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Thanks Happy.
The reason your argument is not correct, quite honestly, is because Mr. Woodford is under a FIDUCIARY duty as a money manager, and contractual requirements, as well as other legal constraints. He'd have to sell if he concluded there was something wrong with this investment. Riding it down like this would be an incredible error in judgment, and I think he is far too experienced to make such a Junior Varsity error. Moreover, the legal compliance department at his firm would not allow it if they thought otherwise as well. It wouldn't happen. I have zero doubt that his failure to divest communicates the message, not the suggestion that he did not invest MORE. He has already invested quite a bit and owns a huge percentage of NWBO. He most likely would have reduced his stake to the point where he would long ago own zero or virtually zero in the company had he concluded that Phase V's report was substantially credible. Instead, he affirmed his belief in the science, made some suggestions for righting the matters that were a possible error, and HELD. To HOLD is a specific decision. To Sell is a specific decision. Woodford HELD, despite a quite precipitous fall. That's serious confidence.
Investing in private equity companies or companies outside of a given jurisdiction is not the same as prohibitions on penny share investing, and in companies that have taken a hit, whether merited or not, that takes them down so much based upon allegations of mispropriety. There are legal standards he must fit, whether he thought the allegations were serious or not.
Again, the fact that he did not DIVEST says something very strongly. He would have DIVESTED from this investment had he found the Phase V publication substantially credible. He also defended the determination based upon analysis of the SCIENCE.
So again, you fail to make your point. You presume to be able to intuit something from failure to act affirmatively. He already acted very strongly and affirmatively, and he has not taken it back by taking the action that your statement would suggest, DIVESTMENT. So again, alleging his "feelings" from his non-action, is a logical contradiction.
His lack of investment may also be due to the fact that the price is below the level at which many funds CAN invest more funds. As to why he is not investing, I'd rather suggest, whether he wants to or not, the Phase V allegations were serious enough, that whatever he actually thought, you'd wait for some resolution of a few of the key allegations. That has happened with regard to the Cognate transaction, which is now addressed through NASDAQ.
However, the price is still very low. And additionally, his fund has taken a good amount of direct attacks, possibly from Phase V related shorts, such that it would be hard, from a PR perspective, to invest, regardless of what he may personally think about the future prospects of NWBO.
Again, I'd look at the fact that he has never DIVESTED to actually be the key reference point, and his statements after the Phase V report relating to his continued confidence in the SCIENCE here, to be the truly determinative measures of his thoughts on the matter.
Had Woodford taken it as seriously as you suggest, he would have been duty bound to DIVEST, not sit invested while the company continued declining in price. His confidence to stay invested and NOT TO DIVEST speaks much more loudly than you suggest with regard to how seriously he took Phase V's allegations.
As indicated before, the relationship with Cognate was fully disclosed in the disclosure documents. That's how Phase V found the information. The issue was, was the crossing of the NASDAQ rule material or immaterial enough for him to divest? Apparently not. And he maintained afterwards that he had confidence in the science here, which was not consistent with what Phase V was alleging.
So I have a hard time taking any comfort from anything Phase V has said so far, given the outcome myself, though no doubt Phase V's report did certainly crush the price and gave quite an opening to shorts to bash the company to a very low price. The end result is that I got to buy at extremely cheap prices. I feel very badly for the longs however, and sympathize, having been in companies I believed were quite solid, to see similar treatment from manipulators in the past. Manipulating stocks down, for profit is clearly a very easy, profitable gig, or it would not be so common in the biotech market. It's very easy to convince people that just about any stock is a scam, if one desires to take that route. Fear is a much easier emotion to inspire than confidence, and is the territory of scoundrels and politicians.
1. It's a safety study with intriguing results otherwise;
2. It's a safety study that allows for some further very broad analysis that of course will be refined on subsequent trials, as they gather more data;
3. The wheeler method of analyzing the data actually does provide a powerful though newer measure against many other patients in similar circumstances that would offer, in effect, a placebo comparison, though again, no one is claiming this is Phase III or even Phase II.
I think the short position on this is mostly noise and over dramatizing the notion that people are drawing too many conclusions... That's nonsense and mostly an emotional appeal.
Thanks. I still don't think you're very clear about what you think is the shortcoming here. You are basically rehashing some points in the research, without actually saying anything quite specific enough about NWBO's actual various approaches/vaccines. The end result is you can say everything and nothing, without saying anything specific, and always take a quote out from somewhere and say, you said "x" - without actually being specific enough to have actually said anything at all.
So, I can't say I feel like you've answered my question or that you generally have made your point with any clarity to be able to analyze exactly what it is you're trying to say. I was trying to see if your point had any specific merit. Thanks for the response. I'll see if in further posts, you'll provide what I was looking for in my request for clarification.
He's not "scared of his own investors", he has a duty to be careful. You clearly don't understand the circumstances fully. He also stayed invested. So clearly he had enough confidence not to withdraw his funds or take other actions to suggest he was a skeptic. I think that says that he still believes that his original diligence leading to his large investment, at least on the technology and ultimate valuation here, was solid. But he still has to take certain steps and care, not to create liability on his own to his investors. His fund is not really a biotech fund either, so this is just a tiny portion of that fund.
The fact that he took so much heat for investing in this tiny company, I think speaks to the forces behind the scenes, shooting at NWBO. They were clearly making any individual at the company and at any fund, a target.
