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Anything between $2B~$5B would be fine with me. WRT commercialisation, NWBO with current management/resources cannot go it alone. They know it and big P knows it. JMHO
In practical terms, the open letter is as good as ignored. If there is any response by management, they will say something like......"gee, thanks for the letter. We are as frustrated as you are and would like to open our presents too. We will give due consideration to your letter and respond as soon as we can. In the meantime, stay tuned". After all this time of stone walling, what else do you expect them to say?
Contacting the regulators and filing a complaint will meet with the same fate, essentially, "stay tuned." Form letter response just like the IRS. Good luck with that.
Investors had their chance last year at the ASM. No friction. Pretty much a love-in and this year won't be any different. LP holds all the cards and essentially, this is her company. Retail and other investors are along for the ride. Practically speaking, their bleating is absolutely futile. SEC? Slap on the wrist. Court cases? All dismissed. FDA? Probably had its hands dirty on the screen halt and is being protected. You can be sure their action will take a ginormous amount of time. By that time I bet we will have seen TLD. Complaint mooted. These are your tax dollars at work.
Look, if you don't like it vote against it by selling your shares. In a heated argument with Les, that is what he told me.
The only thing that matters is top line. We will get it, and I think it can be safely guaranteed, sometime in 2020. If TLD is not stellar, LP, LG and company are off to the Caymans. My bet is that TLD will be stellar. That is why I am holding. I do hope for a buy-out sooner rather than later. I don't think NWBO management is up to the task of commercialisation in terms of management skills and resources. Even on stellar results, I don't think the PPS will rocket, but I do think we could get a MC of $1~2 Billion. JMHO.
Yes, well, that should scare LP and LG to death.
How did you come up with February 11, 2020??
WHICH TOOK PLACE IN 2019. JEEEEEEZE.
The last ASM meeting took place on FEBRUARY 2, 2019. It was, therefore, by date, a 2019 ASM meeting.
So, no, I was not wrong in asserting this meeting was a 2019 meeting because it, in fact, occurred in 2019. It was a belated ASM meeting that should have taken place in 2018(ditto for the 2018 ASM dated meeting that should have occurred in 2017).
If I recall correctly the 2019 ASM took place in February. Why do you think it will take place in mid January?
Yes, I agree it is very important to have 4 RA buy ins. As DI seemed to indicate, it is possible that one or more RAs may not respond and that NWBO will have to decide whether to wait longer or just go with the SAP without their comments. So yes, the RAs are a pacing item.
WRT to TLD, my previous predictions were admittedly wrong about the pps. Hope that TLD announcement before the ASM moots my prediction.
Don't know what is keeping it at current levels but I think the ASM is a pivotal event. I strongly feel no TLD by/before then will hit the share price. Hope I am wrong in this prediction and it is rendered moot anyway by a TLD announcement. Stay tuned.
I believe that they will reveal TLD before the ASM in February, 2020. Not to reveal and repeat "ginormous", "stay tuned", "almost there", "finishing up", etc. just won't cut it. If the ASM comes and goes without TLD, the PPS will tank to new lows in the teens if not single digits. As, if and when TLD is unveiled and is hopefully positive, price appreciation is launched from a much lower base and may just recover to current levels or even somewhat above but almost certainly well below a dollar.
Further, NWBO may be concerned about warrant expiry in April, 2020. So I believe that almost certainly TLD will be revealed before then. With delay in TLD unveiling, there may be muted appreciation of PPS and while warrants may be in the money, it will most probably be disappointing. I believe NWBO management understands all this and while TLD most likely will not be announced this year, it will more probably be revealed before the ASM. I do think that full analysis of results will be presented at ASCO 2020. it sure is beginning to look like that.JMHO.
Looking at her compensation package, one can understand why NWBO selected her over a more experienced and seasoned CFO who would be multiples more expensive. She will do "nuts and bolts". LP has sophisticated and seasoned financial experience so it is a good fit/combo.
