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UCLA Seminar with National Cancer Institute director Dr. Norman Sharpless, the newly appointed acting chief of FDA
Talk title TBA
Date: April 17, 2019 12:00 PM - 1:00 PM
Location: NRB Auditorium
Los Angeles, California 90095
https://cancer.ucla.edu/Home/Components/Calendar/Event/2358/1195
oin us in welcoming Norman E. Sharpless, M.D., Director of the National Cancer Institute, to the UCLA Jonsson Comprehensive Cancer Center.
He will be participating in a ONE DAY ONLY VISIT to UCLA on Wednesday April 17, 2019. Dr. Sharpless will be presenting a seminar that is open to all UCLA staff, faculty and leadership.
Please be sure to save the date! More information to be forthcoming.
Date: Wednesday, April 17, 2019
Location: NRB Auditorium
Time: 12:00 p.m.
I have a simple principle guiding my investment in nwbo based on years non-stop data-based, and even-fud checked DD:
It's a buy when share price is blow $1, ie., the market cap is close to 1 billion on fully diluted base based on two progressively better interim data sets, ie., the data sets indicate a thick and long tail with yet-to-approved or unclear separations between various comparable groups.
The reason is that if the future topline data set were showing no separations, it's still highly likely it will show a thick and long tail, then the underlining vaccine will still be approved, though its approval may have to survive a battle of doubt waged mainly by bears, nwbo haters, nwbo's competitors, etc.
The good start point is DCVax-L's pristine safety profile. Assuming no separations, the thick and long tail will be undeniably a strong indication of efficacy; I believe the company will be able to show various data indicating that DCVax-L's intended Mechanism of Action is indeed at work such as killer cells infiltration, etc. With evidences for a working MOA and a thick and long tail even without clear separations due to cross over, any reasonable person will believe that the vaccine is working, so the final approval shall be no doubt in the card.
After approval, the market cap will move up to where it belongs, ie., at least several billions if not tens of billions.
The above is almost a worse scenario I can come up with at the time being, and I am a buyer.
But I have to make it clear that I do believe there will be separations between the various comparable groups based on what we have known in terms of SOC, other concurrent trials, our trials, etc, and I believe the price is outrageously low in this range.
Because of the long and repeated dilution history, and the never ending wolfpack attacks, we will experience numerous battlefields, like the one currently waged on around $0.3, which will be broken very quickly.
All in all, buy now and forget for a few month and you will be richly rewarded.
Actually Bill the impact on nwbo may just be positive considering how he was hired by Trump. Basically, he is comparably conservative than anyone at that time considered for the position by Trump. For example, the guy considered for the position before him is more liberal kind of guy who thought drugs/vaccines should be approved purely based on safety, meaning if it is safe, then they should be approved.
So I would think the chance of the new FDA boss who is more conservative than Scott Gottlieb is very low, and the chance of the new FDA boss who is more liberal than Scott is quite high.
Under Scott, DCVax-L with a long tail but no separation would be approved, so my sense is that we are better off after Scott's resigning.
One of the reason for his resigning is he has drawn the ire of tobacco companies, thus of some Republic politicians.
In general, his resigning may be considered a loss for big pharm for their future approvals of dangerous ICI, and Cart-t drugs/agents despite serious safety issues, but I don't see any impact on nwbo, if not positive.
I don't think there will be any direct impact at the time being. In a long run, it may all depend on who will be his successor.
Nonetheless if the data are as good as we think, particularly if there are obvious separations between early and late vaccined patients, and/or between early vaccined or total vaccined (including cross-overs) and those who have never received the vaccine in terms of HRs, nobody can deny the approval of DCVax-L for its intended use.
However, if the separations are not there or not very clear, but landmark survivals at 2, 3, 4 and 5 years are apparently better than historical survivals and/or NVCR's for example, then that may really depend on who will be FDA's new boss, and what are his/her opinions compared to Scott Gottlieb over drug/vaccine approvals for unmet medical needs.
Under Gottlieb, the above case of no apparent separations but with long tails will be approvable, imo.
The company just hired a new IR guy, vice president for IR, an insider of WS, and yet this board is still deranged discussion which brand name is appropriate for the company's platform.
Lame, lame, and irrelevant!
Com'on, the long sought IR guy is onboard, or not?
[this board had never ever known what should be talked, which is quite normal actually, thanks, which reconfirms my position]
Oh boy, a twitter account is free. You can easily have one and debate there with Dr. Rago [note it's Rago not Ragu, I know you guys in many times would intentionally misspell for some obvious reasons, prepared for denies in a future lawsuit is one for example], the same applies to AVII.
Any posters without appropriate disclosures about their training, professions, titles, and positions posting on a stock message board are at best of some entertainment value, and their existence, including me, imho are just a waste of time.
People reading these message board are mostly wrong in hoping to find concrete knowledge or even clues for their investments, because of the reason given above.
After some time reading the boards, one may find they can serve as portals where some information may be present which needs to be further checked for credibility, and sometimes it may warrant further investigation.
It is a true tragedy that the several suspects who have spent 24/7 for years posting only one way negative or positive opinions, who in most times either initiate or are engaged in back-and-forth circular debates/discussions still have followers in this board.
We are in a process of revealing whether DCVax-L is truly efficacious in addition to its approved pristine safety profile with undeniable data.
For the Wall Street, DCVax platform is "too good to be true" considering its unprecedented about-to-be proved ramifications of being used in almost all solid tumors and its looks-simple and easy to understand MOA, thereby having been readily discounted thanks partly to creeps such as AF, etc.
Well, the best engineering/design is the simplest engineering/design, and the truth relies not in complexity but simplicity.
Anyone who has an advanced degree and some practical experience will readily understand that.
This proving process has been long, but worthy of its unfolding!
[btw, I have only one post a day privilege, so anyone is welcome to take that advantage]
It's absurd to compare a small unblinded trial with one more chemo added to standard of care to our DCVax-L trial, and said DCVax-L blend results are not any better than those from the trial for methylated GBM patients.
