Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I don't think it is the simplest explanation but certainly reasonable.
Another simple explanation is that he realized he made a mistake and talked with his old employer. Happened to me. I decided to take another job and my former employer approached me and asked me to come back. For a number of reasons I rejected the offer. I did not make a mistake and was convinced of the opportunity.
In Duffy's case, it is certainly possible upon entering the company and reviewing things first hand that NWBO was not the opportunity he thought it was. From his vantage point maybe the results were not anything to write home about and he was disappointed. Maybe he thought there were better opportunities with Merck.
If NWBO were pioneering a fundamental sea change in the way solid tumors are treated and the results were undeniable, why would you leave? How could Merck give him a better deal? If NWBO hits a home run as LP and LG have said a number of times, the share price should very greatly appreciate and he would be a significant part of a new paradigm in addition to being very wealthy. Wasn't that part of the reason he left big P to go with an exciting start-up company with a paradigm changing product platform? Surely he did extensive DD, at least as much as he was able being on the outside. Being on the inside could have changed his perception. Maybe he did not have faith in LP/LG' s commercialization capabilities. Maybe he found a hole in the science. Who knows and nobody is really telling beyond glib explanations.
His departure is a concern and I don't see that he was promoted upon return to Merck or that he received significant compensation that would rival what he could take in if NWBO is successful. With his background and being an insider he would have an excellent idea of whether NWBO had the goods. His departure certainly raises concerns. He does not strike me as a gambler and what looked good on the outside, upon further inspection while on the inside, evidenced, at least to him, that it was less than what he originally thought.
I just don't buy the simple explanation that he got an offer he could not refuse or that he was on a "mission" to validate NWBO. At least equally persuasive is that he did not like what he saw up close. JMHO.
If what you say is true, then Dave Innes is not only naive and out of touch with the perception created by the ASM announcement but rather intentionally disingenuous. If he uses "interesting" as a weasel word, then he is knowingly ignoring what "interesting" really implies. The "elephant in the room" is upper most in investors' minds. Wall Street, physicians and patients are all hanging on with baited breath on what is "interesting." Indeed, last year, a definitive time table might have been "interesting." In fact we were all given a time table by none other than Jerry J. board member. Didn't he say with conviction, and supported by LP, that in 3~4 months there would be a string of PRs regarding developments such that the SP would be upwardly effected in order to create a much better acquisitions environment? Didn't Jerry J say that he was experienced with mergers/acquisitions? So what happened? This was blown as was his, and NWBO management credibility. You would think that BOD members would be clued into the company plans.
This time around, more than a year later, it is too late for timetables and their announcement is completely meaningless. Nobody believes it with management's and even BOD's track-record. It is more than likely that we would all believe that timeline prognostications would be blown. Why waste a perfect record?
In my conversations with LG, I once again explained the foregoing. The only thing that matters, that is 'interesting", is top line. He is not going to announce a partnership, acquisition, merger or anything else of interest unless and until TLD is announced. Potential partners, suitors, etc. have waited this long and assuredly won't make any move until TLD is known. That is the realty. TLD is the gateway to other "interesting" things. Without TLD, nothing else is really of any significant interest to anyone. TLD is top most on everybody's mind.
Skirting top line will confirm the perception that NWBO is again, for no discernible reason, kicking the can down the road. All credibility will be lost and IR a laughing stock. Might as well get rid of it and save some cash and bonus shares. No telling what will happen to the SP. Definitely single digits. LP will end up having to finance out of her own pocket because there will be no financing deal toxic enough to attract the vultures.
Is management this naive? Is the ASM really going to be a nothing burger with no PR build up between now and the ASM? No TLD then but "we are planning to announce it prior to the former ASCO Exhibit dates or soon thereafter...." If that's the case, even the most ardent supporters will have had enough and I would hate to say it, but Scotty would be right. Accordingly, with all due respect to you, you misunderstood DI. If he said what you claim, he is one dumb SOB and should be terminated forthwith.
What the JTM journal article(and SNO update) suggests is that both non-methylated and methylated groups are efficaciously treated by DC VAX L when looking at blinded data as compared to historical SOC. The delta for non-methylated is about 7 months and the delta for methylated is about 14 months. Treatment arm deltas are most probably even longer. Drs. Liau and Prins concluded from their earlier trials that the vaccine was especially efficacious for MES as a whole. They did not break down MES methylated and MES non-methylated. However, they did find that MES, as a whole, is immunogenic. Accordingly, this would suggest that the vaccine is especially efficacious wrt to methylated MES due to impaired cellular repair mechanism, higher thresholds of T cells and less immunosuppressive micr-tumour environment. In other words, the morphology of this particular molecular sub-group is particularly susceptible to the vaccine as an adjuvant to current SOC. The non-methylated MES sub-group is also efficaciously treated, even though it lacks methylation, due to its immunogenicity. I believe, although i am not sure, that methylated MES sub-group makes up a significant proportion of the larger Methylated grouping but not 100%. There are other methylated variants. In the trial, the identified methylated group makes up about 44% of the total M+/M- major groupings. In the non-methylated group I believe there is an non-methylate MES sub-group that makes up a significant proportion of the total non-methylated group. MES, as a whole, makes up a rather significant proportion of nGBM ranging anywhere between 25%~48% depending upon the literature read. Accordingly, as was suggested by Dr. Prins, there was little to no effect by the vaccine on the overall pro-neural sub-molecular group and perhaps some efficacy in other groups,i.e., classical and neural. Assuming that these less affected sub-molecular groups were a part of the un-methylated group, they may have likely masked the significant efficacious effect of the vaccine upon non-methylated MES. Despite that, the delta was still 7 months in this group, suggesting a significantly longer Tx OS for non-methylated MES. Hence, trial results may indeed show that the vaccine is efficacious to some extent extent across all sub-molecular groups especially in the methylated group but not so much in the non-methylated group except wrt MES. Since MES takes up a significant proportion of nGBM and there are a smattering of other sub-molecular groups especially in methylated, the efficaciousness of the vaccine may be especially pervasive in 50% or more of nGBM. Pro-neural tends to morph into MES and it is estimated that upon recurrence 85% of rGBM is composed of MES. Accordingly, the vaccine does indeed work, to a greater or lesser extent, on all sub-molecular groups depending upon their morphology and evolvement through mutation.The vaccine may be efficacious for both nGBM and rGBM which is even a larger market with a really significant proportion of MES where the vaccine is especially effective. JMHO.
