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Don't get your expectations up. The schemes and manipulations used are labyrinthian, highly complex and convoluted. These HF and MMs have collectively billions of resources to devise these schemes making it extremely difficult to unravel and provide understandable evidence in court. The SEC won't touch it as they just don't have the resources. And, these government agencies play musical chairs with the industry they are supposed to regulate. Any court case will take decades to reach a final determination and by then we will all be dead and buried. Jim Cramer was right. The SEC is too stupid to even begin to understand what's going on. The SEC does nothing about the insult and JC still has his TV show with all the gongs. Is the US Attorney's Office any better? I think not. Why waste resources on a case you really can't win. Would take too long anyway.
Cofer's appointment to the board can now largely be seen as a scare tactic that didn't work. A CIA operative with a tough reputation but without any market experience to begin to understand how these schemes work. It is just not his expertise. And NWBO is not about to spend !00s of millions of dollars to stop all of this. It is highly, highly unlikely that it can be done. The MMs were not fooled by Cofer's appointment to the board. A big bluff that fizzled.
What happened to the imminent filing of a court case which LG alluded to a number of times when talking about his famous string of good news PRs? The last I heard was that "the timing is not right". The timing will never be right and the "big stick" court case has gone the way of all these good news PRs. A complete waste of money and the MMs/HFs are laughing at yet another misstep by NWBO management.
DI's advice to look at what is publicly out there rationally rather than emotionally means exactly what? LG has taught DI well. Another yawn. JMHO.
Cherry:
I agree 100% with your last paragraph. Despite good top line the share price is exposed until at least approval. We are still in for a rocky ride for 12-18 months. Ugh.
abc1212:
How about beware of the sheep in wolf's clothing?
Trocprofit:
Agreed.
Marzan:
I appreciate your optimism but predict that you will be wrong. ASCO will come and go without any sound of top line announcement. The only sounds you will hear are those of silence and then the weeping and gnashing of teeth as investors begin to realise that even though we are closer somehow it is still out of reach. Pretty much like Zeno's conundrum. JMHO.
I don't think I am misinterpreting anything. I am just rendering an opinion on what I think might well happen if there are inordinate delays in announcing top line. I have drawn a line in the sand. Just the same as Flipper has drawn his line in September. You may think it arbitrary. However, quite a few investors are going to be patient until ASCO. If no news by then, some or even many may bail. Silence will never the less continue. And, the longer it takes for top line announcement, the greater the chances for MM mischief. Miss ASCO and I believe many investors will depressively take the view that top line announcement is not around the corner. It could indeed take till early 2020.
The steps to top line as described by LP are not a walk in the park. Many individuals are involved and need to be managed and views coalesced. Thousands of queries need to be addressed and resolved. I get it. LP really means it when she says that each step is a multi-month process and critical parts, such as RA SAP approvals, are beyond NWBO's control.
The only news that will move the share price needle is positive top line. Between now and the time of top line announcement, there is a great deal of uncertainty in the market. Bad actors will take advantage of it. As SOS has correctly averred, the sinister forces want to drive NWBO into bankruptcy. I agree that $100s of billions are at stake. Big P and their allies are powerful. They understand what we understand. Even though the results may be stellar when ultimately unveiled, too much time may have passed and damage done in the interim to make NWBO a stellar investment. IMHO, I think that all stops need to be pulled to coordinate the timing of top line announcement with ASCO. I think it is critical and if ASCO comes and goes without such an announcement, the pps will reflect that eventuality. It may, indeed, be out of NWBO's control, but never the less, they and we will suffer for it.
The forces aligned against NWBO are powerful. How do you win when so much is at stake? JMHO.
GGB:
Well, my friend, don't discount my statement so quickly. Something to carefully think about. Some investors are doing just that.
I merely post opinions. If you don't like them you can ignore them. You know how to do that, don't you? LOL.
Anyway, GLTY and no hard feelings.
Um
GGB:
Technology is old? Maybe, but so what? If NWBO has developed it such that it works, who cares? Nah, smart naysayers won't make that argument.
Management is corrupt? Perhaps a little self dealing on the backs of shareholders but I would not accuse management of being corrupt. Rather, I think they have certainly aided and abetted, though I believe unintentionally, the devastating loss of market value through their mismanagement. This is not just the doing of the dark market forces.
Positive posters are pumpers? Nah, certainly not all of them. Iwasdriver is an excellent example of a rational positive poster and definitely not a pumper. You, OTOH.......Oh, just kidding.LOL.
Misinformation? Gee, what misinformation am I spouting? You may not like my opinions, GGB, but that's what makes a horse race. JMHO.
GGB:
I did not say that NWBO will fail to win RA approvals even if they do not achieve primary/secondary endpoints. All I am saying is that ASCO is an important event. No doubt NWBO is/was aiming for it. In November, 2018 most investors thought, latest, top line would come out end of March. Other investors had the temerity to claim, well, top line will likely be announced at ASCO, 2019 as it is a major venue and very appropriate for such announcements. I can recall the outrage when this was suggested. No, surely, top line will be announced latest mid-spring 2019 and perhaps at one of the conferences at which LP presents.
Well, now, after the thinly veiled probability that it would be nice to announce at ASCO, the complexity of the SAPs being submitted to the 4 RAs and probable delay due to back and forth with NWBO, the work involved in collecting data and resolving thousands of queries, etc., etc. described at the ASM puts a wholly different perspective on things. Yes, indeed, the goal posts have been moved yet again. And apologists for NWBO now aver, well, we never really thought that NWBO would be ready by then. Now, some are suggesting, well, SNO 2019 is just the right venue and should give NWBO enough time to get its ducks in order. Well, that is 7 months away. And what do you think will happen to the share price in the mean time? You don't think the dark powers that be won't aggressively spread the FUD and play games, the same as they always have? Isn't their strategy to bankrupt the company? Don't you think that delayed top line results will give them continued chances to drive the share price down? It seems likely to me that if ASCO comes and goes without top line announcement and which is delayed to the fall of 2019, or, GOD forbid, early 2020, the share price goes down. There are definitely investors that have drawn the line in the sand at ASCO. If nothing is announced, they bail. That puts pressure on the stock and coupled with MM machinations, the pps could be in free fall. The best scenario is stellar results announced at ASCO coupled with a statement that NWBO is immediately filing for RA approvals
It is almost a certainty(the only things 100% certain in this life are death, taxes and missed timelines by NWBO) that there won't be any announcement then. And........typical of NWBO telling shareholders at the ASM that news will be forthcoming in the next several months, well, all this will be forgotten and swept under the rug. Indeed, as we get yet closer to year-end/early 2020, investors can pick up shares at a fraction of the pps today. Another golden purchasing opportunity. LOL. JMHO.
Hmmm, are LP and LG part of the wolf-pack? LOL.
The MB is set up for anyone to post opinions and engage in exchanges. To you, it appears that my views are gloomy, but to others, my views rather reflect a realistic position.
