it is not just about the money but a much grander vision--engendering a new paradigm in how disease is treated, indeed, a sea change in medical history worthy of a Nobel Prize. Recognition for a lasting legacy that has helped mankind the latter of which is their fundamental motivation for this undertaking. This is what gives meaning and purpose to their lives. That is what Les told me in so many words.
3. Insofar as an investment is concerned, I believe that Linda and Les' interests pretty much align with those of other share holders. If things are successful we all win. Les and Linda did not go into this to scalp relative pennies. With their resources and alternative opportunities, going the NWBO route is just not worth it if that were their only motivation.
4. Where LP/LG may differ from the alignment with other share holders is in the timing/communication.
They have only one chance to get it right. So, they are going to take their sweet time to make sure, and doubly so, that all the Is are dotted and Ts crossed. They don't care about the bleating of frustrated share holders. They have bigger things to think about and in that context don't give a sh*t about the other share holders. We are along for their ride, period. It is ridiculous, at least to me, that it can even be suggested that the trial will never be unblinded. I am 100% confident that it will be but when they decide and the h*ll with everyone else. it is also more prudent, at this point, to continue silence and reveal TLD when they believe the timing is right. Why risk any comments that may irritate the RAs? The only really meaningful break in silence is the announcement of TLD. That is the safest route and not be exposed or otherwise be stuck with defending any lesser "news". At this point. I trust Linda and Les to get it right and get us over the goal line.
I just hope that we get top line before the expiry of the warrants in April, 2020. Just my two cents.
Marzan:
Les said this to whom? When? Extremely encouraging.
Manibiotech:
You are correct----at this stage. Even after approval, assuming it happens, I doubt very much that anyone would offer $22B.
When I talked with Les several years ago and when the share price was about $12.50, I recall that the MC was around $1.2 Billion. At that time O/S would derivatively have been about 100Million(perhaps more, fully diluted, but I do not remember). Anyway, I asked Les whether management would ever consider a BO. Les said that anything is on the table and for an offer that could not be refused, yes, there would be interest. I then facetiously asked whether $50 per share, after approvals by the FDA, would constitute an offer management could not refuse. At that time, this would mean about a $5 Billion MC. Les, with an edge to his voice, said in no uncertain terms that this would not be such an offer and no, the company would not be interested. Such a price would not be reflective of what they have. When I asked what would constitute an "interesting" offer he said he was not going to speculate but certainly $50 per share was not it.
Even an offer of 2x or $100/share would mean an MC of about $10 billion which I guess might have been interesting to NWBO management. However, at least at that time, I doubt that management was considering a BO valued at over $20B. Perhaps management sentiment has changed since that time.
Anyway, I was an investor in AVNR which had an FDA approved drug for PBA, a disorder involving uncontrolled laughter. I bought the stock at about $2. The drug was the only one that could deal effectively with this disorder but the share price languished at around the $2 level for some years. I got tired of holding it and felt that for a non-lethal condition where TAM was very small, it was not worth holding onto. Well, not long after I sold out, the stock started to rise and the company ended up being acquired for about $17 per share.
IMHO, what NWBO MAY have(we don't really know until unblinding and further analysis, but the odds seem to favour a positive trial outcome for reasons that have been discussed ad nauseum) is a paradigm changing therapy for a horrible and deadly disease--GBM--where little progress has been made over the past 15 years. This paradigm, if the trial is positive, will fundamentally affect how GBM is treated and indeed all or at least many solid tumours. The paradigm is far reaching and could serve as a platform in preparing and arming the immune system to effectively engage with many diseases other than solid tumour cancers(either newly developed or recurrent). This may be a fundamental break-through in how medicine will treat a broad array of diseases. DC VAX may be a platform for many indications, a holy grail for pharmaceutical companies looking for an extremely robust pipeline to add to their portfolios. This is what Les believes they have(no guarantees he has caveated as any lawyer would say). Thus, a very high price tag which BP is not now willing to pay at least until they see convincing evidence. The difference between a PBA drug and DC VAX is one in kind, not degree. If you have any experience with GBM, you will know that it is horrible. Patients are desperate. Any hint that this therapy might prolong life and with a better QOL with ease of administration, you can bet, with certainty, that desperate demand will be off the charts. Had I known about it back in 2006~2007, I would have moved heaven and earth to get it and NO price would have been too high. I will bet you that many if not all those who are afflicted with this terrible disease would do the same thing. A positive out come on the trial will engender an avalanche of desperate demand. The issue will be supply, not demand. And....it is a very good bet that patients will opt for DC VAX rather than the helmet assuming even equal efficacy across the spectrum of GBM classifications, a pattern which both therapies appear to be following. If DC VAX proves to provide even better results further out than Optune, it may certainly become the adjuvant therapy of first choice and an important part of SOC as a mono/combo therapy.