JR:
This post makes zero sense. Why would NWBO care what the SEC thinks if there is no commercialisation? That means no revenue and impending bankruptcy. Your constant implication is that NWBO is a scam and that management is lining their pockets as long as they can. If that were so, why hire anybody and pay anything out in the form of salaries, etc.? By not hiring anybody there is more to keep for these scammers and no outsider to blow the whistle. They have a perfect excuse for not hiring anybody if they were scammers: "Let's wait for results before we hire anybody. If results are great, we can hire anybody. For now, we are obviously cash strapped. Better to conserve scarce resources."
Rather, it seems to me that by hiring these people, they are pretty confident of results and with all the experts, data, etc. that they have, it is a good bet that they already know the likely outcome. Otherwise, why build up infrastructure now if it is a scam? Just does not make sense to me, especially hiring an outside CFO. If you are scamming and hiding something, why risk it?
C'mon, JR, give it a rest.
IMO, this is the right level hire. At this stage, NWBO does not need a highly seasoned, highly sophisticated CFO who, in any event, would be relatively difficult to attract and very expensive to boot. What NWBO needs is a "nuts and bolts" finance manager who can take care of all the administrative financial details and plug the gaps and delays which have heretofore plagued the company. This is also in keeping with the guidelines/compliance required by the SEC in settlement. LP and LG can now focus upon the higher level issues with support from a sufficiently qualified finance manager who can "grow" into the CFO position. CFO is just a title. Practically speaking, this new hire is a finance manager and, at this stage, precisely what NWBO needs.
NWBO just can't seem to win. Investors and naysayers alike have been clamouring for a finance/accounting individual and when NWBO finally makes the right move, harp about not "seasoned enough" or "lack of experience". Nonsense. This is the right hire and is extremely positive. Seems that NWBO must be pretty confident of results and that it will be an on-going concern. Just my two cents.
Marzan:
I have been saying that for a long, long time. Jumping 4x from $0.22 is $0.88. If they jack up the SP through well timed PRs, to say $0.30, you are in the $1.20 range and rather great for the Series B warrants expiring in April, 2020. The lack of transparency/silence has absolutely killed the stock and a low SP launching point would be extremely disappointing.
OTOH, if the results are impressive grand slam home runs, like for example, OS60 is 25%+, both original primary/secondary endpoints met, etc., it may make little difference where the launching SP is. In such a case, launch to over a dollar or two would be a good bet.
I think LP/LG understand all this much better than we MB denizens. They have a lot riding on this with all the shares they hold and potentially hold. No doubt they want to maximise value, even though they have pretty much de-risked. I think in this respect, their views are likely congruent with ours.
I am rather confident that results will be impressive, if not grand-slam homeruns. We could easily see a buck or more and upward from there. A lot of validation and much steeper slope for the naysayers who might still be there. Fingers crossed, but I think it is looking good. GLTU.
IMHO, no not necessarily. They still might make some additional tweaks. Who knows with NWBO?
Anyway, this may have been an iterative process with give and take during the SAP drafting process. RAs may have made comments/suggestions along the way. Note that they have orphan status. This allows for frequent communications at least with the FDA which is the more important RA for NWBO. They may have presented the final draft already and may not expect any further commentary. Accordingly, after a short "grace" period to allow any final comments from the RAs, which they likely do not expect, they move forward.
I think "soon" has greater meaning and timing is pretty much in NWBO's control. I don't know if TLD will issue in 2019, but I am rather confident that it will issue prior to the ASM. Any day now, does not appear to be far fetched. I get the feeling they are confident of results and did not see the need to update blinded data. Why do it if TLD is just around the corner? I would be more concerned if they did do an update as this could possibly signal further delay in TLD revelation.
I finally think all is looking pretty good. Hope for a nice Christmas present--especially for patients with this dreaded disease. JMHO.
Doc:
Curious. How do you deduce no RA comments from this?
Evaluate:
I stand corrected. I am wrong and you are right. I checked the 10-Q and it plainly states that approval is not required but that it is a good idea to seek regulatory guidance and comments on any new/modified SAP. If that is the case, NWBO is NOT handcuffed and TLD revelation is more in NWBO's control. Perhaps in the iterative process, comments were made and then incorporated along the way. That is how we did it with the FCC, another RA, when I was a regulatory attorney. Don't think the process differs much among these agencies. Then the "final" presentation was made on already agreed mods and final sign-off should not cause any significant delay. Accordingly, this is positive, I think that NWBO covered all the bases in a comprehensive SAP doc, and we should see top line, most probably in early 2020, before the ASM. I think that is a good bet. Certainly, well before warrant expiration.
