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Please answer a question. I thought there was a date where, regardless of the number of events, someone looks under the hood of the DCVax-L trial and does an assessment? I thought there was and that September 2016 was it. Please correct my misunderstanding.
Question: Has anyone considered if the FDA data submission and the recruitment halt are unrelated actions?
With apologies to the board, I only get around here every third day on average and this possibility may have been discussed already. Also, I know finance and econometrics, but FDA stuff is totally new to me, so take this into account when responding please. But after two years into this stock I am still here.
Here is my suspicion. NWBO has a bad balance sheet, especially in current liabilities and their effect on cash burn. It is obvious from the delay of Direct Phase II start that conserving cash must be a daily mantra back in NWBO headquarters. Could NWBO suspended recruitment until their cash position improved and they don't want the markets to know about it?
On the FDA side of the coin, the FDA could have required data either from a predetermined point in the protocol or by some special request and if yes to the latter, we don't know the why of it. We know that data was collected and submitted back in the late summer. That is really all we know about the data.
Are we jumping to conclusions when we assume that one is related to the other?
Questions for Tomorrow's Stockholders Meeting
I have been a holder of this stock for two years plus. I have some questions for tomorrow's meeting and I cannot get to it. I am on the West Coast.
I noted that one of the items in the agenda is the reappointment of the auditor. Since the auditor has been retained for two years (I read this on one of the posts either here or on Yahoo so some fact checking may be in order), it is not unusual for a reappointment to occur. Most auditor engagements run for 3 years. Anything beyond that and they are endangering their independence.
Most audits cost about 1% of capitalization. This would put NWBO's audit fee at about $40,000. The company wants to pay the auditor $536,000. This fee means that the CPA is doing more than just audits, reviews, and compilations. They must be providing day to day accounting in the fee and the agenda item's description does not say that. Can someone get clarification on this?
This leads to a second question. Since NWBO is building manufacturing capability, there must be a plan for beginning operations, and that means having a team in place to receive and process orders. And if we process orders, we have to bill for delivered product as well. This means that NWBO needs to retain a regular production accounting staff. Such a staff needs to be built in house. What is the plan for bringing this function in-house? What is the plan for beginning operations and regular accounting? With regular accounting comes standard finance and treasury functions? What is the plan for these functions as well? Will any part of the $536,000 be held back should DC Vax-L be approved and regular production begin anytime in 2016?
Thank you in advance to anyone who wants to take up the task of asking these questions?
Thank you,
Rich
I am sure there are better sources but this is the first one that came up on a Google search.
Analyst Navid Malik has been suspended by Cenkos over his involvement with $NWBO cc @PhaseVResearch @WoodfordFunds https://t.co/oevxr14jTi
— Jacob Plieth (@JacobPlieth) November 22, 2015
I have been having the same thoughts. If Malik is due to be reappointed to the Board and he is on suspension, then the Freeh Group needs to provide a basis to rehabilitate him by the 18th. At least that is my opinion. I think it would look bad for NWBO to reappoint a Board member who is on suspension with his own employer due to activities at NWBO. If LP wants Malik back on the Board, she needs to remove the cloud he is under or it will be worse for NWBO. I do not yet understand how LP is reading this and though she could have the correct perception it is not being communicated and the SP is being affected.
I have been following this board sporadically for the two years I have owned NWBO and after months I finally have a new question. The recruitment was suspended in August on the GBM Phase III study due to NWBO submitting data to an undefined regulatory process. Regardless of the speculation, to what country was the data submitted? Some have speculated that the FDA is reviewing the data but I have been wondering if England is reviewing it. Then I wonder if Germany is reviewing it and I give up wondering about it.
Question for the Board. Yesterday there was a poster session at one of the conferences presented by the MD Anderson team from UT working on Direct Phase 1. Did the data they presented corroborate the data that NWBO presented on Phase 1 back in May? It seems to me that if the same data is presented a second time by an independent source the data becomes more valuable. It survives an argument that the data is hyped.
This question was probably covered previously and if it has I apologize. I try to keep up with the Board as much as I can.
A related question is this. The ASCO information that Dr. Bosch presented were not the official results of the DC Vax Direct Phase 1 trial. I understand that was preliminary information. An official report from MD-Anderson is coming. Does anyone know when that will be released?
