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from a legal stands. How long can any listed company maintain they are in a process doing somethimng and then never do it/ or make zero progress doing it without disclosing that?
1 year? 2 year? a 100 years?
These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and independent experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way
What we know is the trial is not a failure, otherwise the results most certainly would have been disclosed. But what we don’t know is the level of success - are the results ambiguous in some way? That’s why the delay in releasing TLD makes the company vulnerable to attacks. Is the company CVM or is it Biogen?
And I will say this, if the company is holding onto ambiguous results for this long, they still will be exposed to lawsuits and maybe even SEC action.
If they are not unblinded yet than they have not been exposed to trial results. In that case the mandate to disclose negative trial results is a bit different but its not that simple.
Its too bad no one read my post here because my post here is quite interesting https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167260618
1. First of all.
NWBO made certain statements in their 8K's that would be misleading if they had no unblinded
A duty to disclose a non-public material fact may arise if the company makes statements that will mislead unless the company also reveals the negative test results. Joseph W. Cormier Mahnu V. Davar Volume 29 2013
https://scholarship.law.edu/cgi/viewcontent.cgi?article=1016&context=jchlp
Now NWBO repeatedly said this in their previous 10Q’s:
These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and independent experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way
Additionally, the safe harbor provides that only companies and executives that meet a high level of culpability will be liable for predictions. This requires plaintiffs to plead and prove actual knowledge that the forward-looking statement was false or misleading.80 On the other hand, many courts have held that some form of extreme recklessness will satisfy the scienter element of a § 10(b) claim 81.
80. 15 U.S.C. § 77z-2(c)(1)(B) (If the statement is made by a natural person, a plaintiff must prove that that individual had actual knowledge that the statement was false or misleading; if made by a business entity, a plaintiff must prove that it was made with the approval of an executive officer who had actual knowledge that the statement was false or misleading.).
81. William 0. Fisher, Key Disclosure Issues for Life Sciences Companies: FDA Product Approval, Clinical Test Results, and Government Inspections, 8 MICH. TELECOMM. & TECH. L. REv. 115, 120 (2002)
Is there ongoing dialog with the FDA regarding formation of the SAP and will you wait to unblind until after the SAP is approved?
Answer (LP): “Definitely ‘yes’ we won’t unblind until the Statistical Analysis Plan has been approved by all regulators
If the FDA has a different interpretation of the data, the FDA’s differing interpretation under many circumstances should be disclosed to investors upfront. Otherwise, disclosure would be required in almost any circumstance to update prior disclosure that would otherwise be materially misleading to an investor. Additionally, it should be noted that companies often obtain negative information from the FDA during the course of drug or device development. This information is not necessarily an indication of approval delay or clinical trial failure, but such information may, under certain circumstances, be material and require disclosure (sometimes very quickly). For instance, companies that become aware of an approval delay or that a product is not likely to be approved by the FDA, must be cautious about disclosing inaccurate or incomplete information (which can sometime force off-cycle disclosure if material enough to the company’s business or prospects
aha I see
If the trial turns out to be a failure then NWBO did not comply with different SEC regs and management should for that reason be prosecuted.
Therefore I have made the conclusion I just made which is that the trial is a succes which is part of my extensive DD on the trial and there is nothing and no one that can chance my mind on that.
NWBO is mandated to disclose a trial failure different legal sources and lawyers confirm this.They did not THUS the DCVAX L trial is a succes.
I.a duty to disclose a non-public material fact may arise if the company makes statements that will mislead unless the company also reveals the negative test results.
