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That's just the point. Here is a company squandering its much needed cash on conference junkets(must be nice being in Miami for a few days rather than in sleeting Bethesda with the flu) with nothing new to say.
What attendees want to hear is meaningful new information not the same old, same old info they have heard time and again. Nobody cares anymore about all this, except all the money it costs, especially to investors who have lost big time due in significant part to the lack of transparency. If we had some transparency, we would not need to make up a list of questions which will probably be artfully dodged at the ASM. What is cared about is top-line/in depth analysis. It's time to get it out now, not toward the end of 2019 as LP seems to be hinting.
Over the past years, the company has spent big time for expensive booths, conference junkets, etc. and for what? Part of the toxic financings were used to pay for these useless activities and where is the share price? Conferences and exhibitions not only equal zero but are a wasted drain on much needed cash(we need to pay LP/LG and wife's salaries don't we?). Can't LP find something more worthwhile to do or is all this a pretence to show how "busy" she is and worth every penny of her compensation?
It is amazing how some longs continue to make excuses and softball management. Here is another conference that has come and gone with nada to show for it except a tan on LP's cheeks and a hotel bill momento. We should all be fed up. I hope the attendees at the ASM will aggressively pursue management and make clear that if answers or why they can't be reasonably provided are not forthcoming, there will be little or no further management support by at least minority retail shareholders. Don't bother wasting time and resources in the future asking for our votes. Hopefully, Ike Esq. as a lawyer will be able to spar with LP/LG. IR has been a disaster with blown timelines, not by weeks or months but by years, obfuscation and denials that any such thing was ever said. LG has been a disappointment and indeed a costly one.
If the vaccine is efficacious, it will capture the attention of doctors and patients alike; it won't need the ho hum zzzzzzzz publicity of conferences and exhibitions. We have had enough of them. If the vaccine trial fails, all was in vain. JMHO.
A fed-up long
My concern about what management plans to do about the depressed share price is as follows and here is a possible(probable?) response:
"The thing that will raise the share price is a successful conclusion of the trial. We are now doing everything we can to optimise our chances for success and approvals from the regulatory agencies. The advice we have received from our SAB and others has allowed for maturing of the data, our proceeding to data-lock and the follow-on procedures to finally unveiling the data. We appreciate the patience our shareholders have shown thus far, and we understand their frustration. We are frustrated too, but we believe that patience is the right way to go. Stay tuned."
If unveiling takes place at the time of ASCO 2019, it is a very good bet that the share price will be in the lower teens or maybe even single digits. It appears that LP believes that market cap will take care of itself if the results are a "home run" regardless of where the share price is at that time. Accordingly, she is not concerned about share price now, no matter where it goes.
Bottom-line, we go big or go home dependent upon the results.
Accordingly, unveiling of top-line should take place well in advance of ASCO, no later than the end of March to prevent a catastrophic collapse of the share price if we wait too long. We may never recover true value if the share price goes to single digits within our lifetime. JMHO.
I have heard(I will not reveal sources who in my view are very credible) that a legal case has been already drafted and is waiting to be filed. Last year, Les has said to a number of shareholders I know that one of the string of PRs they planned to release would announce a legal proceeding. Les has promised a string of PRs(which he said should raise the share price) before. Crickets.
Senti, thanks for mentioning me and agreed!
Regards,
U
Hi Ike:
My bad. Posted reply to Sentiment Stocks and not to you. Please kindly refer to my post 209239 addressed Hi Ike wrt some additions. Thanks very much for your time and attention.
Best regards,
U
Hi Ike:
Great job. Really appreciate it. You honed the questions just like a first rate attorney.
Anyway, wonder whether it is too late to incorporate the following which I did not see in the list of questions. Anyway here goes and I leave it up to you and MB members to decide inclusion or not. Thanks for your time:
01. Additional sentence at the end: Please give additional colour to your response to the foregoing as to why the hold was "not necessarily a bad thing" and "turning good news into bad".
09. Data-lock is particularly important. I think we need to specify as per the following at the end of the last sentence: "Specifically and in summary, if data-lock has already occurred, when did it occur? If not, why not and when do you expect data-lock? From the date of data-lock to announcement of top-line, how long do you estimate it will take? When would a full in depth analysis be available after top-line and how would this analysis be communicated?"
36. Les has told me as well as other MB members who I won't name that a legal case has been prepared against the manipulators and that an announcement would be made to this effect. Hence, I would suggest adding this follow-on sentence: "Is management still serious about prosecuting a case against these manipulators and has it been prepared"?