If my analysis came from LP would that be better?
Anyway, I think the analysis is pretty close to what is going on. I am very confident wrt RA approvals. I am relatively certain, IMHO, that the UK will come out with approval first. They are extremely receptive and have been greatly influenced by Dr. Ashkans and other influential oncologists there. The build-out/readiness of Sawston is a big clue. If I were to forecast, I believe that UK approvals will come several months after TLD. In any event, I think certainly this year. I believe that the FDA will relatively shortly thereafter render approvals as well as Canada and Germany. Just my take from "reading the tea leaves". I am not concerned about the original end-points. It is all about the tail. That is where the excitement lies. The results will show a long and very robust tail. Undeniable efficacy over a broad spectrum. Broad approval by the RAs. After all Optune met a lower threshold with the FDA approving and NWBO's results will be significantly stronger. Unless COVID-19 really mucks things up, 2020 looks to be NWBO's year.
I know that management's silence is not meant to annoy or disregard shareholders' desire for more information. They believe they have very good reason for relative silence and in any revelation for the reason(s) for lack of communication this could give it away or cause more speculation/confusion. Not very satisfying but in the end, it is all about the results. JMHO.
Doc:
Thank you. I have had a lot of interaction with NWBO over the years and I can tell you that while they are dedicated, hardworking and intelligent, they lack a certain amount of "street-wise" common sense. I have always admired individuals with a lot of street smarts as opposed to those individuals who are professionally and academically credentialed.
David Innes is their link to the market and indeed to the investor on the street so to speak. I wonder whether he has counselled them persuasively in thinking through some of the actions they have undertaken. There are two main constituencies to my mind: regulatory where the science essentially reigns with the capability to execute and "scale up" as LL declared in her recent interview which described NWBO to the 4 corners AND market(public) perception. NWBO management does not seem to appreciate the difference. Perception is extremely important(with factual truth backing it up of course) as it influences investment decisions and quality/level of funding.
IMHO, I think that the science(not silence if you will appreciate the alliteration)is golden, the regulatory atmosphere appears to favour NWBO especially if the guidelines, as LG has said, were essentially written with NWBO in mind, but....the perception engendered is to a certain degree destructive and self inflicted. I do not mean to harp on Mr. Inness but I would have hoped he would have brought at least a modicum of "perception supervision" to the company. Perhaps he has tried but has not been as successful as investors would like and expect. Linda and Les, both being lawyers, are hard-line debaters and it is not easy to get in a word edge-wise. I know....I have tried many times. JMHO.
Doc:
FWIW, here is my opinion. NWBO has a legitimate concern on P-value particularly as it pertains to separation between the cross-over/placebo and Tx arms OS. The bottom line is that even those with late vaccinations have received some benefit despite the fact that very few second resections were done. This is particularly noteworthy and when coupled with the extremely flexible FDA guidelines might permit approval for recurrent GBM as well which is a large market in and of itself. If approved just for nGBM, the vaccine can still be prescribed by physicians off label. Hence if the data shows that cross over patients benefitted even by later vaccination, this would instil confidence in physicians in prescribing for rGBM. This view is supported by LL that "it seems everyone is living longer" and by Dr. Ashkan's plea that the vaccine should be "available to all patients".
It should be noted that the FDA did NOT require NWBO to have a cross-over arm. It was NWBO that included the cross-over arm in its trial protocol. NWBO discussed this with the FDA and told them that it would be more difficult to recruit patients in the trial absent a cross-over capability. The FDA agreed with this and agreed that NWBO have this cross-over function in the trial.
Although the trial has yet to be unblinded, out of an abundance of caution, NWBO wanted the FDA to take note that even IF an overall trial failed to achieve the specified end points, but certain significant and identified sub-groups did demonstrate efficacy and positive safety characteristics, then as to such sub-groups there should not be a requirement to restart another trial but have a conditional approval predicated upon a "phase IV" protocol. NWBO has significant sub-groups that may cover 50% or more of the nGBM spectrum: these are M+ and MES. With respect to M+MES, the vaccine is particularly efficacious due to two pathways--methylation which interferes with the cellular repair mechanism and immunogenicity which involves a greater threshold of T-cells upon which to build and a less immunosuppressive micro-tumour environment allowing more time for T cell infiltration and destruction. With respect to un-methylated MES, it is still very immunogenic and while more aggressive than its methylated counterpart, the vaccine is also significantly efficacious as was hinted at in the JTM article where the overall blended delta for M- was about 7 months. This would include M-MES and other un-methylated molecular sub-groups with much less efficacy masking the rather dramatic efficacy upon un-methylated MES which is the most aggressive of all molecular sub-groups and where the Tx arm could be significantly longer.
There have been extensive discussions with the FDA on all this. The FDA did provide comments with respect to NWBO's SAP. P values and sub-group issues are not de novo issues raised for the first time by NWBO, or for that matter, anyone else. These are important issues and NWBO felt that, although the FDA was well aware and even in agreement, it was important to go "public" with these recommendations and have some specific rather than just overall generic flexibility in the guidelines. The role of p-values and sub-groups and their applications should be important considerations in flexibly considering therapeutic approvals.