My view of your postings is that you are an indefatigable apologist for NWBO. You have complete faith in the LP/LG combo. You see positives with the hires they make. While you are frustrated too, and are walking a fine line financially, you appear to be highly biased and inordinately optimistic. If you prefer polly-anna that's fine by me. Whatever floats your boat. But your views don't float mine.
As I have said to other posters, we will have to agree to disagree. If my posts are too gloomy for you and are not your cup of tea, why waste your time with such a comment? If you are comfortable with your DD and views, my "gloomy" views should nada affect you. Me thinks they rather strike a nerve. What ever. Carry on. JMHO.
We will have to agree to disagree. Quite a few investors' sentiments right now look upon ASCO as a pivotal event. Absent top line unveiling then, the sentiment will strengthen that announcement may not happen until much later in 2019 or even 2020. With a 9 month interregnum to announcement, which is the only news investors are focusing upon, I strongly believe that the share price will suffer new lows. That is my opinion and I am sticking to it. Anyway, good luck whatever you do.
I think that your sentiments mirror those of many investors and certainly those in my circle. Bailouts will only add synergy to the manipulation and it is highly likely that new lows will be reached even in the high single digits.
It may be wise to sell at least some of one's position at current prices. I think ASCO is definitely out. If you wait to bail out after ASCO comes and goes, without any top line news, I believe the share price will rapidly tank. One can always buy back later at much, much lower prices while allocating funds to more promising interim prospects. Not investment advice but just my personal view. Please do what your DD tells you and consider the risk with which you are comfortable. JMHO.
Cherry Tree:
From the explanation LP has given, the data collection in and of itself is a enormous task. And as of the ASM, it does not sound as though it is completed. Conducting parallel tasks appears to mainly involve the data collection process across 82 domestic and international sites. As of the ASM, it appears that the SAP was then not developed and that this task, too, is enormous involving multiple parties. And...it involves 4 RAs with the distinct possibility that there will be back and forth on the submitted SAPs. The timing of the approvals is then out of NWBO's control.
Thus, the sentiment that it would be "nice" to announce top line at ASCO is not really very encouraging at all when considering LP's quoted statement. From the explanation, it appears that LP is trying to temper expectations concerning timing of top line expectations and while not ruling ASCO entirely out and giving some possible hope, LP is letting shareholders down gently, and I think transparently, at the ASM. She has an "I told you so" defence if there is protracted delay.
IMHO, shareholders are being set up for disappointment. LP admits that the process involving 4 RAs is frustrating but by going that route it gives NWBO more chances to win. IMHO, the biggest chance to win is with the FDA. The other chances, IMHO, relatively pale in comparison. Leaving that thought aside and re-reading your quoted statement from LP, I am now convinced that ASCO is not only absolutely out for top line, but more than likely, we won't hear about top line until at least early 2020.
Right now, investor news expectations are focused upon top line. Other news involving DCVAX D and combo trials, etc., etc. won't move the share price needle; only top line results will do that. I doubt that the monies obtained through the sale of the Sawston property will last until the end of 2019. I think before then, NWBO will need to arrange for the sale of the remaining 17 acres and then be left with no real tangible assets unless, of course, the trial is a bang-on success. Next, in the mind of investors, is the return to toxic financing. A R/S certainly won't help.
Delays in announcing top line until much later in the year or in early 2020 will be met with strong and aggressive attacks despite the fact that the process LP described is understandably protracted to those relatively few investors immersed in the knowledge of the process. Frustrations will run high and FUD will run rampant and unbridled. Support by retail investors alone will not be powerful enough to overcome the negative sentiment engendered the longer it takes to reveal top line. Potential investors will likely hold off purchasing NWBO stock. This is the nature of market forces especially when it comes to NWBO.
The longer the perceived delay, the more the share price will suffer. If announcement of top line is delayed toward the end of 2019, say at least 9 months from now, then I would predict the share price will hit new lows, perhaps even high single digits. There would not be any other news strong enough to counter-act the slide in this case. Then, even in the case of stellar results, I doubt the share price would rise 10x from significantly lower levels and share price would likely be below a dollar anyway.
In such a scenario, what can DI accomplish? What news can he share if any? Why is IR even needed? Doesn't the quoted passage tell you all you need to know? Not very encouraging. JMHO.
I have a substantially large network. People who I know and who have invested in NWBO believe the trial has run long enough and all this vague talk about multi-month processes to get to data-lock and top line announcement is wearing thin. Expectations in November, 2018 were that the outside limit for top line would be ASCO 2019 and many were upset even at this date. ASCO is a very important event and certainly a reasonably expected venue for top line announcement even at theatre. If ASCO comes and goes, especially accompanied by silence, I am certain that there will be deep disappointment and frustration. This is a perfect opportunity for market manipulators to take all the more advantage and drive the price down. The chorus of "gee they have not announced anything and they continue with silence.....hmmmmmm....seems like something is rotten in Bethesda(with apologies to Denmark)" will hit a crescendo with little if any buying support from downtrodden retail longs. Indeed, there will be justified fears that the next opportunity may be SNO, but don't count on it, because early 2020 looks more likely given NWBO's history.
Missing an announcement at ASCO strengthens the perception that this could really go on past 2019. There is no question in my mind that the share price will not maintain the status quo but rather deteriorate rapidly especially due to malevolent market forces. ASCO is a watershed event. If missed, I have little doubt that the market will be unkind to NWBO notwithstanding the new guy in IR. But I suppose this does not matter to loooooooooooooong term investors. JMHO.
No, Flipper. DI is not the source, he is the communicator. Patience is not a new theme. It is just another word for stay tuned. JMHO.
Meirluc:
Thanks for your response. Many MB denizens believe that we are closer to the end of the trial and top line announcement. I believe that is a fair statement. From last year's perspective, indeed, we are a year closer. However we are always closer, but sh*t happens, like the partial hold for example, which was not within NWBO's control and the goal line has been moved forward. Here we are, with the necessity of filing SAPs with 4 RAs and most likely requiring approvals from all 4 before moving on with the process. IMHO, I don't think these SAPs will be rubber stamped and even though hopefully NWBO management has been working closely with them, I believe there will be some back and forth. Further, we don't know to what extent these SAPs have been developed and when they will be submitted. My view is that this will take time and it is, at least to me, a more reasonable speculation that top line will not be announced at ASCO and more probably sometime in the fall of 2019. However, knowing NWBO's history, I would not be surprised if top line announcement instead comes in 2020. This, too, is not an unreasonable speculation as an integral part of the process is out of NWBO's control.
I have never faulted NWBO for continuing the trial. They did so upon the advice of their SAB and other professional advisors, all of whom have much more information upon which to base their decisions. I believe this was the correct decision and I do not question it. And.......as I have said many times, I believe that NWBO will ultimately receive approvals from all 4 RAs regardless of whether the primary/secondary endpoints have been met. I have my doubts that they will be achieved but for RA approval purposes, I think we can put these concerns aside.
My concerns were based upon share price appreciation when top line is announced. Share price appreciation and sustainability depend upon how good the results are---as perceived by the market place---and when they are announced.