From Predictable Materiality: A Need for Common Criteria Governing the Disclosure of Clinical T e of Clinical Trial Results b rial Results by Publicity-T y Publicity-Traded Pharmaceutical Companies Katherine Cohen Joseph W. Cormier Mahnu V. Davar Volume 29 2013
https://scholarship.law.edu/cgi/viewcontent.cgi?article=1016&context=jchlp
In the context of disclosures of negative clinical trial results, a duty to disclose a non-public material fact may arise if the company makes statements that will mislead unless the company also reveals the negative test results. This duty arises from sections 11 and 12(a)(2) of the 1933 Act and Rule lOb-5, which expressly impose liability for omitting material facts necessary to make statements made non-misleading. Likewise, section 10(b) cases hold that "when a corporation does make a disclosure-whether it be voluntary or required-there is a duty to make it complete and accurate." 1 ' Applied in the context of pharmaceutical companies, where a drug or device company "has reached a conclusion that test results on a new product are negative, it may, as a practical matter, be difficult to provide any progress report on the product to the investment community that fails to include this 'bad' news without the report being arguably incomplete or misleading."' 112 112. Fisher, supra note 81, at 163 harvardlawreview.org.
“The Sawston facility must also be certified and licensed by MHRA in order to be able to manufacture products such as DCVax-L.”
The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals,
These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and independent experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way
Publicly listed pharmaceutical companies have duties of disclosure to their shareholders, including, in some instances, of emerging clinical trial data. The U.S. Securities and Exchange Commission requires publicly-listed companies to submit periodic updates, including, a statement of ‘management’s discussion and analysis of financial condition and results of operations’. Among other matters, this should include information on ‘any known trends or uncertainties that have had or that the registrant reasonably expects will have a material favorable or unfavorable impact on net sales or revenues or
income from continuing operations
It is possible that clinical trial test results for drugs and devices could be considered material "given the enormous costs sunk into research and the high market interest in potential outcomes."85 85. Cohn & Swick, supra note 59, at 926
4.2.3 Particularised Information on When Unblinding Occurred To the extent that sponsor companies have gained some level of information about interim trial data, courts have required close particularization of when that information has been gained in order to substantiate allegations of securities fraud. Illustrative is the United States District Court for the Southern District of Indiana decision in Vallabhaneni v Endocyte, Inc. 117 Plaintiffs asserted that the sponsor company knew about the investigational drug’s lack of efficacy prior to the DSMB recommendation that the trial terminate based on an interim futility analysis.The plaintiffs argued that new imaging protocols, introduced more than one year before trial termination made it ‘readily apparent’ that the drug was not demonstrably effective in treating ovarian cancer. In dismissing the action, the Court emphasized the need for details about when and how the sponsor company could have gained knowledge about the drug’s lack of efficacy. It stated that, ‘Without more detail, it is impossible to determine how [the sponsor] knew that efficacy was not demonstrated at such an early stage of the phase 3 study given the double-blinded nature of the study’.118 The Court further questioned why the FDA would allow the study to continue if the study’s data and design were as flawed as the plaintiffs’ asserted.117 Vallabhaneni v. Endocyte, Inc., No. 1:14-cv-01048-TWP-MJD, 2016 WL 51260 (S.D. Ind., Jan. 4, 2016).
118 Id at *10.
If the FDA has a different interpretation of the data, the FDA’s differing interpretation under many circumstances should be disclosed to investors upfront. Otherwise, disclosure would be required in almost any circumstance to update prior disclosure that would otherwise be materially misleading to an investor. Additionally, it should be noted that companies often obtain negative information from the FDA during the course of drug or device development. This information is not necessarily an indication of approval delay or clinical trial failure, but such information may, under certain circumstances, be material and require disclosure (sometimes very quickly). For instance, companies that become aware of an approval delay or that a product is not likely to be approved by the FDA, must be cautious about disclosing inaccurate or incomplete information (which can sometime force off-cycle disclosure if material enough to the company’s business or prospects
100% agree moreover
If the FDA had flat out denied the new/amended trial design after NWBO submitted it, than that would have been a material event for that would mean DCVAX L could not be approved not matter what the data would say under that new/amended SAP
https://www.orrick.com/en/Insights/2020/05/Managing-and-Maintaining-Clinical-Trial-Disclosure-for-Publicly-Traded-Life-Sciences-Companies