I agree as well. LP appears to be building an organization with scalability. She seems to be building for the long haul. I doubt that LP is entertaining any type of buyout offer.
I wish to echo all of the key sentiments that Rkmatters discussed. I have worked hard for everything that I have and treat others as I do myself, at least that is what I try to do. I know very little about medicine. But I am a value investor and this site has been a great comfort to me that my investment is everything that I hope it will be. The longer I read this site, the more appreciation I have for the science and the benefit that will come from it. This is a great group of commentators and I appreciate your contributions.
Question regarding the 500K buy of shares this week at $4.10. Does anyone know where this came from?
When I saw this my imagination started churning. On this side of the Atlantic there are laws and regs against trading on insider information. I would imagine that it is the same in Germany. But would that cover people in Germany who observed something in Germany and bought stock here? If that is the case, would that be someone affiliated with a current or future patient? Or could it be someone with knowledge of the reimbursement negotiations? I remember that the original HE notification was sent to NWBO in German and it took two weeks for a translation to be agreed on and released to the public. Does that two weeks represent a quiet period on both sides of the Atlantic? Then, of course, my imagination went further and I began thinking that truly great news would be announced by NWBO in two weeks. But, of course, as someone who is into sci-fi as well as Bourne and Bond movies, I am easily entertained.
When my mind comes down to reality I assume that the 500K share buy was from some hedge fund who wanted to make a quick $240K, which they did off of a $2M investment. 12% for two days of risk is not bad. But the support level moved from $4.00 to $4.50 in two days as well, which means that the price action is more than just the influences of a single hedge fund investor. And then my imagination gets going again.
Does anyone have a guess as to who the masked investor was and the causes of the action that followed?
This is an excellent summary of AF's writings on NWBO over the past several years. I need to remember this. I know I cannot do better.
The Panel has Overlooked This Article. This is a very damaging article. It will drive the ops down on Monday. It needs a response. While I applaud the Washington Post for its article on shorting, this hack job will affect the pps in the short term.
As someone who has spent much of his career doing cost accounting, the techniques and assumptions used by the author would earn a failing grade in an accounting class, people will still believe this trash when they read it. I hope that NWBO issues a PR on Monday in direct response, because it is purposely misleading.
This article shows up on the NWBO MarketWatch page. The Washington Post article does not.
If this is an MDA based research project, then the royalties will be split between MDA and the researchers. In other words, MDA has a much stronger incentive to see this new research succeed then the NWBO research, which probably makes a flat fee payment to MDA.
Question on UCLA. Dr. Lau is currently doing an alternative study on L that is due to complete this fall. Not sure about timing, but that is my understanding. I have also noted some posts indicating that she is slated for the Phase II DC Vac-Direct study. Is this correct? If my perceptions, which are often flawed, are correct then UCLA would be participating in two studies. Thank you to the panel for setting me straight on this. It will make it easier to follow your conversation.
I am wondering if anyone has any comment on why NWBO did not advance by $.10 per share today when the overall market went up 175 points. One possibility is that it was due to a hangover from Friday's $17.5 M raise in financing. Some of the tweets focused on it. Note that AF's tweets are retweets even though they are 3 days old. His tweets tend to stay around for a long time. I am not a professional trader and was looking for a different point of view.
Adam Feuerstein @adamfeuerstein 3d
Reading $NWBO 10-Q, one thing is crystal clear. The company is an ATM machine dispensing endless cash/stock/warrants to CEO Linda Powers.
Adam Feuerstein @adamfeuerstein 3d
Ever wonder why $NWBO has never partnered DC-Vax? Not for lack of trying, per 2005 10-K. http://t.co/C3qjQsaFRE
dds_dave @dds_dave 6h
@adamfeuerstein straight from $NWBO 10q. It will either go bankrupt or dilute to infinity http://t.co/RSv2u9sc6e
Jim Hill @diamonjim 5h
@dds_dave @adamfeuerstein You guys are really clutching at straws about $NWBO recently. This type of disclaimer has been in every 10q.
I get a kick out of the AF tweet citing the 2005 10-K. Was that a typo on his part or is he trying to make an argument based on current circumstances?