I have speculated that if results are stellar and are announced in the relative near term, i.e., ASCO 2019, the share price should appreciate considerably from present levels by at least a factor of 5x~6x. That could put us in the $1.50~$2.00 range and I think the price could hold at those levels until approval. In fact, share price could appreciate even more if stellar results are announced coupled with a statement that NWBO is immediately filing an application for approval. The share price, quite likely, may not appreciate as much as it might were NWBO on a major exchange, but never the less it would appreciate handsomely from present levels. In this case, I don't think the manipulators could overwhelm share price appreciation although they might place a drag upon it. Without institutional buying, I don't think retail support is strong enough for rocket like ascent in the pps.
If results are not stellar and/or top line announcement is inordinately delayed, all bets are off. Even in the case of stellar results, the share price will undoubtedly be at much lower levels than now and even with the same multiples, the share price may not breach the dollar level.
So there is a difference, in my mind, in what is needed for RA approvals and sustained price appreciation upon top line announcement. The bar is indeed higher for price appreciation IMHO.
I am certain that NWBO management understands the foregoing very well. It is obvious and they are pulling out all the stops to achieve stellar results as best they can. Even though the SAP approval process is largely out of their control, NWBO cannot wait too long to announce top line. They may be between a rock and a hard place in this regard. However, I would think stellar results(strong long tail affecting about 60% of the ITT or M+/MES and good milestones, cell memory indications, etc. could possibly counteract failure in the primary/secondary endpoints) top line announcement is pointing toward ASCO. That is the goal, I would think. If delayed beyond that, there will be serious pps deterioration through the strong spread of FUD playing upon investor frustrations.
I agree that DI, et al won't move the needle. Results and timing will. My point wrt DI was that I saw much less incremental value for IR as opposed to a CFO that would inspire greater credibility since NWBO's financial house is not so much in order. At least, then, they could get their reports out on time and not make foolish misses because LP is wearing too many hats. JMHO.
Meirluc:
Frankly, I cannot say. If past is prologue, I would not be surprised if it took that long. There are a myriad number of excuses that can be brought into play not the least of which involves the submissions of the SAPs and RA approvals from 4 separate jurisdictions and which could considerably delay top line. I don't know if the trigger for top line release is SAP approval from any one jurisdiction or it must involve the FDA. They may make inquiries on the SAP and there could be considerable back and forth.
Recall NWBO's expectation that the hold would be lifted relatively quickly and what happened? Was there any explanation for the hold and why it was lifted after so long? Was there any explanation as to why NWBO could not say anything about this? An individual in my network actually spoke to someone knowledgeable of the NWBO hold situation at the FDA. This FDA spokesman said that there was no embargo on NWBO to keep silent on this matter. It was entirely up to NWBO to make the explanations and not the FDA which routinely does not publicly address such issues. Les consistently embargoed himself. No, he couldn't discuss it because then I would know more than other shareholders and pressed further, all he would allow was that the explanations would be made at the "right time..." Excuse after excuse and avoidance in the extreme.
Do we know for sure if the SAPs have been submitted? If not how far in the process are they? All we have are vague timelines which make it easy to move the goal posts once again......and without explanation.
Do you honestly believe Innes, as the new guy on the block, is going to give out any more information than LG did? Is Innes the new "white knight" coming in on his white steed to finally joust off the black knight's(pun intended) veil of transparency and making LG look bad in the process? What makes one think that Innes can quickly provide answers that LG wouldn't or couldn't?
And what does "petal to the metal" mean? To LP it means....."we are going as fast as we can...." And according to Einstein, time is relative and interpreted in one's frame of reference relative to another observer's frame of reference. Those of us who have had conversations with LG throughout the years know about all the missed time lines he has spouted. Never once has any such timeline been met. These are swept under the rug and cavalierly explained away by....."things change or you misunderstood what I said" or even "I never said that........"
So no, I have little confidence in management's vague pronouncements and weasel excuses if and when they choose to make them. And I have very little confidence that they are far enough along in the overall process to provide top line by ASCO. The longer we go in the year without revelation, the more likely it becomes the year of 2020 and ASCO then.
Management has no credibility. Hard to believe anything they say. If Innes is going to make a difference, he has a huge challenge and it certainly won't happen anytime soon. LG is not out of the way. He is still there but now with Innes as an insulation layer taking the shareholder calls that LG has long tired of. How adroit and skilful will Innes be with LG now that he effectively reports to him? LG is highly opinionated and a lawyer who takes no prisoners, Innes included. And who do you think LP will side with? Hard to see real incremental value in DI's hire. Does he also have an accounting degree? The NWBO CFO position is just as open as the IR position was. LOL.
Anyway, IMHO, if top line does not come out by ASCO, many investors, potential and otherwise, will frustratingly be concerned that top line won't be revealed any time soon in 2019. The share price will undoubtedly tank to new lows with such sentiments. Then, as, if and when even good top line results are released, the share price could still struggle to get back to where it is today and in any event, will remain well below a dollar level. Very disappointing to say the least.
LP needs to announce bang on top line results by ASCO. Anything short(pun intended) of that spells disaster. Stay tuned. JMHO.
GGB:
First, I don't get your August, 2016 date. My alias was born on 03/08/14 but I have been an investor since 09/2013. So yeah, I have heard it a number of times and for whatever reasons the stakes have been moved.
Your statement that we ARE closer is correct just as in closer to Proxima Centauri on our inter-stellar travel to our closest extra-solar star. Closer is meaningless to me, and I bet to many other investors, as NWBO has always come up with reasons for non-revelation and transparency. Will they release top-line at ASCO? I am betting no. I am betting that our new IR hire will be parroting the same mantra, "stay tuned", and 2019 will come and go with nada. But surely, we will be closer to 2020. And that is with 20/20 "hindsight" right now. JMHO.
GGB:
"We are closer than we have ever been....." How many times have we heard this and then have the goal posts moved....again? Insofar as NWBO is concerned, "closer" only counts in dancing and horse shoes.
As a shareholder, I am a part owner. I am also an experienced businessman. I make calls on what I see. If we had more transparency, perhaps my opinion would change. But I doubt it.
On one thing we agree. It comes down to the results. If others are comforted by the hire of DI, that's fine. I would be more comforted by the hire of a CFO. JMHO.
Lovely sentiment. But he does not tell you how he is going to do it. LG obviously couldn't do it with his obfuscation, confusing and sometimes contradictory statements, missed timelines 100% of the time, etc. LG lost all credibility. Now DI is on board but his activities are being managed by LG his de facto boss. Now, instead of LG reaching out, DI takes over that role but with the script written by LG. In a very real sense, he is being set up to fail, perhaps unwittingly. Seen it many times in my corporate life. JMHO.
OK, why do you think it is a positive? In summary, I don't see what incremental value he brings. He is not some big swinging "richard" in the Wall Street world. He is obviously controlled by Les. In essence, how is he any different except in name only.