Here are some additional questions that may be of interest and relevance:
A. In prior studies, LL and RP found that DC VAX L did not work especially well in the pro-neural molecular group but did in the MES molecular group. The JTM apparently shows a confounding result where the methylated group(predominantly pro-neural) fared very well wrt to blended results whereas unmethylated(predominantly composed of MES which comprises about 30%~50% of all ndGBM) fared less well with an OS 36 survival of about 14%. Accordingly, I believe the herein below question should be asked:
"Will the announcement of top-line and/or final in-depth analysis provide data on molecular sub-groups, i.e., pro-neural(which appears to predominantly comprise the methylated group), MES, classical and neural(pre-dominantly in the unmethylated group) and provide explanations of MOA pertaining to each?"
B. "It was stated that there were good reasons to continue the trial. What are these reasons and why was it decided to proceed to data-lock anyway despite these good reasons?"
C. "How long will the latest cash infusion from the real estate transaction last? Assuming future equity raises, and the desired avoidance of toxic/highly dilutive financing, how will share price be enhanced to provide greater value for the financings?"
Thanks in advance for your consideration.
Best regards
Ike:
WRT to item 09, I believe that it is essential to clearly determine if/when data-lock has or will take place, to wit:
Has data lock taken place and if so when. If not, what is holding up data-lock and when is it expected to take place. From date of data lock how long will the process take to an announcement of top-line. Thereafter, when would a full analysis be presented and how would it be communicated, e.g., journal?
I asked whether it is on the table, a consideration, not whether they will do it tomorrow or anytime soon.
A probable answer might be....."nothing is off the table, however, we would like to achieve price appreciation through good results and this is our preference rather than a R/S." Not a guarantee against an R/S but it would, nevertheless, be helpful to hear management articulate it.
Anyway, they can call a special meeting for an R/S vote at anytime. LP and cronies control so if it were a consideration, it could materialise relatively quickly. JMHO.
Is a R/S on the table to get to a major exchange?
Perhaps, but it won't be announced anytime that soon and you can take that to the bank. We are not necessarily talking about what could be done but whether NWBO wants to do it. I doubt very much that top-line would be announced that soon. You can be pretty sure that NWBO will do things later rather than sooner. JMHO.
Hi Abeta:
Yes, indeed, it is partly a gut call. Having said that, LP indicated it was a multi-month process to top line--I believe she estimated about 2 months per process and there were 4 steps. There has been some question as to whether at least one or two steps can be done in parallel. Even assuming a parallel process, knowing NWBO's pattern of missed time lines, I still think that top line will come about 6 months after data lock. I think it is a safe bet, that IF data lock occurs at 6/19, top line will be announced sometime late fall. Could be 11/19. JMHO.
One question has been bothering me.
Have 233 OS events occurred? Les has said, to me, that when this threshold has been reached, it is a reportable event. Since it has never been officially reported, to my knowledge, it either:
1. Hasn't happened yet, ergo no report, or;
2. It did happen and Les lied.
My WAG is:
1. Data-lock is 6/19
2. Top-line is 12/19
They are required to meet legal obligations. Their view of "moral" obligations may differ from yours but they are not required to meet "moral" obligations. They have a fiduciary duty among others to do what they think best for the company(and its shareholders) and they are given the latitude to do so. This extends to releasing information beyond that which is strictly required for reporting. JMHO.
Hank:
Thank you. One other thought:
Let's say that big P through their grapevine which must be extensive has surreptitiously obtained information that the trial results indicate failure. Besides showing no interest, they would likely leak this info to their hedge fund friends. The share price would not even be at 23 cents.
So no, I don't believe that big P or anyone else has any info that the trial has failed. I rather think that big P knows the price tag is high regardless of pre or post unblinding, so they will rather wait for results analysis to determine their next move. JMHO.
Doc:
I fully agree with you. What at least minimum revelations do you think LP should share? What should attendees at the ASM do if all she reveals is basically...."things are coming along and we are proceeding towards the completion of data lock and the necessary multi-month steps to unblinding. Stay tuned". "No comment" on the halt. LG then chimes in and says...."look all the information is out there. All you have to do is read it. The purpose of the ASM is not to spoon feed you but to vote on the proxy items...trust us because we know what we are doing. Thanks for your support and see you next year....."
How should long attendees prepare for the meeting---should there be a representative spokesman? Should a list of questions be sent to LP and LG plus the SAB and BOD prior to the meeting? Are you attending the ASM? Unfortunately, I cannot attend.
Interested in your views and anyone else's. Best wishes.