I think the key for trial success is the length, robustness and spectrum reach of the tail. For example, if DC VAX L is very effective for M+ and additively for MES and thus addresses about 50% of all stage IV GBMs where it is very effective, overall OS 60 survival is 20% or better and in certain sub-classifications is even higher and is also shown to have an effect on other classifications although not as robust, I think this is a home-run. I do not think that the initial endpoints in PFS and OS are as important, although Iwasadiver believes PFS will have a successful showing. He is not alone among a number of physicians with whom I have discussed this endpoint. While I think that there will be sufficient arms separation wrt OS, it would not be necessarily bad if there were none significant as this may suggest effectiveness of the vaccine even in cases of late vaccinations and lack of a second surgery after progression. Very suggestive for rGBM which has a much more abbreviated PFS/OS.
Accordingly, I feel that if the trial is roughly successful along the lines I have posited above--and I have reason to believe that DC VAX L has achieved them--then share price appreciation may progress much more quickly than one might think. The question is, in view of the above analysis, why is the stock at nineteen cents? It makes little sense to me but it is what it is---for now anyway. Assuming success, I think TLD could augur a share price anywhere between $1~$2 and this might be conservative. There will be BP interest. JMHO.
Yes, indeed. Assuming efficacy/safety is just the same for the device and DC VAX L across the spectrum, I mentioned QOL(to your point) and ease of administration as additional evaluative factors. I would think that patients would overwhelmingly select the vaccine. There may be cases where the device conceivably has greater efficacy and thus might be selected, however, it appears that at least wrt to the major classifications, M+ and M-, both therapies follow similar patterns. Bottom line, I think with reasonable positive results, the RAs would approve DC Vax L to provide patients with more alternatives.
Thank you very much for your response. Very well articulated and logical as well as objective. Should give all frustrated and nervous longs welcome confidence. Best of luck to all.
A very logical post, as always.
We have had some discussion on these issues, but I am curious to know whether you still agree with the inferences drawn.
1. The issue of PFS. If I am not mistaken, this is the primary endpoint and in order to achieve it, 4 months delta over SOC/placebo is the endpoint. How SOC will exactly be staked is unknown at least to those on the "outside" for now. There is the issue of confoundment wrt pseudo-progression, however, that is hoped to be resolved by adjudication. This is perhaps why PFS was not addressed in the JTM article as the data was affected by the confoundment and thus not clear and unambiguous. I do not think that failure to achieve this endpoint is necessarily fatal to the overall success of the trial. This will depend upon length of survival and the delta from PFS to OS. If the delta is significant but PFS did not reach the endpoint, what is the reason for this? One possibility is that although PFS eventing, overall, is not significantly better than control, progression is dramatically slowed as the effects of DC VAX L begin to manifest themselves and take hold over the longer run since immunological therapies take time for their effects to become evident. Thus, the slowing of progression could, in and of itself, contribute to a lengthier survival. Furthermore, the PFS endpoint may be achieved for some classifications such as M+ even though, overall, the endpoint was not achieved.
