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Naked Shorting, Share trading trend, etc.
As algorithm has observed and reported and I have said the same thing for a long time since we were at OTC, naked shorting at present is highly unlikely as Linda have flooded the market with cheap shares and warrants since toxic financing started a long time ago.
Naked shorting since partial halt has been obvious and rampant, If Black is going after those bastards, that is the period concerning the naked shorting.
It seems and has increasingly obvious the few institutions, i.e., Linda's financiers (all vulture in nature)who are the only institution investors who have interests in nwbo, except Woodford the inapt, have come to a consensus to keep the share price range band at as low price as possible as incompetent Linda has issued too many cheap shares and warrants to the control of these vultures.
Because they already have enough shares and warrants; it is easy to control in a stock of a dime or two, which will involve only around six figure of dollar daily to control the market barring any significantly positive news; it is also easy to control after presumed "success trial data" or presumed "failure of trial data" in terms of dollar amounts and potential loss and potential gain at the expense;
Expect low price in rang band until something significantly positive to be announced while one have to constantly watch Linda's next dump of cheap shares. UK property as beautifully as it seems, don't expect too much from incompetent and greedy and selfish CEO.
Pray for patients and for the trial to be ended ASAP!
A rosy, logic thought about the status we are all stuck at the moment:
I don't pay attention to all those usual tea leaves like manufacturing ramping up/investment, new hiring, conferences, bk, etc., because they more or less are the same, some are genuine while some are deceptive happening all the time in the sphere of small biotech, particularly for a dime or two stock company. Ok it is enough and I shall be back to the point:
The tea leaf I have paid attention to is the recent 8K. I guess Linda already have the report, the so-called interim blinded data/blended data for PFS, OS, etc., and she has already submitted it to FDA, seeking opinion on the next step or explicitly AA. That's how she cancelled her scheduled London speak, and not keen to impress in the upcoming conference in Nov while waiting for, at least the initial response from FDA. That's why it seems we are really in a quiet period now.
Why, because if I were Linda, I would certainly do the same!
With some very rosy blended results, such as the OS which is like 5 or 6 and above months more than the most rosy historical standard of control OS data, for instance if DCVax-L blended OS is around 26 months or more, it will be difficult for FDA not to consider AA.
All just my opinion and as usual no further response from me, at least for today.
It will be all dependent on the actual data. If the difference between "single arm of DCVax" and the "carefully assembled historical controls" is two or three months, the muddy water you are trying to make may stand, but for a six or so months or above difference, you simply cannot make any muddy water at all.
Wait until the final data are known to make conclusion.
The trial will be finally blinded, and FDA will certainly take a look before it nods to AA based on the single arm of data if it so doubts.
The long promised "publication" will at least partially answer all those questions raised in this board.
If the blended mOS is 25 or above, there will be genning chance of AA thereafter!
[As usual, no reply due to restriction and my willingness of not posting any more than I can afford.]
You guys are jumping ahead too much and too often. If Les had not said it to algorithm, yes there might have been stealth application. Now he said it, it must be fake. Why, if yes, that's a definite material news and it will come in a news release or a 8-k.
Or what he meant by that is that nwbo has been in applications to those four countries for approval since it submitted IND long long years ago. See in this case what he said is not a misinformation.
For what I have been watching for Linda and Les for years, they are not that smart as I initially thought.
They are now just stretching the trial to catch so called long tail for one or two more years of data, which is unacceptable if they are not going to end the trial in Nov.
What is the meaning for "anticipating the disclose of interim blinded data," it only means they are going to stretch the trial for longer period of time.
They are cowardly and elusive!
Disclaimer: my shares are locked for final results, but Linda and les should be damned for stretching unacceptably a long time; as usual there will be no reply from me.
Cofer Black shall immediately be sent to McGill in Montreal now. I am sure the short will be caught red handed in setting up a bug in the room or bribing Lisa or other participant for information.
In the underground world, the short is much powerful than the long.
The reason for the nagging question regarding the hold of screening may be simply the FDA's question about whether the trial had been an Adequate and well-controlled (AWC) trial raised in Summer 2015, after "once again" change in screening conditions in Germany, thus the hold of new screening.
The subsequent actions, behaviors of the company, namely and mainly no communications (abnormally quiet, non responsive, etc.) and the company's stubbornness and desires to impress FDA with a "super good" results, particularly OS all explain that is the cause for the hold.
Kind of a marking process based on general multiple items, the company scored poorly early and it wants to make it up in late, which I believe is a success, evidenced by FDA's nod to the removal of the hold late 2016 (of course technically, why not since the company said it would not seek full enrollment, but it did mean FDA has been receptive of the trial since then).
For the reason above, the company could/can not say the reason, fearing it will crash the stock price and most importantly the confidence of patients, investigator, all other involved in the trail about the future of the trial, thus it may potentially ruin the odds of an ultimate successful trial.
Now, it is also no need to reveal why the hold, because the stock price has been crashed, and the data may finally, truly and practically around the corner.
As long as the company is confident it will have a remarkable which should be much better than safe and some efficacy on par with Optune (much better than Optune), it will end the trial and let the process go and release the data.
Now it may be waiting for that decision, and/or its continual communications with FDA. At this later stage with this mature data point, FDA must communicate back to the company on its chance for a successful approval if the results of the trial are like _________.