Not getting into details of the numerous flaws that could inherently relate to any unblinded, small number of trial, but if I have to take the results in their face values, it is only shown that DCVax-L blended results for mytylated GMB patients are at least equal to the most biased, utmost cherry picking, so-that-most-favorable-results generating trial which has ever been seen in history:
Wow, DCVax-L blended results are not only better than FDA approved electric hat, but also "any better than" those of the above mentioned most fabricated trial ever, without the dismay of two chemo drugs combined in quality of life, in an environment where RAs have increasingly been pressured by the public to pay attention to and realized the importance of safety.
This guy has a magic to prompt me to buy more shares anytime after checking his/her subtle positing.
But make no mistake that it's absolutely absurd to compare the two.
This read will be helpful for those who are interested in knowing more about MGMT methylation and outcomes of overall survival in proneural, neural, mesenchymal or classical subtypes, particularly for those who found confusion in understanding our blended blinded data in terms of MGMT methylation and mesenchymal subtype:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467216/
Somatic mutations in glioblastoma are associated with methylguanine-DNA methyltransferase methylation
Partial excerpt:
"Based on the signatory gene expression profiles using data generated from The Cancer Genome Atlas (TCGA) (16), four distinct molecular subtypes of GBM were described: Classical, mesenchymal, neural and proneural (17). These subtypes have also been associated with characteristic genetic alterations (17). The classical subtype is associated with an astrocytic expression profile, with frequent epidermal growth factor receptor (EGFR) amplification, concomitant chromosome 7 amplification and chromosome 10 loss, and focal deletions of 9p encompassing cyclin-dependent kinase inhibitor 2A (CDKN2A). Notably, the classical subtype is not associated with TP53 mutations, which are common in GBMs (17). The mesenchymal subtype is typified by the expression of mesenchymal markers, with frequent deletions or mutations of the neurofibromin 1 (NF1) and phosphatase and tensin homolog (PTEN) genes. The neural subtype exhibits expression of neuronal markers and displays various mutations and copy number alterations, including amplification of EGFR and deletion of PTEN. The proneural subtype exhibits an oligodendrocytic expression signature and is characterized by TP53 mutations. In addition, focal amplifications of the chromosome 4q12 region, which contains the oligodendrocytic development gene a-type platelet-derived growth factor receptor (PDGFRA), or mutations of the isocitrate dehydrogenase 1 gene (IDH1) are observed. The TCGA group has recently published an updated comprehensive genomic, epigenomic, transcriptomic and proteomic analysis of >500 GBMs (18). Patients were categorized into the four different groups and the overall survival was stratified based on MGMT methylation. Notably, the findings indicated that MGMT methylation may be a predictive biomarker for response to treatment, but only in the classical subtype of GBM."
and
"Discussion
The presence of MGMT promoter methylation in GBM is a predictor of response to TMZ treatment and of overall survival. In the present study, the mutations detected in MGMT methylated GBMs were four times higher compared with MGMT unmethylated GBMs. This observation may be attributed to a lack of DNA repair function upon presence of lower levels of the MGMT protein.
In 2005, MGMT promoter methylation was reported to be associated with a survival benefit from alkylating agent chemotherapy in GBM patients, in a companion study based on a phase III concurrent radiation therapy and TMZ trial (13). A number of studies have demonstrated an even higher survival benefit in patients treated with alkylating agents, who presented tumors with MGMT promoter methylation, compared with patients having tumors with an unmethylated MGMT promoter (13,22,23). Therefore, MGMT promoter methylation is a favorable prognostic marker, in addition to a favorable predictive marker for response to TMZ treatment in patients with GBM. The molecular basis for the differential response to TMZ treatment in patients is well established. Alkylating drugs, including TMZ, induce DNA damage by introducing alkyl adducts into the DNA molecules. This causes genetic mutations and cross-links between DNA strands that inhibit DNA replication and thereby trigger cell death. However, MGMT removes the alkyl adducts from the DNA as they are introduced, preventing subsequent mutational damage. Tumor cells expressing MGMT are thus resistant to alkylating drugs (24).
In the current study, the TTP following chemoradiotherapy and subsequent overall survival were significantly increased in patients with MGMT methylation compared with patients without methylated tumors. Thus, the present study confirmed the role of MGMT methylation and its associated sensitivity to TMZ (25,26).
The current study investigated the prevalence and types of genomic alterations in GBM and whether these correlate with MGMT methylation. The results demonstrated that 75% of MGMT methylated tumors harbored one or more somatic mutations, compared with 35% of unmethylated cases. Overall, the mutations identified in MGMT methylated were four times higher compared with MGMT unmethylated tumors. Notably, mutations were identified in the TP53, CDKN2A, PTEN and PIK3CA genes in MGMT methylated cases. Since these cases also exhibited improved overall survival, further investigations should determine whether these genomic aberrations work synergistically with MGMT methylation status and contribute to the response to treatment and overall prognosis. MGMT methylation may play a dual role, increasing sensitivity to TMZ and increasing genetic instability, particularly by facilitating the appearance of G to A transition mutations. The TCGA dataset of GBMs revealed increased frequencies of TP53 and PTEN point mutations in MGMT methylated GBMs compared with MGMT unmethylated GBMs (16). In the current study, mutations in PTEN and TP53 were also found to be associated with MGMT promoter methylation, confirming the findings of the TCGA. MGMT methylation is commonly associated with G:C to A:T mutations in KRAS and TP53 genes in colorectal cancer (27,28). Therefore, MGMT promoter methylation may be an early event in the development of methylated GBM, preceding other characteristic mutations in this subgroup.
In the present study, higher frequencies of EGFR and CDKN2A alterations were observed in the MGMT methylation group. Although the tumors were not categorized into proneural, neural, mesenchymal or classical subtypes (17), the higher frequencies of EGFR/CDKN2A indicate that the MGMT methylation group may be enriched for the classical subtype. Furhtermore, the current study is in accordance with the findings of Brennan et al (18), demonstrating that the classical subtype is more responsive to TMZ, which is reflected by the longer TTP and overall survival observed.
In conclusion, MGMT methylation was strongly associated with the response to TMZ treatment and overall survival in GBMs, as previously reported. Methylation was also found to be associated with a significantly higher mutation rate. Therefore, it is hypothesized that methylation may be one of the earliest preneoplastic events in this subgroup. A larger cohort of patients is required to further investigate the association of MGMT methylation and specific mutations (including those in EGFR, CDKN2A and TP53) with overall survival in TMZ-treated GBMs."