NWBO deals with these foregoing issues rather extensively in its SAP upon which the FDA has provided its comments.
NWBO is pioneering trial and regulatory policy with respect to immunological trials The old evaluative criteria more appropriate for surgery, radiation and chemo need to give way to much more up to date evaluative criteria. The FDA guidelines and, indeed, relatively recent approvals demonstrate a paradigm shift in the way that regulatory agencies view novel therapies and should go about evaluating and approving them. NWBO's trial will be a treasure trove of data and the most extensive of any GBM trial.
Accordingly, when viewed in this light, the letter does not imply desperation and trial failure. Rather, it represents a reasoned approach to recognising novel therapies which could revolutionise the way medicine is practiced. And....the letter echoes what the regulatory agencies have already begun to recognise.
I believe the letter is a harbinger of things to come. NWBO has broken its silence with respect to the FDA. And it has done so through the opportunity to publicly submit comments to the FDA guidelines. JMHO.
You can take that to the bank. The FDA/Hahn and Pazdur are on board. They understand the new immunological paradigm. The FDA guidelines have been written with a lot of carefully thought input from NWBO. There has been discussion about P-values and their application. However, they don't necessarily apply when everyone is living longer including late vaccination. Linda's letter is on point wrt to P-values and sub-groups This is an important area and has been addressed extensively in the SAP on which the FDA has made comments. BTW, would not doubt that several of the 800 statisticians were involved with NWBO. JMHO.
I agree with everything you said. It is very prescient and is consistent with my own research. What is very important is that she now has gone "public" wrt the FDA. All part of the grand "plan". The request for comments gave LP the opportunity to go public. NWBO and the FDA have had a number of exchanges and while still very friendly........the gloves are off.
I asked that question in a recent telecon with LG. He could (would?) not say. He could not inform what the percentage of nGBM M+ MES was from his reading of the literature. He could not expand upon the trials conducted by UCLA where LL/RP suggested that MES--generally-- was especially well treated by the vaccine without distinguishing between M+/M-. He allowed that M+/MES is longer lived which is correct but did not know what percentage it is of the M+ population. He was completely unaware of the Feb. 2018 abstract in the iHub message board preamble that categorizes molecular sub groups in M+/M-. In this context, he could not address the abstract's categorisation of M+ being composed almost exclusively by pro-neural. He could not explain exactly why DC VAX L was efficacious in M- MES. I pointed out to him that LL found that MES generally was more immunogenic similar to melanoma where there was a higher residual TIL population to build upon and a less immunosuppressive micro-tumour environment. Is that correct I asked. He avoided a direct response and he said that we would know the answer to my queries when they unblind.
I told him that if they really have something interesting why wait till April 18 when the SP is in the toilet and surely a financing will be required between now and then. If he announces financing now, without "interesting" news, the SP goes in the toilet and pisses everybody off. You need to come out NOW. The market is betting more of the same and that "interesting" is a bait and switch. He responded that they will not announce anything until they are ready. What more do you need to be ready???? Is the SAP final? Did you data lock? When? Is there anything to a mid-May date that DI mentioned to an MB member? Is that when TLD will be announced? He allowed that he is not saying it won't be announced earlier but he will not say one way or the other.
In conclusion, I told him that many investors who bought into the series B/D-2 warrants 2 years ago fully expected they would be in the money by now. Now they are in danger of worthless expiry. Is that how you reward loyal supporters that help your financing needs---like me???Your waiting for the right moment and continued silence have placed the company, SP and investors in this spot. Stop referring to the nefarious forces as the cause and excuse of the collapse of the SP. The best thing you could do is come out with what is "interesting" NOW and get these warrants in the money rather than using the lure of extension to raise more money. We are all fed up with this ploy. If you don't know what is "interesting" I will give you a hint--elephant in the room. End of conversation, FWIW.
The drop to $0.14 is concerning because I have a gut feeling that another financing deal is in the making. They need money and I believe that another financing will take place between now and the "interesting" ASM, if it takes place. Insofar as the ASM is concerned, if it takes place and as scheduled, it will almost certainly be virtual. I have heard that it would be one-way with no questions from the virtual attendees.
I have just a gut feeling that another financing is around the corner barely a month after the last one. It will be very difficult to attract investors now unless either a highly toxic deal is structured or NWBO management lets the cat out of the bag and is up front with investors as to what is so "interesting." It seems to me that NWBO is between a rock and a hard place and going out to investors for another raise so soon after the last one, if my timing is right, is extremely concerning both in terms of fiscal (mis)management and what this communicates to the market. I would not be surprised to see the SP dip to single digits. I don't believe I am alone in this feeling as even Doc Logic prognosticated, albeit some time ago, that the SP could dip to $0.05. The need for financing and especially the clandestine silence/teasing "interesting" tid-bit have given impetus to SP destruction. Everyone knows that NWBO management has blown every guideline they have given out. LG has repeatedly talked about a string of PRs bolstered by a board director at last year's ASM claiming that PRs in 3~4 months would help to bring the SP up. Can management be trusted? Good managers do what they say they will do. Sometimes unforeseen circumstances interfere. In NWBO management's case, they have 100% blown every thing they have ever said. Is "interesting" just another shuck n' jive?
