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FWIW, below is my questions submitted to Linda, Les and Dave yesterday and Dave's reply:
"Dear Linda,
My name is Dan X. My wife and I have about xxx shares of nwbo for years. Thank you for your hardwork and this opportunity for shareholders to submit questions. Below are my questions:
1) Since the partial hold in 2015, it seems you have been afraid of promoting our own company, and why?
2) You have fiduciary duty to shareholders, in your opinion, why share price has been in this low range for years; is the share price today low, fair or high, and what is your projection in the near future in term of share price? Can you detail your reasoning in regards to the above?
3) It seems you have diverted most financial resources to build Cognate, Advent for manufacturing which seems in the end only fall into your own interest, while the underlying trial has been in constant struggle in many fronts, and as a matter of fact after 12 years, the trial still has yet to unblind. Now we are feeling once again you are diverting resources to build other manufacturing facilities without a clear sign of trial success, so that in the end you are the sole beneficiary of all this, if the trial fails. What is your opinion on the above statement?
4) Instead, why not focus on getting a successful trial done first; with that in place, financial resources should not be a problem, and then we can build manufacturing to the standard asked for by regulatory agencies, which has been actually a common practice for most small development stage biotechs? and
5) What is the status of the trial? How many patients in the trial are still alive today? When will we see data lock, unblinding and topline data?
Your reply and explanation are very much appreciated?
Dan" and
Dave Innes's reply:
"Thank you for your input. I will add these questions to the list
Stay well
Best
Dave Innes"
Simply put, the questions and only questions to ask Linda Powers are:
You have fiduciary duty to shareholders, in your opinion, why share price has been in this low price range for years; is the share price today low, fair or high, and what is your projection in the near future in term of share price?
Can you detail your reasoning in regards to the above?
ARE YOU STILL AFRAID OF PROMOTING OUR OWN COMPANY TODAY?
Why have you divert most financial resources to build Cognate, Advent for manufacturing which seems in the end only fall into your own interest, while the underlying trial has been in constant struggle in many front, and as a matter of fact after 12 years, the trial still has yet to unblind?
Why not focus on getting a successful trial done first; with that in place, financial resources should not be a problem, and then we can build manufacturing to the standard asked for by regulatory agencies, which has been actually a common practice for most small development stage biotechs?
Now we are feeling once again you are diverting resources to build other manufacturing facilities without a clear sign of trial success, so that in the end you are the sole beneficiary of all this, if the trial fails.
Your explanations are very much appreciated?
[I will email the management of my two posts including this one next week]
WARNING: don't get distracted with Sawston, Sawston, and Sawston. Yes, it may be a game changer with Sawston runup/expansion for the fate of the company, aka the fate of our investment, let alone the interests of existing and future patients, BUT THAT IS ONLY FEASIBLE only if DCVax-L trial is successful and approved by FDA and/or UK, Germany and Canada. IF NOT IT JUST WASTES OF MONEY IN THE END!
The focus in the inquiry of the management must be focused on the trial: status of the trial, how many still living, and when was or will be data lock, unblinding, and publication of topline data?
BESIDES THAT, is there any plan or arrangement in place to sustain the company until topline data announcement, is such plan or arrangement involved significant share dilution?
Is there any plan or arrangement in place/in development so that the company can still move forward to test L and D in other indications or subgroups of GBM patients if the trial fails or BLA rejected?
What's the reason that for years the management seems afraid of promoting its own company? is it because SEC or FDA or is it because the trial was deemed failure some time in the past but not announced? Please give some specific color?
All in all, what we should be concerned the most is the FATE OF THIS TRIAL. IF IT FAILS ALL OTHERS ARE MEANINGLESS!
BE AWARE OF DEFLECTION, DISTRACTION, REGARDLESS ITS FROM THE MANAGEMENT OR SOME POSTERS HERE.
Finally, we are shareholders no questions are bad questions or too blunt to ask.
FWIW, below is my email inquiry to DI yesterday. Still no reply from him, and appreciate if you guys know the answer, including those from the company:
"Hi David,
Can you help me to understand why we are not asked to vote for shelf increase as our company is in dire need for financial resources and the authorized shares are quickly run out?