Thank you for correcting me.
How does Iwasadiver KNOW that DI is working behind the scenes, the fruits of which will become apparent in the NEAR future? In the past, questioning LG, I was told the same thing about Cofer Black's role. Nothing, nada and nil. How about this "inside gem? Jerry Jasinowski, BOD member, stated at the ASM 2019 that in about 3~4 months from then news would be revealed such that the SP would accommodate better financing terms(and thus less dilution). Or did he mean ASM 2020?
The statement made by our good ER physician is stated as a declarative fact rather than opinion. But then, I surmise that his "facts" are just as good as LG's and JJ's.
I believe in the science and have done pretty extensive DD on it. That is why I remain invested. But continual apologia for certainly questionable actions by management, a perfect record for missed timeline guidance, etc. is wearing thin. I hope that the undeniable results are revealed before the ASM and certainly before the 4/20 warrant expirations. I am certainly sorry that I ever bought into the Series B, that is for sure. Could have done much better in the market. I am sure a lot of Series B investors will be similarly p****d if there is no TLD by then or the results are less than significant.
I hope I am wrong and the astuteness of hiring DI and Sue Keil will become remarkably apparent in the near future. So far, this astuteness is well-hidden with all the rest. JMHO.
Again, I disagree. And there is no contradiction. Indeed, LP/LG have proven experience in M&A, etc. and have been doing this for years. LP was a principal in Toucan. Fact: they have experience in this discipline.
However, the fact that they have experience therein and certainly arguably, more than Ms Keil, does not mean that LP/LG are ipso facto good managers or that every hire they make reflects good hiring judgement. Some individuals are good lawyers, others, good consultants, etc. but that by no means does this infer that they are enlightened operating business managers or that they have sufficient HR abilities wrt hiring appropriate personnel. So no, logically, there is no contradiction in what I am asserting as far as I can see.
I have spoken with DI a number of times and my impression of him differs measurably from yours. I don't find him particularly astute or knowledgeable. IMHO, I don't see that he has provided any extra dimension other than being essentially a mouth piece for LG. Has IR been measurably improved? Are we better off than we were before his hire with LG? I think not. LG was very responsive and I have had a long and generally amicable relationship with him. He tended to lecture rather than listen and when push came to shove, blamed most of NWBO troubles upon the nefarious shorts. But I place him way above DI who, frankly, I think to be a light weight from the back woods of Oppy. Not even a VP but a senior director somewhere in Richmond, Virginia. Certainly not someone who was in the higher management ranks of Oppy and a WS mover and shaker. As far as I can tell, I have seen no difference after his hire, just added cashflow outflow and stock dilution. Sure, you can argue that he is working behind the scenes and these "secret"activities will bear fruit---just wait and see. Just like Cofer Black. And how about the erstwhile Jerry Jasinowski, board member? At the ASM he trumpeted that in 3~4 months news would be coming out such that the SP would rise permitting better financing. And here we are, almost another year and approaching another ASM which may likely result in another stay tuned admonition.
And even more troubling is that Ms Keil appears to have been working for NWBO for at least 2 years according to a DI conversation with an iHub message board member. Is she just like Cofer Black? Just wait, big things are happening behind the scenes LOL. Have never seen her listed as one of the employees of NWBO before the recent notice. Hmmmmmmmm.
Look, I have not followed this company as long as you have and I am committed and have a large holding. I participated as an accredited investor in some of their offerings on which LG approached me. But puleeeeze, this constant defence of management is getting old and Polly-Anna-ish.