A. LP price tag way out of whack with what BP considers reasonable? What is reasonable? Apparently, $50B MC doesn't sound reasonable to NWBO. OR,
B. The trial failed and big P knows it? I doubt the trial failed. Perhaps PFS and separation are confounded and ambiguous. That is possible. But..........
1. Blended results at least as good as Optune:
2. Looks like a strong long tail and this is an important part of the OS data set which is the "gold standard":
3. Looks to be especially effective on M+ which represents about 44% of the categorised M+/M- population and close to 40% of the entire trial population:
4. Looks to be effective, to some degree, on other molecular groups especially MES. If so, effectiveness on over 50% of the trial population;
5. Excellent safety profile;
6. Patients need alternatives to SOC and Optune. If DC VAX L is just as effective as Optune in the front end stages but more so from a long tail perspective, patients should be availed of this alternative;
7. Ease of administration;
8. Manufacturing readiness;
9. Pricing and meeting QALY criteria--insurance.
So, if the foregoing is likely, and I think the odds are quite favourable, the trial has definitely not failed and NWBO has built a formidable data set that can demonstrate results are fairly well undeniable.
If so, then why hasn't someone from big P, world wide, broken ranks and engaged in serious discussions?
1. Maybe they have and we just don't know. The veil of silence is such that thus far no leaks;
2. Maybe there have been informal "feelers" from big P but LP has shown little interest in these "feelers";
3. Maybe big P is waiting for results confirmation. They know that LP will give them NO DISCOUNT either before or after unveiling results, so why not wait until after results;
4. Maybe there is a conditional deal dependent upon results;
5. Maybe the asking price is ridiculously high, say, $70B~$100B;
6. Maybe big P thinks it can get the FDA to at least delay any determination on approval(and NWBO knows this thus their continuing the trial to make results undeniable--a confirmatory trial decision by the FDA would be a disaster for NWBO so continuing this trial for a while longer takes the place of such a possibility);
7. Maybe the trial failed, LP/LG know it but are continuing all the while milking the company through compensation and favourable interest rates all in collusion with the SAB, PIs including LL and 69 authors of the JTM article. SOS is part of all this as are Bigger and Rago. The case dismissals were effectuated by buying out the judges and the SEC is toothless as in "who's afraid of the big bad wolf".
Take your pick. I have made my choice. My vote? Oh yeah, right now my inclination is to vote yes while holding my nose. Hope the ASM attendees ask the hard questions, follow up and demand answers or why they can't get them. Depending upon the ASM, I may change my mind. Attendees should also make this clear at the ASM. LP/LG no longer get a free pass. Time for some accountability, even if the odds look favourable by reading the tea leaves.
JMHO.
We were talking market value, not pps. The conversation was in January, 2017.
The thing is that somehow Big P knows something. That is, IF they regard DC VAX as a potential threat. Surely, big P can find out trial status from contacts in the FDA. They have long "funded" the FDA so it would not be a stretch to assume that they are privy to some information thru their grapevine.
If the information is bad or indifferent as to trial results, no wonder the lack of interest. If the results are good, then why wouldn't big P break ranks? I think it is too late to freeze out NWBO. I think, as Les has said in April, 2018, that they will continue until results are undeniable. They are taking no chances with the FDA. They only have one chance to go big or go home. The interim data, thus far, portends strong odds that overall, the trial will be successful and that the FDA will be "forced" to approve.
Ask you point out, LP's asking price may be too high, at least prior to unveiling. Normal premiums don't apply. Big P's fishing expeditions may have confirmed this---the price tag for a partnership or BO is much too high, especially if a $50B market cap is a no-go as related in my previous post. Interesting times ahead. Stay tuned. JMHO.
Kam:
There is no deal done. However, the odds that the blinded data portends a positive result are good and even better than a year ago.
What is utterly confounding is that there seems to be no interest, as far as we know, by big P or otherwise in NWBO. Forget Huawei. Wrong company in the wrong country at least for now, despite an "interesting" real estate deal.
Maybe big P knows something. No doubt they have "friends" in the FDA that could very easily leak information for the right price. If DC VAX is such a threat, certainly big P would want to protect their interests, they would want to know. And they could easily "tempt" someone in the agency to find out.
So if the results, thus far, are just so-so, big P would not perceive NWBO as an immediate threat and would show no interest, at least for a significant amount of $$$$$.
However, the blinded results, thus far, are rather impressive. It does not look like they are so-so and at worst, match up pretty well with Optune and are superior in the long tail. So the odds are pretty good that results will be good enough to obtain approval. There can be little question of patient demand....and big P desire for combinations. If this is so....and I think likely, then why haven't we heard a peep about back-room deals being worked? I believe the so-called parallel negotiations LP was talking about were solely related to the Sawston deal.