Since the number of deaths in the trial as of today is known to the company even if the trial has yet to be unblinded, can you disclose the number, and if not, why?
Dan"
Thanks in advance.
As of 26 March the day of this filing, if Linda knew the DCVax trial had no chance of approval, she would be a dire criminal deserved to be handcuffed in our plain sights by expanding company's sawston facility for manufacturing DCVax products.
Yet there is no request for voting to increase the shelf even though the company has been in dire need for financial resources;
and yet Duffy came and went back Merck shortly without loading with significant options;
And how many exact warrants / options will expire in April and early May?
Share price at all time low, and I continued buying today for a tiny 10k at about $0.1453.
I hate buying more and pray the end of this madness.
Perhaps it is interesting because we are not asked to vote to increase shares or reverse share split.
From today up to shareholder meeting day, the company can still inject some indeed interesting news or topic to discuss in the meeting.
Why they don't ask for more shares. They are starving unless they know finance may no longer be an ongoing problem in the future.
It's a plus for me. To express my appreciation, I symbolically bought 10k shares today.
Lot Chinese think (Chinese gov doesn't agree) the coronavirus was released by US military agent during 2019 Military World Games held in Wuhan, China the center of the now designated pandemic in late Oct for the obvious reason; and
Lot Americans think (US gov doesn't agree) it was stolen by Chinese agent from Canadian Lab and released later after it was engineered for weapon use, again for the obvious reason.
Wow, what a wonderful world we are living!
Regardless whether it is a free society or not, it seems people think the same, always blaming on other nationalities, races, etc.
Ironically, viruses blame nobody!
Thanks Lykiri for the information.
If her absence is not covid-19 related as State of California declared state emergency, or other common reasons, etc, one possibility is because of pending news on TLD.
All quiet on the Western Front before big news!
My one minute speculation on what has bee going on around ASM announcement:
1) Linda decided it's time to lock and unblind data;
2) In anticipation of negotiation with Merck, etc., she raised $4 million just as a cushion, and at the same time "rewarding" some "friendlies for the last time at this cheap price. She can no longer do it if she know data is positive in the future;
3) Made that ASM announcement just before or after data lock;
4) Linda might have known the data is positive. Any attempt of substantial price appreciation needed to be quenched in order to protect what's in ongoing, making sure the public have no hint of already unblinded positive data, thus pouring cold water whenever possible to share price appreciation, meaning selling more shares to the market;
5) As usual as long as Linda selling shares, nobody will deduce there is any good news and will be any good news in the near future, and the message boards would still be full of clogged nonsense;
6) There is now leeway on whether to hold the meeting or not, whether to hold it in the usual place or a lot fancy ball room, etc.;
7) Then it comes the unexpected unavoidable rude awakening to those who deserve it, like shorts, flippers, the pitiful who have never bought any shares but screaming fire every day, etc.
True longs laugh all the way to the bank!
You said,
"One point that happens to be correct is that if the OS curves really do separate as many longs hope, the trial would already be highly stat sig. It is fair to question why the trial is still ongoing."
My comments:
Nobody has ever looked at unblinded data since the disband of DMC in the summer 2015, except reports of safety issues if any by clinicians and/or CRO, caregivers, etc.
In other words, nobody knows if there are any separations of OS between intended groups because the goal after Summer 2015 is to catch the thick and long tail if any, or Linda called it additional homerun.
That means even if Linda believes there are indeed separations in OS between the treatment arm and the standard care arm, or the earlier and later vaccinated arms, she has since determined to run the trial farther enough to catch that suspected long and thick tail.
She has in many occasions indicating they would not stop the trial at the initial intended events of either PFS or OS due to new developments, particularly the now well understood nature of immunotherapy in general.
Of course, one additional reason perhaps is that anyone in her position would also exercise caution, because the company has only this one shot.
Ex you seem to be evolving recently, what gives?