If the FDA has a different interpretation of the data, the FDA’s differing interpretation under many circumstances should be disclosed to investors upfront. Otherwise, disclosure would be required in almost any circumstance to update prior disclosure that would otherwise be materially misleading to an investor. Additionally, it should be noted that companies often obtain negative information from the FDA during the course of drug or device development. This information is not necessarily an indication of approval delay or clinical trial failure, but such information may, under certain circumstances, be material and require disclosure (sometimes very quickly). For instance, companies that become aware of an approval delay or that a product is not likely to be approved by the FDA, must be cautious about disclosing inaccurate or incomplete information (which can sometime force off-cycle disclosure if material enough to the company’s business or prospects
To answer my own question I dont think NWBO is waiting for this guidance, nor should they, to come into effect officially at all for the reasons SOS previously already outlined in his blog of Jan 16 2020
https://smithonstocks.com/northwest-biotherapeutics-why-i-believe-there-is-a-high-probability-for-approval-of-dcvax-l-nwbo-buy-0-21/
Proposed New Guidelines Are Very Positive for DCVax-L
This report is focused on comparing the blinded results of the DCVax-L trial with the results from the phase 3 trial that led to the approval of Novocure’s medical device Optune in nGBM. However, it is important to juxtapose this with proposed guidelines from the FDA advising companies on what type of trial design and clinical data will now be acceptable to the FDA in considering regulatory approval. On December 19, 2019 the FDA released for comment proposed guidelines called Demonstrating the Substantial Evidence of Effectiveness for Human Drug and Biological Products. Here is the link.
Aggressive short sellers of NWBO have claimed that the FDA will not approve DCVax-L because of flaws in the trial design. They reference the general agency guideline that approval should be based on two well controlled phase 3 trials which compare a new drug to placebo or effective therapy. Because Northwest executed only one phase 3 trial, the shorts argue that NWBO will have to do a second confirmatory trial. This would be devastating. The new guidelines dismiss this argument. They state that in the case of life threatening diseases with unmet medical need like nGBM that the FDA will consider one well controlled trial as adequate for approval.
Actually, this is already how the FDA is currently operating. It has become common for the FDA to approve drugs on the basis of just one trial. Optune was approved on the basis of just one phase 3 trial. The CAR-T drugs Kymriah and Yescarta were approved for r/r DLBCL on the basis of open label, phase 2 trials that enrolled 115 and 112 patients respectively. Interestingly, the endpoint of these two trials was objective response rate (tumor shrinkage). At the time of approval, there was no meaningful data on survival. The phase 3 trial of DCVax-L initially enrolled 232 patients on DCVax-L plus SOC and very importantly, there is strong data on survival as the last patient was enrolled over four years ago. It is a much more meaningful data base than that which led to the approval of Kynmriah and Yescarta. The mOS of r/r DLBCL before the CAR-T drugs was about eight months and the mOS of nGBM with SOC is about 19 to 20 months. Both would seem to meet the FDA definition of life threatening, highly aggressive cancers. We can easily dismiss the short sellers’ contention that having only one phase 3 trial of DCVax-L is inadequate for approval.
The short sellers also argue that the FDA will not approve DCVax-L because it does not have a large enough SOC group against which to compare results for DCVax-L plus SOC. As previously discussed, the trial allowed patients who progressed on SOC to then receive DCVax-L. As a result, only about 30 patients in the trial received just SOC and never received DCVax-L. This compares to about 99 patients who initially received SOC. The short argument is that this small sample of SOC patients will result in a p value much higher than the p≤0.05 generally required for approval. However, the proposed guidelines state that in the case of a life threatening disease like nGBM, FDA will consider historical results from other trials. In this report, I have identified six trials in which 1,608 patients were given just SOC. The mOS in these patients fell in a tight range of 19 to 20 months. The proposed guidelines indicate that NWBO can statistically compare DCVax-L plus SOC results in the phase 3 trial to these historical results. This is huge.
Looking down the road, this new willingness to accept historical controls also augurs well for future trial of DCVax-L in other solid tumors. The FDA also says that if mechanism of action has been established as hopefully will be the case in nGBM, that it will take this into account as trials are done to expand the label into other indications; i.e. other solid tumors. This could result in the approval of DCVax-L for numerous other solid tumors on the basis of small phase 2 trials like those that led to the approval of Kymriah and Yescarta. This is equally huge.
It will likely be adopted very soon.