Perhaps there have been "informal" dipping the toe in the pool overtures by big P but LP's asking price is way too high. They may have some indication of the results, but just don't want to pay the asking price. In this respect, in a conversation with Les, I once asked him if they would be willing to sell NWBO. He responded by saying that nothing is off the table. I asked him if a market cap of say $50 billion would be of interest and he firmly said "no".
JMHO.
Hank:
I agree that at this ASM, LP needs to be much more forthcoming. If the ASM follows past patterns and essentially results in a "stay tuned" mantra, I believe the share price will dip into the teens. And with continued silence and no news of any consequence, the share price will definitely drift into the low teens and even to single digits. Even with good news, it may be difficult to recover. Forget about it if top-line does not present unambiguous, irrefutable, superb data. LP needs to start being more communicative, open up the ASM and respond to investor concerns or at least provide credible explanations as to why the silence has to continue, e.g., halt.
The conduct of this ASM is a critical event. I hope LP does not blow it, but it is also up to the attendees to demand and insist upon answers in face of any stone walling/stay tuned evasive responses by management. My gut feeling is that this ASM will be no different than past ASMs. If so, we are in for a rough ride. JMHO.
DMB:
Why wouldn't M- patients benefit?
M- is predominantly composed of MES, classical and neural, whereas M+ is composed of pro-neural. As mentioned previously, prior studies conducted at UCLA suggested that the DC therapy had little to no effect upon pro-neural and yet, contrary to this finding, it appears from the article in the JTM that the DC therapy works quite well on M+ looking at blended results(improved as per 2018 update).
MES comprises about anywhere between 30%~50% of all ndGBM and is a major molecular group. Drs. LL and RP concluded that DC vaccine works particularly well with MES suggesting that MES is more immunogenic(higher threshold of T-cells upon which to build and less immunosuppressive micro-tumour environment allowing more sustained infiltration). Indeed, the JTM article showed, on a blended basis, that M-, while a very aggressive group and with an SOC historical mOS of 12.7 months, had a blended mOS of 19.8 months, which is a delta of 7 months(as compared to a delta of about 14 months for M+). However, OS 36 months was rather disappointing when considering the relative size of the MES sub-group for overall ndGBM and by extension, especially in the M- group at about 11% survival but improved by about 20% to 14.3% as per updated 2018 data. Perhaps, there was a strong showing by the MES group which was counterbalance by a much more modest effect upon the classical and neural molecular groups. So far, we don't know definitive reasons for MOA and the contra-indications as described above.
But from the blended data, it definitely appears to support the finding that all patients are living longer and that to a greater or lesser extent, the therapy works across all groupings. JMHO.
Personally, I have no problem if the trial is extended especially if there are good arguments for doing so.
Having said that, I have big problems if LP's ASM is a non-event as in past years and essentially gives no more info than "stay tuned". A lot is riding on the conduct of the ASM and the quality of updates revealed. If there are reasons for non-disclosure of the reason for the halt, just as an example, we as shareholders are entitled to hear them.
Attendees at the ASM need to aggressively get some answers rather than submit to a polite puff-ball like meeting that essentially results in a "trust me management, we know what we are doing". Shareholders deserve more than that.
If the ASM is essentially a non-event, there is little doubt that the share price will be savaged. The "war chest" may possibly get them 4 or 5 more quarters at a quarterly run rate of $5 million( they have a number of obligations to satisfy so perhaps only half or even less is available for basic WC especially if there are trials to be commenced. They will need to go to the capital well again before you know it and toxic financing at low share price levels is, I think, a rather terminal event. As I have expressed a number of times, LP has little if any credibility with Wall Street and even positive top line results could only get us to where we are now or maybe a bit more but nowhere near the one dollar range.
It is time for LP to open up or explain why she can't answer shareholder concerns. But a non-event ASM is a killer. JMHO.
Longfellow:
Well elucidated response. Yes, my predictions are pessimistic but only because of past experience. If management continues with inadequate transparency, obfuscated communications, lack of news and blown or inarticulated time scales, I am quite certain that the share price will continue to flounder. Trust me when I say that both LP and LG have little if any credibility with Wall Street. That certainly does not help with share price appreciation. Resort to blaming everything on manipulation and shorts is shop worn by now. These are the circumstances. Current management should deal with it or hand over the reins to those who can. I think the science is solid. However, Wall Street has a short and limited attention span. There is weighing negativity if the primary/secondary endpoints leave much to be desired. Naysayers will jump all over it and take the wind out of the sails. In order to have any hope for significant share price appreciation, NWBO needs to hit a grand slam on the long tail. And it needs to explain molecular subgroup anomalies as I have pointed out in previous posts.