[Like Mav I am allowed for only one post a day so no offense for anyone who replies to my posts and gets no reply]
Think about it: there has been a huge selling on going in the stock market due to coronavirus fear and multiple years of plateaued inflated stock market, and a dwindling effects of Donald Trump's deregulation, tax cut, etc.
The downfall of the stock market is self explanatory, and NOW IS THE GOLDEN OPPORTUNITY FOR LINDA TO RELEASE POSITIVE NEWS, AND BETTER DECISIVE POSITIVE NEWS.
Because there are a mountain of volume of cash looking for a safe place to park.
With uncertainty gone from positive data, particularly for a developing stage biotech which has perhaps one of the most growth perspectives in history, with the approval of the concept by positive news of treating the most deadly cancer GBM, the DCVax Platform will garner unprecedented attention, followed by unprecedented investment.
And I am not even touching on short squeeze. Trust me there will be one.
Linda it's time.
Bought new shares. Thanks lots to manipulators.
Since when this stock has anything to do with the general market? You can fool newbies, but not seasoned nwbo longs/
Get more dry powder ready since manipulators will never go away until FDA approval.
super excited for this buying opportunities!
Still remember this slide, slide 28 of Dr.Bosch's presentation given December 2019:
https://nwbio.com/wp-content/uploads/Boston-Presentation-v0.2.pdf
" (Near) Future Plans in Brain Cancer
•Unblinding and analyzing the Phase III data
•Combination trials of DCVax®-L with checkpoint inhibitor molecules
•Intratumoral injection of DCVax®-Direct (a related product) in brain metastases
•Intratumoral injection of DCVax®-Direct in diffuse intrinsic pontine glioma (DIPG)"
And now remember the news of annual shareholder meeting of 18 Feb 2020, to be held on 18 April 2020:
https://finance.yahoo.com/news/nw-bio-announces-annual-shareholders-141500981.html
Then it's pretty much reasonable that we are currently in the process of unblinding and analysis of TLD.
Anytime I hears someone says buying nwbo shares is like buying a lottery ticket, I feel it's an insult to the collective DD of so many true longs who have invested heavily based on own profound knowledge of cancer vaccine immunotherapy applied for GBM, the known blinded data and decades of stagnation deprived of any concrete progress in treating GBM patients; we have a thick and long tail of patients indicative from the blinded data, and a very significant portion of patients who live longer than the known prognostic factors can explain ...
Of course, nobody is certain the DCVax-L P3 trial will be approved successful and the vaccine will be approved by FDA, etc., but the odds of that kind of success is very high based on what we have known.
I hope what is developing in the near future will finalize my decision whether going to washington DC or not, and then see you all in the meeting!
He knows nothing beyond fish and chips.
His/her five years old knows better than his $5 rule and OTC minimal requirements preventing big boys take a stake in nwbo. Laughable at the least.
Then, he must have known Donald Trump, and his high standard of human conducts.
[On the other hand, just giving 60 days in advance, and one or two encouraging words will not make shareholders to commit a flight, say from London to DC, or west coast to DC]
Overheard a conversation between Linda and the Market Maker:
Market Maker: what are we going to do now?
Linda: Set one high price at the bid and two higher prices at the ask;
Market Maker: Oh, that's interesting. Okay so it is easy which is just the opposite of what we have been doing for years;
Linda: what exactly were you used to do?
Market Maker: we always set two low prices at the ask and one lower price at the bid.
Linda: Oh, that's interesting.
That's the conversation, and seriously I don't know what exactly it means. I may need resident trolls for help.
Who cares Jerry, and certainly you are welcome to lodge one more complain if you will to authorities.
What we care is we have a date now and plenty of time to prepare to attend and it's time to buy as many shares as one can afford for. As I said in IV because this site is down:
"Depend on how things are developing in the next one or two months, I may attend this time.
[words omitted to comply with TOS] is no surprise today which has been unavailable. Perhaps Jerry has paid the admin 1k on behalf of some evil forces.
Just a joke Jerry. Anytime, there is a news the pathetic site is down.
