Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
If you are really serious, ask this question:
Dear Linda, when are you going to end (unblind) the trial; if not already, why? Do you have enough funding to further extend the trial without unreasonable dilution?
For God sake, please end the trial ASAP.
AVII, you said "Does anyone have a clue what Dan is trying to say here?"
My reply to yours in blue:
You know very well what I have said (provided at the end of post in quotation marks), the first two paragraphs reflect what you have said over the years that 1) the trial failed in mPFS or likely failed in mPFS or it is likely the trial is futile, and DMC might have recommended a halt for the trial due to that; and 2) recently you have asserted the blended mOS is 20 months and there is no separation between the early and late vaccined patients.
If the halt were indeed imposed for futility based on PFS, the reason had to be 1) mPFS for treatment arm were much worse than that of the control arm. If this were true, the only reason would be unexpected high immunization reaction from those patients who had received DCVax-L and acted like progressed (pseudo-progression in effect, remembered Dr. Busch’s famous statement that pseudoprogression wreaked havoc as he commented in a general sense but not necessarily specific to DCVax-L trial in a German conference). If mPFS for both treatment arm and control arm were similar, i.e., the same, or slightly worse or better than that of the other, it would be highly unlikely that DMC would recommend a halt due to futility. So having a futile PFS recommendation, if it were true, could only mean one thing: mPFS for the treatment arm were much worse than that of the control arm, and the reason for that could only be due to pseudoprogression of the treatment arm patients who wreaked havoc. So if this were true, it is highly unlikely that there would be no separation in the OS curves. Have you seen how you have contradicted your own views! Please see my other post which explains why this actually is a good thing here https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140053298
Anyhow, the so-called futile trial or it is unlikely that mPFS would meet its goal theory is just a theory. The evidence or support to that theory is nothing scientific but the only the collapsed share price. In the end, it would be at least equally likely that mPFS has met or surpassed its designed goal (four month separation), and this is in effect supported by everything we have known today but not the share price despite what one would say, believe or speculate. This is one more incentive for naysayers to make a share price which makes it impossible for anyone to believe that trial will be a success.
Finally, if you still don't understand what you have said is in effect 100% contradictory. I will use my one-post-a-day post next day to once again try to help you out.
Now, you can mark my word: As long as DCVax-L is proven safe to use (yes it has been proven), some efficacy of it if proven will get it approved by FDA, and there will be various ways to approve that efficacy according to Linda Liau and I strongly believe her. Plus patients treated by DCVax-L will have better QOL than anything you would have cheer for.
Below is what I have said which AVII has a hard time to understand according to his reply.
"You are contradicting what you also believe (assume) that mPFS failed [or likely failed] and that the now lifted halt for screening new patients was due to failed mPFS. [have you for year promoted this speculation?]
You can argue, as you usually do, that there is no contradiction between the two with the other being no separation in mOS between the early and late vaccined patients. [please just reread your own posts post today and yesterday to see whether you have said that. Of course I don't mean to say you have said that word by word]
Even DCVax-L acted exactly like saline water at the time of the halt still cannot explain it being due to failed PFS. Because if that were the case, the mPFS between the control and the treatment arms would be the same or similar, and as blended OS was trending up, no way anyone would impose a partial halt!
This is my only post so you have final say."
You are contradicting what you also believe (assume) that mPFS failed and that the now lifted halt for screening new patients was due to failed mPFS.
You can argue, as you usually do, that there is no contradiction between the two with the other being no separation in mOS between the early and late vaccined patients.
Even DCVax-L acted exactly like saline water at the time of the halt still cannot explain it being due to failed PFS. Because if that were the case, the mPFS between the control and the treatment arms would be the same or similar, and as blended OS was trending up, no way anyone would impose a partial halt!
This is my only post so you have final say.
Always remember the day when dndn’s confirmation trial (second p3) data released, and the share price collapsed in large volume although the data indicated it was a success.
Because the rigged market, one of my friends sold half of her shares, worthy of a million at heavy loss while other in the same building but different floor started a new position, worthy of six figures (since he could not control his emotion and he left office home staring at screen to watch the price movement).
What happened next is a history, and of course she got very angry and he an instant new multi-millionaires in a few hours.
One other friend even got divorced and since then lived alone until his death many years later: he was fully loaded before that fateful moment of FDA refusal to follow experts’ recommendation and asked for a confirmation trial. Unfortunately, he got margin call, and his account got liquidated and yet still owned million to brokerage. What happen next was very tragic to his family and life.
After divorced and paid back million to breakage with borrowed money, he restarted a significant position in dndn again with mostly borrowed money. Yes he finally won due to his strong conviction and steel will and his strong belief in his own DD, but the results were not really tasty in terms of health and family and the view toward the market.
So back to nwbo, the history indicates anything could happen when the market is rigged. The same or similar thing may not happen this time or may happen in a new form or shape. But we must prepare for it.
Linda must think harder and louder that it’s best interest for all stakeholders, and patients to unblind the trial and forget the publication of any blinded data!
Nothing of significance in the 10K, because it is in essence the same as all the previous 10K: revealing dire financial situation and some trouble with SEC.
In this 10K, the investigation of SEC into disclosure or anticipated publication of blinded data means nothing. Linda was and has been genuine all along the way, but as usual underestimate or overoptimistic of all things she has done. AF might have poked around investigators, Journal editors, SEC regarding this issue, due to the nature of it: unusual, almost unprecedented. The result may just be that LP has failed to pull the publication off as of today. That means she fails to use the publication as a bridge to extend the trial financially for many months more ahead, and SEC will find nothing wrong with it.