2. Overall survival. We have seen from the JTM article and subsequent SNO update that the blended data as compared to historicals(from surgery as opposed to randomisation) is rather remarkable for both M- and M+, where the deltas are 7 months and 13 months from surgery(or 4 months and 10 months from randomisation). We also know that the overall blended mOS is 23.1 months from surgery or about 20.1 months from randomisation as compared to a historical SOC of about 17 months. The blended DC VAX L mOS(from randomisation) compares very favourably to the Optune treatment mOS.
We can infer that the vaccine seems to work remarkably well in the M+ categorisation(I do not know the molecular sun-group(s) making up M+), where anything at or over 8 months delta would be considered a very major advancement. The blended delta is 10 months from randomisation and likely higher for treatment. M+ also appears to be a significant percentage of the ITT population at about 44% of the total classification and almost 40% of the ITT as per the JTM article and updates.
In addition, Drs. Liau and Prins have suggested that the vaccine is very effective for the MES molecular sub-group which overall accounts for about 25%~48% of all stage IV GBM. From the February 26, 2018 abstract(which is included in the iHub preamble to the message board), it appears that MES is categorised as M-. However, I do not know the extent of overlap, if any, with M+. However, I believe it is safe to infer that DC VAX L has significant efficacy wrt to as much as 50% or more of all GBM.
Wrt M+, this appears to be characterised by the effectiveness of Temador in interfering with the cell repair mechanism and supplementation with the DC VAX L adjuvant appears to significantly enhance the effect resulting in the lengthy delta over historical controls.
Wrt to MES, Drs. Liau and Prins have stated that it is more immunogenic than other classifications which appears to mean that there are more residual T cells available to build upon by the MOA of the vaccine and that the microenvironment of the tumour is less immunosuppressive thus allowing more time for TIL, etc. infiltration of the tumour(s). MES is an extremely aggressive strain with an SOC of anywhere between 12 and 15 months. Upon recurrence it appears that perhaps 85% of these cancers morph into MES where DC VAX L appears to be most effective wrt that classification. Significant efficacy in this molecular sub-group alone, which is extremely aggressive and which appears to be a significant percentage of stage IV GBM, would warrant expeditious approval by the RAs, including the FDA, at least for that indication.
Dr. Ashkans has stated, in his capacity as a clinician and PI at Kings College, that the vaccine works to a greater or lesser degree across the spectrum and that the vaccine should be made available to ALL patients at an affordable cost. Dr. Ashkans has indicated that the vaccine should be made available as soon as possible and that he would be continually pushing for unblinding.
Cross-over is an issue that could confound results. Dr. Liau has said as much. There may not be significant amount of separation between the treatment and cross-over arms and that 90% of all patients in the trial have received either early or later vaccination. In fact, Dr. Liau has stated that this may be a trial that measures effectiveness of early versus later vaccinations. I wonder whether lack of significant separation between the cross/non-crossover and Tx arms would necessarily place approval in jeopardy given the above discussion. If there were not significant separation, this might suggest that even later vaccination may be to some extent effective and would bode well, not only for ndGBM but also for rGBM as well.
3. Accordingly, taking the foregoing into consideration, it appears that DC VAX L works as well if not better than the medical device Optune at the outset when looking at blended data and better as time goes out. DC VAX L will have at least 4 years of data in the most data rich trial for GBM in medical history as opposed to Optune. Even if DC VAX L works just as well as Optune, patients should have viable alternatives especially as between a device and a vaccine. Factors such as QOL, cost, ease of administration, relative effectiveness wrt to certain GBM classifications etc. should be given the utmost consideration in addition to safety and efficacy.
4. Further, considering recent FDA approvals, we are witnessing a more open, expeditious and flexible approach by the FDA which bodes extremely well for DC VAX L approval if unblinded results are positive as they are appearing likely to be. I would argue that the FDA in approving DC VAX L would render broad as opposed to limited approvals leaving it up to physicians and their patients to decide upon treatment options rather than imposing same through regulatory fiat. After all, GBM cancers are personal and different from individual to individual. Unless you try it, you may not know whether it works personally for you. Desperate patients should have the flexibility to try this treatment through consultation with their physicians. Furthermore, broad approval may make it easier for insurance reimbursals as opposed to off-label use.