Bought lots of shares in the past two weeks and today around $0.163. Maybe I have underestimated the evil forces of price manipulation judged by my untimely buys.
I have to explain to my wife when she is back from work. "
And in yahoo board:
"Finally shareholders can make arrangement to attend ASM on 18 April. Bought a lot of shares today and the past two weeks. For a 16 cent stock, we have seen many very eager and willing posters who post negativeness on anything nwbo day in and day out, which must say something. Anyhow for those who have done their own DD, it's an easy decision to buy at this low price level.
[words omitted to comply with TOS] is expected down again. Perhaps shorts pay as low as 1k to buy some down time. LOL."
Thanks GGB. It's definitely a good sign, but it also means the data yet to be unblinded.
It's also a good news for me personally that I have bought additional shares at average per share which is less than ASINOWSKI JERRY's purchase price of $0.19 per share last week and this week.
Hope what comes next is open market purchase of shares by LP, etc., or loans from LP, LG, etc, until topline data announcement.
This stock has been suppressed so much it will explode upwards violently.
Next news could well be TLD announcement!
[Disclaimer: this is my one line and only post for days and I receive no compensation for posting]
Again you are over thinking and confused yourself: for years investing in this stock it seems you still don't have a grasp on this management -- they are indeed "deceptive" and "not trustworthy" in terms of goal post and timeline evidenced by deteriorating share price (numerous "small hope-built" financing dilutions compared to a large dilution at relatively higher price once for many months to come).
At the end of the day, only thing matters is everybody's judgement on whether their interests ultimately align with ours.
Based on all we have known, the answer is a reluctant and decisive yes; reluctant is because we have been diluted to death, while decisive is that we have had the basic positively progressive blinded data and we are so close to TLD, although how close is everyone's judgement but no doubt we are close, or never which I don't believe will be the case!
As anyone who has heavily invested in this company for years, if there is no personal vendetta against the short/the wolfpack, I would think he or she is not belonged to this world, you must have been in heaven.
We all want a revenge. In this sense I fully support the management: no definite date for anything deemed important.
Let's wait, add to the position, not sell cheaply.
[I can imagine: Along with the wolfpack being roasted are more than one half of the posters in this board, any other boards, and a large number of wannabe investors who are scramble to buy in the open market - karma]
AV, since you have had time and cared so much about nwbo's Double Blind, Randomized, Placebo Controlled Phase III clinical trial for some unknown reason, and you have provided over years such valuable graphs which maybe only you understand, I would appreciate you can provide more graphs comparing our Double Blind, Randomized, Placebo Controlled Phase III clinical trial with some juicy fancy, you-pick phase 1 and phase 2 trials (there will be abundant for you to pick, maybe IC or Ex, or even learning curve or mini can help you for some raw data),in this way we may be able to better understand your graphs and essence.
Be patient, we will be there with unblinded data! And a lot of not yet invested posters will be dearly disappointed.
I don't know why I have kept buying, though not in the scale I had previously done.
[I should still mention I am allowed for only one post a day, which I am very happy with it]
It is well known there has been not much improvement in OS for SOC GBM patients over many many years, and the OS for SOC GBM patients has been in a tight range, again evidenced by numerous completed trials so it's rational and reasonable for our trial to use the past SOC OS data as a compare as in one option. Of course other options should still stand, such as comparing the earlier and the later vaccinated patients in the trial, etc.
Before unblinding, no one has 100% confidence that the trial will be a slam dunk; otherwise Linda would have committed a "crime" by giving away many tens of millions of shares cheaply. So we only have this chance, and we should not ruin it simply because of not being conservative enough.
The point is nobody really knows how successful the trial will be before unblinding. As a result, we should exercise caution.
[As known I has only one post a day so sorry for no reply/further post today.]
Why are there any pre-approval inspection by FDA if no unblinding of data and no BLA submission have occurred yet?
Guys should find Linda Powers a billionaire to be remarried who is willing to loan the company a couple of millions.
But I do know why I have bought more shares at this price!
It seems most of your questions/doubts including this one come directly from overthinking.