I expect some communication from the company today or in the near future before the vote; otherwise Linda should stop running this company, which means that a robot will be better running it!
Linda must release topline data ASAP!
Price action is purely the result of MM playing game as today may be the day for 10k release.
Those who expect an usually ugly 10k should have sold already, and the last minute thing has always related to manipulators.
If Linda is of a shrewd leader and intelligence, and knows how to fight a battle, she can really turn the usually ugly 10k into a new positive one (a light surprise will just do that), thus injecting a fresh hope to the market and the longs and an equally fresh dismay to those suspicious.
Faced with mountainous high obstacles with already deep suspiciousness of both longs and shorts, can Linda pulls it off this time?
I bought 17,000 shares more betting she will this time. If not, those shares will be put aside to the already high mountain of shares accumulated over the years.
To have a bit more loss, or a lot of more gain when topline data are revealed.
From a long’s (mine) perspective, one thing needs to be straightened since it comes up in the board often:
It is this famous quote, “turning good thing to bad.” In all honesty, most longs’ views are wrong. When one follows this company and its filing and news release consistently, he or she would realize that that quote was specifically in answering to FUD raised at that time regarding whether that 300 or so patients were only screened, recruited or actually enrolled in the trial. So its meaning is that yes the 300 plus patients were in effect enrolled in the trial, and it didn’t include patients from the independent pseudo arm, etc. If one recalls, that temporary halt for screening new patients has never been explained, but what was and has been certain is that it has nothing to do with safety.
The halt seemed to be revealed first in Germany, but it could be actually initiated in US (uncertainty). The halt in Germany (and/or UK, Canada) might be independent with that in US or they actually address the same issue (one more uncertainty).
Weighed on all information known today, it seems that halt in US was related to failed PFS, or very much failed PFS, which on surface is a very bad thing, but in essence may indicate strong efficacy, unexpected and undersigned for. In other words, the more the immunization reaction the patients have, the more the possibility of and serious the pseudo-progression, and the more effective the vaccine.
Now the hard fact might be that the “wolfpack” might uncover this secret, i.e., the failed PFS (it could be a recommendation from DMC to halt the trial due to PFS failure which is the primary endpoint), via either email hacking, or a defected or corrupted or unprofessional investigator, or any other means. All in all, since then the wolfpack and its associates have cast this into a mould in their mind: the trial is a failure with the best evidence being the continually declining and collapsed share price from teen to dimes (short it at will and it’s no brainer), despite in two rare occasions that the company has denied the collapsed share price had anything to do with material negative news that the company might have known or possessed at that times.
The state today which we have all known is that it seems that the company has since strived to achieve an OS result that would see unprecedented long survival patients with meaningful separations among various groups, with the most large and meaningful one being between the early and late vaccined patients.
And of course, this needs time and patience, more time and more patience, but we have seen our patience erode like a tree unrooted in a mudslide due to seemingly endless trial and equally endless dilution! It is thus the time to unblind the trial, or never.
[I should remind those who may reply but see no reaction from my end: I have only one post per day. Sorry for that.]
Find this google translation exceptionally well though I cannot verify since I don't speak German: [a side note though lots of translators have lost their jobs because of programs like google translator]
"STUDIES
Manufacture of immunotherapeutic DCVax®-L for brain cancer patients
In recent years, the Fraunhofer IZI has been the manufacturer of a clinical investigational product for test centers in Germany and the United Kingdom, the effectiveness of which is still being reviewed in the context of a phase III clinical trial.
The DCVax®-L immunotherapeutic agent was previously successfully used in smaller clinical trials by US biotechnology company Northwest Biotherapeutics Inc. in the United States. This advanced therapy medicinal product (ATMP) is based on autologous dendritic cells for the treatment of glioblastoma, a particularly aggressive form of brain cancer.
In order to manufacture DCVax®-L individually for each patient, both tumor tissue and a blood product were taken from the patient and then the cell-based therapeutic was produced in a complex, multi-step manufacturing process. The recruitment of the number of patients statistically necessary for the study was completed in 2015, thus successfully completing the manufacturing and testing activities at Fraunhofer IZI.
However, since the therapeutic is administered in multiple doses over a period of 3 years to the patients participating in the study, cryopreserved clinical trials samples were sent in 2017 to the participating clinical trial sites for patient application.
This process will continue in 2018 until the last scheduled dosage is shipped. Thereafter, evaluation of the clinical trial by sponsor Northwest Biotherapeutics Inc. is expected."
The interesting point is when will it be the last dose of the last patient in the trial administered?
On this eighth day of the fourth month of the 21st century, after a decade of trial, with the last patient randomized more than 29 months ago, and the majority of patients of about 95% patients randomized for almost 36 months, about 50% patients more than 48 months, and a big chunk of patients more than 60 months,
What is talking about is still a publication of blended, blinded data?
I do believe the company is honest in this publication fiasco, but thing has gone unexpected.
The almost yearly spring refreshes, the big day of 1 June 2018 looming large, the good doc's unintentional reveal of final analysis is still on going and the results have not yet been reported,
Yet, people in this board are still taking about that damned publication (according to dear leader Linda Powers), the damned shareholder vote for increasing share counts, the order of how things or news should come from the perspective of great military tactics...
I am expecting topline data because that's only reasonable and normal thing to do. Unless, data may be not a homerun, let alone additional home run, so that dear Linda Powers wants to continue her great game of kicking the can down the road again, dangling a carrot with a different color in the not far distance of Nov 2018, where the last patient will be randomized for whole three years.
Or some kinds of combo trial will finally come to earth, talking about the start day, etc.
Those two would be a danger sign to me.
From my book, the best solution to both the humanity and our share price is to release topline data before 1 June 2018.