Right now, objectively, NWBO is viewed negatively with a lot of distrust. Thus, this certainly aided and abetted the cratering of the market cap. Until NWBO is able to report positive and impressive top line data, it will continue to viewed negatively. I don't quite see Innes' hire improving anything especially since he is an extension of LG. I don't see transparency improving. Company culture in place for years is hard to change especially by a new comer.
Better would have been the hire of a CFO. Brings more tangible benefits. So we will have to agree to disagree. JMHO.
Yes, thanks, but what's the point? NWBO has had nice big booths well located and where did all this get us? Why spend the money here? Nobody really cares. Its the top line data and nothing else. Until then, just like IR, it is a waste of sorely needed resources. JMHO but by all means, thanks for your efforts. JMHO.
Precisely Sentiment, Innes is purely IR. And...he may well fit the role because as a broker, that is what they do to get and keep customers. But, I am beginning to question exactly why he was hired recently.
First of all, Innes is not a policy maker. He is not a decision maker. And everything he does, when facing the public, is controlled and vetted by Les. He as much confirmed this in his reaching out email where he stated that......"Les asked me to reach out to investors...." or words to this effect. He is taking the lead from Les and de facto if not de jure reports to him. Les is now insulated by Innes as LP was insulated by Les.
So I don't believe there will be any meaningful change in information revelations. Without the fuel of information, relations with investors cannot improve because same old won't cut it anymore. The only thing that is meaningful information at this point is when and what top line reveal. If the news is good, you don't need an IR guy. The data essentially should speak for itself. The announcement will be made, assuredly, by LP. Innes is certainly not needed for that. Hence, without any meaningful info to reveal to the hoi polloi retail investor, what is his role? I would say that currently, he is not needed and a poor allocation of limited resources.
Innes, I am certain, did not leave his position at Oppenheimer to work at at deep discount. In order to attract him, I am certain that he is being compensated handsomely with a salary of at least $250K(as rumored and sounds reasonable) plus beaucoup stock options. Personally, I would have opted to hire a CFO. At the very least, NWBO would be able to get its reports out on time. There would be better governance and credibility wrt such a hire.
Right now, it appears that Innes provides questionable value considering that he is getting quite a sizable compensation. In effect, Les continues as a "spokesman" through Innes. The quality of information and transparency will continue as before.
If the top line data is impressive and all endpoints met, then of course, the data speaks for itself. In effect, the revelation of such data acts as its own IR. If the data falls short, no amount of "IR" is going to turn it around. In either case, an extra layer of IR which for all intents and purposes is managed by Les and accordingly, I see questionable value in Innes. Sparse resources can be better allocated to hire a CFO as stated above.
Further, Innes reaching out to retail is shop worn. After introducing himself and serving the "kool aid"(I know because I have already reached out and spoken to him; nice guy but really what else is new?) what else can he say that Les already has said and has in any event written the script for Innes. I don't know about others on this MB but I am tired of the same old. If there isn't a change for transparency(up to now there isn't much if any), then I prefer silence rather than IR which is at least now un-necessary IMHO.
Even if the results at top line are impressive, the share price, without significant buy in by financial institutions, may not rise significantly. Retail is not enough to accomplish significant and sustained share price altitude. Innes needs to reach out to these institutions but he may be significantly hampered because NWBO is a penny stock and not on a major exchange. This may engender impetus to accomplish a risky reverse split which is just what the MMs are looking for--altitude to short, rinse and repeat and back to the pink sheets.
Further, what connections does Innes have? He is not in NY/Wall Street. He is in a relative backwater satellite office. He was a senior director which is not a very senior position at Oppenheimer, not a Vice President. What influence/leverage does he have with the all important financial institutions? He certainly does not appear to be a Wall Street "insider".
These are issues that should be of major concern. Just the hire of Innes for IR is not, in and of itself, of great import. What real incremental value does he add? I have a difficult time trying to understand this. I can understand a CFO. However, NWBO should at least for now choose one or the other considering its resources. If anything, the IR position needs to establish credibility and strong ties with larger institutions. Their interest will propel the stock much more than long suffering retail.
Bottom line, I think at least for now, IR/Innes is a "luxury" that NWBO can ill afford. Just like spending on big booths at ASCO financed in the past by toxic financing and now through the sale of Sawston. And where did all this largesse get us? $0.14 and now $0.27?
JMHO.
My post was specifically referring to what I think could happen if one or even both endpoints were missed wrt to share price upon top line announcement.
I laid out a scenario where even though both endpoints were missed, the share price might still rise due to impressive milestone/longtail data that addressed a relatively broad spectrum of glio IV cancers, e.g., M+ and MES that could account for about 60% of the ITT. In addition, missing the PFS endpoint may be overridden by the possibility that the RATE of progression slows dramatically after PFS eventing as the therapy takes hold as more time elapses.
Insofar as approval by RAs is concerned, I believe that it would issue even if both endpoints are missed due to results as stated above.
Hopefully, for the sake of share price appreciation, the endpoints are met in addition to the other, and I think, even more important metrics. The more obvious the data, the less you need to explain and be placed in a defensive position. To be sure, the naysayers are hoping for no less. JMHO.
Antihama:
I appreciate your thought. But I don't think a defence by NWBO on why PFS failed and why OS milestones/longtail should be focused upon, assuming they are positive, will neutralise negative market sentiment.
First of all, IMHO, it will be a devastating revelation and blow if BOTH the primary and secondary endpoints are missed. Missing just one is bad enough.
NWBO can explain these failures away but it is NWBO that is doing the explaining. What would you expect them to say? Once NWBO is placed in a defensive position and needs to explain itself, it is behind the 8-ball as it were. In order to have an upward and sustainable lift in the share price, the results announced at top-line must be "undeniable". Mixed or ambiguous results won't cut it insofar as the share price is concerned at top-line revelation.
I do admit to the possibility that even if both endpoints are not achieved, other "undeniable" achievements may save the day. Such as, for example, overall OS36 survival for the treatment arm was say 35%~40% and both M+ and MES demonstrated strong showings. Long tail at 60 months was 25%~30% for the treatment arm which also showed a healthy mix of at least M+ and MES. Although other sub-types did not respond as well, the vaccine still worked to some extent. All patients will benefit to a greater or lesser extent. The composition of the long tail shows significant effect on about 60% of the ITT population.
Furthermore, even if the PFS endpoint failed, NWBO may still be able to salvage it. How? Well, even though eventing did not demonstrate improvement, the RATE of progression after eventing was demonstrably and dramatically slowed as it took time, characteristic of immunological approaches, for the full effect of DC VAX L to establish itself. This fact was one of the reasons for the significant survival results reported. And........NWBO plans to immediately prepare an application for FDA approval.