He pointed to Page 24 of the last Q report as information he can only or he thinks it's appropriate at the time being for communication.
That means the only public information announced regarding this issue in question is in the last Q report, which happened in Nov 2019.
After that no further information has been released. All others are hearsay.
You may refer to my previous post: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152283236
Over-thinking confuses and ultimately kills anything on its tacks!
In Summer 2015, there was a planned interim analysis. As a result, DMC disbanded and Linda has since headed on a long road of regulatory pursuit for changing the primary endpoint from PFS to OS, all due to the messed up PFS data because of pseudo-progressing.
Nobody knows and can be ascertain that PFS data would be eventually adjudicated correctly and nobody knows FDA would look at nwbo in the future with a change of smile.
Soon, FDA refused Linda's request for endpoint change (the regulatory pursuit has been ongoing until a certain point, maybe when FDA lifted the partial halt). What happened next is the revelation of the partial halt for new screening -- the stock price collapsed and has never recover since. There have been endless dilutions!
If nwbo were a big P, it will be highly likely FDA would approve the endpoint change, since OS is the golden standard and it is still today and will be in the future.
So the reason for the partial halt could not be disclosed at that time and it continues, which could only be disclosed (and nobody will really care), if topline data is released and it's positive.
So it's as clear as day that the only way for nwbo to exist as a successful company for years to come is to extend the trial as long as possible to catch the long tail -- a significant large number of patients (20 - 25 %) will live a long term, about and above five years, in a manner of statistically significance -- no companies, big or small have never ever approved a big fat long tail with the actual years and days patients have lived in the history! We are close to that revelation.
Nonetheless PFS is still the Primary Endpoint and OS is still the Secondary Endpoint. Although if the long tail exists and it is statistically significant, meaning there are clear separations between the some comparable groups, and FDA will have to approve the vaccine because of that, the best interest for the company is that PFS endpoint is better approved statistically significant. Besides, nobody can guarantee that the long tail will be a clear cut without unblinding.
All these have hinged on the SAP saga we have all experienced for so long! Despite that, I don't think the company will stretch any more longer as long as it receives the initial responses from four RAs; even if no response from say FDA, the company is ready to lock the data, unblind, analyze and publish topline data in the near future, by end of this year or the latest early next year. All my bet is on this, and I have bought a lot of more shares recently.
With regards to the Q report: it tells us, the SAP draft was completed in the quarter (any day from July through September 2019), and the data scrubbing was almost complete with only "a small number" outstanding from a few hundreds of queries as we knew from the last time it was mentioned -- A small number, a few queries remains back before the end of September meaning database lock is ready at any time!
Also bear in mind there are usually three factors a successful biotech company must have:
1) we have a quality product (DCVax-L, suggested long tail without side effects) with real-world demands (in our case for GBM patients) -- this is the first thing a successful biotech company must have;
2) we also have quality and accessible advisory board and committee (Linda is smart enough to use the experts opinions in a continued base) -- this is the second thing a successful biotech company must have; and
3) A good relation with FDA -- this is the third thing a successful biotech company must have, which we are not sure at this point, but I do understand why Linda has traded anything and everything FDA so carefully.
As for my investment in this company, the only part I don't like is the repeated dilutions of shares, and I am dumb enough to repeatedly add more shares, but I can only look in the future, and it will be bright!
(I have no interests to post further).
As of today, 8 October 2019:
https://assignment.uspto.gov/patent/index.html#/patent/search/result?id=northwest%20biotherapeutics&type=patAssigneeName
https://assignment.uspto.gov/patent/index.html#/patent/search/result?id=Four%20M%20Purchasers&type=patAssigneeName
Woops, this message is an accident.
As of today, 8 October 2019:
https://assignment.uspto.gov/patent/index.html#/patent/search/result?id=northwest%20biotherapeutics&type=patAssigneeName
https://assignment.uspto.gov/patent/index.html#/patent/search/result?id=Four%20M%20Purchasers&type=patAssigneeName
Woops, this message is an accident.
It is an easy strong rating, particularly after this small fund raise, and at this extremely low price.
