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Because they don't appear to have the courage to list who they are and where they operate! That does take some credibility out of their claims. I am interested to see how the new firm handles this issue. Either deformation or serious allegation and issues. I am concerned. But not panicked. Do you know anything else about these fellows?
Koman, you are joking? They state that they are short! Still sorting through this stuff.
Until a court tells them to provide information about who they are and where the live! Interesting!
SA will most certainly not publish this hit piece as it is a wild departure from the non-inflammatory works that they like. This article is fit for a law suit as its allegations are clear defamation. Constitutional protection does not protect against a known and willful intent to defame with facts known to be untrue. And regardless, it does not protect against a law suit and the expense of lawyers to defend them.
The author has taken a very shaky and risky step here, which is why he has hidden his identity. And the attempt to add credibility with footnotes is deceptive as it merely gives facial support to the arguments. For instance, the stock transactions highlighted do not speak to the conditions surrounding the negotiations for extension of credit, nor the credit worthiness of NWBO at the time, and least of all it does not speak to the common practice of lenders (clearly other biotech companies used similar approaches to raise capital). Overall its a very biased article unworthy of print.
T.C., I read the hit piece, and am certain it belongs to the departed P as it follows his arguments. I am interested to see how this propaganda affects share trading. The easy answer is for NwBO to PR the halt issue. The failure to do so has increased my concern. I have presumed it (the halt) to be neutral given LP's continued statements of promising results for L, which statements could not be made if a problem were known (assuming the issue preceded the London presentation). I am always impressed with footnotes, unfortunately, which the hit piece uses. Tracking out those critical arguments would be some work, but would likely find major deficiencies in the logic or long leaping presumptions. Clearly a Short instrument to create fear. Time is ticking.
The world class investor, Woody,(and his new team) should bring some fresh air to this company. Hopefully in time to turn the ship. I really don't expect the hit piece to work any more than P s postings did. Concerned?
Cherry,
I was talking about the IMUC post. However, its not a long friendly one, so I am content to let it go.
Cherry, was there something else you thought came out about the CLDX's FDA rejection? Hard to imagine the FDA ever saying OS is not proof of efficacy since it's always a secondary, and condition for approval. It was clear from the first PR that it was a concern about accidental result due to lack of statistically significant numbers.
However, since you wanted a response from me, I did give you the quote from IMUC, which could have legs with GBM trials. Any thoughts?
Cherry,
My concern originates from the below identified PR from IMUC about it SPA for newly diagnosed GBM and the stated position of FDA towards PFS for newly diagnosed GMB trials. I think this raises the bar for any presumption that we get a pass on the basis of PFS. Hence my question to Flipper. I hope this helps you understand where I am coming from regarding that question, and my concern as to whether Tman understood the question. So to repeat myself, assuming NWBO must move to OS to establish efficacy for a NDA or NBA, does the company identify a timeline for that eventuality? I hope it is clear that I know PFS is identified as a primary end point and OS is a secondary end point under NWBO's trial.
QUOTE:
"ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) announced today that it has reached agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma. The phase 3 trial is designed as a randomized, double-blind, placebo-controlled study of about 400 HLA-A2 positive subjects, which will be conducted at about 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have stated is the appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups. Patient enrollment is anticipated to begin in the late third quarter or early fourth quarter of 2015."
http://investors.imuc.com/releasedetail.cfm?ReleaseID=927519
Clearly the longer it takes to reach the preset review number for PFS the better and higher the M. But I don't have any idea how the patients were added, how quickly, or even if it was consistently. What do you think the PFS number is if it happened when you say?
More important is whether the FDA will accept PFS as a criteria to establish sufficient efficacy to warrant approval? Some other biotech companies are announcing the answer to be not. Then when will we have sufficient OS numbers to warrant an NDA? Not many easy answers. The company suggested enough answers to know by some time in 2016?!
The fact that 8K says it was a non-solicitation deal means that AF article about NWBO begging for money is total Bullcra$. Totally a short investors worry article.