Linda doesn't need to or it would not be better to hold until/plan topline release at any conference or special event, either it is SNO or ASCO, etc.
As long as SAP is approved from RAs (not sure about a singular RA, maybe FDA), data will be locked and analyzed, and soon topline data will be generated according to SAP.
The market needs more time to digest topline data if positive after initial surge of share price, say up to $2 or 4 in a couple of days, particularly for a company like nwbo which has been blackened and ignored for so long.
After that it will be a step-up-wise process for further share price appreciation in which whatever events or conferences fall in will just be official venues for further publicity and show of pride.
So I think all will hinge on when SAP is approved by four RAs, but I do think as long as FDA approves the SAP, Linda should move forward without waiting for any of other approvals.
So when SAP is approved, nwbo will act like a normal development stage biotech company with major binary event unfolding.
It should happen in any month from March to June.
Definitely IR needs to be raked up. The guy is well over in his 70s, what can anyone expect any more unless he were a Trump with fat finger on Twitter all the time and is immune to the Rule of Law, given by 30% or something MAGA hat wearing willing and unwilling, innate or infected racist population, plus his age, Less is incompetent too.
Even with a functioning IR, one should have understood now nwbo is a battleground stock, and should not expect much in regard to price, thinking a price hike is only a bonus.
When the trial is unblinded, and the results are around the lines which are as good as expected, there will be no rules existing in buying our stock from most institutions, let alone hedge funds.
Really, a vacation or a break from screen may be the best cure for investors anxiety.
Not selling a share before unblinding, if not buying more, so I watch and get entertain.
There are times in life I have mixed up my investment with my emotion.
Seeing the beautiful 10-year girl in Trump's State of Union speech, and yesterday one more politician passed away from GBM who was late Paul Dewar, a long-time Canadian politician. He was diagnosed early last year.
Hope we will seen a truly effective treatment approved soon.
Just some plain simple facts:
It usually take an average small biotech company from 2 ~ 3 months to have pivotal Phase 3 trial data collected, scrubbed, locked and analyzed for top line data -- nwbo will not be an exception if not for finalizing "ginormous effort needed" SAP;
The framework for the new SAP is already existing which is the old, later found inappropriate version. The new SAP needs to incorporate all things related to fat, long tail, and of course, re-adjudication of PFS, etc. The development work for the new SAP should have started ever since the problem with pseudo progression was identified, around summer 2015.
So there are no reasons to believe the development and finalizing SAP will take as long as most people have thought in this board. My guess is that it will be submitted to four RAs within a month, ie, by end of March, if not sooner.
The big uncertainty is how fast and when nwbo can have it approved by all four RAs. Usually, RA will respond positively in a month if no revision is required, which means nwbo may have an approved SAP in April the earliest or May the latest.
By the time SAP is in place, ie, approved, all other work related to data collecting, scrubbing, etc should long be accomplished. Then, data lock and analysis will take days to complete.
I believe we will be blessed with topline before and at ASCO, if not earlier.
As long as when DCVax-L can be approved by any of the four RAs, the usual process will be from 8 ~ 12 months after submission of BLA, but don't forget, it will be all dependent on data. If the data are as good as most have expected, ie, as good as the two blended data sets have suggested and with at least somewhat separation between various comparable groups, I don't think RAs will sit apathy, and they will act quickly after they have data (BLA).
As I said before: a barking dog never bites! Where are the cheap shares? And Linda will surprise us and the market!
Thank to you all who have attended ASM, particularly those who have shared what they heard from and thought on the meeting. Very valuable feed backs, reconfirm DD, much appreciated!
Excluding that, almost all posts since have been the same ole same ole or new nonsense out of empty holes, particularly posts from a few longs who have been proliferate posters in this board, as for many others who are easily identifiable and have no stake in this company but mysteriously have posted 24/7 for years, they are in my ignored list or skipped to read list.
Those are pathetic, desperate or eager to show and thus will be easily fooled by own doing or deeds. All comes to one purpose: WHERE ARE THE CHEAP SHARES, and can they be cheaper?
Well, good luck on that, but Linda's gonna be surprise us and the market, and she must be, which I believe.
Linda, We have given you all freedom to surprise the market and beat the unbelievers or those with shaky knees.
NOT EVERYONE DESERVES SO WEED THEM OUT.
[above is my once a day post. sorry I have nothing to add, so just a bit of rhetoric]
BSB I thought you and Umibe5690 bought some shares yesterday as GD sold his entire 1.5 million shares for 50k profit, because both of you appeared to be hunger for shares, and there came GD's shares.
I don't know why GD, the monkey king sold his shares, but if it was because LG's answer to IKE's list of questions, then that is a telling:
Most retail investors would be long gone when pps is in the range of $0.5 ~ 1, which would be a good thing because the ones support the share price higher than that would be new retails and institutions.
If one can read what an IR guy or lady has said literally, then a pig can climb up a tree.
If one has to find whether anything is new from LG yesterday's comments is the his deny of more than "a few" patients" out of completely randomized patient population, ie about 31 or so patients seem to out of the equation -- I guess he didn't lie but definitely there are stories behind the scene, and I guess it cannot be bad.
Just because the trial has yet to be unblinded doesn't prevents Linda from talking to FDA, submitting materials / applications to FDA, and even "corroborating" with FDA.
Perhaps, those 31 patients or so are involved; perhaps LG's stress that FDA's involvement in the partial halt is part of it; and perhaps by the time the trial is unblinded, the approval is already on the way to Linda's fax machine.
People are easy to forget that for FDA to approve a treatment, it needs to first check safety -- we have this checked, and then check efficacy -- judged by data reveled from two interim blended data releases I don't think our persons involved, including Linda P, and dr. Linda L, and of course Dr. B and the expert panel cannot find a way to prove it, if not outright approved by raw data in a simple computing in accordance with SAP.
A sudden unexpected 1.5 million sell didn't make a dent in share price yesterday in and of itself says something!
It should and has actually become very clear and simple to understand now the situation we have been in:
Any PRs from or conversations with nwbo are by and of selves are transparent: ambiguities are transparent which convey what exactly they are intended to convey: ambiguities;
Any investors want to know what are the final results, and want to contribute to a successful trial while raking well-deserved profits from their investments, knowing in the meantime not any investments guarantee a profit -- in a sense, Linda is an investor albeit a much much more significant one if not the controlling stockholder.
