As this week's PR from SITC can be transformational, I wanted to step back and share what I see to be the larger breadth of Linda Power's vision and strategy unfolding before our eyes:
- Global company, global revenues, global manufacturing (not just US, Germany first, UK second, other EU countries to piggyback off the PEI and MHRA regulatory bodies, Israel) - Patient first & Compassionate Use (55 person information arm for those not eligible for DCVAX-L P3, Israel, Germany, UK, cross-over design built into trials) - Go Big (no BP partner, no 50%-70% dilution of future revenues for up-front cash to run P3 trials) - Strategic partner Cognate (able to push forward and control critical R&D development, global production quality & approvals, and guard mfg secrets + provide a funding vehicle during this clinical trial phase NWBO is in) - Immunotherapy cancer cure, SOC [interjecting my hope here: be low cost and disrupt the standard $100K+/yr pricing of cancer treatments that gouges the US healthcare system, relative to much much lower pricing elsewhere around the world]
Excerpt from one of my older posts for emphasis:
- even with lots of money, not many other companies could accomplish what NWBO management has accomplished during the same time frame. Not all CEOs have the vision to invest the time and money in the EU when time and money was so scarce for a small company like NWBO. - even while operating on a shoestring budget and staff, NWBO has done what other companies could not. DCVAX-L is the "first" to get hospital exemption in Germany and for UK, the first product selected for the first step of a two-step process to receive early patient access likely in 2015, which leads to revenues.
Exactly. The Cognate relationship today provides many critical and strategic benefits during this critical developmental and funding life-cycle phase NWBO is in. All of this works itself out, if there is anything to work out, during the next phase when there are revenues and large institutional investors and related BODs take on their fiduciary positions and roles and review and approve all new or extensions of manufacturing contracts for market terms.
Pyrr - In your SA article you mentioned that the sample size reestimation went from 240 to 348, but if the blinded sample size reestimation proceedure (BSSR) had calculated 360 instead, then that would have indicated that the event rate was so low that the reason almost would have to be due to superior Tx arm efficacy and not due to super low events from both control and TX arms, therefore warranting the DMC to recommend a halt of trial due to efficacy.
It seems we were so close there. Given measuring event rates overall do not require unblinding, could the DMC have another view of the overall event rate and calculate BSSR again before the first interim analysis? If an additional 3 months gets the DMC to the statistical confidence level, then we don't have to wait 6 or 12 months to the first interim.
Stac, If Direct's Ph1 results to-date are WOW and truly indicate an ability for NWBO DC's to overcome local and systemic immune suppression by the tumor, then I've got to believe there will not only be a company PR Tue or Wed well in advance of the SITC Poster Exhibit on Friday, Nov 7th but also some sort of investor conference call the following week to explain what this means for the company.
That would be in addition to (or because): - publishing the scientific abstract on SITC's Journal for ImmunoTherapy of Cancer which lay people might not understand and most do not read - MD Anderson doctors at the booth communicating with visitors on a one-on-one basis which nobody can listen in on.
This stock is closely held, it's difficult for institutions to take a position.
That makes sense. I would venture that on the retail float side, the remaining holders are longer-term folks who won't sell due to manipulative news or PPS fluctuations.
The storm will be the next run on the news. That's the way they make their money... run it then sell at the top and short it down. Cover, rinse, repeat.
That seems to have been the history.
However I believe the "next run" cycle could last 3-12 mos with a PPS running 3X-10X. There are a number of news items that will develop, primarily Germany/UK sales and sale projections, additional countries, and interim results on L and Direct. These, if positive, will not be short term, ie not be manipulated a day later by AF. The fundamental shifts I see will result in stable institutional investors taking positions. - PPS correction (currently extremely undervalued, go to fairly or strategically valued) - fundamental realignment and perspective of NWBO from "speculative" to "investment"
My intuition tells me that Linda has a plan. I suspect the last 2 weeks of buying from around $4 to $5/sh today were not shorts covering, more so institutional investors. Of course my intuition has a margin of error that competes with Diamond Jim's magic eight ball.
IMO - it's the lull before the storm. MM's have reloaded and waiting to pull the trigger. - by Xena
Thanks for the charts but sorry I'm not good at reading charts. Can you elaborate on the above? Did you mean by MM's to be institutions that are long (recently increased their holdings and when news hits will take on significant positions) or shorts that covered some and are positioned to re-short when news arrives?
Along the same lines of appreciating the depth of NWBO's accomplishments during the last several years in EU (2014 revenue in German, 2015 revenue in UK coming), I would add / emphasize:
- even with lots of money, not many other companies could accomplish what NWBO management has accomplished during the same time frame. Not all CEOs have the vision to invest the time and money in the EU when time and money was so scarce for a small company like NWBO. - even while operating on a shoestring budget and staff, NWBO has done what other companies could not. DCVAX-L is the "first" to get hospital exemption in Germany and for UK, the first product selected for the first step of a two-step process to receive early patient access likely in 2015, which leads to revenues.