Otherwise, I think your opinion has merit and I hope my more pessimistic leanings do not become fact. JMHO.
Yes BSB, I am a thinking man. I have done enough DD to be fairly well convinced about the science and that it will ultimately be approved by the FDA. That is why I am invested. I have made it quite clear that I am no fan of management. The jury is out as to how good this investment might be. I hope we are not too diluted to still get a reasonable return. I don't think management is helping.
As for being a lawyer, I am unfamiliar with your sobriquet of call Saul. Is this an inside joke?
Happy New Year.
BSB:
Why do you think I am a short seller? That is the problem with cheer leading longs who blindly support the management no matter what and recoil at posts that are less than rosy in exposition. My posts are reasonably balanced. I believe in the science. I don't think that management and the board are deserving of unqualified/unquestioning support and the grant of option compensation for yet to be delivered performance.
You do a disservice to shareholders just as much as unthinking bashing shorts do.
It is a rather aggressive schedule and I do not think we get approval until at least sometime in 2020. But if they continue with inadequate transparency and delay top line until the latter part of 2019, two things synergistically happen. The share price continues to deteriorate and further fund raising at toxic levels will be necessary thus compounding the further devastation of the share price. The money raised thru the Sawston deal will last maybe through the end of this year but will be pressed by loans, mortgage pay offs, WC demands, A/Ps, etc.
I hope those attending the ASM make it clear that delays and silence as usual cannot be tolerated and put forth a strong message to that effect. MB posters supporting management's lack of transparency, broken timelines and obfuscation by defending such actions in the name of exigency only encourage management's conduct. I am appalled by the options largesse for lack of performance thus far and the devastation of company market value and feel that the BOD have largely abdicated their fiduciary duties to all shareholders especially the minority retail shareholders. Though it likely will be to no avail, I will vote no to another term for LP. JMHO.
Meirluc, I hope your views and not mine turn out.
The market is funny and even though the tail will most likely be impressive, and if the primary/secondary endpoints are not SS or unequivocally positive, I fear the market may be swayed by this and stunt any significant rise in share price. If data lock occurs in June, we are looking optimistically at top line in early fall. Knowing NWBO and consistent pattern of delays I would not be surprised if top line is unveiled toward the latter part of 2019.
Even though the FDA may have streamlined procedures, I would not be surprised if it took about a year for approval. This is a data rich trial and the FDA may want to go through all of it in detail. In any event, optimistically, I would see approval at earliest in mid-2020. The share price may then appreciate significantly, perhaps to a dollar or more. I am not optimistic on high Multi billion
Dollar acquisitions. But in time, I can see the share price appreciate to $5 maybe even $10. But the days of $20, 30, 50 are over. I would be ecstatic with a price of $2-3 post approval and move on. JMHO.
Will 2019 be NWBO's year. Here are some speculations.
1. Although LP has said that they are proceeding in the process of data-lock, analysis and top-line, they have not reached data-lock yet. Most likely, they will data-lock by the end of March, 2019 and no later than June, 2019.
2. They will probably announce top-line in the September-December, 2019 timeframe depending upon when data lock was achieved.
3. They will probably obtain approval determinations by the FDA by year end 2020-early 2021. I believe it likely that NWBO will receive broad approval from the FDA.
4. I believe that the primary/secondary endpoints results will be equivocal and mixed at best. They will be far from home-runs. I think the market will be influenced negatively by this and weigh down significant share price appreciation.
5. I believe there will be a strong showing for the long tail. I believe OS 36 for Tx will be anywhere between 30-33%(significantly higher for the methylated group) and 60 months should approximate at least 20%. I do believe the strong long tail showing will be due, in very significant part, by the methylated group which will make up most of the tail. Hopefully MOA explaining why results were relatively better for M+(predominately proneural)vis-a-vis M-(MES and other molecular sub-groups)will be revealed in more detailed analysis probably post top line announcement.
6. Even though the long tail will most likely be predominantly composed of M+, possibly supporting an argument that the vaccine is largely a one trick pony, I believe that the vaccine will receive broad approval due to its efficacy to greater or lesser degrees over the entire spectrum of nGBM.
7. Due to the length of time to announcement of top line and very likely attending silence, I believe the share price will deteriorate to unprecedented lows between 10 and 15 cents per share.