As long as Linda has stopped diluting and is not going to dilute our shares, particularly in doing so in the past she could have miraculously maintained if not increased her shares, I will give her my full support and urge fellow investors to exercise patience because
Her interests are aligned with ours, and she is in a position of knowing more than anyone of us of what's really going on and the full scope of data and the landscape of our trial and the regulatory agencies.
She cannot and should not and it is unwise to televise anything that is on going or has done, particularly something with and/or related to the regulatory agencies, so viewer discretion is advised.
She better get it right the first time, because we don't have the second time!
In the meantime, in regard to message noises, be aware and careful. A barking dog never bites! But when they barks they are as always up to something, and it is usually pitiful: where are the cheap shares!
I concur your feeling and sentiment
"We are at 24 cents after three very good PR’s (OS data x2 plus Sawston cash) and with a completed phase 3 trial with topline due around ASCO. Mgt has overwhelming evidence (according to my conversations) of illegal activity in stock manipulation and we have plenty of cash in the bank."
The fact you put out in the quotation marks above in and of itself testifies that there are indeed nefarious forces behind all of this, barring Linda's mismanagement, etc, -- the forces we now commonly called wolfpack.
So it should be very easy to understand at least partially why we have not seen any concrete actions taken by Linda to fight these forces and in that doing giving support to share price -- simply put, it is unwise and futile at this point to do so.
So the best way moving forward is to focus on finalizing SAP, collecting and scrubbing data, and unblinding.
She need to be very cautious and focused, and I trust in most part our interests and her are aligned so we should trust her and give her all the freedom to do her job.
I give no shit to all the noises. A barking dog never bites! And today strangely we have a couple.
Why Linda sold shares at $0.17 while the market price at the time ranged from $0.21 to $0.30 ???
Why Linda exercised warrens at $0.3 while the market price at the time ranged from $0.21 to $0.30, and sold them?
Has she transacted those shares in open market?
Who she sold to?
Anyhow, anything is noise in a time when science will eventually approve itself whether it not only has merit of its self in science but also practicality.
Topline data are days or at best months aways.
BTW, I hope Linda had sold those shares and warrens to me.
I think what Kam said is correct that she sold those shares to a strong hand, and the recipient may want to buy in open market after that. Hopefully she or he is a big fish not like the Bigger.
These market makers are funny.
Real-Time Level 2 Quote
MPID
Bid Price Size Time
CSTI 0.264 3,406 13:50
CDEL 0.264 2,500 13:50
NITE 0.26 2,515 13:45
MPID
Ask Price Size Time
CSTI 0.2649 5,000 13:33
CDEL 0.2649 4,452 13:50
NITE 0.265 9,000 12:54
A more unbiased article about controversial surrounding Huawei:
https://www.nytimes.com/2019/01/26/us/politics/huawei-china-us-5g-technology.html
America Pushes Allies to Fight Huawei in New Arms Race With China
Funny some people are pushing really hard for us not to make any potential significant deal with Huawei or the likes as if we were right now a darling of the Corporate America or the Trump Government and as if no companies in the world were making deals with Huawai, and as if Americans were ready to deprive anything made in China.
Too simple too naive!
The fact is if we can choose we would choose Warren Buffet as our biggest investor or even the stakeholder of control if Linda agrees, but where is the beef?
It is a cancer treatment for Gosh sake, whether it's the Chinese or the Americans or the Russians, let the treatment progress and realize its full potentials given the America has had the first choice.
I prefer all American deals too, and let push for that kind of deals being worked out, but the beauty of Linda Powers in making the Huawei land purchase and our lease back deal is multifaceted, skillfully implemented, and it's warning shot to our adversaries.
If the American companies and FDA don't get it, well at least somebody in the Far East does.
Bravo Linda!
It's not definite but very clear now by today's PR that the company has been working on various stages toward data lock -- it says in the PR that data had been mature as of October last year and now the company is working with experts towards data lock & unblinding.
meaning data lock could be anytime from now -- actually I don't see any reason today why the company postponed ASM to early Feb, unless it expected something big would be happening in late Jan.
Perhapse data lock is one, and now it is postponed somewhat.
It also seems from today's PR the SAP has been prepared or finalized, and how PFS adjucation should be performed has been agreed upon.
As for voting, I still urge investors to vote no to directors, and option to send a message to Linda our disappointment on her performance, particularly share price, knowing that she will not be replaced by anybody regardless how you vote.
In the meanwhile, Les should be doing only one thing: to market the company to the Wall Street, not desperately but in grace as we have enough money in bank now and beautiful blended data.
Yes it seems that's the only way out for Canada and China, and even America as well.
To say the arrest has nothing to do with politics is like to say Donald is a model citizen of the US.
Huawei has invited Western officials/technical experts to check its codes and engineering to assure them; In UK, Huawei allows UK to check its service and equipment supplied to UK.
It feels more and more like the US is luring other countries in its own advantage to prevent Huawai to challenge US own companies in IT dominance in a way contrary to fair competition.
BTW 1, today, Tencent, one of China's biggest Internet providers signed strategic development agreement with Merck.
BTW 2, Linda really needs to work harder to find a rich guy to buy at open market, and the only obstacle to that perhaps is her paranoia.
The question any investor should ask Linda is
Have you made any Wall Street friends by now, not one the like of the Bigger which is a peanut in scope and vulture in nature, unable to support the market?
If not, have you ever tried in that direction, and what’s the underlying problem?
If the underlying problem is you who might have tried to control the company via unfair practice, would you want to change your practice so as to ensure the potential investors or the investors in general?
I appreciate anybody's effort in putting up and voting the question lists for Linda. I think it's better right away email and mail via express the list to her attention.
Don't expect she will respond to most questions, but if she can answer even one or two is an effort not wasted.
She ought to have some pressure from investors, the list on her table is one, and the other is to withhold your votes.
No worry she will get enough votes without your votes.
All in all, if she can persuade one or two major Wall Street funds to be onboard, the nagging problem with share price and thus funding will be the past history!
And with the positive data we have already though blinded, I don't think it will be a problem in that direction, if she can play it fair.