One can question NWBO's actions as a shareholder regarding individual financings, contracts, mfg partners, decisions, and timing, but my overall gut check is whether the ratio of accomplishment, time spent, money used, and value generated is good or bad.
- accomplishment - start of revenues Q4 2014 (wow!), DCVAX-D and L looking strong. - time spent - guessing 3-5 years on EU effort (given how hard it is as demonstrate by how other companies do not take this effort on, this is also a wow) - money used / dilution - 60M shares outstanding is not bad (CLDX is at 89M OS shares, IMUC also 60M OS) - value generated - time will tell on the stock price but it is low currently. However I say this is likely due to illegal naked shorting and other nefarious manipulation tactics.
So far I am very happy with the management team and their progress. If I were in the future where NWBO did ultimately provide a cure for cancer, and I was looking back, how could such a world changing accomplishment be done smoothly without all the challenges we are facing today.
This may be a naive question but since the dendritic cell mobilizes the t-cell and all other mechanisms to kill bacteria and virus, could DCVAX-L theoretically be combined with ebola to create a cure?
I was thinking the issue with not using a SOC chemo/radiation treatment was that there is a 8 day mfg period after tumor resection plus a 30 day quality control testing before making it available to the patient, therefore the tumor had ample time to regrow. The question then is whether DCVAX-L without chemo/radiation follow-up would be sufficient to deal with a full grown healthy tumor.
Also the purpose of the chemo/radiation was not so the dendritic cells could pick up more tumor antigens, not needed because it already has done that during the mfg lysate process. The purpose was to weaken the tumor so the DCVAX-L empowered DC's would reach its target.
Not an expert on shorting but my understanding is shorts / naked shorts only have to cover when NWBO is acquired and all open trades need to be closed out. However until then and in the meantime they are taking on high risk at this low PPS and paying a high borrowing rate, ie XX%. When news breaks out and a sustained upswing in price is clear, they will want to cover and reshort later or not.
I agree. A PR was warranted due to the aggressive drop in stock price, regardless of sequence or timing of a financing occurring. Basically an over 50% over a 6-8 week period is severe and if sustained over a long period of time, it does matter in substance. Good long term investors might capitulate resulting in an increased mix/proportion of "traders" instead, and perception of something being wrong could turn into a reality if potential investors and patients take on the view "where there's smoke there must be fire". IMO there is just continued manipulation and naked shorting going on. So putting out an interim progress update PR is the smart thing to do.
Thanks Flipper. That was an inspirational 50 second video.
For any tectonic plate shifting, disruptive technology, that leapfrogs mankind from the current SOC for GBM or any glioblastoma of brute force chemo / radiation onto a potential cure, onto an autologous treatment platform that uses your own immune system where the only side effect is a mild fever, to cure and save lives, you've got to have guts, gonads, and lots of optimism. Painful disclosure: my guts and gonads got a beating these last couple of weeks, but I never let go of my optimism! I feel NWBO is doing the right thing for society, patients, and us shareholders, where time will tell. IMHO
Red, Hope you get well soon. In case this is helpful where the cause of energy loss remains an unknown, consider looking around your environment for changes, ie mold/mildew, exposed chemicals. This may sound too simple, much to my autologous approach to health, but during this interim time try to get enough fresh air, some sun, eat natural/organic, and exercise. The bright side to a short term illness is that if you take on an additional healthy habit in response, that lasts a lifetime.
The stock being down sharply these last few weeks and closing at $4.00/sh today is definitely a loss for us longs, but if the reason is a net increase in # of shares shorted, then there will be a compensating (squeeze) pendulum swing later. That is why it is best to ignore these temporary price manipulations and be in the game when the price moves bubbly up later.
Agree. The additional financing seems normal to me as well. It's good to see money raised for expansion and growth into EU. With near term cash concerns removed as an obstacle, the runway is clear for acceleration. A positive.
I suspiciously think the AF & bandits are trying to rapidly bring the price of stock down to possibly disrupt the equity financing prior to closing, ie scare investor or to renegotiate terms.
I'm wondering how to reconcile the normal fever one gets when one's body is fighting a sickness vs the DCVAX treatment of negligible fever of at most 2 degrees. Any help?