My view is that a lot of these guys carve up these tiny companies, devalue them and then run them up at will, or work with an acquirer to get a nice little pop after profiting on running the price down as low as possible. The criminals will eventually get their day in court.
They pointed out things that were disclosed in company disclosure documents. They key thing they seemed to discover was the issue related to the percentage of ownership. Most everything else they suggested was problematic appears not to have been substantial or real. They were not a lot more than a blog poster, and most likely they were paid for by an economic interest holding a position (short position) or competitive position that was benefitted by such an attack on NWBO.
The fact that there is truth in a manipulator's statements, doesn't change the fact that they are seeking to manipulate. And if they are using companies and artifice to facilitate their manipulation, then surely the best way to address their antics is a RICO suit... especially if it turns out they were engaged in stock manipulation to benefit parties of interest.
Phase V existed for only one reason, just like all "research" entities like that pop up to take down companies that shorts fear will rise... These sorts of companies pop up over and over again. I would not be surprised if the SEC does not have a formulating strategy to address this kind of manipulation. It's relatively new, but it's happening over and over again and becoming a repeatable pattern clearly intended to hide the identities of the real creators of these "reports".
So you're saying Pyrrhonian that the DCVax L does NOT use BCG, and this is a failing caused because the trial and technology are so old they did not realize it was a necessary step? Just trying to be sure I have your exact point here. This is a reason for your skepticism and taking a short position?
Thank you.
What happens is the drafts go out to the SRO (the exchange - NASDAQ/FINRA), the lawyers for the Underwriters and various parties that are responsible. Comments come back. Each reviewer will have points, that need to be addressed or corrected, and primary areas of responsibility to review. They likely start with the base document of the previous version, update, and send it out and file it with the SEC, knowing it will be updated, but to start the clock and process. When they became satisfied that it was substantially OK, as a base document. But as they move toward the financing and other trigger events, more details fill out naturally and due to changing and updated circumstances, where the stock price is, the market cap, etc.
It's all pretty organic usually.
Hank,
I could see how, given your disposition already, and your belief that there is only one way to analyze this situation and it's some variation on traditional, linear analaysis.... that you'd think that... But that's not what I'm saying. I think the analysis is far more sophisticated than your giving credit for and I think you are completely missing the utility of the Wheler statistical method, and the purpose of the trial as well as the nature of the trial - as a Phase I, with a given set of very particular patients with a particular nature to their illnesses. You're also ignoring the fact that cancer treatment is increasingly individualized, using these very techniques. It's ironic, because Adam F makes that argument, that cancer treatments are increasingly individualized, attempting to DISMISS the logic of this trial (because the vaccine is being deployed against so many different forms forms of cancer, at once, in a small sample), though Adam seems thereby to fail to comprehend the very statistical model that is being used to individualize the statistical result with regard to the very particular illnesses of each particular patient against a validated set of other patients, including a variety of very particular biological and statistical measures for each patient. It's highly granular (at multiple levels, for each individual patient), which is not something you typically see in such Phase I trials. In my view, the more I look at it, the more path breaking I think it is... but to each his or her own.
I'm sorry you're missing this point I'm trying to make, but I can see how if you are insistent on the older view, that's just your perspective, and it's one of many. No skin off anyone's back. You don't have to be invested in this trial or this company, when there are so many great companies, including great companies in similar efforts, using the immune system to defeat cancer. Good luck with wherever you decide to invest... but I'd guess this trial is not going to convince you to invest here.
Excellent!
I and a number of other posters, in the context of another biotech, have often discussed using RICO against naked shorts. I did not know anyone was actually taking that strategy forward. Glad to see it validated!
Thanks for sharing!
Thanks Longfellow. No worries. Appreciate the correction.
I'm not trying to soften the effect, just help another person who is perhaps a bit more taken by AF's argumentation than I am, to see that it's not all that rational. When AF ignores the care of the methodologies applied, to make a general argument that SOUNDS like it makes sense, to the unsophisticated, but is simply a misdirect, it's bound to get me a little annoyed.
I certainly should have checked the correct name. Thanks again.
Another point: One can look at this trial, though a Phase I, as as close to a real world application as one might see for this vaccine, if it's ever approved. In that context, with use of the Wheler method, I agree, it is compelling to me... I think the below is a much clearer explanation than I could make in my other posts.
http://www.nwbio.com/nw-bio-presents-further-dcvax-direct-phase-i-trial-information-on-individual-patient-survival-at-ny-cancer-immunotherapy-conference/
Hankman,
Well, the purpose is to show safety, and take as much useful data as you can from the study. When they treat any individual patient, given that cancer treatments are now "INDIVIDUALIZED", an argument that actually Adam makes in his piece, they use tools like the Wheeler system to determine individual efficacy for a given cancer, against a very large set of real patients, just not the ones in this trial, at this moment. That is true of APPROVED treatments as it is of unapproved treatments. Many approved treatments don't work for subsets of patients, and they use that data to continually refine treatments and improve them, and to combine treatments. Clearly it is a rational approach because everyone at the top of the cancer treatment pyramid is using such methodologies to refine and individualize treatments.
So, while I don't think that is being used to prove efficacy for purposes of immediate approval, it is being used to refine the data to some degree so that it is USEFUL for moving the trial forward so that they CAN begin to craft trials that DO PROVE efficacy.