Thus, it seems to me that the odds are much more in favour of a positive out-come rather than failure--at least I believe it to be so. I do not know this for a fact.
The foregoing summary brings me around to the following curiosity for want of a better expression. In one of your recent posts you stated that oncologists "know" that the vaccine works and that while yours and their paths rarely cross, you and they work at the same trial site medical center. This declaration is highly encouraging and is much in line with my belief but not knowledge. However, in a subsequent post you seemed to back track a bit and rather than confirming these oncologists' knowledge, you stated rather that they have a strong belief that it works. Belief and knowledge are differences in kind not degree.
Do I necessarily think that your statement that oncologists at your medical center "know" it works, even though there is officially at least no unblinding, is an exaggeration? No, I do not. Clinicians may be "blind" to the trial data/results prior to unblinding, but I would submit that clinicians, dealing with patients every day and knowing their detailed medical history, probably "know" what's going on just as Dr. Ashkans hinted. Their eyes are not blind. Is that a fair characterisation of what you meant?
Would appreciate any comments you may have on all the foregoing. Thanks for reading this and I must say that I find your posts professional, prescient and encouraging.
TIA.
Skitahoe:
Why do you think the share price will be dramatically higher after release of TLD? To what level do you think the share price will rise? Just curious.
TIA
They are operating on fumes. We don't know if or when the SAP was presented to the RAs. If the RAs have it, we don't know if they have blessed it or have made comments yet. In any event, management is not only being cautionary but is in need of financing now to keep the lights on. TLD may be around the corner, however, how far away the corner is, nobody knows not even management.
All I can say is.........WOW!!!!!
69 authors is not my point at all. Obviously it is what TLD shows. The fact that 69 authors endorsed the article gives confidence but no guarantees. That's all. The fact that the article was published in the JTM does not affect the facts.
I did. Was told that the process was time consuming and that there were iterative comments and questions that would have protracted publication way beyond that which NWBO thought appropriate for their purposes. This does not imply that they could have obtained publication had they stayed the course, but, similarly, it does not necessarily negate the possibility either. So it was a situation where regardless of whether a tier 1 pub would ultimately publish, it would likely not be done on NWBO's timetable. Hence, NWBO went with the JTM.
Please read Iwasadriver's post today where he states clearly and without equivocation that:
1. His medical centre is one of the clinical sites;
2. His statement that oncologists there KNOW DC VAX works.
Agreed. I have consistently mentioned that robustness of the tail also depends upon its composition. As I said, BP is on the sidelines for now as unveiling is relatively around the corner---or so one would conclude.
Having said this, I do not know the sub-categories where L is especially successful. The JTM shows notable success in M+. Not so much in M-. However, where does MES fit in? Drs. LL and RP found that L worked notably well for MES as it was more immunogenic. It also seems to work well in M+ due to Temodar and subsequently L continuing/strengthening the interference with cell repair. In the JTM, out of ITT population, almost 40% was composed of M+. If you remove 38 uncharacterised patients, then M+ is about 44% of the population. MES composition of GBM ranges anywhere from about 25%~48%. If you look at a February 26, 2018 study(in the intro to iHub message board), MES appears to be in M- and pro-neural is predominantly in M+. Rather confusing but if MES is somewhat additive, it may be that L could work well possibly up to 50% or more of GBM and to some lesser, but still significant, extent on other classifications, i.e., classical. If that is so, I think that due to the individualised nature of GBM, the FDA would more likely grant blanket approval and relegate decisions as to whether to employ L in specific cases up to the physician and patient rather than by regulatory fiat. JMHO.
How do you know this for a fact? NWBO may possibly have been able to get the article published in a tier 1 publication as you put it, but not within its desired time-frame.
Iwasadiver:
What you have said is extremely important--if true. And I for one do not doubt it if you say so. With comments like these, from an honest professional who has done extensive DD, my confidence is reinforced.
This post is the post of the day, if not the year. Glad you are on this MB and post your insights. Happy, healthful and prosperous 2020 to you, your patients and indeed to us all.