I guess I am more comfortable than you wrt the "potential" risk of Cognate overcharging NWBO due to LP's conflict of interest situation. This is how I look at it:
1. The only way to avoid it is to go use another vendor. That is a big risk because with hindsight, Cognate delivered! We got manufacturing approvals in the USA, Germany, and UK in a timely and efficient way. I suppose we indirectly protected our intellectual property in the process too from too many eyes. I'm willing to pay a premium for that.
2. The price of raising $1 in the open market to pay for such manufacturing fees to a new vendor in cash might be more expensive than the risk of being overcharged some nominal %. I am thinking, Investment Banker fees 7%, discount on the stock price to new investors 10%, and giving them warrants at 30% coverage. Also what impact does having to raise 2X the amount of cash we actually did raise in the open market on the SP? More headlines... Then there is the manipulation from shorts who will take advantage of all these new shares and warrants in float to drive the price down, 10%, 20%?
I agree we won't see any of the law firms "investigating" NWBO for unethical activity to put out a PR just because no plaintiffs have come forward to-date. However if there really is no formal suit, then NWBO could let everyone know that there has been none. Possibly putting out a PR of such might be a jinx but mentioning it to an analysts like Larry Smith or at a presentation might be a simple thing to get the word out.
It seems we don't have much coverage from investment analysts. The only ones I see are Summer Street (Buy) and Oppenheimer (Perform) on Yahoo Finance and of course Smith on Stocks (Buy).
A buy recommendation from a new reputable one and their assessment would go a long way with retail and institutional investors. They should easily see through and discount the publicity stunts of AF and attorneys, and possibly the large short interest would present a huge undervaluation opportunity in their view to do well.
Anybody know a good analyst? (I say this facetiously because I know it is LP's and a CFO's job to search them out, and LP has more important priorities now - revenue and clinical trials).
No better time than now to interject a thanks to all the contributors, especially Flipper, Pyrr, Dok, Long, Evaluate, Xena. In case you don't know, I'm reading and appreciating.
Since the timeline to L data is pushed out, it is good to understand what we can look forward to in the next 3 to 6 months. A quote from Pyrrhonian:
Catalysts upcoming:
--Open label Ph I/II DCVax-L trial with adjuvants set to conclude this fall (possibly later). Data on 83 patients. Great confirmatory trial of sorts. This is the type of thing AA could be granted on (not that it will--it won't, but AA has been granted off a number of open label studies that confirm treatment effect).
--More Direct updates--tumor shrinkage beyond 30, 40, 50%? Adaptive Licensing approval from EMA? Breakthrough Therapy designation from FDA? All possible at any point.
--Reimbursement negotiations being finalized for Hospital Exemption. Basically any news on this pops the pps. Could be imminent, as our DD on German sickness funds timelines for orphan drugs are 6 months after approval. That would put it at late Aug/ Sept
--Simple stock pressure. Upward trending. $6 today will be $7 with pressure to buy, low pressure to sell. Supply and demand. Should cause an upward trend in and of itself. The more people see what's going on here the more will want in, and the less will want to leave.
It takes 8 days to produce the vaccine and then it is sent for quality control testing, an additional 35-40 days.
I am surprised about how long quality control takes. Wouldn't the majority quality control be with the production of the vaccine and only minor QC testing on the final product? This QC testing time could be an additional factor why Direct injections are taking awhile.
Afford - The fallacy to AF's article on the 28% tumor reduction equating to no-efficacy is this:
1. Tumor size and reduction is not a valid measure when the trial is not complete yet, particularly when patients have not even received the full set of treatments. The reason is during the initial stage, when the T-cells (B-cells, macrophages, etc) are fighting the cancer, the tumor will actually increase in size because T-cells are stuffing themselves inside the tumor. It is only afterwards when the dead cancer cells are cleansed away that the tumor size will shrink. The fighting is still in process.
2. Tumor necrosis, on the other hand, can present a snapshot view of biological activity or efficacy. The measurement process though would be based on doing a biopsy to determine whether or not the tumor contents indeed include T-cells (active) and cancer cells (dead). Tumor size does not show this.
It seems from this video and my interpretation is that naked short sellers that do not deliver sold shares to buyers can't lose.
- If the company being shorted goes bankrupt (the PPS drop kills a bank loan covenant or pending financing)- they cover at $0. - If the company continues as most do and there is never any reconciliation, except in the case of M&A or going private, then they can delay covering forever and hold onto the cash forever. That also means an unlimited supply of cash. - Reg Sho can force a delivery, after which the naked shorts can just rinse-repeat. Inbetween, they fund the delivery by the cash from naked shorting another victim company.
On the topic of removing shares from the shorting pool:
Despite naked shorting, there are a number of legal shorts and within that category are layers or %'s of legal shorts that are nervous, ready to cover, or confident. We don't have to change the world of naked shorting or the landscape with the little immediate effect Yahoo MB collaboration, just kick off a small chunk of snow from the top of the mountain and watch to see if it turns into a self building snowball with a lot of momentum.