I have reserved final judgement on management but the DI/Keil hires don't give me much comfort. Dr. Duffy is another story and while far from perfect, NWBO managemnent can get some hires right. JMHO.
can't get it right inter-company hats
Sorry, intracompany hats
That was the problem with LP. And an issue with the SEC. You would think they would have learned something by now. wearing many intracompany hats has the potential for conflicting loyalties. No, if she is indeed a hire, she should be working full time for NWBO. Shareholders don't any longer want to pay for building up other organisations at their expense. JMHO
Sorry, I disagree. LG and LP have skads of experience. They do not need a minor league investment banker employee hire. I have no problem with hires so long as they are appropriate. I would have no issue with the hiring of a CFO with experience in M&A, etc. But an investment banker hire? Nah, don't think so. I have run small companies requiring outside funding, M&A, etc. and the last thing my BOD would agree to is hiring an investment banking employee and for that matter an IR guy like DI.
In any event, management is still blind. They don't know what the results are. They have let this trial go on and on for good reasons. There have been concerns with whether the primary/secondary endpoints have been met. They have come up with a telephone book sized SAP to hopefully cover all the bases but they don't know at this point. While I believe hiring any investment banker employee is inappropriate, especially given LP/LG experience and the greater need for a CFO, it is at the very least pre-mature at this juncture. The only smart hire thus far was Dr. Duffy. JMHO.
That will never happen. LG will NOT retire after TLD. You can take that to the bank. DI has no where near the experience and smarts that LG has. LP would not do without LG. They both are in it for the long haul and/or until BO. Compared to LG, DI is the peanut gallery. JMHO
She cannot do that. Conflict of interest and if LP sanctions this, theft of employee services---if she is, indeed, an employee.
No, Keil is un-necessary and a waste of valuable resources. Why hire an investment banker? Rather, engage an investment bank as, if and when needed. Les and Linda have loads of experience in M&A, JVs, partnerships, etc. LG, as GC, can easily vet any interest and valuation. LG has specifically told me that they have a valuation in mind. He did not say what it was but they sure don't need a Johnny come lately to tell them what they already know in spades.
At this stage in the game, the only valuation that the market at large is interested in is RESULTS PERIOD.
If the results are undeniable, trust me, there will be interest and derived value. Interested parties will be there. No need for a hired investment banker employee either now or in the future. This is just as useless and an abject waste of resources as was DI's hire. I have seen no value that he puts forth. He is a puppet whose strings are manipulated by LG.
I am not interested, at this point, in any blinded update. If we get it, it is a signal that we won't see TLD for some time. Such an update would only serve as a palliative. All that matters is TLD and undeniable results. I would hope that TLD is revealed before the ASM. I don't believe any investors would be happy to hear again "ginormous", "soon", "stay tuned", "we are nearly there", "just a bit more to tie up loose ends", etc. Then we are easily looking at ASCO 2020 at the earliest. It would also signal that there is a hold up by RAs in "approving" the SAP. LP made a statement, as I recall, of obtaining RA approval on the SAP. If that is so, then, contrary to DI statements in telecon conversations, the RAs must respond either with comments, rejection, or approval. Then, if as LP has indicated, "approval" of the SAP is required, for the jurisdictions applied for, then NWBO is handcuffed and cannot go forward with this SAP until "approved".
I cannot believe that NWBO has not been in an iterative process, especially with orphan status, with the RAs especially the FDA. They are working with regulatory consultants. If they have been involved in such an iterative process, approval/buy-in, cannot be very far off unless they have hit snags in this process which I personally believe is rather doubtful. Accordingly, I think they are in the home stretch waiting for final approvals which could come at any time.
IMHO, concerns loom IF we get an update on BLINDED results. No need for that if TLD is relatively near around the corner. And....if we don't get TLD before the ASM then I think the Series B warrants expiring in April are under serious threat. A rather ominous prospect. As they say, "stay tuned" JMHO.
Sorry, I don't buy it. Seems a very un-necessary hire and further cash flow/stock options bleeding which the company can ill afford. LG has been bumped up to General Counsel. He has done these kinds of deals throughout his career as has LP. If the results are that good, a relatively minor player is definitely not needed. IMHO, this is another un-necessary hire just like DI.
The only hire that gives me confidence is Dr. Duffy. DI and Sue Keil? Meh. JMHO.
Yes, but not daily fare by all means. Great to go to Izakaya/yakitori bars on side streets especially in more traditional places like Ningyocho near TCAT/Royal Palace Hotel. Great food/beer/sochu and people. Great to go pub crawling in these areas.
Let's hope unveiling comes sooner than later with impressive results!