Is that a dart against he wall type of guess?
Koman, I only have a newsie knowledge of the Cuban case. I agree that the cost to NW would be limited purchases in the future, until the information is made public. Given the pile of stock already setting in his accounts, I doubt that further purchase restrictions had much influence on his decision. Just seems more probable that he would want to know whether an iceberg was dead ahead. His public statement does not share actual information that he may have learned. So does a one word adjective constituents a violation of any confidentiality agreement! I believe the conclusion of the deliberate analysis on IVillage was that the statement meant nothing more than what LP's statement suggested! Therefore probabilities support a conclusion: he knows!
koman, Final REG of FD
https://www.sec.gov/rules/final/33-7881.htm
Quote:
Rule 10b5-1 addresses the issue of when insider trading liability arises in connection with a trader's "use" or "knowing possession" of material nonpublic information. This rule provides that a person trades "on the basis of" material nonpublic information when the person purchases or sells securities while aware of the information. However, the rule also sets forth several affirmative defenses, which we have modified in response to comments, to permit persons to trade in certain circumstances where it is clear that the information was not a factor in the decision to trade.
I admit that I do not practice in this area, and my knowledge is limited to a class some, well a long time ago. However, I do understand the legal methodology for regulation writing which is helpful in interpretation. While the statement is summary of the provisions and helpful it is not authoritative.
koman,
Again a quote from the description of the final rule for 10b-5 interface with FD regs.
The exemption for NW would have required a existing purchase agreement before he got the information from LP. Still sounds reasonable.
Quote:
"As adopted, paragraph (c)(1)(i) sets forth an affirmative defense from the general rule, which applies both to individuals and entities that trade. To satisfy this provision, a person must establish several factors.
First, the person must demonstrate that before becoming aware of the information, he or she had entered into a binding contract to purchase or sell the security, provided instructions to another person to execute the trade for the instructing person's account, or adopted a written plan for trading securities.109
Second, the person must demonstrate that, with respect to the purchase or sale, the contract, instructions, or plan either: (1) expressly specified the amount, price, and date; (2) provided a written formula or algorithm, or computer program, for determining amounts, prices, and dates; or (3) did not permit the person to exercise any subsequent influence over how, when, or whether to effect purchases or sales; provided, in addition, that any other person who did exercise such influence was not aware of the material nonpublic information when doing so.110
Third, the person must demonstrate that the purchase or sale that occurred was pursuant to the prior contract, instruction, or plan. A purchase or sale is not pursuant to a contract, instruction, or plan if, among other things, the person who entered into the contract, instruction, or plan altered or deviated from the contract, instruction, or plan or entered into or altered a corresponding or hedging transaction or position with respect to those securities.111
Under paragraph (c)(1)(ii), which we adopt as proposed, the exclusion provided in paragraph (c)(1)(i) will be available only if the contract, instruction, or plan was entered into in good faith and not as part of a scheme to evade the prohibitions of this section.
Paragraph (c)(1)(iii) defines several key terms in the exclusion. We are adopting, substantially as proposed, the definition of "amount",112 which means either a specified number of shares or a specified dollar value of securities. We have revised the definition of "price" and added a definition of "date." As adopted, "price" means market price on a particular date or a limit price or a particular dollar price.113 "Date" means either the specific day of the year on which a market order is to be executed, or a day or days of the year on which a limit order is in force.114
Taken as a whole, the revised defense is designed to cover situations in which a person can demonstrate that the material nonpublic information was not a factor in the trading decision. We believe this provision will provide appropriate flexibility to those who would like to plan securities transactions in advance at a time when they are not aware of material nonpublic information, and then carry out those pre-planned transactions at a later time, even if they later become aware of material nonpublic information.115"
Koman, from official regulation description cited previously.