And, I think the challenge here is they are going after a very broad set of tumors. You can agree or not agree whether such an endeavor is practical, given the very clear limitations and constraints you have set, and claim are "rational" constraints. I think you simply are being absolute and failing to give credit to the sophistication that they DID bring to the trial in order to get useful data to move the technology forward in some rational fashion that will be focused on trying to prove some efficacy at a later date, with more patients and in narrower subsets. I don't think anyone disagrees that they will have to do that in the future.
Again, the focus is on creating data that is practicable and useful for rationally moving new trials forward to prove efficacy in specific circumstances that will be useful to doctors, treating real patients, in the future.
You can choose or choose not to take comfort from the broader results. I don't think that is critical to see that there is something useful that came out of the trial, even hopeful, and that can be used to move the technology forward with some amount of enthusiasm, at least for now, and until the next data sets are revealed on real patients in real trials.
Biosect, the argument you propose also says that "the [top] 30% did not show a [positive] reaction to the addition of this treatment."
Btw I also despise AF for his twisted and often false arguments, but not every word out of the mouth of a liar is a lie.
I see two points:
1. I agree, the failure of the bottom 30% to respond is not "proof" that the treatment failed in those cases, as with the others, it's possible they could be "outliers".
2. Adam did not consider the Wheeler methodology, which is a bit different than your standard therapy, because you are, in some sense, comparing to a much, much larger class of patients who, in this case, remember, failed all other treatment and were in HOSPICE and set to die, without further treatment.
So, there is some form of statistical measure. You may question the validity of the model, but clearly a major cancer clinic, scholars with substantial background, and the FDA considered it useful enough to a) establish safety across many types of cancer patients; and b) possibly utilize some aspects of the results to begin crafting a better trial, and a more focused trial to profe possible efficacy, or non-efficacy, in a manner that would be practically useful.
The fact is, cellular therapies are not a targeted drug at one mechanism, they are very potent, complex mechanisms, and the "vaccination effect" that results from this cellular therapy, is very complex. I don't think anyone is claiming they proved "efficacy" so much as that by use of this very particular class of patients, who have failed all other forms of treatment and are in hospice, some benefit appears to have been transferred, and now, having shown broad safety, it's time to try to analyze what data they have to construct a plan to prove the usefulness and efficacy of the treatment in specific contexts. It's hopeful, but no one is claiming it proved it "cures" cancer. Even the methods and means used, and the amounts were too variable to have been demonstrative of much more than that there appears to have been something that extended the lives of some subset of patients.
You can quibble with how they use it going forward, but I don't think claiming that the entire trial is invalid because ... you are unable to agree on how to use the data, going forward. Surely these guys have to be more practical and focused than that, and not so theoretical that they lose the forest for the trees.
I'm not sure I get y our point hankmanhub. The bottom 30% did not show a negative reaction to the addition of this treatment. I would expect if there were safety issues, you would have to focus on those patients.
Additionally, Adam seems to think it's all personalized now. So of course you'd then focus on what it was in those patients that responded, that made the vaccine effective, by itself. Of course, later, one might come back and look at the other patients, with combination therapy, and also see if that improves their response rate. One would never entirely dismiss them in the long-haul. But this is about getting the help to where it's needed as fast as possible, which also will be good for investors, but is particularly important for patients and is least costly (lowest hanging fruit) - and most revealing, in terms of discovering the potential, reasonable response reasons and rates for those patients most responsive.
Lastly, Adam ignored the Wheeler result/method and seemed, to be kind, not to have either paid attention to it or possibly not understood it at all, given his failure to address it.
My view on Adam is that he is obsessed with validating his outdated, market theory, for every tiny stock, and he grabs for straws at any opportunity to prove that tiny biotechs cannot succeed. His one-sided approach suggests an incredibly blind bias that makes him ineffective as a commentator and observer. He is certainly less insightful than your average bulletin board poster, in my view, and seems to intentionally look the other way, in at least 3/4ths of his articles. He never takes responsibility for the misses, by the way. Of course, those are years later, so why would he?
I expect that the tick size pilot program may have at least one and maybe other effects:
1. It will bring more into the market to make a market in these stocks, as the profitability of the market maker is improved immediately by the larger spread;
2. I think marginal shorting, by smaller players, will be much riskier, and this could impact / decrease wolf-pack shorting, where you have many small traders nipping at lots of tiny companies with marginal, leveraged positions in very undervalued stocks that move up quickly, and have the benefit of more market makers. I think they will be more likely to get creamed in that scenario. But we'll have to see. This 2nd point is speculative.
1. Immune therapy is getting hot, and other plays are maybe a bit more fully valued if not over valued;
2. NWBO is in the process of being validated by those other companies, and by the recognition of the logic of combination therapies and the cancer moonshot program;
3. NWBO is clearly at a potential inflection point and has an incredibly low value to what it has both in the works, with earlier stage trials, as well as with the more advanced Phase III, and with rumors of pending deals.
A bunch of people I know and respect, have all recently bought stakes in it, as have I. I was not a previous long-term investor, and given the excessive shorting, and the delays, and the obvious shorting related attacks, it was just not the time. I think we are rapidly approaching what appears to be a key, binary, inflection point, and it's better to be in, than out at that time... at least for me. There is only so much that you can lose, and the upside here is pretty incredible if it works as anticipated.
I do find the science compelling and have for some good amount of time.
I think institutions are not far from my own thought process on this, at this moment. It's just too good an opportunity to wait too long on the sidelines.
But, the reality is, none of us know for sure. My speculation about BNY, as a custodian, is real, but it isn't necessarily connected to recent buys utilizing BNY.