CB is a board member, not an employee.
Standing invitation. Not only in Tokyo but also in Shizuoka. Sorry I cannot offer free Sake but I can offer free all Japan ingredients sourced native teas. For example, our best selling product, Benifuhki tea, which won the highest three star designation at the Great Taste International Food and Beverage competition in London, UK. Or our Oriental Citrus Green Tea, delicious iced, which similarly won a three star award designation. Or our 2-star awarded Tachibana Earl Grey tea. All at our factory show room and then a guide through our beautiful mountainous tea farms with a picnic lunch. We can bring some sake and blend with the teas and there you go! Just hope we can get unblinding within my lifetime. Not worried about results though. Keep the faith and let's celebrate in ole Edo. :)
Coming from a medical professional, your posts are logical and make ultimate sense. Like many investors, I am frustrated by the time it takes. But I believe very strongly in the science. I believe we have a long and thick tail. I don't know if this will be enough to overcome failures in the primary/secondary end points but even then, I would be confident of approval. I withhold judgement on management. I don't sit where they do and can only speculate and second guess. GLTU.
Regards,
U
My memory may be faulty, but I do seem to recall that the overall partial halt had its genesis in Germany and had nothing to do with a futile PFS finding. The partial halt was then extended everywhere else.
Further, if there were a futility finding by the DMC at the time, this would constitute material information which NWBO was bound to disclose. Anyway, another example of negative nellies and nattering nabobs spiro-lling down upon the MBs.
I believe you are correct and have been saying the same thing wrt "approval" , "acceptance" and so forth. It is up to the applicant, in the final analysis, to make the case.
"Are you italian"?---using the polite form. "I learned italian about 40 years ago but i have forgotten many words. Anyway, lots of salutations !"
I do not believe that the SAP need be "accepted" as you say or at least formally accepted by any RA. Of course, any RA is free to provide guidance but the final SAP submitted is up to the applicant. Secondly, this is an orphan designation and in such cases free intercourse between the applicant and FDA, at least, is highly encouraged between the parties. I am reasonably certain that NWBO has known for some time and planned to update the SAP in view of developments and concerns about the original endpoints which as it turns out are not entirely suitable for immunological trials, as well as the confoundment/crossover issues attending these endpoints. Accordingly, I am equally certain that during their interchanges with the FDA(and the other 3 RAs), the updating and modifications to the original SAP were discussed and guidance sought and given. And this interchange continued during the actual preparation of the modified SAP. Hence, it is not as though the RAs are seeing these modifications for the first time. I am reasonably sure that they have had a "heads up" for some time. It would have been foolish for NWBO to proceed with modifications in isolation which resulted in the size of a telephone book without relatively frequent back and forth with the affected agencies. Further, I do not believe that the RAs need to agree on the overall submission. Each RA, if they have given guidance, will be interested in seeing their own guidance suggestions incorporated in the SAP. They may have relatively little interest in the guidance given by other RAs, which in any event may be relatively similar and, in any event, would not be required or even suggest final agreement between and among these sui juris agencies. Thus, I think that most of the guidance such that may have been issued was already and largely incorporated in the SAP as the process went along and accordingly, any final review of the submission would be relatively fast paced.
I believe that the RAs are not a significant pacing item if my above analysis is reasonably accurate. In fact, I think that any delays have more to do with NWBO in completing and the submitting the final draft. It may be, even likely, that the SAP is still not finally completed or has been completed only recently. I also think that NWBO has always planned to delay unblinding until 4 years past final enrolments and that is why the secrecy and lack of transparency. JMHO.
FWIW, this is my take.
I do believe that whether or not the original primary and secondary end-points were achieved, these were subject to concern due to confoundment, crossover, etc. and were too close to call. I don't aver that they failed to be achieved, only that there was doubt. Secondly, milestone survival and especially at OS60 was emerging, if not then recognised, as the more important metric for trial success, especially the length, thickness and spectrum of the long tail. This was particularly important for NICE and strategically fulfilled DC VAX L's role as an adjuvant therapy. Surgery, chemo/radiation were employed to get over the short term hump and DC VAX L was to take care of improvements in longer term survival. Principal investigators clinically witnessed that the vaccine was assisting patients to live longer than they would without the vaccine and that it appeared to work to a greater or lesser degree across a broad spectrum of GBM cancers. This is where NWBO management, the SAB, principal investigators and authors of the JTM interim report believe that trial results will win approval, especially if results are irrefutable. Hence, I believe that management is leaving no stone unturned in making sure the results are irrefutable and approval from the initial 4 RAs reasonably certain.