I am not just saying it, I did buy more shares after the fund raise.
The reason is that the downside is 23 cents, but the upside is 500 cents and above, and the odds of the materialized upside is above 90 percent in my humble opinion, based on what we have know so far from blinded paper and subsequent presentation.
Obviously we have a long and fat tail. About one thirds of all the patients in the trial, i.e., about 100 who have survived 36 months have lived progression free -- tell me why FDA should not approve it.
Linda deserves credit for stretching the trial length to unprecedentedly long today, which is unprecedented in the history of ontological clinical trials. The results will be unprecedented and extremely rich in real data.
In my conversation with the company some months ago, I knew the company would have to raise fund in Summer, and I asked the company to do a raise as minimally as possible. Glad they followed through with a small raise, unlike a normal small biotech company which would have raise a significant amount of money just before a binary event. That's the game of this industry but it usually means nothing in terms of the eventual fate of any underlying trials.
To be honest, if Linda had raised a significant amount of money now just like any other normal company would do, that would discourage me. The fact that it is a small raise and the fund is not used to start a new trial, instills confidence in her part.
Yes Linda could have done more in bringing DCVax-L into market as early as possible. For example, if I were her, I would have submitted BLA at least one year ago with the blend milestone survival data for accelerated approval, while in waiting doing what the company have been doing since, including getting a representative SAP done, followed by unblinding the trial, and then submitting additional data for full approval.
In doing so, we would have never seen a share price below $1. Anyhow it's useless now to say what should have been done, so let's look forward for SAP submission and topline data release, which believe or not is coming.
I believe SAP has been submitted, And July surprise is still intact.
At least, we have a new floor price around $0.23, which will not sit there for long.
My prediction is shorts will bring the price up slowly in general, even though I prefer they continue piling up naked short shares. My other prediction is that Ex, AVII, Jerry, IClight and the like will take a long position despite its contrary to what they have been saying in this message board, let alone the swing traders like Scotty and JD. And there are tons of momentum chasers as well.
Humans are a bunch of complex organic masses.
You have been all over the map recently again with yet only negativity, despite now overt compared to covert in the past in manner -- that you have pretty much becoming another iclight.
How come? Fear of something is coming or out of pure desperation.
We know DCVax-L is safe, and we only need to prove it is effective as well with "substantial evidence." You know we are already there, but maybe only if it were a few pennies cheap right?
Ask yourself this "why those 100 patients in the trial who make to 36 months are mostly or in majority progression free?"
Just a remind, please keep your word of never buying any share of nwbo, in the meantime, you are welcome to short as many as you can afford and in any way you want to, including naked short, though it is a certainty you don't have any gut to do anything that is close.
Finally, thank you for your continued support, reminding us we are holding a treasure.
By now if longs have not figured it out why there is no clear timeline for unbliding, etc., then let me borrow a simplified line of word -- you should sell and move on.
In the specific case of nwbo if you have invested for some time, the so-called transparency shall be the last thing you should ask for cause it benefits the shorts much more than anyone else.
Thus it is brilliant for David to continue making smoke screen, Les to file the minimally required documents, and Linda to bring her master plan forward and into the light.
I said it before and I say now:
JULY SURPRISE!
So if you are longs who have done own DDs, what you should do. Buy at depressed price, or simply just hold.
You said you have done your DDs, so why the fuss if nwbo trades today at $0.24, and $3 within a few months?
There are also some other ways to show FDA, and other RAs that DCVax-L does work by providing substantial evidence according to FDA's requirement. For example, if all the patients or most the patients who have lived long such as three years, four years and above have had t-cell infiltration to and around the site of initial operation, or to the site of metastasis, compared to patients who lived less and have not had t-cell infiltration or have had much less t-cell infiltration.
The new SAP should accommodate for such analysis. And if the above is true, then we will have statistically significant evidence showing the vaccine works.
I also believe Linda Liau and Prins do have something else to show immunogenicity of DCVax-L in treating GBM from their decades of research.
The new SAP should accommodate any new findings as well.