Al4door, if you like, you are welcome to use any number you want. My point in that message is not to have accurate accounting of the book, but qualitatively explain its significance to nwbo.
Indeed, any reasonable person would assume the financial resources Linda has secured in that deal will be enough to allow us to at least see the topline data. For that, the true value of our stock should be in the range around $1, but it doesn’t bother me a bit if it still lingers in where we have been for a long time.
BTW, your knowledge and inside on land deals are very helpful.
I cannot stress enough on Linda’s recent deal with Huawei’s purchase of part of the company’s land and nwbo’s right to lease back the land for 40 years:
It removes the most perplexing issue of constant financial stresses, imminent bankruptcy chatter, and it thus assures investors while stirring up the wolves’ holes – if the wolfpack were not disarranged yet it will be soon, and if big pharmaceutical companies are still waiting for the demise of the company or a convenient time to grab yet another trophy cheaply, they will find out soon that time is long gone.
The financial resource of $47 million or so may not be a big deal for big Ps and even some individuals with billions in their disposals, it certainly is a big deal for a constantly struggling small biotech company which has endured all sorts of attacks and defamations from any angle imaginable.
In particular, with the positive data revealed from the two interim blinded data sets which suggest DCVax-L is superior to any existing treatments, including Optune in treating one of the deadliest cancers GBM, in terms of not only efficacy but more importantly its pristine safety profile and its ease of use.
Due to its specific MOA, the beauty of DCVax will not be only limited in treating GBM, but it can be potentially used to treat almost all other forms and types of solid cancers, and in combinations with other immunotherapeutic treatments such as ICI, etc. it can potentially increase the efficacy of these already commercially successful treatments significantly.
The intrigue and peculiarity surrounding the deal may also have cracked open the dam of not only all sorts of speculations but more importantly all sorts of possibilities, not only from investors but potential competitors as well.
So it will be interesting to see what truly awaits us investors ahead, which I can almost feel it, and it will be all good.
It’s almost like a new world and an old world is colliding again. Will it be a bidding war coming soon or it is one already?
The strategy is to delay share price appreciation after Linda secured 47 million land deal. The time has come to gradually reflect the true value of the stock.
For me I only need to ask the two, and essentially only one question below:
Hi Linda, with all the data we have had, including the two interim blinded data sets, have you or your deputy Les ever tried to recruit or contact some significant influential Wall Street investment funds or banks so that they may initiate a significant position in the company after their own DDs? If yes, what's the results?
If some Wall Street funds were interested in the company and wanted to replace you as CEO with any means such as buying out the float and/or making derivative transactions behind the scene so that they can become the majority shareholders of the company, will you be willing to yield or will you instead fight for your continued control of the company but in an open and transparent way?
I will very much appreciate if anyone who attends the ASM asks the above questions.
All those people who scream no transparency should be stop. In a sense yes I agree with you guys that Linda should release any positive piece of news like a normal company, but I applaud her for not having released any insignificant news which can not move the share price but only those required by SEC.
As anyone has understood by now that we have been attacked unprecedentedly, and only news such like topline would move the market.
That blesses those who have conducted their own DD and come to the conclusion that the trial must be a success so that their seemingly-go-now-way stock will move when time comes.
As we know, in the field of GBM, not much progresses have been made over the years, and SOC has stuck in the range between one and two years for overall survival for the GBM patients. So the data released from the previous blinded and blended interim have shown strong probability for the trial success.
Nonetheless, some may still wonder if there are no differences between various comparable groups such as the early and late vaccined patients in OS, etc., then regardless of how beautiful the blinded and blended data may be, the risk still exists.
Well, in addition to the above, we also have had the very beautiful data of those thirty something of patients enrolled after the halt who seem to have received DCVax-L vaccine only, and these patients have all gone through more than 38 months after surgeries.
If we know they perform better than the blended, then bravo ladies and gentlemen, we have a winning ticket. So really don't blame we don't have enough news!
On the other hand, if the market is all smart most of the time, we would not have had this opportunity.
I bought 9k more today.
I am not a fan of Linda Powers. If you wonder why please go back one post of mine to see how come, but as I also said repeatedly she deserve some applauses for taking the trial pass 36-month mark for every patients in the trial, and her efforts of not further diluting the already-diluted-to-death stock, and her recent deal with Huawai.
China is the largest trading partner of the US, and many, many other countries as well. I guess many posters in this board have never ever visited China, let alone recently, that may partly contribute to sort of xenophobia or sinophobia as if the Boeing, the Big Three Autos, and the countless other companies and entities had never been doing business with the Chinese.
So Linda deserves a specific applaud for her looking beyond the obsolete and ignorant “old stock” mentality in pushing forward trying to materialize and realize the full potentials of DCVax platform.
It is also important to watch her closely and convey to her our true feeling on how all things of nwbo have been done, particularly because lawyers by trade are generally so happy walking in borderlines. Because she will be elected anyway, she must be warned so that if things finally pan out as good as expected she can finally throw off her self-interest shackles.
Nonetheless, I fully agree with notbrad post below in quotation marks:
“
I, like many of you, am growing impatient and have been pondering the timing of the unblind. I've come to the realization that pressuring LP to unblind, against her best judgement when she has the most information and the counsel of the SAB (and no doubt LL's too), could potentially lead to the wipeout of my investment. I don't want her to take that chance. If waiting a few/several months if it increases the odds of my investment paying off, then by all means I'm for it. I can wait till June if that's what it takes so that I'm not left with a big empty egg in my brokerage account.
By the way, what is the significance of this 46 months that has been mentioned a few times by some posters lately?
”
Particularly, now the government has been shut down and if Linda is waiting or thinks it is better waiting for something definite from the government (FDA, or even SEC), yes by all means I can wait for a few more months for the release of topline data, even though I believe they have been busy scrubbing, and even maybe have locked the data.
For me, a few more months makes no difference as I have decided to hang on with this stock for years to come if there is no buyout. So really it is critically important to give Linda all means and time at this stage to secure the first victory with regulatory bodies with our DCVax platform if it is necessary!
I expect her coming presentation on 23 Jan will surprise!