That would be a sensible and right thing to do Linda!
[As a side, I would suspect a big chunk of that 12 million or so finance had gone to Cognate, with a big chunk been returned to Linda's control via that so-called management buyout, which we may be able to see from the now outstanding annual report. If that is true, it puts one more reason why she is hated]
Highwayman, I totally agree with you.
As long term investors, voting no seems more sensible than otherwise, because it seems to be the only way that can press Linda Powers to unblind/reveal the trial results.
I have seen much worse situations than us such as a company which declared bankruptcy with a p3 trial still going, but later saw its "penniless" stock rise into teens while the company was still in the process of BK procedure.
Assuming nwbo were BK today, in six months the trial is shown to be positive and FDA approvable. In the court of law, we can recoup out loss and make some profit all depending on the market valuation at that time.
But, to be sure we are not going to go BK by voting no. My point is if you hold your shares, even if bk, it all depends on trial results.
PS: lots of noise regarding privatization fear. Let me tell you, nobody can take the company, not Linda Powers or any other majority shareholder or group can take the company private and ignore our right, i.e., the minority right.
Again in the court of law, if you hold your shares, it all depends on the valuation of the company. Assume the company were privatized today, as long as you refuse to sell your shares or not agree to accept whatever the offer is given, you will be rewarded with due price if the trial is proven positive later.
We have to force Linda Powers to behave even once like a public traded company CEO.
So no fear, and please vote no.
[A side note, I have continually added shares. I bought 5k a couple of days ago, and still have a large order in place as of today, which is a pennut compared to what I have already had; I have lost more than six figure worth of options alone]
Thanks to AVII, Flip for replying to my post.
1) I think the most significant development suggested is that we may be able to see the final trial results before or around 1 June or ASCO, which has not drawn due attention;
2) The promised publication may still be published in coming days, but if 1) is correct, the publication is basically useless. Accordingly, I think the company is now preparing for two routes: publication + final trial results with the interval from a couple of months to more than six month up to Nov 2018, or no publication straight to release of preliminary final results.
3) It seems, if Dr. Marnix Bosch's talk in last ASCO and Dr. Cobbs recent YT talk are true in essence, then we should believe that DCVax-L indeed has treatment benefits more or less to the patient population defined by protocols. Hopefully the effects are clear cut, but it may be somewhat "disputable." That may be the battle ground in the future in terms of FDA approval, and how high the price will go, etc. Nonetheless, if all the above are true, the eventual approval should not be a problem considering its pristine safety profile;
4) I like the quietness of LP, LL, and the gang, but don't like what LP has been done in terms of financing terms, particularly her recent loan term which injected no confidence from her;
5) One thing which I think is a negative is that the company has never talked about anything about that pseudo-progression arm, which I think it may not what is expected.
All in all, DCVax-L is likely to be approved but the road may be not as straight as most have expected; Despite DCVax-L eventual success, Linda Powers has been one of the worse CEOs ever.
Hi AVII, Flip, etc, what are your takes on Dr. Charles Cobbs YT presentation below staring from about 23 min: [please try to be objective by excluding any bias and previous thought,etc as much as possible]
At this point of time as the trial data has matured, never say to me it is not because it will never be, dear leader Linda Power has no excuses whatever to not open up, communicate and be honest:
1) The reason for the temporary half of new patient screening;
2) When do the company plan to end the trial, and have the results published;
3) What have done or what are in the plan in seeking regulatory approvals in US, UK, Germany and Canada, etc;
4) What is the state of company's finance? How many money is still required to get us to the release of trail data?
5) you name it.
I don't know the reason why she can not say something about the above, Oh, yes the yet to be published paper, the embargo, the [you fill the blanks]; coming up with an excuse is easy, particularly for a lawyer like Linda, and Les.
We need truth!
Chinatown1980, Linda Powers is a negative all along the way of DCVax platform development which everyone can confirm looking at the history of nwbo, particularly Linda's money handling. Nonetheless, you ought to understand DCVax-L does have a decent chance to be successful.
As long as that chance has yet to be revealed, which should be coming within the next few months, share price will go noway but up; since Linda has "awarded" herself with such overly generous deal. That fact alone will limit the upsurge to a slow steady one.
If the publication finally comes out confirming that very decent chance of success; then market will response in a predictable way: surging price in a step up way. Linda's bad behaviors can be temporarily forgotten.
After that, if some decent wall street funds are onboard for long-term gain, then it is a decent chance she will be forgotten for what she has done torturing this company and particularly her investors, and instead will be remembered for her greatest achievement.
There will be endless publications about her stories in different colors and angles, all heroic and victorious.
But for one, I will never forget what kind of a selfish, short-sighted, greedy, arrogant person she has been as a CEO of a publicly traded company!
This is exactly why she has revealed to be such as distasteful person/CEO of our company.
Compare what she has got, an overly generous financing at about 40% below market price, 10% interest, and free warranties with that of Neil Woordford's: Above market price, no string attached: no warrants, no interests.
Woodford showed his belief in the odds of successful DCVax-L and believed the market had underappreciated the company;
What our dear CEO Linda Powers has done shows her lack of confidence, or just outright selfishness.
She is so disgusting that I can only buy shares as my nose is covered. Unfortunately, I have to endure her bad behaviors in months or even years ahead as I cannot see she being replaced.
My correction in [ ]. Your statements in " " as a whole:
"You should have said "that is no longer correct".
The 2 just reported transactions took place a few days ago, after my post.