Regards,
U
The point I am trying to make is that there is interest in the DC VAX platform by BP. The reason that there has not been a BO, JV, partnership, etc. may be that LP's asking price is too high, at least for now without unblinded results confirmation.
I am not averring that LP is positioning the company for sale or partnership. Accordingly, it makes no difference on what exchange NWBO is on. If NWBO has a platform that is a game changer, there will be demand by BP. The exchange NWBO is traded on is not an impediment to interest which a BP may have. If an offer is not to LP's liking, she won't take it and go it alone.
Bottom-line, if the DC VAX platform engenders a new paradigm in how GBM, indeed solid cancers and other disease in general, will be treated, everybody is interested and the market will have no choice but to ultimately recognise it. Some institutions are prescient and recognise value much sooner than their peers and break ranks. Regardless of whether there is a bidding war or on what exchange NWBO finds itself, a paradigm changing platform will naturally and ultimately rise to its value. LP is patient and can wait for the market to come to such an understanding even if other investors are frustrated by the wait. Insofar as LP and LG are concerned, NWBO is not just an investment vehicle. It is the culmination of their life's work. They want to make their mark and leave a legacy no matter how long it takes and what challenges they encounter. In so many words this is what Les has said in past conversations with me and I believe in his sincerity. As an investor, however, I prefer sooner rather than later.
To be precise, Dr. Ashkans said that the vaccine works on ALL GBM cancers to a greater or lesser degree and that it should be made available to ALL patients at an affordable price. Dr. Ashkans made clear that he would urge unblinding as soon as possible and that we should work with the RAs to make the vaccine available.
I believe BP is interested however, the sticker price is too high. They may be in collusion with HFs, etc. in getting the share price down in order to negotiate better terms. They look at value based upon multiples of the then extant share price. LP, on the other hand, looks at MC value where share price derivatively falls out. Big difference and for now, BP is on the sidelines. They may be betting that although the trial may be successful, NWBO going it alone in commercialisation, will face severe challenges and require BP intervention which BP may leverage for significantly better terms. I do not believe the latter will happen. If LP cannot get an offer she cannot refuse, she is willing to go it alone.
It depends on how much they buy and how diversified their portfolio is. For example, I was a CEO and I received lots of options in addition to stock grants. I believed in the company but I never bought any stock on the open market. I had more than enough through compensation and wisely invested my money in other opportunities to keep a balanced and well diversified portfolio. Even then, my company stock composed a majority of my investment portfolio.
Furthermore, naysayers and complainers always find fault---"Oh management did not buy on the open market, or if they did, it was token and never enough."
Here are some thoughts about LP/LG goals for NWBO and whether they align with other shareholder interests. I am speculating but am piecing together some of the conversations I have had with LG and information from other sources.
LG has said that he has been fortunate in his career and has amassed enough money to fund a very comfortable retirement. Initially, he planned to completely retire and enjoy life in Florida playing tennis and engaging in other pleasurable activities. Certain family events and the opportunity to join NWBO put off retirement. Why did he do that? Family reasons and the opportunity to make a real difference for the benefit of humanity. LG has said that working at NWBO is a "labor of love." It is something that gives great meaning to his life if he can be a part of an endeavour that has profound significance in improving the human condition and alleviating, to whatever extent, the suffering of disease by mankind. LP has the same perspective and this was an important reason as to why he joined her in this undertaking.
He has said that it is a great opportunity to be able to do something for your fellow man and that there is nothing wrong if you can profit from such an endeavour at the same time. The primary motivation was and is to achieve this goal and leave a lasting legacy. This is important to Les as he is at an age where the meaning of life and what one has done becomes the focus, not the money. Both he and LP have enough money to retire many times over and so their primary motivation is their contribution. If they can make money doing so, so much the better.