Thank you for pointing out my error. AF was sued years ago and won. He has not been challenged since. Since cash is tight at NWBO, a suit would be considered an unwise move at this time. One hope I have is that if and when NWBO succeeds they will go after him.
Jim Hill and someone over on YMB noticed a 'massive dump of stock' right before the AF article was released. A few questions come to mind.
1. AF was charged by CREW of tweeting the pending negative MDA article to a select group before releasing it to the public. He may have repeated this today. If this was the case, then IMO that tarnishes The Street and Jim Cramer for recklessly disregarding his illegal behavior. They were warned with the original CREW complaint. That makes them complicit.
2. If this is the case, then it underscores that his practice of releasing information to a non-public select group before releasing to a public group is a standard behavior, not an incidental behavior. This adds to the growing evidence against him.
Furthermore, IMO, reading his article he assumes that LP is withholding information she is obligated to release by law when there is no evidence to support the assumption. The timeline of events make it impossible for her to know in December what the DMC determined in the spring. Am I reading this wrong?
I had written something in response, but as I posted it the previous post 17109 by flipper appeared, and it is great. So, I deleted my info and refer you back to his post. I have not figured out how to delete an unneeded post.
When one increases 'n' while maintaining the same p-value, it, in effect, narrows the confidence interval. The result is that the lower bound for acceptance is raised. To compensate you can lower the p-value, which would decrease the lower bound of acceptance. One of the things that I did not understand is why NWBO had such an unnecessarily high p-value equivalent to a 99% confidence when a lesser confidence level was needed. Now the p-value makes more sense.
I noticed some tweets on my Marketwatch page and some of them are from AF. Apparently he is equating early enrollees, which according to him are unaccounted for, with the 55 rapid progressives that are the subject of compassionate use. He has another one hitting LP. I am anticipating another hit piece from The Street based on misinformation. I am new at this stuff, and I would appreciate an independent view from someone who really understands this stuff better.
Thank you for the thoughtful reply. I agree with you.
I appreciate Evaluate's point that Dr. Buzdar said that PR communication should only happen at points specified in the study. However, you make the more important point to me. I was trained in the social sciences, not the physical sciences. The general qualities of research and the statistics are similar, but your application is far different. In the social science realm there is a concern for 'usable knowledge.' For DC Vax Direct, IMO if there is a clear improvement that was discovered using an accepted technique, and that improvement can accelerate the research into a Phase II study, then people should know. Why wait for a pre-selected date in a research design that was not well thought out? There are ethical and moral questions at stake by waiting on the data. My advice to NWBO is to not be anxious to publish a PR, but also not be hesitant when strong data warrants it.
I bet the research design for Phase II has been rewritten to include lots of pre-determined dates for publishing data.
I have some questions on DC Vax Direct. The purpose behind it is to estimate when it would be appropriate for LP to issue PR's.
The Direct Phase I/II study consists of 36 patients. The 36 slots where intended to be filled by 6 or 8 different types of cancers. Sometime ago I saw a post listing the cancers and the number of patients that each cancer required. I cannot remember the list of cancers being tested in the study. My questions are these.
1. Will MDA report individually on each cancer as they complete the study, or only when all cancers have completed their protocols?
2. Though MDA will report at the conclusion of the overall study of 32 weeks, can they report if they prove the point of the study prior to the 32 weeks. As a hypothetical example, when ,if after the 4th injection, it can be shown that there are no live tumor cells in all patients, can and should MDA report then? What if after the 4th injection 80% had no live tumor cells? or 50% had no live tumor cells?
3. Extending this hypothetical to individual cancers - Say cancer type 1 had 4 patients and all four were shown to have no live tumor cells after the fourth injection. Can MDA report on these four patients at that time?
Of course, AF would question anything but a final report for all patients after 32 weeks, but it seems to me that the study is constructed around an overall goal of evaluating the viability of DC Vax-D and a series of sub-goals of evaluating its viability of different types of cancers. As soon as LP knows the answer to any of these, and the answer is positive, then she should be able to proceed to the next phase for that cancer. Then, as this happens, we as investors should know.