For those who misread the form:
Deal A)
. LP loans NWBO $4M at 10%. [yes]
. She has the option to convert the loan to 17.4M (via prefB conversion at 10x) + 8.7 M warrants. [yes]
. She gets as gravy another 8.7M warants [no, you already counted above, because the warrant gets 1/2 the number of shares]
If she can keep the ship afloat that would be a nice deal. Even if stock collapses she still gets paid back at 10% interest.
Deal B)
Somebody (Cognate or somebody in the deal?) owed LP $5M and used 29M Pref A + 29M D2 to pay it off. So the private transaction was done at an effectuive price not much over $.10/share"
[It is Cognate pref A + warrants that were transferred to Linda Powers following Management buyout as part of the deal; the deal worth 0.17 per share, and the warrant gets the same number of shares.
The above two transactions alone if all become common would give Linda Power around 80-90 million of shares.
The bad news is how price had ended at that bottom price around $0.14 ~ 0.17 where in the end Linda got most of her shares plus warrants. She is not trustworthy IMO.
The good news is she (nwbo) first paid Cognate for service, then Cognate paid her (toucan/her personal account), and then she loaned the company from her personal account.]
Lock data, unblind data, do a preliminary but decisive analysis, and then report to the public while continually monitoring data, do detail analysis!
The DCVax-L trial is already beyond unprecedent in terms of length and data richness.
Obviously, if no data available at this year's ASCO, you are more than suspicious Ms Linda.
No more tricks, share dilutions, excuses! You have already made your money back with fatty profit. It's time to do your job on behalf of all shareholders.
BTW, I am talking about nwbo so obviously it is on TOPIC!
I have promoted to vote No for authorization to increase share counts and I have firmed my position after yesterday's disgusting no-end dilutive financing with deep discount to market price, though in a tiny dilution.
By saying that I have drawn the ire of of many posters in this board, which I strongly disagreed. By cheering any actions Linda has done, particularly her repeated failures in securing non-dilute funds with the results of unprecedented huge dilution to all investors except herself who has miraculously emerged as the control stakeholder again while all other investors have experienced unimaginable dilution.
Linda job well done for yourself and a few of her associates!
We must not encourage her irresponsible action and must vote no, which after yesterday's disposition financing may come any day for a vote as she must think she has secured enough votes.
I believe there are always ways, non-dilute ways of financing with a promising treatment on the cusp of final results with huge market implication;
Unfortunately, she has failed, simply unwilling to take her due risks.
It's no doubt at this point that she has enriched herself, only herself:
1) She is the largest stakeholder of nwbo;
2) She gets paid from so-called management buyout from Cognate in an undisclosed amount and/or derivatives ;
3) She may have had her money back from early investment and more.
4) She will be the biggest beneficiary if DCVax-L trial is successful, which I have no problem.
At the same time, we have continually suffered in many fronts in various magnitudes of which most are avoidable and repetitive!
If Linda ever issues a cent of more dilution, I would like to ask the whole management and board members of nwbo to forego their monthly salaries, cancel all unnecessary activities such as conference, exhibition, sponsorship, etc., and focus on making the publication a reality and bringing the trial to un-blinding ASAP.
If the trial is successful, you will have your salaries back plus interests.
If the company is still short of fund to achieve 1) the publication; and 2) unblinding the trial, then it shall re-mortgage UK facility, or any other way of the nature of non dilution.
BTW, who is or are yesterday's financiers?
Re: Internal investigation(s):
the company has made strident progresses in this front: 1) it has seen Cognate forgive lots of nwbo's debt to it over the last couple of years; 2) finally Cognate bought out management meaning Linda and Toucan now has nothing to do with Cognate legally with Cognate still serving as DCVax-L manufacturer for nwbo (now based on contract), so there will be no longer any "double dealing" in the future, and it has also laid down solid foundation for a possible clear buyout of nwbo in future.
So it seems the part of the internal investigation concerned with good governance is completed and results have been released in an implicit way (see above).
As long as the part of what Mr. Cofer Black is hired to do seems to be in progress. It won't make any sense to take public actions at this point to go after wolfpack. Actions will be taken after the success of DCVax-L program.
The market reaction may be muted because of no details having been known about the so-called management buyout, etc.
IMHO, anyone is still talking about mPFS and mOS at this time is either an accidental or intentional FUDster, for 1) this topic has been exhausted, and 2) such time has long passed.
Instead we should look this way: whether the mPFS and/or mOS by the initial design is/are met or not shall serves as only a bonus. If yes, bravo to the company, patients and investors; if not, bears or those "enthusiasts" who have never had a position, I say you win in this debate in this specific issue, but DCVAX-L still has other way to win thanks to Linda's stubbornness or her out-of-touch approach or her unyielding will to not comfort to shorts demands to un-blind trial.
So what is the most important or sole important thing at this point of time is that we are looking at whether there is a long tail. If yes, how long and how fat it will be. This is and should be the only thing that matters now in terms of the chance of DCVax-L being approved by FDA, etc. (plus that bonus if it turns out be the way we expected--two strokes of luck!)
Focus on the following (others may just be FUD IMHO):
Blended Controlled Treatment(Early+Late) Treatment (Late only)
n n n n
1y
2y
3y
4y
5y
Repeat the same statistics based on sub-types and/or in reference with various historical data for all data.
If there is a substantial reduction of deaths between groups such as 25~ 65% or more reduction between control and treatment, or between early and late (vaccine receiving) treatment group, DCVax-L will get approved.
One more new ole ole ole evidence Linda [no] Powers has liberated short hedges. These scumbag hedges are all in golden positions to reap profit if success and laugh from a bank hole if no success. All thanks to brilliant Linda [no] Powers leadership.
She has only a way to clear her up: come out with a successful DCVax-L trial and indeed go big or go home before June.
Otherwise damn you!