8. With the announcement of top line, even though the long tail results may be very positive, even remarkable, the much lesser remarkable results wrt to the primary/secondary endpoints will have the market's attention and serve to weigh down any significant appreciation. I believe that after top line announcement, the stock could appreciate to the $0.30 to $0.50 levels. I believe that the stock will not appreciate to the dollar level.
9. The share price will stagnate around these levels or even lower pending FDA approvals most likely in early 2021.
10. Without a buyout or major partnership, share price performance will be relatively disappointing.
11. I don't believe there will be a buy out or major partnership anytime soon. Due to the relatively small price appreciation after announcement of top line and pre FDA approvals, any Big P interest will be a low ball offer likely unacceptable to LP who will chose to go it alone and hopefully go big after approval by the FDA (and hopefully other RA).
Bottom line, while there will undoubtedly be progress in 2019, this year will not be NWBO's year insofar as share price appreciation is concerned. In fact, IMHO, I believe significant share price appreciation will not occur until after RA approvals sometime in the 2021 timeframe. We still have a long way to go and the fortitude of longs will be sorely tested. Further, there is little to no pressure on LP to hurry the process. Shareholders appear willing to go along with further delays as evidenced by posters on this MB. Les does read the MB as he knows that it represents a microcosm of shareholder sentiment. Shareholder willingness to put up with inadequate communications only serves to continue management's pattern of conduct. The so-called $47 million war chest is not as large as many shareholders think. There are mortgages, loans. APs and the WC requirements including the weighty salaries of management. Thus, shareholders can expect further and significant dilutions. There really isn't sufficient funding for combo trials. If pursued, the war chest will be sooner depleted. So, 2019 will not be THE YEAR for NWBO, even though we will see progress, at least insofar as share appreciation is concerned. JMHO.
We will have to agree to disagree. And no, I don't think 2019 will be the year. More like 2020. Data lock will probably occur mid-2019. Top line likely end of 2019 or early 2020. Approval, if it happens sometime in 2021.
Share price? Probably will go to single digits. Good news is that it could be a multi-bragger for those investors buying then. JMHO.
Tilt:
More precisely, it is the inadequacy, infrequency and obfuscated phrasing of any communiques when they do issue that raise more questions and concerns. Why hasn't NWBO explained what the halt was about especially after it was lifted?A response by the FDA indicated that there was no embargo on NWBO in explaining the halt and its lifting. There are many examples of statements made but unfulfilled with long gaps of silence, e.g., the release after a year of the long promised article in a second tier journal, the delay in months, not several weeks, of business announcements, etc., etc. When the news was finally announced the needle on the share price hardly moved and is now below 21 cents. There is a complete lack of credibility in NWBO management, especially due to the manner of their communications or lack thereof. Thus the excessive devastation of the market cap of the company and damage to less favored shareholders. LP has made sure that she and friends are protected by the sheer volume of options and shares held as rewards for yet to be produced results. This whole situation is a travesty and utterly embarrassing when a so called biotech journalist runs rings around NWBO management and gives them repeated public spankings.
Sorry, don't know about you, but I certainly cannot give management a passing grade when seeing the destruction in company value occasioned on their watch. There may be excuses, but it is what it is and management is held responsible for increasing the value of the firm they manage. Instead, devastation has occurred and in their greed they have taken advantage of the situation at the expense of ordinary shareholders.
JMHO.
Keep in mind that continued and lengthy silence will support the downward trend of the share price to new lows. Depression in the share price whether by dilutive financing or lack of transparency/positive news---the result is still the same. At unprecedented lows in the share price, even quite positive news may only get us back to where we are now.
No notice of an ASM yet. LP up for re-election--so I suppose an ASM sometime relatively soon will be necessary for a vote. I think she will be re-elected because she and friends have controlling interest. However, in principle, I cannot vote in favour of her re-election. The utter silence and lack of transparency have done much to devastate the share price.
I once had a conversation with Les about the extraordinary silence. He responded by saying that every time there was communication, they were attacked. So they chose silence---what else should we do, he asked? My response was that obviously silence was the wrong strategy, just look at the absolutely excessive drop in the share price. And it is utterly embarrassing that an ignorant "journalist" like AF was running rings around two lawyers who should know better. Don't ask me what you should do...I exclaimed! That is your job and why you are paid nice salaries and options. If you are not skilled and creative enough, then it would be wise for you to get out of the way, resign and get someone else who can do the job. As an IR and communications official, your performance is definitely found wanting. Silence.....and then his meek response..... I am sorry you feel that way. As a CEO, I would have thereupon requested his immediate resignation.