Thank you. I came in shortly before that time so this gives me some perspective. And thank you as well to XenaLives and Highwayman for your responses.
Thank you for pointing out my error. I use MarketWatch and they push the updated market price to my screen. I mistakenly assumed that they also push the volume. However, my larger question is still on the table. The average volume is 1.2 m per day and we are on track for another 400K day, which is where we have been for the past week. People must not be selling.
Can anyone explain the low volume that NWBO has experienced over the last week? The average volume is 1.1 m shares, but lately it has been within 200K to 400K shares. Today, volume is an unbelievable 4K after the market being open 1.25 hours. Today is a head scratcher.
This leads to the question of whether shorts are really having any meaningful impact at lowering the price.
I agree with you. In addition, every time AF posts anything on NWBO, we should be there to discredit him. After all, an independent government watchdog non-profit has judged him to be a stock manipulator and has filed a complaint with the SEC. Tacking this onto the comment section of everyone of his posts will cause more and more people to stop reading him. Further, comments should be submitted to every service that re-runs his posts should be aware of his now questionable reputation. I intend to send a comment to MarketWatch, my business new service, next time they re-run one of his posts. If they don't balance his comments with a more accurate piece, their editorial judgment can also be questioned. This is a lot of work, and it will take a long time, but AF can now foresee his influence having less and less impact over time.
I agree with you that the SEC will probably not bring charges against AF. I hope you are right that AF will play it cool while the SEC is looking at him. However, AF survived a lawsuit some years back and the guy is pretty cocky. So, he may think that he is invincible and continue on as if nothing is different.
I noted a new AF tweet on the NWBO Marketwatch page today. Apparently, the Committee for Responsibility and Ethics in Washington (CREW) requested the SEC to investigate possible illegal manipulation of NWBO stock prices. The complaint mentions AF and cites his actions on or about June 18. AF's tweet in response is that LP probably put them up to it. Please read for yourself.
http://www.citizensforethics.org/legal-filings/entry/crew-sec-investigation-manipulation-drug-company-biotech-stock-feuerstein
Thank you for the great answer. It was comprehensive and to the point.
Re: German Negotiations & Pearson Article
My opinion of the Pearson article is as follows. It is not unusual for a startup to offer equity to a third party for a necessary service when conserving cash is important. A textbook example is legal fees. So, I have no problem with granting Cognate equity in NWBO for manufacturing. This is a balance sheet question. The real issue is the amount of the transfer cost from Cognate that hits NWBO's income statement. If this is too high, then the insurance companies will object and seek a rate lower than NWBO wants. This impacts profit and not equity.
This thought has raised a question in my mind. Are the Germans seeking information from Cognate via NWBO before establishing a insurance rate for DC Vax L, and if yes, is this causing some of the delay for the Germans and NWBO to come to a resolution on rates? Any answer to this question without direct information from NWBO is pure speculation, but it is an important question to keep in mind as we wait on information from the German negotiations.
Thank you for your comment. I was not aware of the "automated" nature of the manufacturing process. In economics there is a production function called a Cobb-Douglas function. It is basically f(x)=K^(a)*L^(1-a). It basically relates the amount of labor to the amount of capital that a production process uses. It is used with budget constraints to fund the marginal rate of labor and the marginal rate of capital. With individualized care I thought that manufacturing was highly labor intensive (high mpl). Now that has shifted to a high mpc. When an economist maps this over to a supply and demand chart, the equilibrium chart shifts down and to the right, meaning that the amount of revenue is high and the market share is high. The prices may even support the idea of substitutes, meaning that DC Vax becomes a real substitute economically, not just medically, for chemo. The implications of an automated process are very significant.
I agree that another site from MDA should be recruited for Phase 2 of Direct. Can the research design identify data release dates favorable to NW? Remember that Dr. B of MDA said that companies should not release data other than at the conclusion or upon specified points in the research process. If the design identifies the data and the release dates then AF and others will have nothing to complain about when NW releases data prior to the study's end.
Your post is the first post that I have read that mentions an automated manufacturing process. Can you elaborate on this? Is there anything more about how this is done? The implications for quality control and cost control while increasing scalability is potentially very significant. Thanks for the info.