Man you have told your unpleasant personal experience multiple times, which may have led to your grudge and stiffness of a view where it applies.
The same situation you claimed you had been gone through was an uncomfortable one which I fully understand if true, while others who have also gone through the same treatment may not agree with you because that (only) treatment may have saved their lives.
When patients have run out all the treatments, anything that gives hope is something deserve to try, but there is always a price to pay, even an FDA proved drug may kill someone. So one ought to take thing in perspective.
You can cite all you want and how much you want to from FDA or any source relevant to prove what you want to say, as long as approval or not of a candidate drug/treatment by FDA, the rule of thumb or the principle for the decision has been always and will always be the ratio of benefit/risk.
If DCVax-L can be proved to have some benefit and almost no risk except low fever, etc., I bet it will be approved. I can tell you almost all documents of FDA, developed or under the development are pivoted around this principle regardless of the forms, shapes or lengths of the documents !
So don't fool yourself while thinking you can fool someone else too. But unfortunately it seems you do have some success to drag a lot of posters, including those seemingly "sophisticated ones" into these FUD-effect discussions in this investment (note not an patient advocate) board.
Pity those who have engaged in such discussions with you over the years, knowing who you are, including myself in this post or maybe that post before. Many investors have all come to know this, but always readily forget when they reading a long FUD post like yours. It has been and no sign to see it will change anytime in the near future that
SOME BENEFIT DIVIDED BY LITTLE OR NO RISK = SUBSTANTIAL IMPROVEMENT, particularly in the treatment of GBM.
FDA cannot deny its own golden rule!
[so what that means: as some benefit is in essence average (median) benefit, so that some patients may experience no improvement at all or even deteriorating, but more patients may experience substantial improvement or even cure, and the rest just a bit improvement in a sense that its overall benefit will be greater than risk. Most importantly, the majority of patients will experience an improved quality of life. For terminally ill patients, this is very important. At least in my view, a quality of life is better than a couple or a few months of life improvement, although for political correctness or commercial reason, we have not been at that yet.]
In a blood river of still drunken stock market, a tip of certainty on the DCVax-L trial, either from the anticipated publication or FDA or any source from anywhere would be a fire on shorts which will be remembered in the history.
Too much cash will have survive the bloody market with trimmed profits, and will find a way to pile on.
Just a bit of sure thing next week. It will fry shorts like never before.
It's never a question of not parking your cash in a newly successful biotech company when a bloody market is unfolding.
Have a good weekend.
I have a hunch while we all are waiting for the disclosure of interim blinded data, FDA may come before the publication in a surprise move to all: to grant DCVax-L AA.
I have no reason to believe the company has not submitted a copy or an application for AA based on probably the same stuff: the interim blinded/blended data, if not more, and of course FDA has more extensive data.
I believe both directions are active, and they are not hindering with each other, but complimentary.
1) Your observed "I disagree. It is highly unusual for so many authors to be on a publication. It is also unusual to include all of the participating doctors as authors. Typically only the authors that substantially contributed to the writing of the publication and to the actual R&D of the drug are included...simply administering the vaccine to patients would not normally merit inclusion as an author on a peer-reviewed publication. I suspect that there is a reason so many researchers want to be on this publication."
It strongly suggests the reason for the halt is FDA-related which was induced by discord of maybe one or two doc in the trial, who were probably phoned into a sedated conversation by AF or the kind. There might also be financial incentives involved (for more see my previous posts);
The fact if the publication is published with 65 authors will be in and by itself very significant. Not only will it mean that the trial as it is is backed by almost all doc investigators involved in the trial, so the discord over potentially various issues is over, which is also evidenced by the lifting of the halt by FDA in last Feb, but it will also mean the contents (blended, blinded data) are significant, maybe unprecedentedly significant.
2) the naysayers can say anything and post as many posts in as many message boards as any one can find, the motives behind are nothing but
a) As it has been observed and strongly suspected, there are tenacious persistent force which wants to drive the company to bankruptcy or at least into a very difficult financial thus bargaining situation. This force is most powerful and relentless, probably backed by big pharms;
b) Some individuals seeking to get in the stock at a price as low as possible who thinks by bad mouthing the stock they can just achieve that when a definite sign of success is revealed (kind of conservative investing). When the time comes, they want to get in the stock in stealth while continually badmonthing or discount the significant news as long as they have not got enough. These are some savvy retail investors who have been burned badly in their previous experience investing in small biotech;
C) Anyone in between a) and b) willingly and unwillingly.
By now, we should be clear who are in these categories, and the best approach seems to make them dry, not reply to any of their posts.
Nonetheless, be prepare financially,mentally and technically, when the publication comes out, all these naysayers will make any effort possible to discount its significance regardless. But with overwhelming detail data though blinded/blended, a mountain will be moved!
1) Anyone who is still talking about speculated interim analysis futility halt recommendation today is just wasting his/her and others' time in this board as we have long passed that time point, and are looking forward to the disclose of how fat and long the the tail will be. Any long who has given anyone without shares but has repeatedly raised the old useless point like one above is pure [word omitted]!
2) Anyone who has disputed over where is the start of that 6 ~ 9 or so time frame for a publication per Linda Powers is also wasting time. The fact that Linda has canceled for three times of pre-scheduled appearances says it all. The publication will be significant, or as a material news and it will be seen anytime.
In a side note, anything from 2 to 12 months or so would be normal for someone to submit a manuscript to its actual publication, which is common sense and experience for anyone who have published some papers in first tier journals.
However, if a manuscript is of very significant content, novel in nature, that publication may be featured publication, and its publication will be fast tracked. I have seen some published in two months of time in whole, including submission, returned for revise from reviewers, and re-submission/publishing.