On the Management:
As I have said many times in the past, the reason for the ultra low share price is because we have not had a major long fund which has taken a significant role after Neil fiasco, and the reason is Linda Powers has scared off any of those kind of funds, and the reason again is that she has shown the only thing she cares is the control of the company, which in general is okay, but the problem in her case is that she doesn’t want to do so in a natural way, ie, let the market to decide how that kind of control will be.
It is suspected she had seemed to be reluctant to see price appreciated fearing that she might have to put substantial financial resources in order to maintain her control; even today she is the only person with the so-called preferred stake which can be converted at convenient price and time to maintain her control in case some unexpected events take place –- the impression still is that she will do her utmost efforts to control the company at the cost of everybody who is the owner of this company, let alone the vast numbers of retail investors.
So she was really the person who was solely responsibility for the misery and ultralow price that all share holders had to bear in the past.
Hopefully the future will be different as we are waiting for the topline data from the trial to be announced in the near future and the company just secured substantial financial resources which should be enough at least for a year.
So financially she has no excuse to once again resort to her dirty suspected tricks if necessary to maintain the her control of the company at any means, fearing one or few substantial funds or parties will taken over the company by buying out the float either gradually or suddenly via open market in combination with other derivative ways. Nonetheless, she must be welcome to such moves if there are any, and if she still wants to maintain the control of the company, she must compete in the open and free market!
Until she sends off that signal, the journey will still be treacherous. As we can only judge anybody by what he or she has done, but not what he or she will do. We must send her a signal of our unsatisfaction and disapproval of her past performance. ASM is one of such occasions we can do so. So I am going to vote no to all proposals except company’s auditor.
For those who lack experience, let me assure you she will 100% survive as CEO after ASM because she will still be the one who has the most votes even without any yet votes from retail investors. Besides she has not had any competitor for her job, but it is important to send a signal of our unsatisfaction and disapproval of her past performance!
At this point of time, nobody can kill this company and this company will rise into stardom in cancer treatment arena if the data are as good as we expected, which I think they will be.
At this inflection point and beyond, I sincerely call upon Linda, you get to change in your behavior and don’t stand in the way for DCVax platform to achieve its full potentials ASAP!
In God’s name, what I said above are my true belief and I have been a substantial investor of this company since German HE news and my share counts have only significantly increased over the years, and I may continually purchase shares at the time I deem appropriate, because I believe it is a right thing to do and it is a sane investment even after considering the so-far-not-very-positive factor of Linda Powers.
Anyone should do what is important in your life and let this stock plays out itself, because it will regardless whether how many posts bulls and bears continues to feed in this board.
All matters have been repeatedly disputed/discussed in all angles scientific, technical or financial.
All hinge on whether there will be differences between various comparable groups, which can only be known after top line and beyond. Fortunately, Linda has no reason or has run out of any reasons to not release topline within a very reasonable short period of time: from now to within two months or three.
For a stock which will be easily manipulated up or down 15% with measly 1 million shares of volume a day -- a quarter of million dollar of which maybe only a quarter of that quarter million is real with the rest go from left to right hand or vice versa, really there is no reason to worry about these measly trading, for both bears and bulls.
Whether Linda's upcoming presentation is once again a carrot or not really doesn't make any sense as we are close to data announcement.
If I have to guess to make a post more interesting, Linda's presentation must have something in mind; if only a carrot dangling like in the past, she will be shamed in ASM shortly after her presentation. And it seems her presentation is added recently and even today her name is missing from speaker list. Could that be a discussing about topline data, who knows?
Again nothing is important as we are siting at a laughable one tenths of a billion market cap waiting for perhaps the most important news in coming years regarding cancer treatment in human history.
Last warning for fellow longs, if you don't want to push out of this potential life-story significant investment, don't be fooled by anyone including yourselves, but please do make adjustments as to what you can lose in case unthinkable happens.
For me, I will go bolder to increase my position.
As for ASM, I will vote no to all, as the whole management will not deserve anything they have asked for for years. Until the topline data, I am pro buying stock and against the management (she will have a pass in anyway, so doesn't really matter how you vote).
As said before, anything will change immediately if a big long is coming onboard. I mean anything!
Answer to your Q re Doc's statement: his imagination or at best his educated guess, ie, those are not facts.
Now let me say something not related to your post or his.
Now that the treasure box has been cracked open by the external force of Huawei, which still needs to be confirmed in more specifics, the financial side of nwbo has changed from constant night to day.
The reported interim results are very positive suggesting success of the trial, which still needs to be confirmed as well as whether there are differences w/o statistic significance between various indicators/endpoints: PFS, mOS, and early and late vaccined patient groups in terms of OS -- mOS, milestone two, three, four and five years of survival, etc. If you believe the standard care for GBM has not improved much over the years, it is reasonable to believe there will be significant differences discussed above.
With torrent nagging financial issue behind us, it is just a technical issue as to when the share price will be reflect the new reality -- move to where it should be -- normalization process, and I would guess it should be around $0.5 ~ $1 range.
With topline data basically anytime from now on to within months, with positive revelation, the market cap should move up to between $3 ~ 10 billion dependent on which existing comparable company you compare, or what parameters you use to evaluate the company with various valuation methods, which are equivalent to a share price from about $3 to $10.
That is just for DCVax-L for GBM.
Short investment thesis:
The price in the range of around $0.2 will be the bottom, even with the worst scenario without FDA's nod for approval based on the current trial results -- the two interim blinded results have indicated the worst case would be ambiguity or mixed bag of efficacy, with its pristine safety profile DCVax-L will be destined for eventual approval by all authorities, even with a supplementary trial.
To be clear I believe the above presented is just for the argument purpose to see what could be the unimagined worse case, despite my belief that DCVax-L will be approved based on the current trial (I am 80% sure).
With a market cap of currently around $100 ~ 150 million at about $0.21 a share, and the worst case presented above, I don't think share price should go down any further, although it is likely to see big swings of a few cents in either way, but eventually it will come to reality--the platform is still promising, and with an improved design it will be readily a success (I don't know why I once again come to this worse case?)
The biggest issue at this point regarding share price is that we don't have a big caliber long fund in support -- the Bigger fund is just vulture in nature and just in this time goes long; with a true and substantial long fund's support, the open market will be supported, and the current MMs's cheap game will be over. In this sense, any fund who can commit itself in tens or several tens of million share purchase in the open market will be in my view such a big caliber long fund.