In such circumstances, while I think negative market forces are powerful, they are not powerful enough to overcome the reporting of undeniable results coupled with an application statement. I can see a sustainable surge in the pps. This may be why LP is now biding her time, letting the trial to continue to accumulate data, under advice from her SAB and professional statisticians, to achieve "undeniable" results regardless of whether these endpoints are met. To be sure, the less explaining you need to do and the more obvious and undeniable the results are, the better the chances for significant share appreciation, regardless of malevolent market forces. I believe LP and LG are well aware of this and are preparing themselves carefully for top line presentation. After all, undeniable results and expeditious RA approvals thereafter are the goals. JMHO.
DMB:
For the last time, I will restate my views on PFS.
1. I do not believe that PFS is pivotal for FDA approval purposes. If other metrics are positive, whether or not the PFS endpoint is met, will not be dispositive wrt RA approval;
2. If upon top line announcement, PFS is missed or ambiguous, it is my opinion that naysayers will claim trial failure and the nefarious forces that we know are out there will keep a lid on the pps and drive it down. We have seen this before when good news has been turned into bad. As before, NWBO will keep its silence so as not to possibly negatively affect its chances for approval. Naysayers will claim that failure in the endpoints will make approval riskier. The overall cacophony of FUD will drown out positive news as the negatives will be accentuated. Continued silence will only add to the downward pressure. LP needs to avoid this possible scenario and she is undoubtedly pulling out all the stops in an attempt to do so.
Bottom line, PFS does not make a critical difference when it comes to approval. However, given market realities and the manipulation that we have obviously seen, PFS, as a primary endpoint, if missed, will IMHO negatively impact the share price. Over and out.
Thank you, LF:
I think that if the trial reveals data as good as we expect, the FDA will be hard pressed to cater to their constituency, BP. Glio is a horrible and deadly disease and current treatments give very little hope for longer lasting lives, safety and a good quality of life as well as ease of administration. Because the vaccine is safe and if it shows signs of efficacy, the FDA will commit political suicide if it is "selective" as you aver.
Rather, the FDA will tell its constituency......"look, we can't in all conscience deny the results and impede approval now. It's political suicide. You guys had your chance. Instead of playing foolish market games with your HF buddies you could have made an offer that NWBO could not refuse. They had a lot of dissatisfied shareholders over there clamouring for an exit venue. Now it's too late. You have the money. Five or even ten billion is chump change to you guys after all the favours we did for you. If you think they are a threat, buy them out. Then maybe in combo with their product you can salvage the revenue streams of your own crap products ."
I also think the FDA knows that LP and LG are politically connected. LG did some legal work for Trump and so he can pick up the phone and talk to him as, if and when necessary. The FDA commish does not want to find himself in deep brown tapioca in order to bail out greedy big P. Even the FDA has its limits.
JMHO.
Thank you. I appreciate your take. As you are a physician and well networked, I take your comments very seriously. I hope you are right. GLTU.
Umibe
Hi Marzan:
Did anyone ever tell you that you are quite cute when you get upset?
As a PhD in Chem Eng, I hope you read chem reactive relationships better than you read my posts.
First, I am a long and have quite a considerable stake. I bought into the convertibles as an accredited investor. And.....I have averaged down considerably. So, I can confirm what I have always and consistently stated: I believe DC VAX L will ultimately be approved by all RAs including the FDA. If the other evaluative criteria result in what we now expect, whether or not the PFS endpoint will be achieved is of relatively minor importance(I can't say no importance because it is, after all, a primary endpoint).
However, where the share price is concerned, that depends upon market forces and how the market perceives the trial results. In this case, not regulatory approval, technical failure by failing to meet primary/secondary endpoints will be focused upon by manipulators having a malevolent agenda. They will claim the trial failed. They will claim that approval is in jeopardy. And as you know, Wall Street just hates uncertainty.
Accordingly, it seems quite likely, to me at least, that the share price may be negatively impacted if that is the case. It certainly is a fair possibility and I think that LP is well aware of it. That is why she is pulling out all the stops to try and avoid such a scenario. After all, financing will no doubt depend upon it. We don't want to go through more cycles of toxic financings and debilitative dilutions due to a low stock price. Thus, in such a case, it is important that the endpoints are met. These when coupled with long tail and milestones, etc. will go a long way to ensure reasonable and sustainable share appreciation. There, not so bad is it, my friend Marzan?
Please re-read my posts on this subject several times for a complete understanding. If you are having any difficulties in comprehending my english, please don't be shy or embarrassed. Don't hesitate to ask. I will be pleased to assist you and relieve you of your confoundment. There, you see, you have something in common with PFS after all!
OK, Marzan, hope we are now on the same page. Still friends? LOL.
Your pal,
Umibe(not Umibie--no such word in Japanese)
DMB:
Then I would respectfully suggest that NWBO should not have published the article in the JTM in the first place based upon the import of your argument. What goes for PFS, a primary endpoint, should also apply to survival. So why did they publish the article and focus upon survival? Because they wanted the "good news" implied by the blended results to impact the pps. Unfortunately, the insignificant appreciation did not last long. Further, other investors I know raised questions about the lack of information on PFS. A reasonable interpretation, and that is all we can do, would be that the silence and resort to adjudication wrt PFS, a primary endpoint, signified that there may have been confoundment and the blended results were, accordingly, of concern.
My point is that PFS endpoint achievement is probably not a significant factor regarding RA approvals provided that other evaluative criteria are strongly positive. In fact, it is rather likely, having spoken to an oncologist familiar with immunological approaches, that PFS eventing may happen earlier than would be hoped for in applying the therapy and may even not significantly extend beyond SOC. What is likely to happen is that as the therapy begins to take hold in time and despite eventing, the rate of progression is slowed significantly engendering a concomitant effect upon survival, which, after all, is the "gold standard". The oncologist community knows all about this. Short sighted and superficial Wall Street does not. They rather focus upon Primary endpoints and forces with an agenda, and there are plenty in NWBO's case, accentuate the negatives and their cacophony overwhelms any positive outcome thus placing downward pressure upon the share price. Thus, there is a distinct difference between what is weighted for RA approvals and what will motivate Wall Street. LP and LG may know the regulatory environment quite well and they have brought Innes on to better understand the Wall Street market environment especially given financing requirements and the need to boost share price as alluded to at the ASM. That is all I am saying. JMHO.
If I knew that at least the blended data suggested that the minimum threshold would likely be achieved, why not give out blended figures with a caveat, just the same as in survival. What is suggested by PFS is that the blended figures indicate that they may be close to the minimum threshold(or even not) and they are hoping that adjudication confirms that at least the minimum threshold has been reached. If blended results suggest, as in the case of survival, that the blended results are promising, with the caveat that such Tx arm results will at least be confirmed(by adjudication) if not be better than blended results suggest, I would address that.
With NWBO, you just never know. Apologists for NWBO try to defend their silence by spinning it and the selective release of information regardless causes confusion. To me, invoking Occam's razor, the simple explanation for silence is that from the blended data, there is reason for concern and confoundment. Accordingly, adjudication will take place to clear it all up. If on the other hand, PFS blended was say 15 months, that would be quite positive with a caveat that adjudication, never the less, will be performed for confirmation purposes so that the results are undeniable. In such a case less confusion.