The current nagging question for a share holder is the company needs more funds to sustain its trial, service its debt, etc., but at a one or two dimes per share, and the strong suggestion of PFS and OS results. It may be well worthy of a buy.
It seems the only possibility the trial will fail is that the control arm patients behave unexpectedly well, a total contrary to what IMUC, Optune, and other similar trials have reveled.
[this is my only post and unedited; take what is worth in your own risk]
Great find. Thanks. People are confused on the timeline for topline results according to Dr. Cobbs "The results of that trial probably coming out in the next six months and seems promising," which should be instead very clear:
Literally and practically, what he said is that the results of the trial will come out in September, October, November, December 2017, January 2018 and February 2018, ie. the next six months starting from his presentation time of August 2017.
Having said that, the company should come out state clearly what are the current timeline regarding the topline trail results. So it is indeed worthwhile to email/phone the company demanding just that.
I understand the company has a model or models to predict quite accurately what kinds of result it expects/wants, meaning how many more time will still be required to conservatively achieve that, thus the difficulties of issuing a news to clearly say that.
I believe 233 OS events have been reached, and we are all waiting for the topline results, which could happen anytime from now to "the next six months"
Please pay attention to the difference between "the next six months" and in six months.
Please ignore noise in this board, which has been plenty.
As usual you are quick to respond irresponsibly,and negatively.
From my long term manufacturing experience before I moved to academics, I can tell you only one of many reasons why Kat's vaccine cost is high:
At the time of her vaccine preparation, the trial had long been halted for new patients. As a result, the entire manufacturing process had to to started, adjusted solely for the manufacturing her one-person vaccine.
That's a huge cost for the whole system initiated to prepare only one-person's vaccine, which should not be translated to future batch/mass production if the vaccine is approved.
This is a basic knowledge, applied to almost all processes, and known by anyone with an average IQ with a few seconds of thinking.
But you are of course exception, as being a negative spin machine.
no reply to anyone since I have enjoyed my once a day post]
Too many novices recently in this board, and sadly a lot of old timers also conform to that bizarre speculation.
Without a short news release on or about anything new to DCVax-L trial, there will never be any formal publication. Such is just a common sense!
The current run-up of price has nothing to do with leak of any sort about data, nothing to do with any hint of publication of any sort, but it is about timing:
The last two remaining events may have been reached, and an announcement is imminent;
A short time further, data will be announced as is reasonably speculated/expected;
And the general market has been favorable to biotech stocks for some time now, and particularly to IO companies. It may just be a delayed and much sprung-back action as far as price is concerned.
All funds who have shorted or held a bearish view in the past now have to come to term as the time is near;
So far no major pumping article from any of those funds is a very positive sign: they don't want to dump before the news!
One thing for sure is that there will be mountain of change shortly!
Agree on your first half on naked shorting, but bet a difference with your second half of post.
For the first half of your post to be true, and yes it has been, is because we don't have any, not a single deep pocketed long fund on board. The pathetic Woodford is a history, a long gone history.
So if data come out positive, even an ambiguous one like missed PFS and clear SS OS or vice versa, there will be and I have no doubt there must be some deep-pocketed long funds onboard as the long-waited de-risk becomes eventual reality.
As a result, shorts cannot, and will be utterly unwise to do what they have been doing for so long a time; and with media reports, the price will also be supported by "masses", meaning the new retail investors.
If we were $3 a piece now, I would not believe the initial spike will be very drastic, but at around $0.18 a piece, I will bet my house on a drastic rise of share price, due simply to short covering!
As promised yesterday I have sent email to Les Goldman, Linda Powers and Neil Woodford asking them to look forward and come up jointly with a solution for the company to smoothly move into the next step: get DCVax-L p3 trial results/data analyzed and published.
I urge everyone to write them in your own way. If enough investors write them, they may listen.
FYI: the email I sent are as follows:
"
[My name and email address]
Jun 7 at 10:32 PM
To
lpowers@nwbio.com lgoldman@nwbio.com
Message body
Dear Linda and Les Goldman:
I have been a long term investor of Northwest Biotherapeutics (OTCQB: NWBO), and thank you for all you have done for the company and shareholders. Today we have finally come a long way toward the long awaiting revealing of the trial results.
However, in order for the trial to be finalized (now only two OS events outstanding), analyzed and for the results to be published, one significant obstacle is to secure enough funds for fulfilling company's debt obligation and also for the general operation of the company.
I have emailed Neil Woodford, asking him to take the initiative to contact Linda for a solution moving forward.
My hope is Mr. Woodford can finance the last step of the trial for the common good of all investors of both Northwest Biotherapeutics and his funds.
Best Regards,
[my name]"
"
[my name and email address]
Jun 7 at 10:29 PM
To
neil.woodford@woodfordfunds.com
Message body
Dear Mr. Woodford,
I have been a long term investor of Northwest Biotherapeutics (OTCQB: NWBO), and thank you for your prior support to the company as the main financier for quite some time.
You may be aware of Dr. Marnix Bosch's 5 June Presentation on updates about DCVax® Clinical Programs which confirms the great potentials as your prior DD has uncovered.
As DCVax-L P3 trial draws close to meeting its targeted 233 OS events, which could be reached next month as Dr. Bosch has predicted (as of 5 June 231 OS events already occurred), the company is in its last step to the final analysis of data which will determine whether the trial is a success or not. However, the company is also in a dire financial situation, which if not handle appropriately, could mean one more repeated devastating dilution of the existing shares, or even default on its obligations.