I also think it's a bit of a tug of war, with shorts still pulling hard and getting a bit shrill and desperate, I think, in recent weeks. That is also, a very good sign. The more shrill and louder they get, in the context of all of the above, and a rising price, overall, the more compelling the value proposition. I think they are greedy to keep this little cash generating machine to themselves... It's far easier to short an unknown, tiny biotech than make money honestly.
Thanks and true.
I thought this was interesting, and expect he will likewise find himself in hock again, maybe after shorting one of my new favorite biotech stocks:
In 2011, he bet that shares of Orexigen Therapeutics Inc. would fall and wound up owing $7 million to his broker, Merrill Lynch, authorities said. He couldn’t pay, and he, an unnamed accomplice and MSMB Capital eventually extinguished the debt with a $1.35 million settlement, they said.
Part of that money came from his next firm, authorities said. After the collapse of MSMB Capital, Shkreli launched MSMB Healthcare with about $5 million from 13 investors. He paid himself “far in excess” of the agreed-upon 1 percent management fee and 20 percent profit incentive, according to the SEC.
Shkreli then used cash from MSMB Healthcare to invest in Retrophin, the pharmaceutical company he founded in 2011, even though it “had no products or assets,” prosecutors said. Later, he used the assets of Retrophin to repay angry investors in his hedge funds, prosecutors said.
Shkreli is confident that he will be cleared of the charges, according to a statement on his behalf.
My honest opinion... BNY is the choice of institutional traders, funds, money managers, etc. Generally they are used quite a bit as a legal "custodian".
https://www.google.com/#q=bony+custodian
https://www.google.com/#q=largest+custodian+banks
http://www.nasdaq.com/article/what-is-the-market-share-of-the-5-largest-custody-banks-in-the-global-custody-banking-industry-cm635397
Goldman was fined because it's prime brokerage systems did not actually confirm ownership of shorted shares. It seems unbelievable, but it is a real circumstance. I do think that for reputable brokerages, that should not be an issue, but, if it happened to Goldman, it could happen anywhere, and it's certainly at least possible on the edges and with non-US brokers that problems of that same sort could persist in the system without anyone being the wiser. If Goldman was "unaware", imagine who else could be...? It would definitely be against the law, but a brokerage could have it happen without being officially "aware" of it, as was the case with Goldman, and the SEC would have to be carefully scrutinizing everyone to make sure that they were updating their systems and not relying on the improbability of being caught. They said the multiple systems simply did not talk to each other, so they did not know....
https://www.sec.gov/news/pressrelease/2016-9.html
[/FOR IMMEDIATE RELEASE
2016-9
Washington D.C., Jan. 14, 2016 — The Securities and Exchange Commission today announced that Goldman, Sachs & Co. has agreed to pay $15 million to settle charges that its securities lending practices violated federal regulations.
According to the SEC’s order instituting a settled administrative proceeding, broker-dealers such as Goldman Sachs are regularly asked by customers to locate stock for short selling. Granting a “locate” represents that a firm has borrowed, arranged to borrow, or reasonably believes it could borrow the security to settle the short sale. The SEC finds that Goldman Sachs violated Regulation SHO by improperly providing locates to customers where it had not performed an adequate review of the securities to be located. Such locates were inaccurately recorded in the firm’s locate log that must reflect the basis upon which Goldman Sachs has given out locates.
“The requirement that firms locate securities before effecting short sales is an important safeguard against illegal short selling,” said Andrew J. Ceresney, Director of the SEC’s Enforcement Division. “Goldman Sachs failed to meet its obligations by allowing customers to engage in short selling without determining whether the securities could reasonably be borrowed at settlement.”
The SEC’s order finds that when SEC examiners questioned the firm’s securities lending practices during an examination in 2013, Goldman Sachs provided incomplete and unclear responses that adversely affected and unnecessarily prolonged the examination.
“SEC exams ensure that market participants are following the rules, so there will be consequences, including in the determination of remedies, when a registrant fails to provide complete and clear responses to examination staff,” said Andrew M. Calamari, Director of the SEC’s New York Regional Office.
According to the SEC’s order, Goldman Sachs employees who were members of the firm’s Securities Lending Demand Team routinely processed customer locate requests by relying on a function of the Goldman Sachs order management system known as “fill from autolocate,” which was accessed via the “F3” key. This function enabled employees to cause the system to grant locate requests based on the amount of reliable start-of-day inventory reported to Goldman Sachs by large financial institutions, even though its automated system had already deemed this inventory to be depleted based on locate requests processed earlier in the day.
The SEC’s order finds that when Goldman Sachs employees used this function to grant locate requests, they relied on their general belief that the automated model was conservative and the granting of additional locates would not result in failures to deliver when the securities became due for settlement. In doing so, the Goldman Sachs employees did not check alternative sources of inventory or perform an adequate review of the securities to be located.
The SEC’s order also finds that Goldman Sachs’s documentation of its compliance with Regulation SHO was inaccurate as it failed to sufficiently differentiate between the locates filled by its automated model and those filled by the Demand Team using the “fill from autolocate” function. In both cases, the locate log simply mentioned the term “autolocate” to refer to the start-of-day inventory utilized by the firm’s automated model as the source of securities underlying the grant of a locate.