So, bottom-line, I would say that NWBO has some PFS concerns. The "foot prints" indicate it. Does not ipso facto mean they failed to achieve the end point. JMHO.
Hi Doc:
Your response to Sentiment is appreciated as an indirect response to my post.
Perhaps, I have not been entirely clear about my concerns. I am rather confident that NWBO has enough for approval, EVEN if it misses the primary/secondary endpoints. That is my opinion. It is not shared, for example, by my investment advisor or others who I know and are fellow investors. Most of Wall Street has a limited and superficial attention span. In-depth research on the science behind NWBO's trial has not generally been done. Even Wall Street analysts who have followed NWBO(for example, Carol Werther) did not exhibit any in-depth knowledge about the science. Accordingly, NWBO has not only been ignored by mainstream Wall Street but has been pilloried by naysayers preying upon a small company with relatively complex(to limited attention-quick buck Wall Street)bio-technology.
On the other hand, I am concerned about the share price upon top line announcement, if the primary/secondary endpoints are not met, as I have previously explained.
Why do I believe DC VAX L will ultimately be approved? As you might have gathered, I am a rather unsophisticated(as compared to others on this board and, of course, experts in the field) simple thinker when it comes to things bio-technical. I try to dumb things down for ease of my understanding. As Einstein once said...."if you cannot explain general relativity to a child, then you have not understood it..." Anyway, here goes:
As a patient, I would be concerned about the 6 following factors if I were to pursue DC VAX L therapy:
1. How long can I live?
2. What would be my quality of life?
3. How safe is it and what are the side effects?
4. How easy is it to be administered?
5. How expensive is it and will it be covered by insurance?
6. Are there other and better alternatives?
I think with its more flexible regulatory approach, the FDA will follow the above considerations in reaching any approval determinations, including an assessment of manufacturing preparedness.
What we know from the blended results published in the JTM and updated thereafter are the following:
1. The ITT(minus 38 patients)categorised the trial patient population as methylated(M+) and non-methylated(M-). From the blended data, the M+ population appears to have fared extremely well(even when adjusted for randomisation) with a delta of 13 months from historical SOC to blended results. It is reasonable to expect that the treatment arm may fare even better. The M+ population was approximately 44% of the total characterised patient population(293 patients). M- also appears to have fared rather well with a delta of 7 months from historical to blended results although OS36 month survival was only 14.3% blended.
Furthermore, both the principal investigators in the US and UK(Drs. Liau and Ashkans respectively) have commented that patients seem to be living longer and that the therapy works, to a greater or lesser degree, throughout the entire spectrum of cancers that characterise stage IV glioblastoma. Furthermore, Drs. Liau and Prins have found that MES, largely M- and much more aggressive, responded particularly well to SOC and thus DC VAX L because it was more immunogenic. Both MES and M+ would comprise a patient population of over 60% where DC VAX L is suggestively more effective.
It should also be noted that tumours cannot be simply characterised as 100% MES or classical, etc. These tumours are striated and very heterogenous and mutative. Tumour composition will be different intra-inter tumour for any particular patient. There will likely not be facile determination that the tumour is this or that type. This is a highly individualised approach. Accordingly, I believe that if approval issues for DC VAX L, it will be broad and not narrowed to a particular molecular, M+/M- or other sub-group. Rather than imposing a regulatory fiat, the FDA will most likely leave it up to the patients and physicians treating them to make the decision whether to use DC VAX L for a particular cancer. As a practical matter, physicians will be able to prescribe off-label anyway although insurance coverage may not be available.
It bodes well that 69 physician/scientist authors signed on and thus endorsed the JTM article. NWBO's SAB is composed of prestigious physicians who would not risk their reputations. There have been technical papers in support of the science, i.e., Dr. Carlo Rago, who has also placed his money where his mouth is. Those naysayer professionals have never offered a scientific rebuttal of the science. The best they could offer is that the publication of blended data is pre-mature. Rather, we should wait for unblinded results.
Accordingly, bottom line, it appears that DC VAX L enhances survival across the board and suggestively, in a significant sub-goup or groups, that survival extension may be significant.
While it is true that we need to await for top-line results, it appears strongly suggestive that the response to the first concern is quite positive. A patient has a good chance of living longer and perhaps in at least a significant minority of cases achieve an effective long lasting remission.
2. Administration of DC VAX L would likely ease the side effects of rad/chemo and inducing cell memory to mitigate recurrence and lessening the dosages and length of time on SOC or at some point avoiding the rad/chem part altogether.
3. Safety and side effects are of relatively little to no concern.
4. Ease of treatment is obvious
5. If approved, very likely to be covered by insurance and pricing, when compared to other less effective and/or tolerated treatments, is extremely competitive. Nicely set up for NICE(pun intended).
6. Currently, the helmet seems to be a viable alternative. However, it is more expensive and lacks sufficient long-tail data(no QALY). If DC VAX L is at least comparable in performance at the front end(and blended results appear to be so; treatment results would likely be superior) but is better at the back-end(long tail), it would appear that DC VAX L is the preferred alternative and would have orphan status to boot.
It is obvious that NWBO has been investing and gearing up for commercial manufacturing capabilities and upon RA approvals will have the capacity to meet at least initial commercial demand. I don't expect this aspect to be a regulatory hurdle for NWBO. They have been at it a long time.
Accordingly, I believe that the odds of FDA approval(most important in my view of the 4 jurisdictions) are extremely high regardless of whether the primary/secondary endpoints are met.
Having said all that, I believe the case for the share price appreciation upon top line announcement is decidedly different and depends upon meeting endpoints. Wall Street at large, as I have stated herein above, his a limited attention span. It follows popular trends. Other therapies which are decidedly limited in their efficacy, highly toxic and dangerous have garnered the interest of Wall Street and the companies possessing these drugs have seen their market values reach incredible levels. Why is it that these therapies are embraced by Wall Street with all their warts and liabilities whereas promising therapies that are safe, show promising albeit blended data results, go after an extremely broad market(solid tumours both operative and non-operative), have an ease of patient administration, possess manufacturing preparedness, have a platform pipeline(DC VAX L and D) for many indications rather than a "pill per indication pipeline" and is relatively cheaper than most other like therapies are not only shunned but pilloried?
However, and unfortunately, it is what it is. Thus, failure to meet primary/secondary endpoints constitutes a technical "failure" in the trial. The loud chorus of naysayers will latch onto this "failure" and accentuate the negatives over any positives. How will NWBO respond? Most probably by silence as has been the case up to now. NWBO does not want to jeopardise the FDA approval process through any defence and thus, until approvals, it will elect to stay silent just as before. The market needs to be spoon-fed on the value of NWBO. It will not come to any realisation of its value on its own any time soon. The market will only hear the incessant chanting of failure though only technical and of little approval consequence when measured as against the evaluative criteria indicated herein above. The share price will be battered if the end points are not achieved simply because Wall Street will not believe anything else. It will be a Johnny come lately, if at all, when it ultimately begins to realise that DC VAX L/D is a new paradigm in treating disease through the enhanced invocation of the immune system. This is not hard to understand, but for some reason, Wall Street doesn't understand or does but the forces that be are against a little company's engine that could but now can't because it has run out of gas.