As a share holder, I earnestly hope both you and Linda Powers, CEO of the company can look in the future, and come up with a solution for the common good of all investors.
Can you please take the initiative to contact Linda?
Thank you and best wishes,
[my name]
Please don't forget write on subject line. GL!
Urgent please take action:
I am going to write to Woodford Fund/Neil Woodford today to ask him to once again come to the support of nwbo after his funds have invested around $180 in the company.
It's time for him and Linda to come to the table again. The company only needs about $7~10 million to see the final results of DCVax-L trial.
For that reason also, I am going to write to Linda Powers as well.
I promise I will do both of that, and urge every investors to do the same.
BTW, I started buying again today, only 9k at $0.165, but most of posters know I already have had a very significant number of shares.
GL and be happy!
[this is my one per day post]
Let me put this way: the whole paragraph re PFS is nothing of concrete substance. Note the key words, "to the current knowledge, bra bra bra," which means tomorrow the company may have know PFS data and it can decide to release it.
But no mistake, the wording of such doc has always been tricky. Bottom line is LP can release PFS data anytime she elects to after today (the current).
Before release of topline data, all businesses are just as usual.
Today's form D: my preliminary sense is that it is very significant!
It includes all directors and senior management in a legal stealth financing "coup" to purchase shares as one means.
By 2 May, a total of $52000 worthy of stock has been purchased. The limit of this purchase is $5 million worthy of shares, etc., according to Rule 506(b).
So I guess the arrangement has been made and no further toxic financing with the usual wolfpack financiers will be conducted until the final DCVax-L data are announced.
Interesting!
[I am limited with one post per day by this site, so I cannot reply to anyone. Sorry!]
Ladies and Gentlemen, investors or non investors, please put RS, bankruptcy, and other similar chatters on the back burner until after the data, which may come any day from late this month to late June!
Now focus on what kinds of data we will probably see. My worst case scenario based on all public information available today, including my estimate that 248 PFS events were reached during Nov 2016 ~ Feb 2017, and 233 OS events have at least not been reached in Feb 2017 (of course the later the better):
We missed in the median PFS primary, meaning there might be no separation when 50% PFS events occurred between both arms, but we will definitely see some separation if not very significant separation of PFS after 50% PFS events, and/or when the 248 events were reached;
We will see meaningful OS separation between the two arms: the early vaccine arm (the treatment arm) and the late vaccine arm (the control cross-over arm), much more meaningful OS separation between the treatment arm and the control arm (those patients in control who elected not to cross over) or the historical data.
I don't see any problem for FDA to approve the treatment if the above turns out to be true.
Any other scenarios are more or less much positive than the case above, which will be readily followed by FDA approval.
Now it's time for countdown!
All Sings Point to Big June!
I guess it is Les who again lent the company, this time the amount is $ 1 million on 5 May which is due on 30 June.
My rough estimate is that the company have about $5.6 million since 31 March. Together with certain prepayments, without serving any debts (withhold) to Cognate, the company should be able get to mid June.
But the company may still need to come up with $ 2.5 million loan payment. Probably it will be funded by another collective loan from directors, senior management.
The big thing is that we may hear something definite from late May to mid June.
That's my guess.
" 12. Subsequent Events
On April 14, 2017, the Company entered into Stock Purchase Agreement with multiple investors. The Company issued 1,384,615 shares of common stock at a price of $0.26 per share. The Company also offered Class A Common Stock Purchase Warrants to purchase up to 1,038,461 shares of Common Stock at an exercise price of $0.26 per share (the “Class A Warrants”) and Class B Common Stock Purchase Warrants to purchase up to 1,038,461 shares of Common Stock at an exercise price of $1.00 per share (the “Class B Warrants”). Both the Class A Warrants and the Class B Warrants are exercisable immediately. The Class A Warrants are exercisable for five years and the Class B Warrants are exercisable for three months. The Company received gross proceeds of $360,000 from this offering.
On April 19, 2017, the Company entered into a financing in an aggregate principal amount of $2,250,000 in the form of promissory notes with Toucan Capital Fund III, LP, an officer of the Company, Leslie Goldman, certain directors of the Company, Jerry Jasinowski, Robert Farmer and Cofer Black, and an unaffiliated investor. The notes bear interest at 10.0% per annum and are payable on demand with seven days’ advance notice by the applicable holder.
On May 5, 2017, the Company entered into a loan agreement (the “Note”) with an individual investor (the “Holder”) for an aggregate principal amount of $1,000,000. The Note bore interest at 10% per annum and will be due by June 30, 2017.
During April 2017 and May 2017, certain existing Class C warrants holders exercised an aggregate amount of 4,900,000 warrants at an exercise price of $0.01 for cash."
Ask AVII who at least knew something that really happened behind the scene: a long existing conspiracy or orchestrated shorting/destruction scheme against nwbo share price/the company.
He is the guy who "happened to" first locate the video, spearheaded the premarket, market and after market excessive discussion of "the failed trial" stressing in a manipulated way of the words used by LL "not help" the trial, possible design "issue", etc. All these had done so to aid the dumping (a big chunk of it naked shorting) shares, to make the market appear to "finally realize the trial has no hope" despite patients seeming to be living longer than would have been expected.