TLD and how it is presented is of critical importance. it is here where the ball game is played. There cannot be any ambiguity in the long term survival metric and it must be shown to be irrefutable. I can understand the time they are taking to insure this as much as possible and utilising the success of L to significantly shorten approval times for other indications and confidence for off-label indications. In addition, irrefutable results will confer tremendous credibility upon Direct thus enhancing the value of the entire DC VAX platform. Successful TLD will then, undoubtedly, significantly raise the share price and continue to do so through approval and beyond. It will, undoubtedly, invite partnering and perhaps even BO offers although I believe the latter is pre-mature. Conservatively, after release of successful TLD, I believe the SP could rise and settle between $1 and $2, most probably 6 to 8 times multiple over current pps.
I reserve judgement on NWBO management's stewardship thus far. If they bring in impressive results, they achieved the goal. If not, management failed us in this critical moment. Like the captain of a 747, he/NWBO management earn their keep during critical moments of the journey. LP could be in the CEO hall of fame or hall of shame depending upon results. They have only one time to get it right. I am betting that they will and am giving them the benefit of the doubt. I don't sit where NWBO management sits and I don't have all the facts or professional assistance and experience they have. LP, LG, MB, KD, etc. are definitely not stupid people and I trust them much more than MB denizens and other non-professionals who do not even work in the field. It is my strong belief, not certainty, that the trial results will be impressively successful and released at least before the next ASM and more hopefully by the end of this year. I am reasonably optimistic. JMHO.
Indeed, you can never really tell what a reg agency will do. I have had a lot of experience in that realm but it is still a crap shoot.
Having said that, the SAP is not a BLA or an NDA. That is why I think the odds are that the RAs will not critically review it or spend much time on it. Why should they? It is a better use of their time to wait and see what data from the trial NWBO submits and how it has been analysed. It is then that they critically evaluate the data and methodology plus applying/weighting various criteria that they think important in reaching a decision. Will they be influenced by the SAP? To some extent, but it is hard to say how much. The FDA/RAs' position, I believe, is that the data, analyzation and presentation/explanation is up to NWBO to make their case. It is not up to the RAs. This is like a bench trial. The judge/jury are the RAs and NWBO is the applicant. The judge will not help them make the case. It is up to NWBO to do it. Hence, the judge won't wade into the weeds(including the SAP) until the trial starts, i.e., unblinded data and the accompanying SAP are submitted. Hence, I don't believe that the RAs' SAP reviews will take much time. They will likely say...."thanks and noted...unblind the trial and let's see what you got and make your case". I don't think it is any RAs' role to help an applicant make his case but rather to maintain neutrality and objectiveness in reaching a decision that is in the public interest. That is the constituency that the RA serves. JMHO.
The request does not come from the FDA. It is not their trial, it is NWBO's trial and it is up to them to make a decision on when to end the trial. NWBO is free to develop its own SAP and amend it. The FDA won't bless it or approve it. Likely they won't make any comments. Essentially, as I have said ad nauseum, the FDA will decide what data metrics are key for their determination. The FDA will likely tell NWBO...... "let's see what data you submit..." It is at that point that the FDA will start to decide what they will do. And for sure, the original metrics will be included in any final approval determination.
Candidly, I don't see waiting for FDA/RA "approval" of the SAP as a pacing item. The pacing item is whether or not they have completed the SAP and submitted it. The RAs are not going to "approve" it and I would think they would spend little time on it. The real evaluative process begins with unblinding and I think NWBO is pretty much on its own wrt the SAP until then. I think that the FDA/RAs are pretty much up to date on developments since the original SAP was developed and I think they will review what NWBO has put into the the SAP and all the voluminous data. This review will begin in earnest after unblinding and not before.