Has the share price been priced for failure? No, I don't think so. If it were, the price would likely be a couple of cents or $0.00. It is now priced at "highly doubtful that the trial will succeed" price level. If the primary/secondary endpoints are not met, then the "highly doubtful......." level will give way to a sharply lower level..
I have to believe that NWBO management realises all this and is working very hard and deliberately to pull out all the stops for share price appreciation. It is possible that although the primary/secondary endpoints are not unequivocally met, that the share price could still rise. But they would need to hit some grand slam home runs in milestone/long tail, etc. that overwhelmingly drown out the technical failures. This is why, IMHO, there is no rush to unblinding. NWBO management is deliberately taking its time to get its ducks in order. But, at the same time, it can't take too long(much past ASCO) to announce top line. The share price will be very fragile and no doubt, NWBO is now between a rock and a hard place. While PFS may be "fluid" as Flipper claims, still, to my mind, failure to provide blended data on PFS, the need for adjudication and otherwise overall silence seems to indicate some jeopardy that this lowered endpoint may not be achieved. JMHO.
GLTA
Sentiment:
I hope you don't mind if I proffer some predictions on share price appreciation upon top line revelation and then approval.
1. If the primary/secondary endpoints are met plus miles stones and reasonably thick and diversified long tail( a best case scenario), I believe that share price will appreciate 5-6 times over the then share price. Let's assume that top line comes out at ASCO or shortly thereafter(with guidance not silence from NWBO). Let's further assume that the share price is about $0.30 just about where it is now. I think the share price could possibly approach $2.00 and would most likely settle somewhere between $1 and $2. The market will reckon a multiplier effect based upon the then prevailing price. That's how the market works in my experience. I think a 5 or 6 times multiplier is reasonable and upon approval by the FDA ( and other RAs but the most important is the FDA), I think the share price could rise to $5.00. I don't think the price would riseuch higher due to commercialization concerns, rate of market penetration, profitability, etc., all legitimate concerns. I also think a buy out could be offered at about the same level. I don't think big P would offer much more and I think that LP/LG would take such an offer. They are getting on in age and perhaps well realize that the commercialization challenge is a bit beyond them at their age. Otherwise, I think big P will let them go it alone and take their solitary chances. There will still be malevolent and powerful forces out there.
2. If topline announcement is delayed beyond ASCO, and in silence, I see the share price tanking and possibly declining to $0.15-$0.20. If the results are as in 1. above, I still see the price rise to
about a dollar or a bit more. Upon approval, the stock could possibly appreciate to between $3-4 per share.
3. If the primary/secondary endpoints are missed, the trial will have "technically" failed and the long tail good news essentially overwhelmed if not buried by an avalanche of accentuating the negatives, increased risk of lack of approval or issuing a CRL and stoked fears of massive dilution due to low stock prices. I see the share price tanking to $0.15 or even less. Management will have lost all credibility and many longs will become fed up and this will weigh heavily on the share price as well. It will be a long tough road to approval for the share price which will stay at abysmal levels. I do think that there will be ultimate approval but I don't see the share price appreciating much over $2.00 especially if LP and LG continue to lead NWBO.
I am hoping for the scenario 1above but I have real concerns that the PFS primary endpoint has been met.
OK Flipper, you make a good case. Assuming you are correct, why weren't blended PFS results published along with OS in the JTM? I can understand adjudication to confirm good results or add on to them, but the complete silence here does raise concerns. Why talk about blended OS data but say nada about PFS?
JMHO.
I hope you are correct on meeting the endpoints. If these are met, plus long tail, etc., I believe the share price will take care of itself.
But in the event these endpoints are not achieved, NWBO is already placed in a defensive position of having to explain and defend the results by diverting attention from the negatives to the other criteria. The nefarious forces will be all over the "technical" failure overwhelming the other positives as "spinning" and on and on. We have ample evidence of spinning good news into bad. What happen with the good news JTM? It was decried because, in part, the article appeared in a middling journal. All price rises were short lived.
Failure to achieve the endpoints give a huge platform to the naysayers to attack the results with..."no matter how you cut it and spin it, the fact remains that the primary and secondary endpoints were missed. The trial has failed here. Is approval a slam dunk now....."
FUD returns big time. LP and LG know that this scenario needs to be avoided. That is why they are pulling out all the stops. JMHO
Meirluc:
My point has nothing to do with FDA approval. As I have often averred, I believe that even if the primary/secondary endpoints are missed, with persuasive milestones/long tail etc. achievements, the RAs including FDA will eventually approve.
My point has to do with what happens to share price if these endpoints are missed upon top line announcement. I believe that the market will focus as will the nefarious forces thereto upon the "technical" failure of the trial, and the increased riskiness of approval because of the failure. The market will focus more on the negatives than the positives thus blunting any sustainable rise. There will be disappointment all around adding to downward pressure. Focus will be on needed financings and increased dilution caused by weak share price. The downward spiral is synergistic.
NWBO needs to avoid this scenario. The primary/ secondary endpoints must be met. LP knows this in spades. She is pulling out all the stops including adjudication. Silence on PFS and adjudication seem to suggest concerns on meeting the PFS endpoint. There may not be sufficient separation on OS. These possibilities are not to say that RA approvals are necessarily doomed. I don't think so. But the market reaction will be negative. Investors will need to wait until at least approval for any share price rise and sustainability. JMHO.
GGB:
You make a very valid point to which I have alluded in previous posts.
Candidly, I believe that big P and other experts, real and so-called, think that DCVaxL works. The real question is not whether it works but how well.
As an investor, even assuming that the results are stellar at top line announcement and all endpoints are comfortably achieved with milestone/long tail home runs covering a broad spectrum of GBM cancers, i.e., M+ and MES for example or about 60% of ndGBM, would the price rise significantly and be sustainable in face of nefarious forces keeping a lid on any rise and then walking the price down again casting doubts upon commercialization challenges, dilutive financings, etc. Would investors need to wait months if not a year for reg approvals after top line announcements? How powerful are these forces? Is it a question where, as a practical matter, you just can't fight nefarious "city hall"? I must admit that I don't know the answer to that. We have seen how well these forces conspire to keep the lid on when good news issues. The data published in the JTM was excellent as were the updates at SNO. We are close to the finish line but the stock price languishes and there is not enough momentum to keep the upward spike going for long. FUD and manipulation continue rampantly and unchecked. CI darlings not even in phase III are bought out at billion dollar valuations but NWBO can't sustain itself at $300 million.
However, just imagine market reaction and what the manipulators/shorts will do if the primary/secondary endpoints are not met. The focus will be that the trial failed; that this failure is attempted to be salvaged by appeal to other criteria; and, hence approval is still highly risky and will not issue anytime soon if at all. The stock continues to languish at current levels and well below a dollar. Any reverse split to get uplifted to NASDAQ, etc. will be met by furious shorting, thus nullifying the reason for the R/S in the first place. Back to square one and rinse,repeat. Financing will be required with once again deep discounts and warrant incentives.