Let's not lose sight of this fact - when good news hits, there WILL be a short squeeze, DESPITE the existence of naked short sellers.
Look, go to town! All 6 of you haha.. Don't you see how small your reach is? These are message boards. Do you know what the daily traffic is for these things? Taken as a whole they're barely impressive. And then you divide that by the number of stocks and differing topics and threads and you get maybe a few hundred looking at ALL the NWBO boards a day. On average. Then you need to convince those from this very small pool of viewers to enlist in your mission.If you convince 10 I would be shocked.
It is still very early yet and response small still, but after posting the goals of Dok/myself onto the yahoo MB on 5/23/14 on Friday at 4pm (right after mkt close, Memorial weekend) the Collaborate to Remove Shares Available to Short message, I've already got 10 thumbs up within 1 day plus several replies from investors indicating they'll take action.
Remember there were only 55K shares available to be shorted on as of 5/22/14, not a lot of shares for retail investors to "take off the table". I wouldn't be surprised if Shorts used up all those shares Friday fighting the price spike, and there would be 0 shares available for them to short.(!!!) And we still got a 5% PPS increase. LOL. If so, any shares removed from the pool available to shorts, creates a short squeeze for that number of shares. 1 large retail investor taking this very minimal effort / action that does not require spending money only 5 minutes, can make a difference.
Timing can make a difference too - if PR's, Direct results, an excellent article from you posted on SA , and the efforts of hard working investors removing shares from the pool fall into place, that can be the first domino or the 2nd wind in a short squeeze. I choose to knock the shorts off the shorts, as they have chosen to short cancer patients and small retail investors.
You could be right too. As in investing as in life, who knows for sure about anything. I could be talking to myself this whole time for all I know. I hope I'm logged into the real IHUB site. I only believe I own the NWBO stock because I see it says so on my computer screen. That had better be a legitimate site. Regardless I still have to believe. I believe we all contribute, each in our own small way, and together in a big way.
We're getting news on Direct shortly, hopefully DCVax-L too. If we get good news, as I expect - all I suggest is that those that are extremely over weighted in the stock - take something off the table. It doesn't have to be all or most of your investment. But take a small piece off the table. Use it to buy a 2nd stock with a potential breakthrough therapy in a different disease.
With good news, I think the dynamics change, so I don't think the immediate reaction would be to sell some stock. I agree if one is over-allocated and the SP goes up without news. Then yes, sell some, but if NWBO presents 2 more case studies of different cancers and patients showing tumor necrosis and systemic tumor regression, then NWBO just became a different type of investment and justifies a larger allocation within my portfolio, IMO. The concept being that if my allocation goal is 5% extremely speculative, 15% speculative, 20% small cap growth, and 60% mid/large equities, for example, then NWBO just moved into a speculative category for a 3X larger allocation. So where, I may have been overallocated originally, with good news that may no longer be the case. If we get guidance on German revenues this year, then it could even move into the small cap growth category. Of course this is a very subjective matter.
BJoe: Thanks for the research. Either Optionhouse, Ameritrade, and Smith Barney all have different rules for how they govern the # of shares they loan out or we got a similar situation to the Too Big To Fail one, where a Too Big To Know What the Hell is Going On Even Though I Work Here situation is going on. Troublesome. Like you say, it seems a no margin account is safest.
Thanks for the feedback and highlighting 2 ways to fight shorts and bump up the price next week.
1. Charles Schwab. It sounds like the same as the Etrade policy. In effect => do not borrow money (no margin) on your brokerage account (cannot have even a penny owed, algorithm driven) => this removes shares your broker can lend out.
2. Buying stocks is another way to fight shorts. (ie with cash or allocating more of investment diversification into NWBO)
I assume your comment on this collaboration plan not working refers to the likelihood and assumption that investors on this MB are 1) on margin + will not let go and 2) possibly most true longs are powder dry or are already over-allocated in NWBO. Possible, likely a % are, but I guess not more than half. At only 55,000 shares available to short, short on ammunition, short on morals, short on curing patients with cancer, and soon to be short on shares to short, I believe even 1 investor with the means and the will can make that happen.
If my shares sold for $150/sh each, I would not worry about what tax rate I was paying. I would be thinking diversification. Because diversification keeps a rich man rich and a poor man poor. I am trying to move from the level of long-time biotech investor poor to diversification rich.
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, and the efforts of hard working investors removing shares from the pool fall into place, that can be the first domino or the 2nd wind in a short squeeze. I choose to knock the shorts off the shorts, as they have chosen to short cancer patients and small retail investors. 
AI