Accordingly, both LP and LG have extremely strong motivation to succeed in establishing a new paradigm in medicine and the way disease is treated. Hopefully, DC VAX will be a fundamental platform with which to build the foundation of this paradigm. Both LP and LG have a grand vision and are working hard, not so much for the money--they have enough of it--but to realise this dream. If they do, they, and indeed we, will benefit financially. But much more importantly, a huge benefit for mankind will have been achieved.
They will stay the course and take however long is necessary in order to achieve success in this trial. We, as investors, would like sooner rather than later. LP/LG want to assure success as much as possible and this may take longer. Management, investors, and indeed patients, all want success. There may be some misalignment in the steps and timing. From my own personal perspective, while they may have made mistakes in judgement/execution(I cannot make a judgement on this because I am not privy to all the facts and circumstances that they faced), I have little doubt in management's sincerity. From what I know through my own DD, I am confident that the trial will be a resounding success and TLD, whenever it comes, will confirm this confidence. JMHO.
I would definitely agree with this. Unique and well thought out technology, sterling SAB, 69 authors on the JTM supporting impressive blinded data, undoubted recognition by at least some of big P as evidenced by Dr. Duffy formerly of Merck and approaching/then joining NWBO for employment, no physician that I know of offering a well-thought out rebuttal on the science other than grapefruit juice and too early to conclude anything--it is all very compelling. There have been buyouts on significantly less positives.
If so, there has to be interest by at least some of BP, even though perhaps a majority is short sighted and arrogant. Hence, I think it reasonable to conclude that it is mainly an issue of valuation and that LP, et al know with a good deal of conviction that they have a huge new paradigm in medicine not limited to just solid tumour cancers but to many diseases by "training"/strengthening the immune system in overcoming disease. Hard to place a finite value on such an outcome.
Hopefully TLD will be announced relatively soon for patients. That is a priority. Selfishly, I hope revelation is before expiry of the warrants in April, 2020. GLTU.
Umibe
With firm validation from a successful TLD result, BP will not discount the promise and value of direct. Again, my point is that LP knows what she has and has a "cannot refuse" valuation in mind. She is not going to sell out cheap. She may think the value is $50B while big P may think it less than $10B at the present time. Even if TLD is stellar, there may still be a large valuation disparity.
My bottom line point is that I am quite certain BP understands the potential of the DCVAX platform. It is not that they have ignored it. It is rather that the sticker price is too high. I think we both agree that it is more of an issue of valuation rather than a disinterest in the platform.
Thank you for your message. Although this happened almost 13 years ago, one can never forget the ravages of such a disease. I am optimistic about DC VAX and firmly believe it will signal a new paradigm in medicine. Best for the Holiday Season.
Umibe
My point was not that some or even perhaps a majority of BP execs may be asleep at the switch but that not all of them would be especially wrt a paradigm changing treatment for GBM and indeed many solid tumours. Rather, I think it more likely that it is a valuation issue where NWBO and BP may be far apart. This may change if TLD is very positive. I don't believe that BP is blind to the potential of DC VAX as a mono-therapy or combination cocktail. Surely Dr. Duffy has recognised this and it is rather certain that BP realises it as well. Bottom line, I think it is a valuation issue which may be better bridged by TLD and follow-on deep dive analysis. JMHO.
"Quite optimistic that TLD will change the situation for them....." is quite telling. LP/management have a phalanx of advisors...SAB, PIs, professional statisticians, etc. and accordingly, have much more data and interpretive understanding than anyone on the outside. With this aggregate team, a veritable virtual NWBO, they are the experts in immunological approaches and know more than anyone including the RAs. NWBO et al are the teachers with the amount of experience and knowledge gained in conducting this long standing trial that has been adaptive throughout its tenure. Badly architected trial? No, I don't think so. Prescient, yes, as it is adaptive knowing all along that time and developments have their impacts and NWBO slogged it through resulting in its crowning SAP, a truly ginormous task, which is completed with their satisfaction.
If what you report is fact, and I have no reason to doubt you, DI's statement is a hint if not over the top.
Quite the opposite of pessimistic, I'd say.