OTOH, I do believe that the trial will be successful. But the question is---how successful? Les and DI have both said that the FDA proposed guidelines which they appear to be following in practice is "huge" for NWBO in terms of ultimate approval. It means that historical sets can be used as comparators in analysis, in addition to sui generis trial comparators. This appears to be a mixed blessing at least insofar as market perception is concerned. The implication is that IF the trial's end-points can relatively comfortably be achieved, what is all the fuss about? The long tail, which we all believe is long and robust is icing on the cake. Surely, by now, NWBO has some degree of confidence as to the degree of success in meeting all these criteria. They have all their professional statisticians, the SAB, the PIs like Drs. Liau and Ashkans and reams of data which we, as investors do not have. However, in light of possible confoundment caused by pseudo-progression(adjudication should clear this up, I would think at least to some significant extent) and cross-over(not enough and SS separation), there is an obvious concern that these primary and secondary endpoints may somehow not been met or the results not considered to be undeniable. The original SAP was expanded upon to incorporate new developments/information as the trial progressed over many years. This, of course IMO, hints that perhaps the original end-points were considered to be in jeopardy of achievement and hence other evaluative criteria, more in tune with immunological therapies, needed to be incorporated into the SAP. The compilation of this SAP was a "ginormous" task and required review/agreement with the relevant RAs---or at least NWBO thought so. Much time and effort was spent on this task. So it seems reasonable to assume that there were issues wrt to the initial endpoints such that a more "up to date" SAP was required. I don't claim that the endpoints had failed to be achieved only that NWBO's analysis of the overall blended data may have suggested a close call and that it would be accordingly prudent to modify/expand the SAP. Hence, LP's statement that investors should be focusing upon the long tail results of the trial. That is its length, OS mile-stone achievements as well as its robustness.
NWBO would certainly require stellar results in the long tail in order to de-emphasize any ambiguities or failures wrt to the original endpoints. For example, a stellar result at OS60 could be 25% overall survival covering M+ and MES( methylated and un-methylated?) which comprise close to 50%(?) of the spectrum with a smattering of other sub-groups. Especial efficacy in MES(just M+ and also M-?) would be stellar as this is the most aggressive and short lived grouping as well as a significant percentage category. The question is whether, in fact, the results will be that stellar. I say this, not in terms of whether approval will issue, but rather what market perception will be and the impact upon the SP. If not so stellar then we might just see a very modest SP recovery but with relative doldrums and drifting until RA approvals issue sometime during 2021 or God forbid even as far out as 2022. Stellar/undeniable results would also give urgent impetus to expeditious RA approvals. I would think that the main approval driver would be the FDA, although UK approvals would have some effect albeit not as significant as would be an FDA approval. Less than stellar/undeniable results could lengthen the time of approval and keep the SP in the doldrums.
In any event, we don't have any specific information on the tail and the robustness of its composition. We do have some historical perspectives from the JTM/SNO where in the M- case(55%+), historical SOC/OS was 12.7 months whereas blended OS was 19.8 months--a delta of 7 months from surgery. In the case of M+(its' composition in terms of molecular groupings has not been entirely clarified and which comprises about 44% of the categorised groups--38 initial patients were not so characterised), SOC/OS was 21.7 months and blended OS 35.1 months, a delta of almost 14 months--as per updated SNO from time of surgery. My math skills fail me in reconciling an overall 23.1mOS with the forgoing figures, however, this translates to 20.1 months from randomisation compared to 15-17 months SOC. This is a rather limited cushion that suggests that the mOS overall figure demonstrates significant efficacy for some groupings,i.e., M+/MES and little to no efficacy for other groupings. To some extent this conclusion flies in the face of statements made by Drs. Liau and Ashkans that all patients seem to be living longer and that the vaccine should be made available to all patients as it works to a greater or lesser extent on all nGBM.
The bottom line is we just don't know the extent of success, although I believe that we will have enough for eventual approval. So the extent of success and the length of interim time to approval are great unknowns weighing heavy upon the SP further burdened by the urgent need of financing coupled with silence/teasing carrot dangling in terms of an "interesting" ASM which now may be virtual without the ability to ask questions. Although there may be a broad spectrum as to what NWBO management thinks may be interesting, the elephant in the room is TLD. That is the ball-game. Anything else that may be deemed interesting by management has to pale in comparison. Unless there is something definitive addressed wrt TLD at the ASM and in preceding filings/PRs, management will surely lose any shred of credibility and needed financings will be hugely toxic. LG has said that they can get money when they need it and that is a true statement, at least for now. What he has not said is the source of funds. Vultures can well come in on highly toxic terms which are calculatedly profitable to them. However, how easy is it to get financing from friendlies on less toxic terms who now don't believe management stories anymore. How much more difficult will it be if "interesting" turns out, in essence, to be nothing more than a stay tuned as in years past?
Accordingly, FWIW, COVID and current economic environment call for expeditious and decisive action. The SP is in free fall. There is nothing propping it up. Is management content to let it drop to, say, $0.05 and then with TLD announcement, expect it to rise 6~10 fold? I don't think such multiples would apply, at least in the shorter term. Anyway, that would translate into $0.30~$0.50 which is not very satisfactory. Even a $0.14 base with a 6 fold increase would be relatively acceptable. To stand by and let the SP fall to single digits, an unsatisfactory launching platform on good TLD, is inexplicable and inexcusable particularly when ASM expectations have been stoked and further financing certainly looms in the short term.
If NWBO has something really "interesting"--think TLD elephant in the room--then come out with it NOW. No need to wait until April 18 when the SP is completely in the toilet. I am sure that any investor they tap for an upcoming financing is sure to require assurances wrt to TLD/announcement as that is the top and almost exclusive topic of "interest."
So, yes, Senti, I am very concerned about the SP and its precipitous drop and I think much more, if NWBO does not break its silence soon and especially if there is another financing looming around the corner. The time to come out with what is "interesting" is NOW. Let's hope it is really interesting rather than yet another diversion and carrot dangling ploy. JMHO.