Without any concern of BK in at least the whole 2019, and with topline data expected to be announced within months, there will be much more positives than negatives (if there are any. Linda this and Linda that is obsolete; face it, she will not go anywhere. the only way she will be gone is she presides a buyout from a big P, or even Huawai!)
As we enter a bear market, health care stocks will shine; the self-destructive Donald would surrender to a face-saving deal with the Chinese.
It is just that a big caliber long fund is still on its way here as Mr. Warren lost billions of his investors' money in a single stock (APPL). I know nothing about these pathetic WS gurus, but would prefer to put my 80% worth in a tiny biotech company because it will outperform all stocks currently existing in a few months!
Things may change very quickly and if not, the topline data will change them once for all. That is only a wait of months for the worst.
If I have extra dollars I will be adding though I already have enough: 80% of my portfolio is in nwbo.
What I have heard and observed is that more investors are coming onboard and they are smart:
As long as there are no significant dilution I am happy which I have said before and that's the only problem I have had with the management.
Now that since there will be no dilution or no need for dilution before topline data, those on the sideline before and those who come to know this company recently will take initial positions in anticipating of topline data anytime from now to next few months based on strong scientific indication, including the two interim blinded data showers of 2017 and 2018.
The problem with the share price after Woodford is that there is no support (at least by a big fund) and the Bigger fund is just a peanut which is long but vulture in nature in my dictionary. So it really is that the share price has had not support except a price where mass retail investors would buy.
It is the best interest for MMs to maintain a low price for their profits or low cost maintenance of the market.
All these may change, because it not now there will be never for those funds which have so far been hesitant to get in big, or they can have fun and make profit at much higher price, like in dollar; I guess with two interim blinded data sets, it is most likely some funds may come to believe the strong possibility of success of the trial.
On the other hand, Linda has been successful in executing her masterplan recently which I believe is because of the strong data we have known today and the very fact that the trial is concluding with topline in horizon; the recent Huawei deal is an example, and I believe it is just a harbinger for more to come.
In some common license deal, the potential licensee will require to buy in the open market for a substantial amount, such as 10%, in addition to upfront money, etc.
All in all, there will be a variety of possibilities for substantial share appreciation, but I see nothing for share price in opposite direction (a temporary share manipulation of a few cents with low volumes is of course a possibility, but that is not my concern or a trend in my dictionary)
I would buy as much and many as possible if funds are available!
A random thought about the recent Huawei deal and the ignorance some poster shown:
Shenzhen City where Huawei headquarters locates was a village roughly 40 years ago before China implemented its opening up and reform policy. Today it is perhaps the most dynamic and vibrant city in China, more than the traditional most active and today-still-is Shanghai. Shanshen with its population of approximately 15 million is now well integrated to Hongkong, even Zhuhai by any modern transportation existing in the human's world.
Can anyone think about this that 40 years ago New York City, or Chicago or Los Angeles were not existing, just was Shenzhen city, let alone Huawai?!
So the mentality is quite different in what we are thinking and what the Chinese are thinking.
For us, nwbo is a struggling small-cap developing biotech company, but for Chinese nwbo is quite well established, more than long ten years in pivotal stage cancer vaccine trial (OMG! ten years!). I have no doubt they can and will pay very dicey expensive price for a partner deal or even an ultimate buyout deal if no strong enough resistance due to sinophobia or today's Donald Trump Syndrome.
It's exactly because China's biotech or health care industry is relatively lagging that Chinese government has encouraged its development more than others, this and that lies the opportunity for major M&A!
Out of the box, anything is possible and it's a pity we had the exactly Chinese thinking about 100 years ago, and today what we have left is only that WE ARE THE BEST IN THE WORLD, and yes the fact is yes we still are. Kind like the stock market, when it peaks, watch out! Then, it comes Donald, OMG!
All in all, never think never! Perhaps the best moving forward for the company is to give Huawei a license deal for anything outside of the US, and let a f**k*g big Pharm take the crown jewel US market?
About the Reason for the partial hold for new patient screening and the subsequent company’s actions, behaviors:
It is most likely the company had its first interim analysis in summer 2015, and there is thereafter no further interim analysis which has been conducted.
Results: It failed its primary endpoint PFS, due to yet to confirmed but strongly suggested pseudo-progression at the time, but today there are strong evidence and data indicating it is indeed pseudo-progression that wreaked the havoc. Because of that, DMC recommended the company to start a new trial with new primary endpoint, but the company refused, out of the consideration that “it seems every patient lived and is living longer.” DMC disbanded and the trail continues per “the protocol.”
FDA suggested to the company to stop new patient screening while the company raced with time to prepare and submit “certain information from the trial” for regulatory review in an effort to persuade the FDA to hold on and let the company to complete its enrolment, but FDA wanted the company to sort the mess out first.
The negotiation between the company and FDA then continues over a variety of issues, which may include how to adjudicate PFA events, change primary endpoint, modify the protocol, use milestone 3 years, 4 years and 5 years of overall survival as the primary endpoint, etc. Over the long process, some issues may become non issues, but new issues may emerge, etc, all seems pioneer in nature.
Hoping to have a definite nod from FDA and matured enough data, the trial marches on and on and on, obviously passing the previous planned PFS, mOS analyses, the said moving forward to lock the data, etc.
Today, with strong data known although on blinded base, including 2017 and 2018 interim blinded data in a positively trending fashion, the company is confident enough to finally decided to move forward to completing the trial (in all my faith, I strongly believe the company has started completing the trial without any hesitation! And the topline data will be out within the next few months if not a couple of months before next March)
News about FDA’s nod is still a possibility before data lock, but with Donald plays the US and the world like playing his favorite toy, and now the government is partially shut down, including FDA, the chance of a breakthrough with FDA before data lock becomes increasingly impossible.
I believe as long as the company finalizes or prepares its SAP, the trial data will be locked and soon after the topline data will be released. (except for topline data, the company may choose to not announce all other processes, such as data lock)
At end of the day, it’s the patients living longer or the undeniable efficacy that matter for the patients, us investors and FDA approval!
To conclude, please also not forget the demonstrated pristine safety profile of DCVax-L, which in today’s world and to a substantial degree is much more important than some efficacy which will warrant approval, but judged by today’s data known the efficacy of DCVax-L is lots of more than a blessing and is a substantial advancement in how humans treat GBM.