Thank you sir. It happened some time ago. It is a horrible and absolutely frightening disease. My wife was a heroine. She endured and was brave. There was nothing then to give hope. Hopefully, DC VAX will change that. Patients with GBM are absolutely desperate as we were. Desperation demand is there and immediate. GLTU.
Thank you all. She passed away in February, 2007. She had stage 4 GBM. She had seizures and was frightened about when they would happen next. Horrible disease, and horrible SOC. Trust me, if NWBO has a sea change vaccine, desperation demand is there and immediate. It don't matter what Dr. Buzdar or other status quo physicians say, patients will grab on tight to such a therapy that is safe, easy to administer, adds relatively significantly to life extension and may be a relative "cure" for some indications where there was no hope before. You can count on it. Looking forward to TLD.
I do agree with you that big P has a very good idea of what NWBO has. I do believe that there have been at least informal "feelers" by big P but the sticker price may be too high. I do believe that big P would offer mid~high single digit billions or even into the low double digits in oder to protect/enhance their franchise. The JTM article/updates are just too compelling to ignore. Big P has definitely come across this. Dr. Duffy is undeniable proof of this.
I do not necessarily think that big P executives are blind and not knowledgeable enough to understand what NWBO has. If I can somewhat understand it, and I don't work in the industry, they are miles ahead of me. These large companies do a lot of intel marketing and keep up to date on all developments, complementary drugs, threats, etc via a swat analysis. FWIW, when I was CEO of a major Apple subsidiary, the company did extensive intel marketing and we were all up to date on what was happening. Same must be true of big P--I would bet on it. I don't think big P executives, deep down, poo-poo what NWBO appears to have and what the relevance may be wrt to their own products. I am sure they have discussions with their researchers/consultants. I don't believe these executives are stupid or dismissive. However, you may be correct about misjudgements by some top executives. In my long career, I have seen some amazing gaffs by top execs that make you scratch your head in disbelief. But not all big P top execs are like this. There must be some, even a distinct minority, that are prescient, understand and may break ranks. You would think that if there is even a scintilla of evidence that you have a sea changing development on hand with unblinding happening relatively soon, big P would be all over it.
Accordingly, if one believes that NWBO has a game-changing platform for a broad array of solid tumours including one of the most difficult to treat of all--GBM--then the sticker price would be high. Big P may have thought that it could get a significant discount prior to TLD or RA approvals but....through informal channels....understand that there are no discounts pre-post TLD/RA approvals, and this has been forcefully and abundantly made clear, then BP might as well wait for results before considering a hefty price tag. In sum, NWBO and BP may be very far apart in market value evaluations for now, and as you say, BP may not be able to afford it. However, this may not be entirely advantageous to NWBO as they may price themselves out of the market having to go it alone thus taking multiples of time to reach the valuations they believe the company is worth. TLD should tell the tale, hopefully soon.
Uncharted territory my friend. If DC VAX L does what we longs believe, and have good reason to do so, and is not a change in just degree but in kind in not only treating GBM, one of the biggest challenges in oncology, but has potential for treating a broad spectrum of solid tumour cancers either as a mono therapy or in combination with other drugs, i doubt that even if the current pps were a buck today that a BO would occur at $2 bucks. Perhaps as another poster has speculated, the company's valuation in that case might start at $50B.
In a conversation with Les, admittedly a number of years ago, we talked about company value and at what price would management entertain a BO. He said then, when admittedly there were less outstanding shares, that he would not be interested in $50/share when I threw out that number. The point is that NWBO management appears to know what they have and their valuations may be currently far apart from those of interested suitors.
If the trial is successful, patient demand will go through the roof. If you have any experience with GBM, you will know that patients are desperate and are willing to grab onto anything that would spare them the ravages of the disease itself and the current SOC. I know desperation. My wife died of GBM and it was horrible. We were desperate. BP understands this. Desperate demand is there. Question is: what is TLD and if results are positive, what is the valuation in a sea changing paradigm with desperation demand? It certainly ain't anywhere near below a billion. JMHO.