Consider that in mild COVID-19 cases, the virus has not migrated from the upper respiratory system to the lungs. In this case, there would be at most little inflammation in this region and making it anymore susceptible to bacterial pneumonia. However, if the disease has already migrated to the lungs, it could very quickly develop into viral pneumonia. That is very deadly all by itself and vaccination against bacterial pneumonia may be of insignificant effect and benefit.
I don't know whether vaccinating against bacterial pneumonia is part of SOC in cases of diagnosed COVID-19. I don't know whether it is a standard protocol in severe colds and upper respiratory infections even with fever or in non-COVID-19 flu strains. I will have to pose this question to my own doc when I see him next week. But you could be correct. Anything is possible.
I don't think that is correct. What happens, according to my understanding, is that the virus invades the epithelial cells of the small air sacks in the lungs. The virus replicates itself, thus killing the cell. The mucus engendered by inflammation in fighting off the attack fills these air sac spaces thus interfering with oxygen exchange. You become short of breath. As the lungs fill with liquid you literally die by drowning. Nasty piece of work especially for elderly and those with compromised immune systems. How about a COVID-19 lysate? COVIDC VAX V(for virus).
Scotty, why do you think so? It would be interesting to hear an educated and scientific reason as to why you think the trial failed and NWBO won't get approved. I am quite certain NWBO will be approved by an RA and upon an expedited basis.
I am listening..........
Prime Minister Abe has stated his resolve that the Olympics take place as scheduled and of course he is under a lot of economic pressure. The President of the IOC has kind of backed off and will follow WHO guidelines. Some events have taken place such as the spring sumo tournament but without spectators. It is being televised. Personally, I think the Games should be delayed until 2021 early Autumn. Holding the Olympics in the hottest time of year in Tokyo is just madness. The summer is a killer. WTF was the IOC thinking? Abe? Abe has spoken in broad generalities but no specific plans on how to conduct the Olympics if it goes on as scheduled. He is like a deer caught in the headlights. Foremost in their minds are politics and money. Health seems to take a back seat. With influx of people coming in for the Olympics, Japan risks a crises. Do you let China in? How about Italy? The logistics alone are daunting. Postponement seems to be the best alternative. I have a stake in all this as I live in Japan. Hospitals not prepared. Respirators are woefully inadequate. Test kits? I have two docs that take care of me and no access. This is a nasty disease especially for the young, old and those with compromised immune systems. Having the Olympics is a huge risk to these constituencies. As they say....sho ga nai(it can't be helped).
It will get a heck of a lot higher if the Olympics take place.
Indeed, in any event, whether this is brought up in the proxy for the ASM or thereafter as you posit, they will need the increase. They would like support for this. Accordingly, I still believe that they need/will deliver at the ASM where TLD is sure to come up. They need an answer for this. JMHO
Fear that once again, NWBO will not deliver something "interesting" at the ASM and once again disappoints. Thereafter, absolutely no management credibility and no need for the IR function. Any timeline for TLD, if it comes, will not be believed. If TLD is good/stellar, it will not be impacted by COVID-19. Luckily it is being discussed ad nauseum now and by the time NWBO hopefully announces TLD, people will be tired of hearing about the virus and its rate of increase abating.
I think NWBO management understands it has to deliver not just "anything interesting."
Assuming that the ASM takes place in person or virtually, you can be certain of two things:
1. Vote to increase shelf, and;
2. TLD discussion.
WRT to item 2 above, if there is no PR/filing, and even assuming that LP does not bring up TLD at the outset of the AS meeting, shareholders in attendance/participating will undoubtedly raise the issue. This is especially true if LP requests an increase in the shelf. She cannot avoid addressing this issue. It will, of course, be a concerning sign if LP does not initially address it and instead shareholders have to bring up the discussion.
I believe that LP wants shareholder support. I think LP understands the need for credibility and what will happen if discussion on TLD essentially turns out to be "stay tuned." Timelines on TLD may not be believable if revelation is planned--"if all goes well"--at ASCO/or in a couple of months which would be around mid-June. It is well known that LP/LG have never met any guideline they communicated. Thus, a conditioned caveated guideline will be a huge disappointment and the market will react accordingly. Even a guideline for revelation in say two weeks from the date of the ASM will be treated with a modicum of skepticism but because of the date proximity, investors/market may hold steady awaiting this short-term event.
However, if top line is not announced in a PR/filing, say, just before the ASM, I doubt very much that LP will announce a fixed/drop dead time-line for TLD. There is not much else of "interest" except top line at this point. Investors/Wall Street are interested in one thing: success or failure and if not a failure, the degree of success--is it mediocre or stellar overall and, of course, how the results are presented.
I doubt that LP will announce a partnership or any collaboration with a partner depending upon TLD results. TLD is "interesting" in and of itself and is the "gateway" to all other things "interesting." Since TLD is foremost in everybody's mind, it is difficult to come up with anything else that is of significant interest such as to boost the SP.
Undoubtedly, between now and ASCO, NWBO will need to raise funds. This weighs upon the SP. "Interesting" and exhorting shareholders to make plans to attend and giving a lead time to April 18th to do so obviously underscores the importance that management assigns to this ASM. Hence, they need to deliver.
I am certain that LP understands all this and will be very well prepared to address TLD, either through announcement or otherwise, at the ASM. It is critical in how she handles this issue and instills confidence.