Thus, it is critically important for the primary and secondary endpoints to be met, not necessarily for RA approvals, although that would be helpful, for share price appreciation
and sustainability. If these endpoints are not met, investors had better plan for a very long term ROI. JMHO.
Hi ADVFN_doclee:
You are correct that an R/S, by itself, does not change the market cap. There are fewer shares O/S but the price rises proportionately so that the MC is the same as it was pre-R/S.
However, in the case of NWBO, do we have any precedent as to what would happen(more precisely what did happen) in connection with an R/S? Indeed we do. Post R/S, the share price was devastated by short manipulation and, of course, by devastating dilution engendered by vulture financing. Post R/S, the share price cratered to $0.14. So we know that after the R/S, the MC was not safeguarded in the least, but was literally slaughtered.
In NWBO's case, I submit that not only is an R/S unnecessary, but NWBO's history tells us that an R/S set the stage for manipulation at a higher altitude and management's destruction of shareholder value through highly toxic vulture financing. Repeated financings at high discounts to market plus warrants just devastated the MC. I don't know about you, but burned once by an NWBO R/S is more than enough.
If management decides to go the R/S route once again..." because we need to uplist to Nasdaq, etc. in order to attract institutions and anyway things are different now, blah, blah, blah...", shareholders would be extremely naive to go along with this.
An R/S would give MMs much desired altitude to short away and management to once again engage in repeated toxic financings. Management will forget history and repeat it again. No thank you. Rather, get the share price up by achieving the important endpoints. Forget about artificial props. If NWBO hits the data home run, it is a new ball game. Everyone will want to get in. Period. JMHO and two cents.
Hi Cherry:
Thanks for sharing your discussions with Mr. Innes(DI). You have also raised an extremely important issue wrt a reverse split(RS). Here are some comments.
First off, I don't know DI but with over 30 years in the markets and managing $175 million in assets, he brings two important capabilities to NWBO: a client book and market experience. As such, he will bring alternatives to financing/clients which NWBO likely did not have available previously. He will hopefully be able to advise and guide management wrt to market reaction and the suitability of whether a reverse split is advisable. For reasons that I will explain herein below, I firmly believe that an RS is not advisable and would engender disastrous harm to the share price. I have been through a couple of these and, trust me, they were not pretty.
In order to attract an individual like DI, NWBO most probably had to offer him a handsome compensation package and NDA-like information, all of which convinced him to leave his likely well-rewarded and comfortable position at Oppenheimer. I doubt very much that he is exaggerating his background. It is easy enough to check. Managing $175 million in assets means that he has been quite successful in his business and would have little to no reason to jump over to NWBO. By doing so, he has invested not only his money but also his career in NWBO. DI is certainly not stupid and would not have made a move like this where he is "fully" invested unless he was convinced of the opportunity. Relatively few individuals invest both their money and careers in a single company. Diversification is usually better, unless, of course, one is pretty sure about the configuration of the tea leaves.
I think that DI's hire has important ramifications. However, I think many on the MB ascribe too much concerning DI's influence. DI is the new guy on the block. He is not going to change PR policies over night. Changing NWBO's secretive culture is a difficult if not impossible undertaking. At least de facto, he will be vetted by LG, his boss for all practical purposes, on what he can say to investors and what he can do. DI can certainly recommend a certain course of action, but LG is the decision maker. Right now, DI is an extra layer between LG and investors. It will be DI who takes up the bulk of responding to shareholder and MB inquiries. Since he is likely being well paid for this, let's hope that his hire is worth it to enable LG to pursue other important activities. IMHO, if he can dissuade any RS course of action, his hire will have been well worth it, at least to me. DI will need to be very skilful in his dealings with LG who, I think, is very difficult to persuade and is a lawyer to boot. DI certainly cannot circumvent LG with LP or the BOD and so he will be walking along a tenuous tightrope. Certainly not an insignificant challenge.
Right now, I think that DI has been well indoctrinated by LG. His statement to you wrt to an RS and that there is "nothing off the table" is very reminiscent of a similar oft used expression by LG. I doubt very much that DI will reveal any more information and be less circumspect than LG has been. He will be schooled by LG until it is felt that he can fly with less(pun intended) oversight. In this respect, I expect little change except for the IR mouthpiece. It should be well noted that DI's at least official role is to manage IR. It does not mean corporate media marketing and PR. For now, at least, DI will be parroting the company's various mantras to the shareholder/potential client constituency. In this respect, DI will not bring anything new to the table.
Is DI an appropriate hire for IR? Yes, indeed, I believe that he is. Brokers are skilled in IR; that's what they do in order to be successful. You don't get a $175 million client book, if you are not skilled in IR. So undoubtedly, DI is a good fit for this position.
NWBO needs to have very strong positive results for four main reasons: approvals by RAs so it can become part of mainstream SOC for at least ndGBM; credibility for its platform for other indications; NICE/ insurance reimbursements; and, last but not least, share price appreciation.
If NWBO is going to get any significant share price appreciation, it must achieve the primary/secondary endpoints in addition to OS milestones/longtail which covers a relatively significant spectrum of ndGBM, e.g., M+ plus MES as an example which likely corresponds to about 60% of the ITT. In fact, all important endpoint protocols should be met for purposes of significant as well as sustainable share price appreciation. If that is the case, the share price will rise organically without need for an RS. The value of the therapy is undeniable and the demand by patients(and doctors) for it unstoppable and over-whelming. This appears pretty obvious to me.
In the above respect, LG's statement on April 28, 2018 is prophetic as well as telling in connection with NWBO's strategic direction: they will continue the trial and collect data until the results are "undeniable".
Not just for RA approvals but also for all the other objectives mentioned above including critical share price appreciation. Thus it is vitally important to achieve the PFS and OS endpoints for the share price appreciation objective even if falling short of their achievement would not necessarily derail RA approvals at least wrt some jurisdictions. Accordingly, LP is in no rush to get to data-lock but is "proceeding" towards it and is thus very vague about the timeline to top line data revelation, all the while collecting data and hoping that it optimally covers ALL the bases. LP and LG know this is critical for the all important share price appreciation objective.
OTOH, if the PFS/OS achievement of the endpoints falls short, an RS won't help. It will just give the shorts more welcomed altitude to short the bejesus out of the stock.
Bottom line, an RS won't be advisable in either case. If the results are stellar and all endpoints are met, the share price will overwhelmingly take care of itself---at least I would think so. If the results are mixed and endpoint achievements fall short, an RS won't help. Nefarious market forces will make sure of that
The real question is whether there will be appreciable and sustainable share appreciation in the face of stellar top line results or are dark market forces too powerful to prevent what would otherwise be a corollary result? This would be a case of great science but a bad investment none-the-less where you can't fight nefarious "city hall". What a shame. JMHO.