The SEC’s order finds that Goldman Sachs violated Rule 203(b)(1) of Regulation SHO and Section 17(a) of the Securities Exchange Act. Without admitting or denying the findings, Goldman Sachs consented to the order and agreed to pay the $15 million penalty. The order censures Goldman Sachs and requires the firm to cease and desist from committing or causing any violations and any future violations of Rule 203(b)(1) of Regulation SHO and Section 17(a) of the Exchange Act relating to short sale locate records.
The SEC’s investigation was conducted by John C. Lehmann, Jason W. Sunshine, and Charles D. Riely of the New York Regional Office with substantial assistance provided by John L. Celio, Katy Chiu, Josephine LaFata, and Jennifer A. Grumbrecht of the National Exam Program. The case has been supervised by Sanjay Wadhwa.
quote]
OK. Great!
ttp://www.nwbio.com/nw-bio-receives-u-s-patent-on-broad-processes-for-producing-more-potent-dendritic-cells/
"This patent has also been issued in Europe, Japan, Australia,
New Zealand, India, China, Korea, Singapore, Russia and other
countries.
The standard methods used to produce dendritic cells today
involve several key steps, which start with precursors of dendritic
cells (called “monocytes”) obtained through a blood draw, then
develop the precursors into immature dendritic cells, and finally
develop these cells into mature and activated dendritic
cells. The standard methods cause some premature activation
of the precursors before they become immature dendritic cells, and
this premature activation orients the cells toward becoming an
undesired cell type rather than dendritic cells. This has to
be stopped and overcome by treating the cells with a biochemical
factor known as IL-4. This redirection results in conflicting
signals, and dendritic cells that are somewhat “confused.”
In contrast, the patented NW Bio processes closely track the
natural processes that occur in a healthy person’s immune
system. NW Bio’s methods avoid the premature activation of
the precursors (monocytes), and develop pure immature dendritic
cells — avoiding the conflicting and confusing signals, and the
need to override those signals with IL-4.
Building upon the pure immature dendritic cells, NW Bio’s
patented methods develop mature and activated dendritic cells that
are far more potent than dendritic cells produced in the standard
way. For example, NW Bio’s dendritic cells produce as much as
10X or more the amount of signaling compounds which are key to
mobilizing other active agents of the immune system, such as T
cells (which infiltrate and attack tumors) and B cells (which
produce antibodies)."
Yes, there seem to be some articles indicating that DC's from older patients, and older mice, don't work or are defective, and that immature cells, are necessary as well, from the blood, to educate.
IF you find the specific article, that would be great.
Thank you.
Dendritic cells are a specific type of cell. I don't want to misinterpret your question, but here are a few links that could help.
http://www.nwbio.com/dcvax-technology/
In order to make DCVax for a patient, the patient’s immune cells are obtained through a blood draw (called a “leukapheresis” or “apheresis”). These immune cells are precursors of dendritic cells, called “monocytes.”
For DCVax-L, the monocytes are differentiated into dendritic cells, and matured, activated and loaded with biomarkers (“antigens”) from the patient’s own tumor tissue (which is collected in a simple kit at the time of surgery to remove the tumor). The loading of biomarkers into the dendritic cells “educates” them about what the immune system needs to attack. The activated, educated dendritic cells are then isolated with very high purity and comprise the DCVax-L personalized vaccine. DCVax -L is administered to the patient through a simple intra-dermal injection in the upper arm, similar to a flu shot. The dendritic cells then convey the tumor biomarker information to the rest of the immune system agents (T cells, B cells and others), as “marching orders,” and the immune system agents then fan out through the body searching for anything with these biomarkers and attacking it.
For DCVax-Direct, the monocytes are differentiated into dendritic cells and partially matured. DCVax-Direct is administered by injection directly into inoperable tumors. These injections can reach tumors located virtually anywhere in the body, with ultrasound image guidance. After injection into the tumors, the DCVax-Direct dendritic cells pick up the tumor biomarkers (“antigens”) in situ in the tumor. Then, like the DCVax-L product, the dendritic cells in the DCVax-Direct product then convey the tumor biomarker information to the rest of the immune system agents (T cells, B cells and others), who then act upon it throughout the body.
Importantly, each activated, educated dendritic cell has a large multiplier effect, mobilizing hundreds of T cells and other immune cells. As a result, small doses of such dendritic cells can mobilize large and sustained immune responses.
Also very importantly, DCVax-L is non-toxic. In clinical trials to date, stretching over a decade and including over 1,000 treatment cycles, there have been no toxicities such as chemotherapies involve – no “serious adverse events” – related to the treatment.
https://en.wikipedia.org/wiki/Dendritic_cell#In_blood
In blood[edit]
The blood DCs are typically identified and enumerated in flow cytometry. Three types of DCs have been defined in human blood: the CD1c+ myeloid DCs, the CD141+ myeloid DCs and the CD303+ plasmacytoid DCs. This represents the nomenclature proposed by the nomenclature committee of the International Union of Immunological Societies.[10] Dendritic cells that circulate in blood do not have all the typical features of their counterparts in tissue, i.e. they are less mature and have no dendrites. Still, they can perform complex functions including chemokine-production (in CD1c+ myeloid DCs), cross-presentation (in CD141+ myeloid DCs), and IFNalpha production (in CD303+ plasmacytoid DCs).
OK. I hear you. Hard to know if they need much at this stage. It's late in the process, and what they really need is someone to negotiate those deals for the combination therapy trials. Companies at this stage and this tiny, are not that hard to manage, with the right people, experienced people, in place. They shouldn't be, anyway.