Then, same thing happened WRT LL's second video some months later. The guys in IV were talking about "youtube" video in lengths in the morning which I checked and found its nonexistence in the morning, and it only appeared in the afternoon (note: the only video was available in the morning that day is LL's facebook talk).
Believe or not, there is indeed a wolfpack, an orchestrated conspiracy, and a huge naked shorting scheme existing against the company. Because of that, my share purchases afterwards have been tagged with it, and I am now completely ready for nothing or very much higher than I would expect return if the company can have some positive DCVax-L data, or some similar concrete news.
I strongly believe the company knows it very well, but it's better not stir up the hornet's nest yet if the company cannot have a concrete approve for its prosperous future yet.
That will soon changes after positive DCVax-L data are released. If that is the case, I believe the orchestrated short scheme will be readily destroyed, and somebodies would be charged for orchestrating the shorting scheme, etc.
Patients were killed by Cart-T, first in Juno's trials and now in Kite's trial while the Wall Street has yet to be awaken from last night's dope. So when DCVax-L is proved to be the king in IO soon, the Wall Street will still have dope itself in endless parties but would have new song.
I reviewed one of my previous post, and thinking whether I should add more as price has come a long way to become much easier to handle:
" Dan88 Saturday, 07/09/16 11:36:54 AM
Re: None
Post # of 74519
The current development regarding FDA's order to stop Juno's pivotal P2 trial due to deaths of patients has a very significant meaning regarding the future landscape of cancer treatments:
Cart-t as a group may have run into corner as the investment world finally comes to a long overdue conclusion: this class of treatment is dangerous, cumbersome and costly, and its benefit/risk ratio is so unfavorable.
CI as a class has shown some success with very limited treatable patient population due to its nature.
Increasingly, more and more people will realize DCVax as a therapeutic cancer vaccine platform will emerge as a new and broader blockbuster cancer treatment class due to its pristine safety profile and potential significant efficacy; with combinations with CIs, the platform may be potentially a cure for some cancer indications.
At this point of time, anyone who is debating on the purpose of debating is obviously naive or up to something that a normal investor will not do. So please stop engaging in such distractions, either from an old topic which has been discussed before with no new meaning but endless new speculation; something to do with fine prints pulled out from company's sec filing which have been covered in the previous discussions; and any other FUD such as tailored, sometime out of context copies and pastes of some selected FDA documents, and ambiguous subjects such as comparing a "lackluster device" to a potential blockbuster cancer vaccine treatment in any angle negative or ambiguous possible, etc.
The bottom line is if DCVax-L or D is proved to be better than any existing treatment in any indication in terms of safety and efficacy, it will be approved by FDA; even if L or D might be shown similar in efficacy and/or even safety to that of any existing treatment, it will still be approved by FDA as an alternative which can applied for specific patient populations.
While one may get carried away from a useless debate, he or she must always remember that at $0.5 a piece per share, basically the market has priced the company a failed company, the L trial a failed trial, LP a failed ceo, and all long investors failed hairballs, and nothing less.
Don't tell me the company will go bankrupt if you are genuine and have a bit biotech experience, only if LP had nefarious motive if you believe. A company like nwbo will not go bankrupt at foreseeable future, though it is a likelihood that the company will survive simply by diluting its existing share holders.
Nonetheless, as long as the potentials of D still exist, as long as there is still likelihood that L may still be used in combinations with other agents such as CIs even if L is proven a failure in brain cancer indication, a market cap of around $100 million will be normal, which will give you roughly $1 per share of stock price.
Not saying the company has not filed a BLA (rolling application or not), not saying the company has not sought AA, but what I am saying is the current situation indicated by share price has totally denied any possibility of those and regarded the company a failed company with a failed L trial.
It is then a natural, logic, reasonable and certain conclusion as long as investment is concerned: buy nwbo shares as many as and as much as one can afford at this option price.
It is either $0.5 loss or $30 gain or $300 gain.
It is my strong belief that there will be a major short covering coming within the next few weeks judged by current ultra-low share price (it should have never been at such a low price, no reasons, absolutely not), the closeness to a major revealing of many optional developments in the company, and the current on-going change of tide shifted from cart-t and/or CI toward DC-based therapeutic cancer vaccine treatment (cure) (note: it is my speculation)as well as the general trend of money inflow to biotech, which is on going.
Because unless shorts have bullets penetrated their heads making them totally blinded, a major short covering must be and will be coming, even if I prefer it not! "
FDA approved a drug called Radicava (edaravone) for ALS, which has been marketed in Japan years ago and the approval is based on a trial which was conducted in Japan.
That says something about the mind and thought of the current FDA. It has actually stun me, and it seems FDA is now far more flexible than I could imagine after Donald Trump took office.
And a rumor is flying today that within FDA, CNN is dumped and replaced by FOX News.
All doesn't matter for me since I believe DCVax-L will be approved based on the most stringent FDA standard, but the flexibility of FDA doesn't hurt either.
Very soon it will be approved for not only safe but effective in treating GBM.
Bio, I know where you come from and particularly well you are one of those who strongly don't believe "the naked short thought." But I tell you it is there unless we don't have gravity on earth (not literally), meaning no rebukes stand today which contradict that.
My belief of the existence of huge numbers of naked short shares began last year after relentless price drop, seeing round upon round of toxic financing, meaning LP had failed to find even a single financier who would be long the stock.