"Rule 100(b)(2) sets out four exclusions from coverage. The first, as proposed, is for communications made to a person who owes the issuer a duty of trust or confidence -- i.e., a "temporary insider" -- such as an attorney, investment banker, or accountant. The second exclusion is for communications made to any person who expressly agrees to maintain the information in confidence. 28 Any misuse of the information for trading by the persons in these two exclusions would thus be covered under either the "temporary insider" or the misappropriation theory of insider trading. This approach recognizes that issuers and their officials may properly share material nonpublic information with outsiders, for legitimate business purposes, when the outsiders are subject to duties of confidentiality.29"
CaptianO
Filing a frivolous law suit can bite. But what you suggest would certainly put a chill on legitimate law suites. Who would want to take the risk of getting their head cut off. That could lead to an unrepresented class of complainants. Such as yourself, after you lost your life savings because of a stock sales team who got your attention and money in exchange for worthless stock. Merely projecting, but I think you understand that some cases are very legitimate, and we wouldn't want attorneys to be afraid of taking on those cases where someone was stupid, but swindled. The cost of that is to live with a few frivolous cases. Big deal.
koman, Final REG of FD
https://www.sec.gov/rules/final/33-7881.htm
Quote:
"Rule 10b5-1 addresses the issue of when insider trading liability arises in connection with a trader's "use" or "knowing possession" of material nonpublic information. This rule provides that a person trades "on the basis of" material nonpublic information when the person purchases or sells securities while aware of the information. However, the rule also sets forth several affirmative defenses, which we have modified in response to comments, to permit persons to trade in certain circumstances where it is clear that the information was not a factor in the decision to trade."
I admit that I do not practice in this area, and my knowledge is limited to a law class I took some, well a long time ago. However, I do understand the legal methodology for regulation writing which is helpful in interpretation. While the statement is a summary of the provisions and helpful it is not authoritative (however persuasive). But we are not arguing before a court, so heck, it should do for now. NW agreed to provide financing with PIPE. So, not Insider trading if plan was agreed on prior to disclosures. However, would it have been possible for him to change his mind and not buy or to offer less financing? Would have to look at actual text of reg for that interpretation. Enjoy
Koman is correct about the terms for domestic hedge fund or commercial banker financing. NW has offered very favorable terms under all three of his deals. To see the difference just look up any biotech SEC filing of financing and you can see! CLDR is classic example, discounted shares 25 percent and gave favorable war rents. Very dilutive. Perspective is different as NW wants to grow the company as means to make money. Warren Buffet like, with long term hold. Other guys are focused on short term gains. Their approach is dilutive to existing shareholders and causes stock to fall in value!!
Agreed, fly on the wall would have been nice. I think its highly probable that the outlook for NWBO is very good. Otherwise, NW would have made the financing less favorable, or not at all. As far as certainty of the legal issue, please look at my response to Koman with specific exemption to this type of disclosure. The matter is very certain, as in black and white.
In point of fact, all those updates to NW are likely to have happened. In a game of chicken, NW would most certainly have won as he had all the leverage with the $30.0M funding. And most important, it is all within the boundary of the law. From a large investors standpoint, appropriate as well. As far as being FACT, yea, pretty sure that it is. What do you think management meeting are about (the next dividend?).
I find it a little foolish to believe that NW wouldn't ask about the Hold since there is absolutely not down side to doing so. Unless, of course, you believe him to be an unsophisticated investor?
koman,
I will look when more time is available to me. For now let me just say that the disclosures on the hold are (is) adequate for purposes of obligations on NWBO. Frankly, I don't like not knowing, but do take some comfort in the fact the NW knows and still put down $30.0M.
I think the answer is NW is a long term investor with an objective of growing a company, rather than a short term investor with interest in a quick profit. Engaging in transactions that eliminate the complaints about dilution are more likely to encourage other investors to support the capital value, which is critical to success.