The tennet for FDA approval has always been "substantial evidence of efficacy" on the basis of the drug/vaccine is safe, or the risk and beneficial ratio is obviously in favor of approval.
I recalled one example: when the Wall Street discounted ARNA's drug, but in favor of VVUS' and even OREX's drug, because ARNA's drug was least effective of the three. My reasoning had always been FDA must approve ARNA's drug simply because it is the safest of the three, and it did provide substantial evidence of efficacy despite being the least effective. Although the three drugs were all approved, they provided opportunity of going long ARNA when its share price was very cheap and going short VVUS when its share price was on the roof due to the Wall Street stupidity.
SO if the company can supply "substantial evidence" of efficacy, DCVax-L should be approved because it is safe. It may sound simple but it will be or has been very complicated to accomodate all into the SAP.
And I believe there should be multiple ways to do just that.
Keyword: drafting.
That only means that the company has obtained comments/suggestions from FDA, and other three RAs in regard to its SAP, after maybe several rounds of communications, along with other subjects of matter.
So the company has moved forward to draft the SAP as per recommendation of RAs. Depending on situations, after submission of the drafted SAP, the company may elect to lock and analyze data.
A JULY SURPRISE IS PROBABLE, INCLUDING OTHER MATERIALS NEWS and/or BESIDES TOPLINE DATA ANNOUNCEMENT.
How many of you have bought nwbo shares since ASCO. I did buy a lot as my prediction of the bottom around $0.26 have been reached.
July surprise!
[drafting means start anew. Yes the old one is and has been replaced by new one due to comprehensive new progress in the trial]
Linda, we don't need any useless pr or so-called transparency which is for day trader, the wolfpack, and knee-jerking longs.
What we need is
JULY SURPRISE!
JULY SURPRISE!!!!
you are so funny on your statement "a couple of dozen longs who still support them," in that maybe you meant them in this message board.
Most longs don't check this board, let alone stick to this board. They have done their DDs, and have other things to do.
To confirm one's own DD doesn't require checking a message board on a daily basis, and it is very easy since this company has not bombarded the general public with useless PRs.
To PR anything like a "normal small biotech company" is no different than throw a stone into an ocean; there will be initial splash if you have a good/sharp eyesight/hearing, and it will go nowhere, besides it's just a waste of resources.
Imaging the company announces SAP has been submitted; the company has received encouraging comments from RAs regarding its SAP; SAP has finalized; data will be lock and analyzed on a future specific day/period ...
Things like that can only do a favor for the wolfpack, ie, the naked shorts, and day traders, knee-jerking longs. At end, it will do no good for long suffering longs and the company.
Linda must surprise the market, deal a rude awakening call to the naked and clothed shorts; restore credibility and reputation once for all by issuing a serial of concrete material news.
Setting the trap is the first thing the company needs to do. We need David to release smokescreen; we need Les to file minimally required SEC filing, and if necessary slightly going over regulations is fine in order to achieve decisive victory.
Again, if Linda has one half of my intelligence (well yours as well), the above is a roadmap she needs to follow.
We need darkness now and I refuse anything except topline news!
Pure nonsense!
With an outdated/obsolete SAP, how data should and can be analyzed after initially-intended events had been reached?
CEO has said persistently and repeatedly the trial will not stop at interim -- thus there was not any interim analysis taking place except the 66-event safety look in 2014 (trail expansion), and the company hinted and has demonstrated they are aiming at long-tail (milestone survivals of 3 ~ 5 years hard data (not derivative).
There are tense negotiations behind the scene between the company and FDA, and other three RAs.
To be able to appropriately and effectively analyze trial data, a new SAP is necessary, and we were nearing completion of the SAP at the time of ASCO.
Mind you the trial is adaptive; the advancement and progresses achieved in the past decades in immunotherapical treatment of GBM have called for a new mindset and a whole new full set of parameters.
Definitely FDA is well aware of that, so are other RAs.
Woody selling? A low IQ question for sure. He would rather hang himself than selling nwbo at this price!
So who are selling. It's the few knee jerking longs, traders and moments chasers who change mood daily depending on one or two pennies of share price directions.