Then, my belief was shaken up a bit during and shortly after nwbo moved from Nasdaq to OTC, which it was reasonably believed that anyone with a major naked short position would cover and go long unless these guys were out of mind.
But every evidence after that says otherwise. So these financiers (shorts) along with their cooperator, like NITE, etc., must have accumulated too large a naked short position each that they cannot practically cover without seeing price goes skyrocket.
It is purely this belief I have made the recent two large purchases, and I am going to do so each time if the price drops a penny or two.
The ultralow price has made average down and initiate a new position super easy.
[I appreciate most of your posts, hope you can hang on. End of my first and last post for today]
It's writing on the wall: I 100% sure there are around 50 millions to 100 millions of naked short shares which still have not yet found a way to cover:
From the perspective of ultra low share price we are having today, the need for further financing or the fear for a toxic dilution is unlikely the reason at a market cap of merely $33 million for a potentially blockbuster cancer product which may be confirmed in a short time.
The only reason I can come up with is there is indeed around 50 millions to 100 millions of naked short shares in the book which still cannot be covered if around 20 May we don't see a major share price appreciation, considering on surface almost all financiers (shorts) of the company must have piled up millions of shares each after rounds upon rounds of toxic financing in numerous spread out accounts so that they are kept below the reporting 5% thanks to Linda's incompetence in financing such as her shortsight or selfishness or greediness when we were in sunny days when she could easily secure at least one year or so of operating funds at much high price, which almost all other small biotech in the similar situation would usually do, a common practice. She has failed us, which is not my point today.
The point is if there were no significant naked short shares existing today, there has been no reason, absolutely no reason that these financiers, with millions or tens of millions of shares pilling up would not let the price go free market, if not hype the share price which is actually usually the case for almost all small biotech companies which have a major binary event around the corner would do, particularly in a market cap of a negligible tiny $33 million in the case of nwbo. I have invested in several dozens of small biotech companies before with a binary event around the corner, none have behaved like we have seen for nwbo.
So If no major share price appreciates with significant volumes around 20 May, I cannot come up with any other reason except that the market forces, i.e., those financiers, funds, etc., which have involved in financing and trading of nwbo, excluding pathetic Woodford funds, must owned much more naked short shares than their publicly traceable shares.
So it is their interests to maintain ultra low price as much as possible, let alone bankrupt the company. Besides, they still are dreaming that they can for the last time get a major toxic financing. They may get it, but it's all dependent on Linda's capacity.
My confidence in the company's odds to report positive DCVax-L results has not changed, and I have adjusted my target price much higher due to my strong belief in the existence of a huge number of naked short shares, dozens of millions, or even hundred of millions.
Thus, I have made two major purchase of shares yesterday and in the last week. There is going to be a sign irrefutable in a very short time indicating that the vaccine is an ace.
[this is my only post today]
Just saying the company can release m-PFS and/or mOS (or average PFS and/or OS) data blinded at any time.
This will not violate any rules (except that stupid restriction on PFS after 20 May) or compromise trial integrity since the company will still be unblinded.
But it will inject vitality to the company in terms of market perception, easy financing and a huge relief of pressure for long suffering investors.
Another way of injecting confidence, though not as the same as the above in significance is to refinancing UK property to take most principles out of the property in order to fund the continued operation until the final PFS and OS data are released.
Or a more significant way than the refinancing UK property is that company's directors once again put a significant amount of money, for instance, $8 million into the operation as a loan and saying the funds available are enough for the company to see the final results.
Or have a usual speculated partnership deal released with significant money amount upfront, though I don't give it a dime before DCVax-L data.
I am weighing on one more significant purchase of shares. I must be crazy or I am exceptionally sane since I already have had a huge stake in the company!
Today is a tipping point in favor of buyers technically and fundamentally. So I am a buyer today for additional 100k at average of around $0.193.
Any new shorts are unlikely and any new naked shorts are technically to manipulate or defend existing naked short shares.
At this price and at this stage, only one month away for a potentially binary event. The company may release if not whole at least PFS data in May.
Although our usual financiers, ie shorts have sold lots of their shares while keeping warrants, there are still lots of unsold shares in their hands. At this price, considering incoming binary event, which could potentially occur in May for PFS data, and OS data in a later time, it is highly unlikely it will do any favor for the shorts to cash out their shares (not much room left for profit) or short new shares unless they have brain damaged.
Instead, shorts will start hype the price while eagerly waiting for the data release.
If data are positive, the shorts can suddenly become major shareholders to ride the wave up, and if data are negative, shorts can easily close their short positions.
At the end of day, it is data that rule! In conclusion, the best strategy as of today as long as the price is low is doubling down.
The company wanted to modify the trial in order to make OS as primary endpoint or at least co-primary endpoint along with PFS, thus as this is in the process, no interim analysis or analyses have been undertaken. There is certainly no data regarding IA whatever.
The shorts have taken this advantage to smear the company.
Regardless what is the result of that regulatory process, the company has to treat the trial as such so that OS and PFS are the main endpoint, kind of the same as the two co-primary endpoints.
And regardless whether or not FDA has agreed with company's application to make OS as primary endpoint or OS and PFS as co-primary endpoints, FDA has no choice but approval DCVax-L as an effective treatment for nGBM as long as DCVax-L demonstrate survival benefits in a significant way.