I don't think that investors will tolerate "stay tuned" or other vague illusions. Of course, LP probably has the votes to do as she pleases, but will sacrifice the support of most shareholders, retail at least, if she does not deliver. Many accredited investors, including myself, will be highly pissed if our warrants expire worthless on May 2nd. I have said this to LG and my dis-interest in participating in any further raises due to my distrust of management and their lack of credibility. I am sure many other long-suffering investors feel the same way and a blown ASM will be reflected in the SP. Vulture toxic financing and painful dilution will severely and negatively affect the value of investment in NWBO even despite the success in TLD. I have further said that good managers do what they say they will do and those that don't are lawyers. After saying that the ASM should be "very interesting", I responded that for now, I trust but please do not disappoint.
Accordingly, I believe NWBO management is aware of all this and therefore will deliver. They certainly would not sanction such a PR if they could not deliver. They have given themselves enough time. A less than "interesting" ASM is deadly and really no further need of the IR function. Nobody would believe them anyway. JMHO.
Maybe the shorts think they can drive it lower for now. Who knows?
Doc:
Keep the lid on so warrants expire? So, no interesting news at the ASM?
Doc, I can tell you this much. I can guarantee that TLD will be a subject at the ASM. That is a 100% certainty.
Attendees will have opportunity to ask questions, so even if management does not first address it, an attendee definitely will. Whether the ASM will then be very interesting/exciting will depend upon how she responds. I can also guarantee that LP is thinking about this. In fact, it has to be foremost in her mind as it is in ours. There is no way she can escape and management is absolutely certainly thinking about an appropriate answer if they are not going to unblind by then.
Of course, and this is speculation, LP may play the shorts by giving a stay tuned response. The stock tanks. The warrants expire. Then on or before mid-May TLD is announced with stellar results.
Gotcha.
Expectations under control????? It was NWBO that created them in the first place. NWBO gave fuel to the fire. They did not know the impact of their words? Interesting and two month lead time so shareholders could plan to attend? Just to say gee we can't talk about TLD but we will announce it on X date is just kicking the can down the gravel road once again. And who would believe them? They never once met any guideline and when they do miss it is swept under the carpet. Explanations are...well, things change.....duh. Credibility is at stake. If the ASM does not deliver, what do you think is gonna happen to the SP? What's gonna happen to the warrants? A lot of pissed off investors including me. They will need more financing. With a blown ASM, toxic financing at bargain base prices. Pissed off? That is not the half of it. But then, investors did not issue the announcement. NWBO did. Nobody held a gun to their head. The words were vetted. Do you think LP is stupid enough to go to the ASM without her clothes on? "We "plan" to release TLD sometime before ASCO unless something unforeseen happens. Other than that, we can't comment now but when the time is right we will let you know. Isn't that interesting?" What do you think will happen at the ASM and thereafter???? AF is licking his chops. A lot of people will be fed up. The market? Well, you guess. :(( I am betting LP/management ain't that stupid. They will deliver since in terms of credibility they have little choice.JMHO.
No, not significant.
The PR is one in which Dave Innes must have had significant involvement. He understands the power of words and phrasing.This is not a hastily cobbled together PR without sufficient understanding of what it at least implicitly implies. It has set up investor expectations. This is obvious. It is just plain stupid if NWBO puts out a PR like this and then thinks..........."ooooooops, didn't think people would take us so seriously on this. We got to back pedal on this lest we get hung at the ASM." That would be the height of mis-management/mis-communication. If NWBO does not deliver at this ASM and kicks the can further down the road, it will have lost all credibility. If the TLD subsequently does not hit all end-points and is not stellar and understandable by Wall Street, nobody, at least market wise, will believe their analysis and explanations. They will be adjudged as non-credible. Long suffering investors will then need to wait for RA approvals before they see any real movement in the stock. There will be further financings one more toxic than the other. We all expected unblinding last year at least by September. DI bet a steak dinner. Here we are in almost mid-March and no unblinding, nothing. We have the company volunteering a very positive PR which implicitly, at least, promises that this ASM, at long last, will be interesting. You have the General Counsel telling accredited investors that not only should the ASM be interesting but "very interesting and exciting.
IMHO, NWBO put itself in this box. With apologies to my friend Longfellow, NWBO has no viable option but to deliver on its PR, lest credibility is completely destroyed. We all know--management, investors, patients, physicians and Wall Street---what interesting really means. It has to be at least significantly tied to TLD if not an unblinding. IMHO, LP can't stand up at the ASM and essentially say....we can't say anything about TLD, stay tuned, but here is a little tidbit that should tide you over until we can talk about TLD blah, blah, blah. I just can't imagine LP setting herself up for this. Why then voluntarily issue such a PR? It does not make any sense. I can't imagine Dave Innes agreeing to let a PR like this go out without any thought for the obvious consequences and then back-pedal. This would be an IR nightmare. Plain common-sense would argue against it. I know there are two versions but I choose to believe Kabu-san's report. It just makes sense.
Indeed, and why would they build up expectations and not fulfil them by at least some modicum of expectation satisfaction rather than engendering an acrimonious ASM because interesting did not turn out to be interesting?
Because they want to "play" with investors? They like pissing off investors? If they don't care about the average investor, why put up such a PR in the first place and then dash expectations at an ASM? Wouldn't a simple PR just announcing date, time and venue suffice? Why make excuses for a two month lead time? Why hold an ASM at all? Let a shareholder force it, then hold the ASM in a broom closet and answer all questions with a "stay tuned". They can certainly do that if in control. And.....they have been doing it. Vultures will still provide financing because they can steal from longs, give money to NWBO, sell the shares which they got at deep discount and hold the warrants. They make some money on the sale of the shares due to discount plus get free warrants. What is the point of it all? To further destroy credibility and make it all the more difficult to complete ever more toxic financing?
It's crazy and makes no sense to me. Nobody is that stupid. No, I am betting on hearing something significant tied to TLD. JMHO.