Due to its unique MOA, the implications of DCVax to play an important role in future cancer treatment in a whole are huge.
Merry Christmas and a very happy new year (I used low cases for the obviously reason)!
Even a blind elephant can see this deal with Huawai is golden, and a huge win for nwbo and its shareholders.
Before this deal: we are nobody, struggling quarters after quarters for survive for years. We are an abandoned orphan, who nobody wants to adopt, not by big Ps, even not by our government. In one word: we are cursed, and beaten to the ground by naked shorts wolfpack.
We have a so immense a platform (DCVax) that it has the potential for treating or helping to cure more than 90% of solid cancers, which is perhaps a single most fatal threat to the existing big Ps for potentially losing of their lucrative chemotherapy and a big chunks of ICI and cart-t business. The established big Ps are “burdened” with their legendary and existing business, if possible, no one wants to get into DCVax business since it will be a fatal threat to their existing business model.
Thereby, it is easy to understand why we are heavily shorted with unlimited faked shares; why FDA seems to have ignored us for so long even though we are just some short miles away from FDA headquarters; and you name it.
Politics aside, the Chinese has the view of big pictures. Its government encourages its people and its corporations to take risks, and of course short-cut, to move forward, to catch up, and to lead. Besides cutting age IT, AI, etc., one field Chinese government is encouraging the most is biotech. It will be the next big thing in China although it is still at its infancy. That’s why the coming of Huawai in doing business with nwbo because our platform Dcvax is a perfect match for any ambitious big Chinese corporation to get into the field and move forward in a lighting speed. And they have the resources to do so.
Now with this as a wakening call, we will never be ignored. Those big Ps who are relatively less burdened with chemotherapy, ICI and cart-t may finally realize if not now there will be never a chance to get onboard and lead again; For the US government particularly FDA, the future revelation is definitely not pretty if it continually ignores. To deny any future buyout deal with Huawai will be baseless since we are deemed a “garbage” by FDA and big Ps, and how can you say a deal of a “garbage” will be a national threat which ought to be protected?
Anyhow, I don’t see this deal is nothing but good, and its implications will be unfolding positively. For the advancement of mankind, I don’t care where DCVax will be used commercially first. Particularly if the US has declined its first right, let others to take it.
If I were a short, I definitely know what I should do unless the short is brain dead, and that is none of my business.
Now the purchaser has been known and it is a fierce Chinese telecom & smartphone company selling the most gear for today's high speed communications and more phone sets than Apple around the world.
It is the same company whose CFO Meng Wanzhou was arrested in Canada at the request of the US early Dec and is now out on bail... fascinating story still unfolding... due to Donald Trump's trade war with China...
Huawei, a private company with huge financial resources, which has invested more research funding than most western companies, one of the reason for its spectacular ascendance, thus at ire of Donald...because it is pausing to dominate new generation of communications -- 5G, etc
Politics aside, the company seems not to use the land it just purchased for making new generation of gears or fancy smartphones, or expanding its UK research base into the newly purchased land, instead it seems to allow NWBO to do all the necessary work for commercial use in the future, 20+20 years at least.
One implication is it may want to diversify its business and get into biotech and this is just a first step.
So it seems money may be no longer a problem because I don't think this land purchase is the first and last from Huawai or other biotech companies from China due to the publicity brought about by this deal to potential Chinese companies.
Besides, with the money in hand, Linda's hand has strengthened and she can make deals upon deals with other companies, toward eventual buyout by a multinational big P.
Without even a bit of worry about the demise of the company, anyone including wolfpack will eventually come to realization:
NWBO's success is an eventuality and unstoppable!
Linda ought be given maximal flexibiliy possible in terms of when exactly the trial will be locked and topline data be published.
The reason is quite simple: the only thing wolfpack has not been paniic yet is they know there is no imminent danger of topline data or its equivelent like substantial interests from long hedgfunds, or substantial lisence deals, buyout, or the like, as there now will be no concern whatever of the demise of the company for at least one or two years due to the recent secured funding from the sale of property.
Unless there is a mole in FDA who is feeding the wolfpack of inside information, in my opinion the only hope for the wolfpack to not be panic is a clear guideline from Linda.
If you are longs who do not depend on flipping shares to average down and have hold the opinion that no matter what the trial will be a success, and the the treatment will be approved, I don't think it will be hard to not give her all the resorts she can have.
Because of wolfpack, we have been suffering too much; the patients have been suffering too much; and the general investment community have been deprived of true and correct information about this company and its disruptive and promising immunotherapeutic platform. So it's time to give Linda the trust and means so as to uproot the wolfpack once for all, because it is the best interest of all stackholders and patients.
I believe we are near the truth\news, and I have no problem to wait a few more months if we have to.
The way LP/LG put out a news piece in ambiguity regarding unblind days obviously has its reasons -- I am holding why at this time!
The property transaction suggests the deal is signed with a big P for license right of only L, and the way or term it is at this time is provisional -- the big P would only take a friendly risk which is all written in the terms suggestively.
Until a definite signal takes shape, certain, the P would emerge and the deal would be finalized -- either a license deal or a buyout. All depend on
a sudden truth -- a yielding of authorities to fact and truth.
Until that day, we will continually see ambiguity, or total silence.
I prefer the latter, but doubt it (Linda has failed me by behaving exactly like a normal CEO, which most in this board love to have, but not me).
Have made my minded, the only thing I can do is buy as long as I have funds!
Buy
[Referred to Basin Street Blues's post] regarding naked short practice here of nwbo, your opinions and analyses are pure nonsense!
Even a kid can infer the naked shorts are alive and well even after nwbo delisted from NASDAQ to OTC. Linda's previous toxic financing/dilutions just exacerbate the situation.
No time to detail my opinion, interested check back my previous posts regarding naked short activities attacking nwbo.
Very interesting, people even the ones making living by trading are blind, and brain dead regarding this issue, and it is appalling!
Regardless, the share price will appreciate reflecting on the fact we have known today. Wolfpack just hopes we don's have a momentum, and that's why they pour cold water (naked short selling) at any good news in a very patterned sneaky way.
Time to go and buy (not misspelling)