This includes various scenarios. Besides the obvious ones, if DCVax-L can demonstrate a truly long tail in either PFS and OS for a significant portion of patients, such as more than 15% ~ 25% (in reference to approved CI treatment) survival at three years excluding pseudoprogression patients, or 30% or above including pseudoprogression patients(compared to about 10% or so for historical standard cares), it should be no problem for FDA to push the button of approval.
The above is my speculation at this point, there are definitely other possibilities.
It has nothing to do with compliance of laws or regulations! It is just a pledge from the company that PFS data will be still blinded until after 61 days for the earliest. Nonetheless, it is strange such request was raised in the first place.
Linda is incompetent in managing a small biotech company, particularly in the area of financing, which is the most important part of small biotech CEOs. Her biggest strength is her thick skin and resolve to see the full potential of DCVax-L if it does exist.
She can only be vindicated with a successful DCVax-L trial.
Woodford is pathetic and incompetent too in the case of his investment in nwbo. His clients and investors should bombard him to see his $180 investment go down to merely millions by taking no action, or actually negative actions talking negatively about the company in the excuse of government. He is a loser!
Anyone who has stomach should be buying today; yet we may see one more financing at term either worse or better. But what you can lose considering staggering profit potential in a few month?
The cost of a trip of a family to either far east or Europe can give you 100,000 shares. If DCVax-L is successful, your shares will be worthy of one or two millions of dollar; if not, well you just have to take one less oversea trip.
Usually if some ones (some short funds) think it could be spun negatively and they are ready to dump some shares (naked short) to paint an essentially neutral if not good news as bad news, then they will find some one to upload it in youtube, which would be alerted in message boards.
I don't think it is coincident in the past that all those "eventful" talks of LL had been first reported or mentioned by AVII. In one occasion, namely, the Dec talks of LL of which Facebook one was available in the morning (I checked it at the time) and the youtube one was not available (I checked it) until afternoon (I confirmed it), but yet AVII and his buddies were talking it in the morning as if that talk were already available in youtube. I was definitely sure at that time, one of them later uploaded it to youtute.
Unless it is some clear and indisputable information. It may go the usual pattern.
Our stock has had no splash, even not some bubles in the investment community since Woody's disaster move, and he is talking noble.
Pathetic.
His clients should take actions to bombard him for his inaction and indifference in the excuse of governance.
Patients are living longer. Let us see how longer they have lived and are living, relative to concurrent/historical controls.
That day is just an arm length away!
The other playbook of running a cash-depleted small biotech company like nwbo, in face of a binary event, to live or to die. Actually a playbook of running such a company in a NORMAL way or the way that naysayers would have expected (must be noted by definition naysayers would be always naysayers on a company regardless what the company does!)
Background: NWBO needs financial resources to run its business, and it is faced with a live or die binary event anytime from now to June.
A NORMAL company in such situation would at least do the following (either the company is confident or not in its chance to excel from the binary event): [I say this based on my observations of small biotech companies from my decades investment experience!]
1) Release news regarding any conferences to be attended and/or have attended, with/without abstracts, or presented materials;
2) Release news regarding progresses of any patents in application or granted, highlighting the importance or potential huge future financial implications of the patents, such as DC+CI, etc.;
3) Release news regarding any existing, future and concluded P1, P2 trials, highlighting the potential and financial implications of those trials. As naysayers have pointed out any P1, P2 results are readily "cherry" picked, meaning it is easy to "pump."
There is a long list of those trials that the company can make a splash in the investment community, such as the combo trials with big pharms, the excellent or "excellent" Direct trials, the DCVax-Prostate p3, the DCVax ovarian, etc.;
4) In nwbo website, the company can add a job section, posting multiple job hiring announcements, full of implications of future success and the company about to become a big pharm;
5) Update the investment communities about its manufacturing/plan/progress developments in UK, Germany, and US, touting the huge expansion of its closest cooperator Cognate which has embarked on a crazy expansion in all angles, such as continual personal hiring, floor space expansion, new equipment ordering/installation, etc.;
6) Do whatever possible to continue the company, such as reverse split, diluting the shares to raise enough funds to survive, careless of the interests of investors. As long as Linda has a company to milk, she can just make the outstanding shares ballooned to hundreds of millions of shares, so no worry about her future as CEO. In the process, victimize you little investors;
......
But the reality is that we have had nothing of all of the above. why Linda is solely focused on DCVax-L and its near future data readout? Is she not worry about the capability of the company to continue to exist if the data readout were not good, although she can just let the trial of DCVax-L aside now and selectively do some of the list above?
Why Linda is not running our company in a NORMAL way? Why? If she sees the light at the end of tunnel, do you?
Great News: Now the Playbook Is Out, Shorts Must Run!
It's out there how the company must pay its debts:
a) $ 0.5 m [checked] in March
b) $ 2m [to be checked] in April
c) $.5m [to be checked] in May
d) $5.5m [to be checked] in June
With last weeks' raise of $3 million plus December's raise of about $10 m plus payments to QA/QC, successive lock-in PFS/OS data, etc., I guess the funds available today are enough for the company to handle all its financial obligation before June.
It seems to suggest once again before June it is highly likely the public will be informed of the topline data of DCVax-L P3 trial.
It is also suggested from various signs and this filing that it is likely the trial will be stopped for efficacy earlier than June, not by the company but by FDA.