Hi Marzan:
I envy your optimism. But we must walk before we can run. IMHO, billionaire status is a long way off if ever, at least for most of us.
The first thing that needs to happen is TLD announcement. The results need to be undeniably positive coupled with a statement that based upon these results, NWBO is expeditiously filing the requisite applications with the RAs. This will raise the SP and although there will be funding and further dilution, the positive news with the odds-on certainty of approval will sustain a much better SP. There will undoubtedly be behind the scenes activities and at least some collaborative partnership in the offing.
Accordingly, the ASM takes on importance in terms of management credibility. Management has voluntarily issued what can only be interpreted as a very positive PR. I believe the word "interesting" is a code word. I would not expect any PR to come out with "stupendous", "unbelievable", " amazing" or other superlative adjectives although LG was more exuberant in describing the ASM as "very" interesting and even 'very' exciting. I believe that the "interesting" code word must involve TLD in some material way. I cannot imagine that the ASM will not discuss TLD in some material fashion. This is, by far, what is foremost in investors' minds. It is an "interesting" sea changing event. Can you imagine LP saying something like....."sorry, we cannot be specific about TLD at this point but what we can tell you is that we are "close". It is a ginormous undertaking to put the SAP together and submit(or present) it to the RAs. We hope we can provide more information at an appropriate time. However, having said that, we can provide this [unrelated] interesting information..........." I would imagine that even NWBO management and the head of IR understand that this would be a blatant "bait and switch" completely undermining whatever credibility they ever had. This is especially so when they have exhorted shareholders to attend the ASM and have given them 2 months to plan such attendance. The implication is that this time around, the ASM is particularly important. I cannot imagine that management gathered investors around only to tell them that......."although we cannot say anything definitive about TLD, we would like you to vote favourably upon increasing authorised shares....." An "interesting" ASM would rather become a contentious ASM unless management considers contentious to be interesting. I rather doubt that. It would have been much easier and safer not to raise investor expectations as this PR obviously has. A much simpler PR just announcing ASM date, time and venue would have been more appropriate rather than raising expectations and then deflating them at a "nothing burger" ASM. Accordingly, I am cautiously optimistic that management understands the importance of credibility and is not pulling a bait and switch.
What does still concern me is the conversation Alpha had with DI where DI appeared to be back-peddling on the ASM notwithstanding DI denials to the contrary and that the conversation was misinterpreted. Alpha emphasized he was reporting what he heard and I regard Alpha as one of the board's more astute and reliable posters. However, I have a similar respect for Kabunushi-san.
Therefore, we can only hope that management has not cavalierly issued what could amount to a bait and switch PR, understands that it has raised ASM expectations and will not avoid investors' primary, and probably singular, interest in things TLD. JMHO.
Excellent. Thank you for the effort.
It does evidence, however, the importance of management communicating clearly and precisely--when they do. Too many times these communications are misunderstood or misreported. LG is famous for this yet he adds to the confusion.
Let's hope the PR is followed through at the ASM(hopefully not postponed) and we are all pleasantly surprised.
Again, many thanks for the follow-up.
U
I'm listening.....
Interesting. And what kind of a "business development" do you think it is?
Doc:
Bingo!
Best wishes
Nice apologia for NWBO management. What else would one expect from you?
Quite frankly, it is NWBO that has set high expectations. It is LG that has expanded upon it exuberantly. It is they who need to follow up. Perhaps it would have been much better just to announce the date and venue for the meeting and sign off with...."see you there, Love and kisses, Linda."
It appears that DI is now back-tracking. The PR seems to be turning out to be a fiasco. What mis-management that they can't get a simple PR right without screwing it up. I can well understand LP/LG remaining silent all these years. AF ran circles around these "lawyers" when they did speak, all to shareholder consternation and embarrassment, not to mention the savaging of the SP.
In any event, I cannot imagine anything other than interesting involving top line. If management states at the ASM that:
1. We have data locked;;
2. We are going to unblind and analyse that data for TLD;
3. We will announce TLD mid-May
4. We will discuss the TLD at ASCO
This is sufficiently interesting though rather disappointing but not terminally so. It may be enough to hold off the hyenas. But TLD must follow shortly. Sorry, but to me nothing else is really interesting. As it should be. After all, it is all about TLD. It is about its being very interesting and very exciting. Without such a result, nothing else matters. A poor/even mediocre TLD is not interesting. After a 12 year trial it would be pathetic.
IMHO, if interesting has nothing at all to do with TLD, then the ASM will not be interesting but rather contentious. I don't believe that LG thinks a contentious ASM is interesting. JMHO.
Your concept of interesting is most probably different from management's idea. Dave appears to be back-tracking. Duped again? Hope that management and DI are not that duplicitous and the ASM turns out to be very interesting and exciting.
I have no reason to doubt your report of your telecon with Innes. Just indicating timelines for when things are expected to take place and kicking the can yet again to mid-May is not only disappointing but discouraging.
The PR set up investors' expectations but it seems now to be just a pump for the purposes of raising funds and thereafter inexorable deflation of the SP. Business as usual and no change.
Management has been careful not to give any definitive guidelines on timing and one of the important reasons cited by LG were the nefarious forces and not telegraphing NWBO plans. The idea was to catch them with their pants down. So, if the main subject of interest is to give guidance that "interesting" events will unfold up to mid-May or thereabouts and thereafter, and this is what the PR means by interesting, management now seems not to care about catching the shorts but continues to adhere to vague forward looking statements. If this is the case, the ASM is a nothing burger, shareholders have been duped once again and the interesting PR was released for purposes of the last financing. That's it.