Accordingly, I just don't see dragging the announcement of top line past year end. November is 4 years after last enrolment. They have all the data they need. The FDA/RAs are not going to "approve" the SAP so there seems to be no reason to unduly delay unblinding. As LP has said, they do not need a conference to announce TLD, although it would be nice if there were a convergence. If the data is irrefutable, NWBO does not need a conference. The results will speak for themselves. The time for unblinding is nigh. ASCO 2020 is a very scary thought. JMHO.
I am hopeful that overall PFS is as well. But, overall PFS could fail to achieve the 4 month end point, however,it is possible that a sub-group like M+ and/or MES could do well. Or it could be demonstrated that although the PFS end-point was not met, the vaccine was able, in time, to dramatically slow progression thus contributing to enhanced OS. It does not necessarily follow that a thick OS tail, ipso facto, requires a fat PFS tail. But I am hoping for it. As I said in many previous posts, the ball game is played on the long tail. How long is it? How thick is it? What is its composition? Failure to achieve the original primary and secondary endpoints may not be a bad thing and, as I have suggested with a proper explanation, turn a seemingly bad thing into a good thing. I am reasonably confident that the tail will tell the tale. JMHO
GLTA.
Joey:
I am afraid no one has the real power except LP and her camp. Frankly, she does not care about shareholders as she has effective control and can do as she pleases. Retail shareholders banding together to demand unblinding before NWBO is ready is an exercise in futility. They will unblind when they feel like it, period. Unfortunately, retail has no power or leverage to do anything except sell if they don't like it. In any case, LP could care less. LP has larger shareholders in her pocket. No doubt they have access to more info than the regular shareholder. It is what it is. Bleating about unblinding and threatening to go to the regulators if they don't do so soon is a waste of time. The FDA does not hear you. Neither does LP.
You either believe in the science and the eventual success of DC VAX or you don't. At this point in the game, management is largely irrelevant. Management brought us all here, for better or worse. The only thing that matters is TLD, whenever it comes. If it is unambiguous and meets the endpoints, this will be clear in TLD. It will be short and sweet. If TLD comes with a telephone book of explanation, it is not so favourable, at least for the SP. Even though they have an SAP the size of a telephone book with various approaches, the original end points will not be thrown out. They will be considered with everything else. Hopefully, we won't get a TLD that shows the original endpoints failed to be achieved, but wow, look at the long tail. Depending upon the length, composition and thickness of the long tail. IF, for example, 25% of patients in the treatment arm survive for 5 years and the composition is, say, 50% MGMT methylated, 30% MES(due to immunogenicity) and the balance a smattering of other molecular sub-groups that is pretty much a home run regardless of the showing of the original end-points. Of course, it may well be that the primary PFS endpoint was not met. However, there may be a showing that the delta between PFS and OS significantly exceeds control(perhaps including historical) and that even though PFS failed to achieve the end point, DC VAX L was able to dramatically slow progression as its effects began to manifest themselves over time leading to enhanced OS. It will be interesting to see whether there is significant separation between the control/crossover arm and the Tx arm. Would lack of statistically significant separation between those arms signal a failure? Technically yes, but if the later vaccinated crossovers, survived longer than the non-crossover arm/historicals, then even late vaccination would have efficacy, even though a second resection did not take place with a more up to date lysate. Accordingly, success can be pulled out of seeming failure to meet the original endpoints with a wow long tail and simple explanations for why the original endpoints were not met and it was, essentially not a bad, but rather good outcome. It's all in the explanation and presentation which needs to be articulated succinctly and simply so that Joe Q public and Joe Q Wall Street can easily understand what the data really means and why it is so promising and susceptible to relatively expeditious approval by the FDA and other RAs. It is at this point that NWBO management earns its keep. The past no longer counts. It is the data and how management presents it. That is the ball game. If they blow it because it is ambiguous and not presented properly it is there where management failed us all. TLD and its' presentation is where it all comes down too. JMHO.
And there are protocols and procedures in place for many years that have been overtaken by new information and data overturning the older and out dated paradigms. Older and many years protocols may be right until they aren't.
Jeeze, give it up.
She may be traveling so fast that the universe is over and she never had a chance to cash in. Poetic justice, relatively speaking.