If there are a large number of naked short shares there, for instance in the range of 10 m to 50 m, then those shorts have to run and cover, at least half of those shorted shares!
Of course how they will do that, they will have a strategy on timing, quantity, message board chatter, and you name it.
Conclusion: Naked shorts will play a significant role in the runup to topline data release. So will these Noteholders whose interests are to see the success of the company, particularly with their load in the line, and plus their more than 4 m shares now in line too, it's not hard to see the noteholders will act positively.
Shares price will be most likely appreciated !!!
Today's 8K is the best news that investors can imagine in the recent tough financial situation:
First, it indicates the company now has enough $$ to pay that $11 million note triggered by its moving to OTC, and wait for the final data readout in and around June, if not earlier by regulatory agency;
Most importantly, the most-lethal weapons of the naysayers in the most recent weeks is a huge speculated dilution, dilution and dilution, at $0.25, $0.20 or $0.15 for each piece of shares for a total of millions upon millions of shares. That has been turned upside down by Linda.
Good job Linda, and thanks!
I would guess he would take her to MD Anderson to see dr. B for a nice chemo treatment. Not kidding, as he does have a daughter, and judged by his indifference and "conscientiousness," he would ask chemo for her daughter. He had that kind of experience, and he hated anything which "has not been approved" but chemo. That's the reason for his passion against vaccines. His daughter was a victim.
Hey, that's not DCVax, was it?
In the case of nwbo (now I am on topic), for a tool to be working, it requires objects to be worked with.
Fortunately, there are numerous retail investor objects in this board to be worked.
Shorts (aka, the naked ones, aka NITE, EX)know topline data could come in the near future, but stress via tools it will only come several months away.
I think Linda has played smart in this one. We shall see!
Maybe the company will instead have a CC next month, and one every quarter thereafter!
For that being turned out being true, the company will announce topline data, the successful PFS data and positive trending OS data.
It's a long shot, but practically a possibility since we have had over 248 PFS events sometime between Nov and Feb.
QA/QC, and locking of data may be moving fast behind scene!
If the company elects to do just the above, it absolutely doesn't contradict what it has said in its early Feb news announcement.
I guess the short interests and many retail investors both see such a possibility, the former pretending seeing it impossible while the latter mostly stop posting altogether!
Expect the shorts to interpreter the company's early Feb news announcement "literally," and "logically" for the first time ever. Actually they have done just that, and yes, any data are several months away!
June, July and even second half of 2017, LOL
The market (ie, nite, ax.) says why there are still so many retail investors hanging out their in message board, meaning there may be still 2 millions of so shares wavering in the low branch that shorts can pick them up from the ground.
Let's go get them.
If you really want to see share price increase, sell your tiny holding.
After that I grantee you the price will only be up. LOL
Disclaimer, I have some dry power handy!
BTW, to whom it is concerned, I am talking about my humble analysis of share movement of nwbo share price, so it is on the topic.
This is my empty-content post dedicated to NITE and its twin brother ARXS, as well as my fellow "long" retail investors!
NITE and ARXS
Actually what he said is very bullish in my opinion. My interpretation of his words is that there is a growing ethic concern for the company to release the data (he believes that the data is there and have been kept for more than one and one half years) by the company if HR is anything close to 0.7. So by keeping it, it is unethical!
So he guessed since the company has not released the data because HR is no way close to 0.7, the trial might be have some problem; otherwise why the company has not published the data or why FDA has not stopped the trial due to an overwhelming success (indicated by 0.7 HR in August 2015).
When he was talking about that, he might be just appeasing his host (MD Anderson) who is strongly again nwbo, or maybe against anything not chemo, by even forgetting what he was talking about is called immunotherapeutic vaccine in which it is very rare one would see a success at such an early time of the trial, let alone a success with such an overwhelming efficacy evidence indicated by 0.7 HR.
So the worst of his guesswork regarding DCVax-L p3 trial data is that in August 2015, there must have had no obvious treatment efficacy (HR0.7) because if that is not the case, then the company would have released the data by now due to strong ethic concern.
Well, the HR was not 0.7 at that time (it is even not in my wildest imagination that I would think that could be the case), but it may just be close to 0.7 now or in the near future.
Then, if that is true, there will really be an ethic concern for the FDA to stop the trial before the 233rd OS event is reached so that the magic vaccine (at 0.7 HR) can be made available to suffering patients ASAP.
Not any of the experts you ask your question to but I will try. Docs in the video are just talking the obvious truth that they have not seen huge immune response with DCVax-L in their site for a dozen of patients treated.
Should they or us expect huge immune response from DCVax-L? If your answer is yes, then you certainly have not done your DD.
The very fundamentals of DCVax-L is 1) its pristine safety profile, which is a big plus; and 2) not yet approved efficacy.
You can check 1) now, and as long as the 2) is concerned, nobody knows at this time but the final results will be out, maybe as early as late March but not later than June.
If you believe Dr. Liau has said, "all patients live longer," then the only worry if any should be if there is indeed some separation. If yes, DCVax will be an approved treatment this year.
On the other hand, the fact these doc in this one site in treating a dozen of patients observing no huge response is actually a good thing besides it is an obvious truth, which any investor should be aware of because it means our worry about pseudoprogresssing "wreak havoc" may be just overblown in and of itself.