Celator was worth $60 million, until it wasn't. The pre-approval market cap of companies with very exciting new technology is not what Adam Feurstein suggests with his outdated intelligent market theory that takes outdated and irrelevant data to come to a wrong conclusion.
Up approximately twice that on Friday actually, and for the year, up over 40% so far. 2013 has been a good year so far for ACTC, and I hope it continues and that this is just the very beginning.
Scandal,
Since you think this is a debate, but sought to take my posts out of context to pretend that you're scoring points, and because this bulletin board makes it hard to scan previous answers, my answer to you is simply to direct others to read my previous post here;
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=78540931
And the subsequent posts.
Discussing anything with you seems to be pointless. You were fighting with ghosts.
One last point Scandal, because your last point of your post is grossly inaccurate. It is not that no other research organization can create fundable stem cell lines BUT ACT, because of the blastomere technique. That's inaccurate. Yes, ACT does not destroy the embryo, but the NIH policy, if you understood the case law related to the Sherley vs Sebelius case, does not currently make any such distinction.
Instead, the Guidelines make the distinction that research on ESC lines, is NOT research requiring the destruction of an embryo. Sherley's attorneys made the argument that all the stem cell lines that are allowed under the current definition of embryonic stem cell in the guidelines requires destruction of the embryo, and therefore they should not qualify because of Dickey-Wicker. However, the court disagreed that such a connection was necessary. First of all, the embryos from fertility clinics were not created for research, and second of all, the lines derived from the stem cells, are not derived from embryos created for research. But more importantly, the lines themselves are not embryos, so funding research using the stem cell lines, is not technically funding the creation of embryos for research. And the guidelines themselves ensure that the embryos are donated in conditions that are very carefully managed and disclosed to avoid a blurring of the line that would make the embryos a creation for research, for instance, by some desire to profit, for instance.
So the guidelines do not prohibit new stem cell lines from being created through methods that destoy the embryo. In fact, without the change to the NIH guidelines, that I discussed in my just previous posting, the only method to create new stem cell lines for research involves destruction of the embryo. But by including ACT's method, the NIH is allowing that there would be a reason and utility to fund cell lines derived by such a non-destructive method. And so, this is furthering the desire of most good persons to see a method that can be supported by just about everyone, without moral qualms or questions.
The embryonic stem cell registry, created by NIH, provides a means for the NIH to certify new stem cell lines, created by the traditional method, for use in NIH funded research. The primary focus is to ensure that the stem cell line creators followed the NIH Guidelines for moral creation of the line. Currently that NIH certification process does not allow ACT's method to create embryonic stem cells for NIH funded research, but hopefully soon, after the change goes into effect, it will.
So you really missed the point of most of the discussion and debate.
See also,
Paste to browser: hescregapp.od.nih.gov/comments/FR_Notice_2-23-2010.pdf
"In Section II of the final Guidelines, hESCs are defined as: ‘‘For the purpose of these Guidelines, ‘human embryonic stem cells (hESCs)’ are cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.’’
This definition had the unintended consequence of excluding certain hESCs which may otherwise be appropriate for Federal funding. For example, the current definition excludes hESCs from an embryo which fails to develop to the blastocyst stage.
Therefore, the NIH proposes replacing the current definition of hESCs in Section II with the following: ‘‘For the purpose of these Guidelines, ‘human embryonic stem cells (hESCs)’ are pluripotent cells that are derived from
???VerDate Nov<24>2008 16:25 Feb 22, 2010 Jkt 220001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1
mstockstill on DSKH9S0YB1PROD with NOTICES
8086 Federal Register/Vol. 75, No. 35/Tuesday, February 23, 2010/Notices
??early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.’’
This proposed change in no way alters the rigorous ethical standards set forth in the Guidelines."
Here are the NIH Guidelines, as they were published in August 2000, under President Clinton:
Again, you'll have to copy and paste them to your browser: www.gpo.gov/fdsys/pkg/FR-2000-08-25/pdf/00-21760.pdf
Or you can go here:
Click for google search: http://www.google.com/#hl=en&output=search&sclient=psy-ab&q=65+Fed.+Reg.+51%2C976+(2000)&oq=65+Fed.+Reg.+51%2C976+(2000)&gs_l=hp.3...1419.1419.0.1628.1.1.0.0.0.0.69.69.1.1.0.les%3B..0.0...1c.-njcdv29rDs&pbx=1&bav=on.2,or.r_gc.r_pw.r_qf.&fp=4d5ad5fc55e3e15d&biw=1080&bih=764
These guidelines reflect the current policy.
The NIH is now redefining embryonic stem cells to include stem cell lines created by means of the blastomere technique, or any technique that uses an earlier stage embryo. Such earlier embryos are not currently referenced under the relevant definition included in the Guidelines / NIH Policy, created under Clinton.
Scandal,
I have no desire to spread misinformation, but from the gist of your posts, I think you believe what you're saying, whether it is fully informed or not.