Bottom line and I have said this before: the science is solid, the management not so much. I hope for a BO.
Unfortunately nothing. No notice of ASM next week. Note that it was last held January 21, 2018. Continued silence. The business transactions that LP was referring to, to be announced weeks after ASCO, turned out to be a real estate deal involving Sawston.
I have speculated that the deal with Huawei could be part of a larger partnership or BO. However, I believe the odds now are low especially with the fraud charges, concerns about surveillance, and the tariff tiffs. I don't believe that Huawei is a front for anything, biotech is not in its expertise and that this is quite likely just a real estate deal especially since recent events.
I also believe that data-lock and unblinding are months off and I now think, upon information and belief, that the trial will continue for some months to hopefully insure a long tail home run. I think that there is some confoundment wrt PFS and OS primary/secondary endpoints and the whole trial success rests upon the long tail. There are some cofounding questions that I have previously raised concerning MOA and why it appears that DC VAX may be working for the methylated group made up of pro-neural in contradistinction to previous studies and why the unmethylated group composed mainly of MES(it comprises anywhere between 30~50% of all nGBM)did not perform better and where M-OS at 36 months is only 14.1%(although it is about a 20% improvement over 2017 data). The vaccine supposedly works better on MES because it is more immunogenic according to LL/RP. We also don't know as to whether the long tail is a one-trick pony composed mainly of methylated pro-neural. All things seemingly point to a Hail Mary long tail pass and touch down strike. They need it to make the trial an undeniable success as Les has declared in April, 2018. Most likely, the reason for all the silence is that the SAB/LP(there are good reasons to continue the trial)are dragging their feet in proceeding to data lock because it is still not yet undeniable. Top line results may be announced earliest at ASCO. Continued silence, a ho-hum ASM(if it takes place at all), no news, etc. will all conspire to bring the pps to all time lows. Even the announcement of top -line results, if successful, could be met with a less than enthusiastic market response and bring us back to just where we are now. Disappointing and I hope I am wrong.
I believe in the science. I believe NWBO management is in significant part responsible for the share price devastation. I believe the naked shorts, manipulation, etc., especially now, are shop worn excuses for lack of transparency. I hope for a buy-out even if it does not achieve full value, so that new and professional management can steer NWBO through approval and commercialisation. I do not believe current management has this capability. I think this would be better for both patients and investors. JMHO.
My nom d' plum is Les Goldman. I am an alien. I can guarantee that no aliens have ever visited earth. NWBO MB denizens are ciphers living in a virtual reality. Is NWBO really real?
I, too, believe that there are UFOs. Indeed, it is a fact that there are UFOs....that is unidentified objects. But that does not mean that they are of extraterrestrial intelligent origin. The odds that they may be are miniscule. The interstellar distances are unimaginably huge. Voyager, which is now proceeding to interstellar space(it is in the Kuiper cloud belt which is the farthest object still associated with our solar system), is traveling at about 7km/sec. At that speed, it will take about 75,000 years for the spacecraft to reach the closest star system which is Alpha Centauri(about 4.3 light years distant from the solar system). In order to achieve meaningful interstellar travel, one must attain relativistic speeds, enough so that the travelers' proper time slows relative to earth bound denizens and distances shrink. However, there is a practical limit to the relativistic speed that can be achieved. At significant relativistic speeds, the spaceship encounters deadly electron and proton radiation that easily can penetrate any shield. The bigger the shield, the more fuel is required. Practically speaking, interstellar travel is highly unlikely except possibly for a type two or three civilisation. They would be unimaginably far advanced and would be Gods to us as we are to ants. They would have no reason to visit us assuming that they could find us as we are in a back-water in our galaxy, about 25,000 light years from the centre stationed on the tail of one of the spiral arms. However, it is possible that von Neumann type probes could possibly colonise the galaxy in a period of 10 million years or so. In all probability, these forms would not be carbon-based but rather silicon based(courtesy of Ray Kurzweil of the "Singularity").
The answer to Fermi's paradox---where are they?---is that they are there and not here and will probably stay there. It is easier to explore a virtually rendered universe unless we are already in one. The universe we inhabit with NWBO may just be one. As James Jeans once said.....the universe is queerer than we can imagine.
Are you serious?