Unlikely though the theory has been around for a long long time as those without shares by their own words were eagerly pointing this out as a possibility, and after some time "a fact", and happy to repeat at any moment they have had, contradicting an apparent flaw: if an interim analysis, if it were conducted at all, showed no effect in terms of PFS for whatever the reason, and the DMC thought it would be futile to complete the trial, it might recommend the company stop the trial. While the FDA might be notified, it was non of the business of FDA if the company wanted to continue the trial since patients would not be harmed and they were continually receiving the standard of care; FDA has even had no business to impose a partial hold for the company to screen any new patients;
On the other hand, if the vaccine seemed to speed up PFS events due to reasons known or unknown, such as pseudo progressions, only logic is for the FDA to order the company to stop the trial because patients in the trial were harmed. That meant the company had had to stop administrate any vaccines to any patients pending on the company to conduct investigation which could show that reason was false. Then, the FDA might allow the company to continue to administrate vaccines. It was in essence a safety problem. In such case, the trial had to be stopped while investigation initiated aiming to approve otherwise.
We know that was not the case,
In addition, it would put the company in a position of intentionally lied when it had said twice that it had not been aware of any company-wide news or events that could explain the sudden drop of share price in a significant magnitude.
Adding on top of that is Neil Woodford November 2015 multi-ten million dollar financing deal with the company at $5.5 per share, and his now famous words "nothing untoward" in regards to company's situation at that time.
So I don't believe PFS theory at interim has any truth. Instead, I kind of believe that one or two AF like minded investigators in the trial might report to FDA about some presumably irregularities of the trial, such as record keeping, manufacturing changes thus agent changes, suspicious screening criteria for earlier and later patients, etc., considering the trial had been up and down in a period of more than 10 years. The investigator(s) might be recruited by AF or the kind, or they might be just rebellion for unknown reason.
Anyhow, FDA for whatever the reason believed it was for the best interests of patients and the cause to impose a partial halt so that the company could not recruit any more new patients, so that the company might consider to start a new trial from scratch. But the company thought otherwise, and had always believe it had the winning hand: it can at end show FDA how patients treated with DCVax-L live longer, much longer than placebo patients even they later all crossed to being treated with DCVax-L, let alone the norm, including Novocure's (NVCR) Optune therapy device.
After a long back and forth between FDA and company, FDA lifted the halt last Feb, suggesting the dispute or discord has been fully resolved since then.
So I do feel the awkward position for the company in regards to whether such information (the reason for the halt) shall be released or not.
For the integrity of the trial, the company decided it better not disclose the reason until the trial integrity concern becomes no concern. That I would think is when final data are announced, or the company can choose never disclose it, and it is perfectly fine and legal.
BTW, my current sentiment for the stock is strong buy.
[this is my one post a day restriction imposed by IHUB admin and my lack of enthusiasm of posting more]
Now that first step validation is needed: the long-having-talked, already having-tired of waiting publication!
For the sake of three canceled conferences now, Linda should have a better timing on things for God sake.
I have published papers in almost all top journals in my previous field of study. Never ever have I failed to predict when or around when in a month of margin of error my next paper will be seen in public.
Of course mines are not as the big caliber of a paper as the one we anticipate, let alone in completely different field.
She must rebuild her credibility step by step!
I guess most people have figured out now that Linda is a huge liability in terms of stagnated share price because Wall Street just doesn't have the time and wits to really figure it out otherwise.
So market is innate to even her most daring, honest, beautiful words. I call it Linda syndrome.
It however has presented a stunning opportunity for mass retail investors.
People should have figured out now that a safe treatment, like DCVax-L in a pivotal Phase 3 trial, is already at 50% success by itself with another 50% hinging on proving only a slight efficacy or significantly improved quality of life! So for what we all have known, it is a home run indeed, with or without a word like "additional"!
When the news come out, not from Linda's mouth, but from hard tested trial with results peer reviewed, the flood gate will happily open.
As far as she is not going to dilute heavily again, I am willing to give her all means at her disposal for six months.
Rewarding to shareholder, particularly long-term shareholders will be only half of the story, with the other half to be a just, harsh revenge to those who are behind the naked shorting, etc.
Share price shall be in steady climb now as most don't expect any thing we have not heard from ASM from today's and tomorrow's conference sessions, and as those watching price move on a daily basis for trading purpose have adjusted their positions, ie, sold. (all serve as a floor)
[No, share price moving up is not due to anticipating of LP's presentation, it is because: see above]
It seems the price has been mostly suppressed by no significant demand as versus naked shorting, though the majority of those naked shorted shares have been done and yet to cover, hiding; any institution naked shorting at this time at this price is nothing but suicidal.
I do like a bit of secrecy at this time in terms of what cards Linda has been holding, particularly regarding final data lock, and various regulatory passages, etc.
If she doesn't resort to any mass share dilution, as many have pointed out there are a few options in her disposal which can avoid just that, she has my trust at the time being.
I am willing to bet more on her based on new development (from ASM).
Now I seem to understand more of why the company has been so bizarre and out of norms for so long; it appears that the company not only has a horrendous naked shorting wolfpack to deal with but a foe so formidable, which might be its regulatory body FDA, that explains some of the reason for the partial halt: FDA might for what reason suggested to the company to start a new trial due to the length of the trial and maybe some changes in trial protocol, which also involved manufacturing change (optimization), etc.
The good thing is the halt was lifted, meaning FDA finally went the company's way with a weary eye fixed on the company.