Koman,
I suggest you read the copied language I sent you because it does address your question. The FD regs do not apply to "any person who signs a nondisclosure agreement". So it doesn't matter what type of purchase it is. Frankly, to get double indemnity I could look to see if an unregistered sale is one under the 1933 act or the 1934 act. However, since the answer is in the agreement, it does not matter. So I ask you, if you were about to put $30.0M on the line, would you want to know about the Halt issue? Right.
http://media.mofo.com/files/Uploads/Images/FAQs-Regulation-FD.pdf
Koman,
Perhaps the following will help you better understand the FD REGS.
Quote:
Regulation FD specifically excludes certain
communications from the scope of the regulation. These
exempted disclosures generally fit into the following
three categories:
• Communications to a person who owes the
issuer a duty of trust or confidence. This
would include counsel, financial advisers, and
other so-called “temporary insiders.”
• Communications to any person who expressly
agrees to maintain the information in
confidence. There is no requirement that the
individual agree not to trade on the
information; a promise to maintain
confidentiality is sufficient. Note, of course,
that insider trading laws would still apply.
• Communications in connection with an
offering of securities registered under the
Securities Act of 1933 (the “Securities Act”).
Koman, 10b-5 is excluded as it does not apply to violations of RD, as was cited in the text I sent you. my memory of security law class is that this is the insider trading prohibition statute!
Koman, maybe my site did not cover the issue adequately. It appears flipper and smokey have addressed the matter. I think from a pure reasoning perspective the SEC showed adjustments to the regs with intent of not interfering with capital formation. PP is a clear method for fund raising and the fact it's an unregistered offering puts limits on when such stocks could be exercised. So the potential for harm is minimized. Most assuredly NW knows the halt issue, and still put down $30.0M. Says a lot!
Indeed, confidence in the company. The question for many investor is whether the HALT has any teeth. Accordingly, the $30 million question is whether NW obtained information under a confidentiality agreement about the Halt Issue prior to his agreement to put down another shelf purchase. I believe the rules are elastic enough to permit that occurrence. I guess the question is would you throw good money after bad, which is the gamble he would have taken if he did not ask the hard question.
www.sec.gov/rules/final/33-7881.htm
Somewhat related,
Quoted:
Third, to remove any doubt that private liability will not result from a Regulation FD violation, we have revised Regulation FD to make absolutely clear that it does not establish a duty for purposes of Rule 10b-5 under the Securities Exchange Act of 1934 ("Exchange Act"). The regulation now includes an express provision in the text stating that a failure to make a disclosure required solely by Regulation FD will not result in a violation of Rule 10b-5.
Fourth, we have made clear that where the regulation speaks of "knowing or reckless" conduct, liability will arise only when an issuer's personnel knows or is reckless in not knowing that the information selectively disclosed is both material and nonpublic. This will provide additional assurance that issuers will not be second-guessed on close materiality judgments. Neither will we, nor could we, bring enforcement actions under Regulation FD for mistaken materiality determinations that were not reckless.
Fifth, we have expressly provided that a violation of Regulation FD will not lead to an issuer's loss of eligibility to use short-form registration for a securities offering or affect security holders' ability to resell under Rule 144 under the Securities Act of 1933 ("Securities Act"). This change eliminates additional consequences of a Regulation FD violation that issuers and other commenters considered too onerous.
Koman, perhaps a clumsily expressed question to Senti. As you know the FD Regulations prohibit companies from engaging in selective disclosures to individual shareholders unless they also tell all other shareholders. My question is focused on the quoted regulation that Flip pulled up from somewhere. I did not look closely at that quoted material at the time, and was certain I did not see an appropriate cite to the location within the regulations. However, I think Centi may have confirmed the interpretation to that regulation, and hence reviewed the regulation. That quoted regulation was supposed to offer an exception to the selective disclosure standard where the purpose of the selective disclosure is to induce a person to acquire stock in a special offering to provide financing to the company. If true, then NW would certainly have asked questions about the HALT. My comment is that Larry did not address this issue, rather did a Hail Mary on the issue by concluding that NW did the deal because he was invested at over $150.0M, inferring that he had not real option. I truly doubt that position is correct.