Scotty, I am a lawyer. There may be some contracts to that effect, however, I have never come across them. If you find a broker to list and represent you, it is the norm and accepted practice that the broker is entitled to a fee because the broker materially changed his position and incurred costs in anticipation of earning a commission. The seller will sign a brokerage agreement. In fact, brokerage contracts with which I am familiar clearly specify that the broker is entitled to a commission regardless of who brings the buyer. There may be an agreement between seller and buyer as to who pays the commission but that has nothing to do with the broker. The seller is obligated to pay or have the commission paid to the broker. Trust me: brokers always want consideration if they become involved.
Hi Doc:
On the whole, I agree with your comments. Further, from the info out there, I am swayed that the odds are favourable for FDA approvals. I would agree that PFS, although a primary end point, is not an as important as other metrics such as OS and particularly the long tail.
If PFS fails to meet the end point, I don't think that is curtains for the trial. After all it is a surrogate for the OS gold standard. More importantly, immunological therapies like DC VAX L take time to manifest their efficacy and demonstrate it at the long end. Indeed, I would think measuring the interval between progression and the death event would be more meaningful. I believe that even though there may be earlier progression, I think that as the treatment begins to take hold, it acts to slow the rate of progression and even in some cases reduce it to zero, thus extending OS and the building of the long tail.
However, there are some unanswered anomalies, at least to my mind. For example, in prior studies, Prins and Liau found that the vaccine worked especially well in MES which is a large sub-molecular group categorised in the major group as per the JTM of M-(unmethylated) and where MES constitutes anywhere between 30%~50% of all nGBM. This was because MES is a more heterogenous and immunogenic sub-group. On the other hand, they found that the vaccine had little to no effect upon pro-neural which appears to predominantly compose M+(methylated). Apparently, this sub-molecular group is characterised by methylization interfering with cancerous cell repair mechanisms allowing longer survival. From the JTM data, it appears that blended results show very significant survival as compared to historical controls. This may suggest that DC VAX L indeed works on this sub-molecular group in contra-distinction to earlier findings. Further, even in the M- group, the vaccine appears to be working perhaps due to its MES composition, but not nearly as well as the M+ group. In fact the blended results for this M- group at the OS 36 milestone shows 14.1% survival(which is about a 20% improvement over 2017 data reported in the JTM). One would think that this group would survive at least as well if not better than the M+ group. Why isn't that the apparent case? M- is also composed of classical which makes up about 25%~30% of nGBM characterised by the mutation EGFRviii and the focus of the failed CLDX trial and which seems to respond to chemo/rad and to some extent DC VAX L. Neural is less than 10% of this population and may not respond at all. Perhaps these latter molecular sub-groupings act to pull down the supposedly superior results wrt MES thus pulling down overall M- performance at the OS 36 milestone. In addition, we need to understand the composition of the long tail. Is it a one trick pony composed of predominantly M+? We don't really know, at least at this point, what the MOA may be to explain these and other possible anomalies. Hopefully, unblinding and analysis will shed some favourable light on all this. JMHO.
I would rather say that Chinese companies buy value. Of course, their value yardstick may be/is different than the seller's yardstick. But you can substitute Chinese for any denomination you want. Same all over the world. Indeed, depends upon how good a negotiator you are. Frankly, in this respect, I think Linda, Les and their phalanx of legal advisors got it covered. JMHO.
Thanks for your post. It is questionable whether the US government has oversight in an NWBO/Huawei acquisition transaction. This is not my legal specialty but FIRRMA and CFIUS were created by special legislation as a cabinet level committee under the US treasury Secretary to screen certain foreign based transactions involving US companies or funds.
Most of the applications to the committee or I should say notices of intended acquisitions were voluntarily made. In more benign times, the US wanted to encourage foreign investment especially by the Chinese. They did not want to scare the money away for obvious reasons. However the security landscape has become less benign especially wrt the tariff tiff between the US and China and accusations of fraud and possible espionage initiatives that have been alleged but are far from a serious cause of action. Trump talks big but he knows that he cannot do without chinese investment and he and the Chinese President are playing chicken and power bluff. In the end saner and wiser heads prevail and a compromise is worked out.
Now, in certain cases, where critical technologies that may affect the national interest are involved in an acquisition, the committee will have oversight and may recommend that such an acquisition is contrary to the national interest and block it. However, what is a "critical technology" and what is its connection to the national interest? Is DC VAX such a critical technology that its transfer by acquisition to a Chinese company is contrary to national interests? I don't know but I am sure that IF there is some follow-on deal, either licensing, partnership or BO, that LP/LG have it covered. They did not go into this, structure a deal and then say, oooooppps we did not consider government oversight. Note that the Meng/Huawei case and the closing of the Sawston transaction were roughly contemporaneous. JMHO.