A lot of the answers to your questions are in the next post #15493. Note that the batch for three years is made at one time for an individual. The total costs and revenues from that action are charged to the income statement in one period. The balance sheet is unaffected. The rationale is that NWBO earned the money by completing the batch, even though the batch may take up to three years to be used. I understand that intuitively it would seem like revenues should be earned as the vaccine is used over three years, for which the cost of the batch would go onto the balance sheet and prorated over three years based on use into the income statement. With each use, and portion of costs (assets) would be expensed as the revenue came in. But this does not happen since the action that triggers the earnings is the completion of the batch and not the use of the batch. This is strictly a set of transactions that affect the income statement only.
You asked another question about whether it would be more economical to make a batch at one time or on an as needed basis. First, the science would need to be in place to allow that to happen. It is probably the best use of the tumor sample to process the batch all at once (keep in mind I am a financial type person and not a scientist). Assuming that you could make successive batches over time, it would depend on the cost structure of making a batch. I have no idea what the cost structure of DC Vax manufacturing is. I can imagine that there is a significant portion of the cost in writing off R&D costs in the balance sheet, but here again, I am making assumption. In software, R&D is written off as it is incurred. Other industries are not the same way. I do not know the expense and capitalization rules of the drug industry. Finally, I also assume that the process of making a batch is fairly labor intensive, and this factor, if true, would be a good reason to conclude that it is more cost effective to make a batch at one time and not two or three batches over three years for an individual.
My apologies for not being clear but I have limited information. I follow this blog closely since I have been holding a long position in NWBO since October. This investment has been a real education but I believe in the stock as well as its people and technology. So, I try to learn as much as I can through this blog.
I have some background in accounting and finance, and IMO, the discussion about when the vaccine is used should be immaterial to when the cost of producing it and the revenue from selling are put on the books. The vaccine is custom made using the patient's own genetic material. Given the course of treatment extends three years, and if a patient only uses two years of vaccine, the books should still recognize both the cost and revenue from the full three years of vaccine. The additional year of vaccine would be discarded since it could not be used for another patient. For this reason alone, NWBO should negotiate with the insurance companies for full payment at the time the batch is completed. In accounting, all cost would be expensed in the first year and all revenue would be recognized in the first year. There should be no argument for ratably recognizing the expense and revenue over three years since the product cannot be restocked for later sale to another party. The implication is that the sp should be higher sooner since the revenue is recognized sooner.
Can NWBO simply release a PR every month or two with all the data updated without it being considered "hype"? This means do not include statements about the data being "encouraging". Simply put all the data out there without "cherry-picking" any of it. Let others interpret the data or hype it or whatever, but NWBO is simply updating data that is already in the public domain. With appropriate admonitions about not ready too much into the data since they are not results, how is that hype?
Can you answer a question for me? I am retired and studying economics, so I am familiar with the standard statistical methods from social science. We have something called a difference of means test where the aim is to calculate the mean of two groups, say A and B, and their confidence intervals, which are based on the standard deviations of each group. If the confidence intervals from each group do not overlap we can conclude that the groups are statistically different based on the characteristic that was tested. In this case we are looking for progression free survival of a control group of patients who have been treated, say Group A, and another group who have been given a placebo, say B. If A has a smaller n then B and the number of events have been fewer, then its confidence interval will be larger than that of Group B and may cause a CI overlap. To avoid this the company can increase overall n, or they can increase the n in Group B only either to move the Group B mean away from the mean of Group A, or decrease its CI so as to not overlap with the CI of Group A, or both. Adjusting Group A's n does not seam like a reasonable thing to do since you want to conclude the test sooner rather then later. Am I translating the terms and concepts correctly here? Thank you.
Retweet Pyrr's SA Article on Risk - Reward
I use Marketwatch to check my stock quotes. Everytime I look up NWBO I have AF's latest tweet advertising his latest unprofessional piece. He then retweets it and has his followers do the same. I have to look at his ceramic head for days despite the fact that there are more relevant posts to read. The article on NWBO risk reward is great. It lays out the investment picture in a balanced way. It is a great service to investors to have it highlighted. If people who tweet regularly, retweet their earlier posts of the SA article then perhaps I would not have to look at the ceramic head for another couple of days.