The company, still in shock, wants to have a sure hand in dealing with FDA in terms of finally asking for its approval: the company wants to show as good as possible results to FDA, or the company kinds of waits for FDA to correct its previous wrong in dealing with the company by suggesting to the company: the data is better enough, stop the trial!
So aware of any possible regulatory passage ways, old and new, the company chooses silence because it for itself really doesn't know which way is the more plausible way based on its previous unpleasant experience with FDA. So keeping quiet in this front is the best way forward.
To conclude, today's buyout news shall serve as a mirror to that will be potential price of nwbo, considering nwbo is much much more broad and applicable in treating all solid cancers.
Celgene to acquire Juno Therapeutics for $9 billion, or $87 a share
Sanofi to acquire Bioverativ for $11.6 billion
If we have the same offer, our price shall be in the range of $12 _ 20.
My takeaway purely from reading rogers (thank you rogers for taking the time) posts regarding ASM is:
1) Linda suggested targeted OS event s were reached but the trial will continue as that event number is minimal or a floor but not the trigger for data lock. In this sense, she or the company has been consistent as their previous use of the “minimal” preceding the targeted OS event number. So no contradictory here, which I buy it. Keyword: the trial is continuing and will be until it is enough judged by Linda or based on certain conditions unknown at this time;
2) Manuscript was submitted in last fall. Based on the strictness of not hinting any more detail, the writing must be of substantial significance. Dependent on unknown situations, it will be published any day after today. Because there was no vote on share increase in this ASM, it becomes more likely that the company is indeed waiting for the publication before that vote;
3) Black realized how badly the company has been attacked, and is still collecting data, weighing on the next step. If I were him, I would launch actions if any after at least the publication of blinded data, or mostly preferably after unblinded data are made public.
4) All the above suggest Linda will not say anything substantial in the coming conference, but I hope I am totally wrong.
BTW, please don't launch any new trial before final data are known because we don't like one more substantial dilution!!!
BTW2: if I may guess a price move next week, I would say there will be a floor at 0.23, of course not a trigger for capitulation or upside breaking out either. Or It may surprise anybody by resuming the steady climbing after a short time hiccup depending on if there are significant demands for shares by institutions. As long as there are substantial institutional interests, share price will only climb.
Before getting jump the gun or jump out of window, Linda ought to and must show something, not her self dealing with huge options locked to her and her friend Les' coffers, not any dilutions, not any the same ol the same ol, even not the start of phase II trial -- cause we don't have money so we are not ready.
Please show us something of not the ol, the ol, even something you have long promised but badly over due.
It's a puzzle so many investors support you like in a cult for you have laid down everyone of them? So you are free for self dealing?
So show us something, not a shred of self enrichment, but something we can take a new breath!
Although there get be some setback in share price temporarily, it shall be unstoppable for it to march towards $1 before something of substantiate coming in the public eye, but we don't want the appreciation disappear in the same way as your promise never came into effect.
You have been given so many chances, but this time may be the only one we can afford.
So please show us something substantial!
The best thing to happen if it will happen is
To merge Northwest Bio with Cognate without issuing a single more share! And it shall happen before not after positive data if any are released.
That and only that will Linda's interests be aligned with ours! Other than that there will always be a time bomb waiting for explosion with our supposed debt owned to Cognate plus the fact Cognate is the single largest shareholder of our company with numerous known and unknown tricks in Linda's dispose.
Merge Northwest Bio with Cognate without issuing a single more share!
That and only that will it be possible for us to see the true market value of DCVax Platform!!
By conscience, I will not vote as a protest to Linda's grabbing of the control of the company in trampling the vast numbers of retail investors at any cost (well actually she has inflicted the maximal harm to us retail investors by many ways, huge dilution is one).
Never ever thought she could not or shall not say anything to promote the company, though excuses are abundant, such as lawsuits, naked short evilness, secret communications with FDA, etc.;
Never ever thought the price would be so low in the range of teens and twenty for so long a period if not for Linda who had willingly waived her fiduciary duty, and later regained the control of the company as the largest shareholder again (by practically the owner of Cognate);
Linda and Les have run the company as a cat plays with a mouse, cruel and yet self beneficial, like a bandit holding a treasure, unfortunately.
The share price has been steady in appreciation and will continue this trend, not because we have a great leader who has done her duty, but she has forced us all to experience possibly the worst possible situation, starvation despite we are the owner of that treasure.
She must forget all the "debt" our company has owned to Cognate, and she has stolen from us so much that the Cognate has become the new owner of our company, how convenient, ridiculous, sarcastic!
This recent "forced" yes vote by issuing the series A and B at such ridiculously low price, at such a ridiculously huge amount of shares is in essence a coup. She succeeded but shall be no more.
If DCVax-L is as good as we all have expected, can she be trusted?
The only thing she can gain my trust is to completely forget the so-called debt to Cognate. Cognate is already our "god," our "master," if DCVax-L is a huge success, what will we be at mercy of Cognate?
The only solution thus to me is to merge our company and Cognate ASAP without increasing a single more share (ie, without any dilution), and with the cancellation of all the debt of our company to Cognate.
Anything short of that she will always be suspicious.
Thus, the solution is to immediately merge Northwest Bio with Cognate without issuing a single more share!
That would be the only way she and us are aligned and we can all be rewarded with a right price if DCVax platform is proved to be a success!
you have summarized it very well:
"It is possible that NWBO is pioneering this blended 'everyone is living longer' endpoint as a novel surrogate for IO trails and that is what the publication is about...that would actually be very cool and big impact." Even if it is actually not a surrogate but for a full approval.
The fact that all the hypes have been on Cart-t in recent years are because it behaves like an traditional chemo drug working for only a very small portion of patients, and if work, it shrinks tumors, and that's what is desired in today's society, people, etc. -- all impatient -- nurtured by fast food revolution.