And this should also not be a surprise at all since the pseudoprogreesors should be excluded from the trial according to the trial rules/protocol. This actually means the site has done a super job to truly exclude any pseudopressors from the main trial.
No one should expect DCVax-L would kill patients due to uncontrollable immune response, just as the case associated with Cart-t like Juno, etc., and that's the beauty of DCVax-L.
Moderate, can you please remove that now proven false in-stick post by Pyrr.
Thank you.
Sorry, let me say you have not done your DD adequately. Yesterday you seemed to doubt the total number of patients (331) who have been SCREENED, RANDOMIZED, RECRUITED/ENROLLED, AND TREATED IN THE TRIAL, simply effected by a flaw laden deceptive post. Wow, I said to myself at that time, particularly saw you claimed you had 100,000 shares which I have no doubt that you truly have by the way.
Now come to your question in the post I am replying now:
First of all, the trial has always been designed and aimed for at least two endpoints: the primary PFS and secondary OS endpoint! There is no change there. They are always there.
Second, anyone in Linda's shoe should consider the possibility: if in case PFS failed to meet its 4-month benefit in a statistically significant way, or even if it meets it, but OS benefit trend may be murky due to the effect of patients cross over, what should be or can be done to prevent a potential death penalty to the trial?
The answer is that a further de-risk is needed before data is un-blinded. Nobody should doubt the company has spent and still worked hard to negotiate or have a ongoing dialog with the authorities towards achieving this goal.
Among many things that the company could be in seeking, one may be to promote OS endpoint to a co-primary endpoint in parallel with PFS, so the mentioning of "the main endpoinS," in the recent news release or sec filing.
Even without the seeking for co-primary endpoint status, in accordance with the initial design protocol, the OS secondary endpoint is still very important. If there is a way to show unequivocally that DCVax-L can truly provide significant OS benefit, coupled with/without the PFS primary endpoint meeting the target, the OS benefit alone should garner approval from the authorities.
However, to be able to achieve that goal would require painstaking efforts, for this I applaud LP's efforts and her steel mind for not giving in any internal and external pressure to be "more transparent." Sorry guys!
I also applaud her resolute to see the trial to the very end to gain as much and as many data as possible in a blinded way.
All this is to try to guarantee the trial would not be failed prematurely. That's important for me and I think it is important to anyone involved, investors, patients existing or future, and the general S&T advancement!
So it should not be surprised to anyone that the company must consider more than one endpoint!!! While the company must make sure the trial has reached its 248 PFS event number, it must also take adequate consideration on whether it has enough OS event number for the reason above.
[this is my only post for today] God bless!
Whatever the form of a possible future approval is. It will be based on data.
So everyone, docs, patients, and anybody can judge how good and robust and safe is the approved vaccine.
The reality of the world now is the corrupted FDA has given no chances to lots of small biotech companies with provable products.
FDA ought to be changed and trust the judgement of the people!
Again NITE showed up shortly after 8am taking up the front bid and ask.
If the trend continues, it will opportunistically intervene after a significant block of shares are bought at a significantly high price for the day.
Then, the price would be back to what it seems to be where NITE so intends.
Since retail investors are peanut in terms of the control of shares, some retail investors would be gone if price increase by 25%, some more at 50%, more than 60% of retail investors would be gone if price increases by 100%, which is around $0.8 per share, not any CEO in this situation should take a serious account of what retail investors are thinking, demanding, etc.
Linda should be focused in her job. Make sure first of all the quality of data, sorting out important outstanding issues with FDA, before releasing accurate indisputable data, which will draw not only the attention of massive retail investors, but most importantly the wall street institutions which would not take a position at the time being due to well-known reasons (one is what NITE workers and contractors have been doing day and night in message boards and in the media).
Until then, we may stuck in a tight range, and after that, NITE will be taken care of in a tsunami of recognition and wakening at the Wall Street.
Approval or not in a narrow sense for investors, at least for me is the only question in my mind.
What do the FDA, us investors and most importantly the patients consider whether DCVax-L should be approved or not?
Firstly and foremostly, it is the safety, followed by efficacy, or in combination the ratio of risks and benefits, with the safety the most problematic for approval for almost all drugs/vaccines/devises ever developed in the eye of FDA, and rightfully the eye of the public
which we all seem to know very well until we stumble on trivial things, typos or a not well-versed PR, etc., willingly or unwillingly, insinuated by FUDsters.
Now let review what we have or what we can agree upon:
I guess DCVax-L is safe, or very safe compared to any other class of drugs/vaccines under development or approved, such as CIs, Cart-t, etc.; with the risks portion in the ratio of risks/benefits is very low, close to zero, we only need to see or confirm some benefits, ie, efficacy of DCVax-L in treating GBM patients, and then the FDA should have no problem to prove it to be commercially used.
Of course, this matter will not be a clear cut, or black or white thing. The most complex and hard enduring experience we investors have all been experiencing in this investment is a testimony. But I will quote Dr. Linda Liau's reply below in conclusion:
"Dr. Liau's answer
Hi Xxxxxx,
Yes, the patients do seem to be living longer with DCVax; and no, I did not mean to say that DCVax would not get FDA approval. I was making the point that, whether or not the study fits a particular category endpoint, there should be a way to get approval if the data shows that the entire group of DCVax patients (in both arms) does better than concurrent/historical controls who have not gotten DCVax.
Hope this clarifies the issue.
Thanks,
LL"