Larry does not address restrictions on selective disclosures under FD Regs. which might explain NW willingness to finance even with halt to screening in place (exceptions). Accordingly, didn't you look and see exceptions when a party is engaging in a corporate financing by stock acquisition? This would suggest that NW knows the reason for the halt and is unconcerned. Your comment please.
CaptainO,
I am occasionally looking at the board. I have a pile of work that landed on my desk, so can't possibly chat. Besides, since I have been accused of being this Pyr fellow, I thought it might be prudent to understand his position on matters. So I am reading his post, including the ones he sent to me before leaving. I think he is a very bright guy, and has made arguments I would make were I seeking to discredit the PIII. But those arguments are flawed. And were I without work it might be possible to share the shortcomings with you. But not today, or tomorrow. I may discuss the matter with JMLogan on Ivillage as he appears to have a very good head on his shoulders and would likely be fun to engage in debate with about this subject. Besides he opened the issue for debate and no one has picked up the challenge. But again its a time issue.
Good luck
rather "advice"
RK,
I thank you for the advise. Question: the issue of confused DC and freeze-thaw (five times) creating necrotic antigen targets. I see Roosevelt U study from 2000 and another form 2005. Pyr states that company did not change protocol to account for required addition of elements to move DC from confused state. I don't see the article that sets that issue into perspective, and do we know the PIII protocol?
Flipper, I agree that it's highly speculative to assert any probability of change in screening protocol. And admit that it almost seems pointless since there are only 40 something candidates to add (11 percent). But does it appeal to your sense of logic to first examine the exact reliability of cytokines predictability as expressed by LP. The objective would be to eliminate individuals whose D cells were ultra low producers of cytokines . I will look tomorrow for analysis LP put out.
Not really available today! I really don't think the proposition of screening change is the most important issue I presented! That was necessary to bring it current. Although I think it is a possibility as the predictability seems quite strong! I hoped to see conversation around the exciting possibility of yet a more exacting predictor of success! A conversation about those findings should naturally be first in line for review . Once validity of that proposition is exhasted then a discussion of the highly speculative matter of Whatever ( quoting Sentiment) (screening adjustment). Truly disappointing as proposed screening adjustment is like all other guesses that have been thrown out (we will know for sure when ...). But I am not there to form that discussion. Talk about the exciting development, no !!
Missing the point. They changed the protocol to exclude RP at screening. No more than what I am putting on the table, as a mere possibility.
Flipper, you said they wouldn't change screening for a decade old trial. I point to rapid progressers as evidence you are mistaken. You then take your ball and run home. Why end the conversation on that point. Really. This is too much work. Tell me now how my view, which is supported by LP video in London, is FUD. How does pointing out better knowledge and knowhow of NWBO translate into FUD?
Yes, but what planning. Also reason exist if they had information outside the trial that was important to the trial. For instance, if they became aware of a new predictive analysis such as Dendritic cell generation of IL-6 and 8 and other cytokines. After all they have just learned that 1) dendritic cells vary in the amount of cytokines they are able to produce (mine are more powerful than yours type of analysis(see minute 25 of LP video in London)); 2) the higher the cytokines production the greater likely hood of survival and therefore high production is highly correlated to survival (I have greater likely hood of survival than you (LP video minute 25)); 3) they can determine cytokines production levels at the very end of the manufacturing process (so they can tell that my dendritic cells can out produce yours at end of manufacturing process (you guessed it- LP video). Suppose that could be a reason to suspend screening to add that criteria to screening, such as dendritic cell capability for high cytokines production. As it only offers upside to survival results of the trial, with no downside. Breath now !
That text seems good enough. If you want to prove that point then we would have to review the actual charter! I think the idea of NW shorting is a brain dead idea for longs! A 20 million fund holder shorting would certainly need good PR were that to become public. And given the fund states it does not short really greases the frying pan were it true!! Not to mention the lack of any real strategy based reason to do so! I can't possibly talk about this any more! Time to see the family! Good day.