The reason no HUMAN embryonic research was funded prior to 1998, was that it was not UNTIL 1998, that James Thomson, at University of Wisconsin developed a technique to isolate and grow embryonic stem cells. The technique was embodied in the WARF patents, and anyone seeking to do the research needed to have access to those patents. There were many more factors than the notion that NIH was in the way. There is no indication that NIH was in the way.
http://en.wikipedia.org/wiki/Embryonic_stem_cell#Research_history_and_developments
http://stemcells.nih.gov/info/2001report/preface.asp
Prior to Bush's policy, which had nothing to do with Dicky-Wicker, new lines were created, but not many yet because it was still early after Thompson's breakthrough. During the Bush years, research was limited to the contaminated and early lines, created when the science was still in its infancy and the techniques were not yet perfected. They could not create new lines. Once Bush was out however, we could go back to the policy that was being put into place under Clinton, which allowed NEW lines to be created and for research, ultimately to be funded. However, the policy was not fully finalized when Clinton left office, so it was not put into place.
http://en.wikipedia.org/wiki/Stem_cell_laws_and_policy_in_the_United_States#Federal_law
Clinton, prior to Thompson's work, was cautios and directed, in 1994 that NIH not fund human embryonic research to ensure, given the crudeness of the science at that moment, that embryos were not created purely for research purposes. That was 1994. However, upon Thompson's breakthrough in 1998, the NIH was able to develop responsible ethical guidelines that could respect the boundaries of Dickey Wicker, while still allowing new stem cell lines to be created under very careful circumstances, which apply now under the current NIH policy. That policy was effectively restored under Obama, and Bush's policies were set aside. Basically, under carefully scripted circumstances that are already allowed, for fertility treatment, embryos are already created. Using the excess embryos, donated under carefully managed circumstances, scientists were allowed to create stem cell lines, which, not being embryos, could be studied and funded by NIH. Thats very broad brush.
Adult stem cells have been studied for many decades. But Embryonic research is extremely new. They did embryonic research on mouse stem cells, and that research was funded by the normal channels, including NIH.
You seem to think Clinton prevented the research and Bush funded it. Again, this is a false understanding that gets repeated and repeated by the right wing, as though Bush were the inventor of stem cell research.
Clinton developed a policy to advance embryonic research.
Let's look at the description of the U.S. Court of Appeals, in the Sherley vs. Sebelius case, Decided April 29, 2011:
I can't put a link to a pdf here, the bulletin board corrupts it - but hopefully you can paste the following in your browser to read the full opinion:
""www.cadc.uscourts.gov/internet/opinions.nsf/DF210F382F98EBAC852578810051B18C/$file/10-5287-1305585.pdf"
The historical record suggests the Congress passed the Amendment chiefly to preclude President Clinton from acting upon an NIH report recommending federal funding for research using embryos that had been created for the purpose of in vitro fertilization. See O. Carter Snead, Science, Public Bioethics, and the Problem of Integration, 43 U.C. DAVIS L. REV. 1529, 1546 (2010). Dickey-Wicker became directly relevant to ESCs only in 1998, when researchers at the University of Wisconsin succeeded in generating a stable line
5
of ESCs, which they made available to investigators who might apply for NIH funding.
For that reason, on January 15, 1999, the General Counsel of the Department of Health and Human Services issued a memorandum addressing whether Dickey-Wicker permits federal funding of research using ESCs that had been derived before the funded project began; she concluded such funding is permissible because ESCs are not “embryos.” After notice and comment, the NIH issued funding guidelines consistent with this opinion, see 65 Fed. Reg. 51,976 (2000), but the NIH did not fund any ESC research project while President Clinton was in office.
Early in 2001, President Bush directed the NIH not to fund any project pursuant to President Clinton’s policy; later that year he decided funding for ESC research would be limited to projects using the approximately 60 then-extant cell lines derived from “embryos that ha[d] already been destroyed.”
Upon assuming office in 2009, President Obama lifted the temporal restriction imposed by President Bush and permitted the NIH to “support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” Exec. Order 13,505, 74 Fed. Reg. 10,667, 10,667 (2009). The NIH, after notice-and-comment rulemaking, then issued the 2009 Guidelines, 74 Fed. Reg. 32,170–32,175 (July 7, 2009), which are currently in effect. In the Guidelines, the NIH noted “funding of the derivation of stem cells from
6
human embryos is prohibited by ... the Dickey-Wicker Amendment.” Id. at 32,175/2. The Guidelines further addressed Dickey-Wicker as follows:
Since 1999, the Department of Health and Human Services (HHS) has consistently interpreted [Dickey-Wicker] as not applicable to research using [ESCs], because [ESCs] are not embryos as defined by Section 509. This longstanding interpretation has been left unchanged by Congress, which has annually reenacted the Dickey [sic] Amendment with full knowledge that HHS has been funding [ESC] research since 2001. These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which Federal funding is prohibited, and research involving [ESCs] that does not involve an embryo nor result in an embryo’s destruction, for which Federal funding is permitted.
Silvr Surfer,
You seem to still think it has something to do with an intention to sell or profit. Actually, the sales on an uptick will ultimately MINIMIZE the amount of shares that a recipient of shares would have to sell at tax time.
Additionally, a broker, in this kind of arrangement, which is the safest for the company and for the corporate insider, MUST sell on an uptick. He has no choice. So you should just get used to it. It's a function of this kind of compensation. It has nothing to do with intention or bad faith, so there is no point making that point. It just doesn't make sense, though it sounds good and I know others make it on these boards. It's false drama. While it sounds good to other unsophisticated investors, it is not relevant to anything in relation to the stock or the company. Personally, I prefer to hear meaningful points, the rest is just noise. But I also realize that many posters like to make these kinds of points if only to make a point that seems meaningful or important. But ultimately, as indicated, the tax sales are just a function of the compensation method chosen. Not much to see or really to analyze.
Good luck!
Caldwell is dead.
Lanza has a diversification plan filed in which his broker determines, based upon his shares, and assets, when to sell, without ever consulting Lanza, based upon some general principles that may be changed and updated without refiling of the plan for public review.