So if proved successful, DCVax platform will be like the tortoise in The Tortoise and the Hare Story who comes up behind and win the day.
We are witnessing a real and truly paradigm shift in cancer treatment!
Thanks TC. I would venture to say the recent so-called long institutions who bought that $12 million financing certainly include Chardan. So the withdraw.
If I were Linda or Les, that would something I would do. I like the steady small increase of share price these recent days which exclude those sour grapes who want to get back in again but not because of uncertainty, no guts and most importantly their greediness.
Continuing this trend, maybe we can trap as many naked shorts as practically possible, though the total naked number may not be meaningfully high enough unfortunately due to generous Linda Powers in multiple previous financing (before the $12 million one).
But, I would hope the best situation would be news, a significant positive news from the trial announced at a time most would not expect.
That I can call it a dream based on anything the company has done so far, but one never knows.
Linda is not a super lady as some thought. Instead she is shorter, bigger in relative sense, and incompetent. She is good at crisis management for her own again.
Despite that the stock at the present price, and in in fact any price of less than $3 is a STRONG BUY!
Simply because its huge upside potential of several billion at any sign of L's approval, then tens of billion considering the platform potential.
The market price is not only based on econ 101 assessment, the penetration ratio of a supposed market total, etc., but the whole pile of the potential market. This is particularly true for big pharms whose existence is most of times not to share the pie but to own the pie, plus the market tends to act exaggeratedly, particularly for small biotech. And have I forget naked short?
All come to a huge upside potential of $10 ~ 20
I don't know why so many people argued with you regarding nwbo's potential market cap. I think you are confused.
You said "The global glioblastoma multiforme (GBM) market size to reach USD 1.15 billion by 2024:
Think this way, what would be the market size ten years ago, twenty years ago predicted by the same expert 11 years ago, and 21 years ago:
It might be some very insignificant numbers, and if those numbers were to be predicted 50 years ago, then they might be just a few million or even zero.
You seem to be a very sharp person but sometimes seem to be very stubborn.
The best prediction as many have pointed out is to look at similar companies, like juno, kite, blue or even Optune, or simply to pick up economy 101 to evaluate the potential treatment patient numbers worldwide, the costs of treatment per person, profit margin, etc.
Even that stupid Optune device with miserable patent penetration, had reached a MC of around 3 billion for some times. Man, you are out of date.
[I may ask admin to give my more posts a day, but I am refrain.]
Less dilution than I thought which is gooood
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=12462747
Item 1.01 Entry into a Material Definitive Agreement.
The discussion in Item 3.02 of this Current Report on Form 8-K is hereby incorporated by reference in this Item 1.01.
Item 3.02 Unregistered Sales of Equity Securities.
Regulation D Offering
On December 29, 2017, Northwest Biotherapeutics, Inc. (the “Company”) entered into Subscription Agreements (the “Subscription Agreements”) with certain unaffiliated investors. Pursuant to the Subscription Agreements, the Company sold to unaffiliated investors (the “Series B Offering”) an aggregate of 381,079 shares of Series B Preferred Stock, par value $0.001 per share, at a purchase price of $2.30 per share, and issued two-year Class D-2 Warrants (the “Class D-2 Warrants”) to purchase up to an aggregate of 3,810,790 shares of common stock, par value $0.001 per share, at an exercise price of $0.30 per share.
The Series B Preferred Stock will be convertible into common stock, but only when common stock is available or after 6 months following issuance. When sufficient shares of common stock are available for issuance upon conversion, each share of Series B Preferred Stock will be convertible at the option of the holder, at any time, into a total of 10 shares of common stock, par value $0.001 per share, for a total of 3,810,790 shares of common stock (the equivalent of a conversion price of $0.23 per share of common stock). Shares of the Series B Preferred Stock will only receive dividends if the common stock receives dividends, and such dividends would be in the same amount, on an as-converted basis. In case of a liquidation event, if the Series B Preferred Stock is still outstanding at that time, each holder will, with respect to each Series B Preferred share owned by such holder, be entitled to a liquidation preference of either the amount paid for the Series B Preferred share or the amount that the holder of such Series B Preferred share would have received if it had converted such share to common stock immediately prior to the liquidation event.
The Class D-2 Warrants are not currently exercisable and will become exercisable only when shares of common stock are available for issuance upon exercise.
In connection with the Series B Offering, the Company entered into voting agreements with certain investors, in substantially the form filed as Exhibit 10.2 hereto and incorporated herein by reference.
The Series B Preferred Stock and Class D-2 Warrants described in this Item 3.02 were offered and sold in reliance upon exemptions from registration pursuant to Rule 506(c) of Regulation D promulgated under Section 4(a)(2) under the Securities Act of 1933, as amended (the “Securities Act”). Each of the offerings was made to an “accredited investor” (as defined by Rule 501 under the Securities Act).
The foregoing is only a summary of the material terms of the documents related to the Series B Offering. The foregoing description of the Series B Preferred Stock is qualified in its entirety by reference to the full text of the Certificate of Designations of Series B Preferred Stock which is filed as Exhibit 3.1 to this Current Report on Form 8-K, which is incorporated herein by reference. The foregoing description of the Class D-2 Warrants is qualified in its entirety by reference to the Form of Class D-2 Common Stock Purchase Warrant which is filed as Exhibits 10.1 to this Current Report on Form 8-K, which is incorporated herein by reference. The foregoing description of the Subscription Agreements is qualified in its entirety by reference to the Form of Subscription Agreement which is filed as Exhibit 10.3 to this Current Report on Form 8-K which is incorporated herein by reference.