Again, without revealing top-line, I doubt anything of material interest can or will be revealed. What may be revealed may be of mild if not questionable interest and nothing to write home about. This may be supported by LG telling an investor not to change pre-existing plans in order to attend the ASM. Of course, this flies in the face of the unmistakeable exhortation to attend the ASM and giving investors enough lead time to plan ahead for this important event.
DI's attempt to kick the can further to mid-May is a blatant ploy to back track on investors' expectations fuelled by the PR now that the objective of raising capital has been temporarily fulfilled.
It seems to me, if the foregoing is generally the case, that NWBO believes that it can continue to miscommunicate, keep dangling the carrot and hide behind legalese parsing. Just as LG has said many times..."you misunderstood, I did not say that, etc., etc." I can hear it now....."interesting does not mean top-line and need not be material or earth-shaking; it just means something of interest. You set up your own expectation." Spoken like a true defence attorney.
However, if the ASM turns out to essentially be a nothing burger, the SP will be destroyed especially on the heels of another financing. The discount and warrant offerings will be giveaways to the vultures who will once again profit on the sale of shares and get free warrants with a highly reduced exercise price. NWBO then might as well fold up IR. No need for it as no one will believe anything management says. No one will make or take calls from DI or LG. I doubt DI intends to be positioned that way, but if the ASM turns out to be a non-event, he has himself and management to blame. The science may be good but management's abject lack of credibility may well sabotage it and our investment.
NWBO----say it ain't so.
Tough to back pedal from that expression. Implicit in that expression is materiality and a resulting boost to the SP. After all, NWBO needs more funding doesn't it?
Doc:
Absolutely agree. LP must produce. Kicking the can further down the road is not an option. Corona virus cannot be an excuse. The in person ASM may not take place but a web-cast is an alternate option in place of it. More delay and excuses are deadly and it is management that set the expectations which are, at least implicitly, quite favourable. In the interests of credibility, they need to follow through. Talking about "interesting improvements" in blinded data is definitely not going to cut it. That era is over.
I personally would be disappointed if top line is not the topic of "interesting". So would the market be similarly disappointed leading to more toxic funding and pissing everybody off. LP needs to deliver. April 18 is the deadline regardless of corona virus or other excuses. I am betting that LP will come through. It is really a last chance to establish confidence and credibility in management. JMHO.
I do agree that the COVID-19 is a factor weighing on the ASM and venue.
However, my point was to express holding true to the gesture of exhorting as many shareholders as possible to attend the ASM. Extending such an invitation to the multitudes but then having the venue in a small legal conference room sounds a bit disingenuous to me.
However, I do understand the need for alternatives wrt to the corona virus.
Nope. Sorry but the raise was at $0.171/share with warrant extension for one year and repricing exercise price by $0.08 on D-2 warrants.
PR saying "interesting" is not exuberant. LG's saying very interesting/very exciting is.
Exactly. The wording is clear and in my view unambiguous. I believe that it is a sincere PR and that the wording was carefully chosen to give a strong hint without revealing the subject matter and thus preserving the element of surprise. There are three essential elements in this PR:
1. The ASM should be interesting and the PR was further confirmed by LG to be "very" interesting and "very" exciting in various telephone calls with shareholders. This is a fact as I was one of these shareholders. IMHO, interesting relates to something material and which should consequently positively affect the SP. My guess is that top-line results will be addressed and the results thereof will be very interesting and very exciting. Without top line revelation, partnerships/collaborations, RA updates and other materially interesting topics will not issue as TLD is the gateway to these. Anything less, IMHO, is a blatant come-on to "lead on" shareholders and for fund raising activities prior to the ASM. It is certain that NWBO will require funding. If they raise funds prior to the ASM, they will need to deliver at the ASM. Otherwise, it will be regarded as yet another not well disguised "pump" to pry at least one more funding prior to the ASM where, in fact, nothing really materially interesting comes off leading up to and including the ASM. All credibility will be lost and any further financings will be highly toxic if they can find willing investors. Nothing management says will have any credibility. Attempting to raise funds prior to the ASM could be interpreted as a signal that nothing really materially interesting will happen and the SP will tank accordingly resulting in a highly toxic financing no doubt pissing everybody off. You can forget "interesting" at the ASM and substitute the word "contentious".
If, on the other hand, they wait until after the ASM to raise funds, however, they have not produced anything of material interest, same result as above. Accordingly, IMHO, NWBO is between a rock and a hard place. Their PR(and LG augmented confirmations) have placed them in this position. It has been their calculus. They have raised the expectations and it is they who need to follow through.
Accordingly, I have to believe that they will have a materially interesting ASM and I think it involves top line. I cannot think of any thing other than this to be materially interesting. Thus, I am cautiously optimistic. I doubt very much that management has come out with this "interesting" PR only to fall short and not follow through. Their very credibility and support is at stake. It goes without saying that LP/LG realise all this.
2. The meeting is important because it should be interesting and the PR essentially exhorts shareholders to attend.
3. The ASM, which is especially important and which should be attended by as many shareholders as possible, has been scheduled for April 18th, approximately 2 months from the date of the PR, in order to give shareholders enough time to make their travel/attendance plans. Hence, NWBO wants as many shareholders as possible to attend this especially important meeting. Accordingly, it is very difficult to believe that this ASM will be held, as in years past, in their lawyers' conference room. If they can afford the big booths at ASCO, surely for such an interesting ASM where shareholders are exhorted to come, NWBO should be able to afford adequate space such as a hotel ball room/conference suite. If the venue is as in years past, the invitation to shareholders rings hollow. Thus venue is important as it points to sincerity and management's genuine desire to have shareholders attend. Otherwise it is disingenuous and is just going through the motions.
I take management at their word in the PR. I believe they are genuine and I believe they will deliver. Not doing so is suicidal. JMHO.