Check the posts, and it's obvious who have sold, like Maverick, let alone scotty, JD and the like.
Nothing wrong with it, and it's your money but if you guys are not polluting this board by endless nonsense I may buy another 500,000 shares so you guys would come chasing again.
Who care.
If Linda has one half of my intelligence, the wolfpack and all the above will be gone forever very soon !
See I can also talk nonsense since nothing is new here. The good thing is I only has one post allowance a day. Thanks God.
If Linda has one half of my intelligence she would have been made aware of the obvious pattern of disappointed bb sentiment (due to an event or a news piece which doesn't transfer to a penny or a few pennies of stock price gain IMMEDIATELY, fuelled by wolfpack, and its willing crowd of a variety of compositions).
She would have made numerous rounds of contacts/consultations/discussions with RAs regarding broad and diverse issues about the way or ways forward to the eventual approval of DCVax-L and/or D, including a workable SAP for L.
Assuming I am a person at one of the RAs offices who reviews proposals /requests by, and communicate with Linda, I would tell Linda to draft a brand new SAP, instead of just FINALIZING IT. The reason is obvious as the trial has accumulated unprecedented long years of rich data which no other cancer trials have ever produced, and the initial or its revised version simply is not adequate or appropriately representative, thus it warrants a new draft.
If Linda has one half of my intelligence she would have long determined and planned for a serious of strikes which will not only rip off the last bones of the evil wolfpack but also put those self-claimed nwbo shareholders and the for-ever existing sideliners who attack the company from any angles possible 24/7/365 along with the wolfpack, for a sadly potential few pennies of cheap entry point and/or a pathetic potential few pennies of high flipping point, forever in a life-long sour mood.
The consequence will be huge: it will clear the way forward, and bring much needed credibility to the company. In the meantime, reward those who have endure with handsome gain, in a much anticipated exaggerated fashion, short squeeze.
I would ignore retail investors' endless harassment, letting David to fully deal with the knee jerking, nervous retail investors and/or those who pretend to be investors, and exercise a true leadership to finally bring a truly revolutionary cancer vaccine into surface, and in the process fulfill the duty of taking care of company's shareholder in dollars of sense.
Linda ought to have all means at this time. David ought to make some smoke and screen to cover her grand plan, and Les ought to file all minimally necessary SEC files on time.
Before we see the beautiful dawn, we need a very darkly night to sleep, and to make a perfect duet nobody ought to know when the darkness would end.
So let's be patient for Linda to deliver. At this price range, it is a dream coming true for me to be able to add.
Yes, those placebo patients who chose not to receive cross-over treatment, for an unknown reason, all took a mystic ancient Chinese medicine.
Since then, their tumors have disappeared, and they live and live and live.
This has of course muddied the trial as Dr. Linda and entrepreneur Linda both recognized in multiple occasions.
So entrepreneur CEO Linda has dragged her feet, and kicked the can down the road for years, and she has so far refused to release the trial data.
Not only has the situation muddied the trial, but it has now become a national security issue, since the Chinese are invading.
It has been getting so serious that Donald Trump will soon intervene bypassing FDA chief to personally shut down the trial at the request of Jerry on behalf of all the wolfpack members, particularly its bb squad spearheaded by AVII, Ex, and some other unidentified partners, on the ground of national security.
So I am scared, very scared. And I start doubting myself why I have held so many useless shares, and continued buying and buying? In the meantime I seem to understand just now why those people who have posted nothing but negativity 24/7/365 for years haven't bought or shorted even a single share.
To make thing even worse, it is said I am prohibited to buy or sell any shares, because I am a Chinese, even though there is a saying perhaps to kill the yearning for food is to eat more food, even I planned to buy more share, but it is all now prohibited.
How can I kill my yearning?
Stay tune
OMG, one more mystery Flipper44? take a break. It's a weekend.
Maybe AVII, EX, and the like can answer your new investigational question?
They are all geniuses hanging on message board 24/7/365 for years without taking a position, long or short.
some of really sick people