Lanza and Rabin are actually paid directly in shares instead of cash. They have immediate grants of shares rather than options, which are tax deferred. Given their incomes, they would pay the maximum tax rate on their shares. Depending on what the shares do when they are GRANTED, they would owe tax on the price immediately, before the year is out, even if they didn't sell any shares, of 35%. This has been repeated by me over and over again on certain boards where a good number of the same posters post over and over again, that they don't understand why Lanza is selling. As a fellow investor, I find it maddening that people are often so dense.
If the stock went down by half after the grant, for instance, they'd likely have to sell 2 x 35% to get the taxable rate out of the same amount of shares. With a penny, payment in shares is very risky, so his broker probably takes ANY rally opportunity to sell a good chunk, to a) reduce the percentage sale of shares, and b) to maximize the immediate income from the sale of the shares to pay the immediately due taxes without incurring a penalty for late payment (which would require, if a penalty were incurred, the sale of more shares). Tax wise, it's very risky for the broker to delay or to miss any opportunity to sell on a slight rally or on a schedule if no rally is in sight or even a down period in the shares looks to be ahead. The broker has a fiduciary duty to get the best price for Lanza's shares and not to concern himself with what retail investors may think. I doubt he even reads bulletin boards on the company, that's not the broker's concern.
But I know, if you see an incorrect (annoyed/annoying) point repeated enough, over and over again, it tends to sink in, even if it's not particularly telling, meaningful or true.
Tax Consequences of Stock Grants: http://fairmark.com/execcomp/grants.htm
There is a lot of noise and angst and back seat driving on the internets... but much of it, even the best, often doesn't amount to much.
Good luck to all who are sincere and working to invest their hard earned dollars, no matter where those funds are placed or what company or investment.
Since your post, they have been up, as high as 40+%, and now are up approximately 28%.
http://www.google.com/finance?chdnp=1&chdd=1&chds=1&chdv=1&chvs=maximized&chdeh=0&chfdeh=0&chdet=1344904837455&chddm=10166&chls=IntervalBasedLine&q=OTC:ACTC&ntsp=0
There is no doubt that they will continue to fluctuate wildly as such stocks do, all the time, based on very low daily dollar volume.
They will, unless Planet X knocks our planet away from the Sun, or something similar, always be able to raise more money, if they have a product that looks promising and there are greedy potential investors with available cash somewhere. The only question is price and dilution.
Even mentioning bankruptcy in this current context is hyperbole. I do think you mean well, but it's highly unlikely at this moment, given the facts.
Additionally, on the AMEX listing, those are the facts.
I'm not worried. That's not to say that anyone should look to me. But I don't find your arguments compelling about bankruptcy. It's kind of like saying, just before FB went public, well, if the IPO goes bad, they could go bankrupt. Theoretically, anything is a possibility that can't be discounted, but even with the IPO going badly, nothing like bankruptcy was really realistically possible. But, it could have been said, theoretically, and theoretically, a person saying that could say, that no one could say they were wrong... and when the IPO went badly, they might've even said, "See! I was right!" - even though they didn't go bankrupt.
In that context, you're absolutely right.
I follow the company very closely. Plus Gary Rabin the CEO just spoke to the specific potential for damages in the most recent conference call.
There is no "treble" damages on this issue.
The only person who typically posts on "treble" damages on any ACT message board is me, and that's usually in the context where bashers say that the patents are worthless, and I point out that if someone steals the IP, and brings a treatment to market, the company, under patent law, is entitled to TREBLE damages for violation of its patents, as a serious disincentive to the violation of IP rights.
That's the only instance that I've seen intelligent discussion of legal matters related to ACT in which the term "treble" damages is used. If you'd like, post a link to whatever discussion you think you saw and I'd be happy to dissect it for you.
Just so you don't confuse people further, also note that the ONLY reason that ACT's lines don't currently qualify for NIH funding is because they are non-destructive of the embryo . . . well, it's not that simple.
The situation is that the legal definition that allows for funding, of "embryonic" stem cells is that the stem cells are derived from a specific stage of the embryo's development, in a particular manner.
However, ACT's method, known as "blastomere technology", removes one cell, in a non-destructive manner, similar to pre-implantation genetic diagnosis, performed on embryos before they are implanted for fertility treatments, though it does not require such testing to derive a stem cell line. Using this technique, a family or a clinic or a researcher may remove one cell, and develop that one cell into an immortal line of cells that can treat millions of people. The embryo remains viable to be implanted to complete the fertility treatment, and in fact, tests for predisposition to various diseases can be performed on those cells, and cells that represent specific disease predispositions actually would be very useful as well as healthy cells. The technique from which the blastomere technology is derived is a routine procedure in fertility treatment.
The embryo remains not only viable, but this test is very typically done before the embryo is implanted to avoid conditions such as tay sachs disease.
That method of deriving stem cells without destroying the embryo is patented by ACT. However, the derivation comes from a very early stage embryo, much earlier than the standard method that requires destruction of the emryo. Ironically, this means that they companys cells do not qualify legally, at this time, as embryonic stem cells under the law that now exists for NIH's funding. NIH has proposed a fix to this that should ultimately make that funding available. However, in the mean time, the company has progressed its own treatments beyond the point where such funding is particularly important for any treatment currently in trials.
http://news.sciencemag.org/scienceinsider/2010/02/nih-expands-definition-of-human-.html