I don't agree. It has very little to do with current share multiples. It has to do with market value. You do a market valuation and then the share price falls out derivatively. It may be that big P may be willing to do a deal for say$1B~$5B, but LP is not interested. If, as according to you, BP would never pay up more than double current share price--$0.44--with a billion shares outstanding, there is no way LP would agree. NWBO's sticker price and the price BP is willing to pay may be very far apart and so no deal. Does not mean BP is not interested. It may mean that LP is not interested in their interest.
If NWBO's vaccine turns out to be truly a sea change in how GBM and other solid tumors are treated, do you really believe that BP's offering price would be below a $1B level based upon current share price?
Perhaps, through their own DD, big P believes unblinded results are nothing to write home about or they are interested but LP's asking price is unrealistic as far as they are concerned.
In discussions with LG, he placed a very high valuation on any BO/partnership and that NWBO management would never sell out on the cheap.
If results turn out to be relatively stellar, especially long tail and its composition, do you really believe that BP would only pay up double current share price? In sum, I think LP knows what she has and is not selling out on the cheap. No bargains for BP, I think. JMHO.
If it were a winner through all the hints you have itemised, and a sea change in how GBM and indeed solid cancers will be treated, why is the share price where it is? Why hasn't BP made a play for it in order to protect its franchise? You would think that at least one of BP would have broken ranks by now to corner this little "gem". Surely they realise what you have described. At least some of BP have come to a patent cliff and need to refresh/upgrade their drug portfolios. DC VAX L at least would seem like a good combo fit. BP has many resources scouring the market looking for compatible fits developed by small biotech companies like NWBO but who don't have the resources/weight to get relatively expeditious approvals and engage in successful commercialisation? Why seemingly no interest in NWBO? There are always leaks known by the cognoscenti putting such companies in market plays. Is this just a very tightly well kept secret?
Is it because BP evaluated the platform and found it wanting, that the results of the trial are underwhelming? E.g., primary/secondary endpoints achievements have either likely failed or are not undeniable? That there is a long tail but made up overwhelmingly of M+ and that a broad approval is felt rather unlikely. Or that long tail results are for some reason not undeniable?
Or is it because there is interest but the sticker price is way too high? Is it because BP would be willing to make a deal in the single digit billions but LP is holding out for at least $20B and accordingly, for now, BP is not biting?
Hi Senti:
Would like your opinion on the Series B warrants. Do you think they will just let them expire if TLD not announced by then? I think they expire on or about April 20, 2020. What do you think they will do? Reprice and extend for 6 months or longer?
Regards,
Umibe
Yes, but hope Santa does not fill our stockings with coal.
I was in AVNR and had a cost basis of about $2.25. Sold out too soon because I was tired of waiting. PBA was an annoying disorder but far from life threatening. The market was also small. Management was somewhat like NWBO and I thought AVNR was going nowhere. I sold and got into something else which was a huge mistake.
I don't want to make the same mistake with NWBO. The opportunity with NWBO is not a difference in degree but one in kind compared to AVNR which in the end turned out highly successful due to a BO.
Let's hope not
The beginning of the new decade is next week. The end of the new decade is 12/31/2029. Let's hope we are not in the same place then as we are at the end of this decade(12/31/2019). Better now?
Let's hope we are not in the same place we are now at the end of the new decade.
IMO, I do not believe LP/LG have the skills, experience and energy to run the second stage--commercialization. Les is in his 70s and Linda is getting up there in years as well. I think it will be a long haul before full value, whatever that is, will be achieved. Call me pessimistic but even with stellar TLD, I don't believe we will go beyond a PPS of a dollar. Even with RA approvals, I think the market will take a wait and see position and look to revenues and profits if NWBO goes it alone. I don't think the share price will hit $5 any time soon if NWBO goes it alone. Granted, a BO in the relatively near future would leave a lot of value on the table but with things NWBO, a bird in hand is worth two in the bush. As I said, I would welcome a buyout even if it is in the $2B~5B range.
"Full value" is a very long term proposition and I for one would not feel comfortable with LP/LG at the helm. JMHO.