While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.
thank you Flipper if it wasnt for you I has way less answers thanks have a wonderful Xmas
To put it in perspective, these are comments made by LP/LL to FDA dated 23rd March 2020. Surely we must be close to this guidance being fully implemented ? Are NWBO now waiting for this implementation prior to release of TLD ?
thanks lrdpdx77 100% agree have a wonderful Xmas
thank you Mionaer
Only thing that needs to be translated here is the word "missverständlich"
Thats all you need to know
I agree with you lrdpdx77,
Im also invested in other biotechs and the trend, unfortunately, at present in the markets is that positive read outs are no longer a green light for whales to jump in. Heck if anything its a green light to short the biotech stock after positive TLD.
Im afraid that the days for huge gains after positive TLD are for now over. Im convinced that the DCVAX L publication we are waiting for will show that DCVAX L will be the new SOC for true GBM. What I am however not so convinced about anymore is if that will set the SP to a level that most investors want it to jump to. The market yells at listed companies: SHOW ME THE MONEY. DD showed some sort of survey on Twitter of ¾ of people thinking NWBO SP will be above $20 at the end of Q1 after publication, I hope it will be so but Im afraid many will be disappointed if they have this as a price target.
We need uplisting, revenue and approval for a MC of > $ 20 billion.
if the trial had failed they had to disclose this many months ago within 4 business days as they themselves have said they would they did not do this thus the trial is a success.
CVM did indeed disclose their failled trial after they have become fully aware approval is unlikely.
I have spoken with a highly reputable SEC lawyer specialized in biotech on this.
You think I would invest what I did without paying a SEC lawyer a lousy $500 for talking with him 45 minutes? Its laughable some here think they are believable on anonymous MB
Its not Just LP ex and you know it
Even if your falsehood in a parallel universe were true and NWBO management and its scientific board of directors and Dr Liau are all aware the trial failed but the SEC does not require to disclose as such then you are also and still saying they all have no problem
- leave investors such as the last lender in delusion not telling there is no product DCVAX
- treat patients for months now with the knowledge of unblinded data, taking their money knowing fully well the treatment is not efficient
Thus you ARE asserting Prof Keyoumars Ashkan Prof Dr Liau, NWBO's scientific board of directors, and management are all swindlers and con artists?
That IS what you are saying. wow
NUTS completely NUTS
BS
Its typically you to post nonsens without source. You are now asserting you know better than westwicke lawyers. NO one believes you without reliable source.
https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
Anyway you are wrong as always
Statements made by life science and medical device companies are thoroughly scrutinized by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), since investors rely heavily on these disclosures when making their investment decisions. Mistakes made while disclosing events of the clinical trial lifecycle can cause a serious crisis for your company: analysts may downgrade your stock, investors may dispose of your shares, and your stock price may plummet. Such errors will also harm management’s credibility and reputation, your company’s most valuable attributes.
The bad news: Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
1) Will DCVax-L be approved in 2022 by any RA? [YES, UK by June 1st, FDA by August]
thanks Yes I have been buying 25% of my monthly salary for a long time. Now at 220k shares, hope for you, you can pick up some more :)
Of course the trial failed. Everybody knows this.
Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
I think we should all prepare to wait as far into Q1 could be Jan could be March 2022 then the SP will move to >5$ finally
meanwhile I bought another 10K shares today at 81
yup lol yes thats me
so are you saying the trial failed? are you?
so you have no problem asserting NWBO management and its scientific board of directors are swindlers, crooks for not disclosing a failed trial and will be investigated by DOJ and or SEC?
https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
The bad news: Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
if the data would show DCVAX L is inefficient and just does not work then t would be incredible unethical for NWBO/Advent to continue to offer the treatment. Dr Liau would of course also stop her support.
The approval for compassionate treatment would also be revoked.
But legally they are in that case allowed to continue to offer the treatment as the are many dodgy treatment of all sorts of lethal illness offered without FDA approval as log as its safe which has been proven it is.
We won’t know what Advent gets paid, but it will be less than Cognate was paid because we own the site they’ll manufacture DCVax-L in.
we should also realize that there is a big difference between actual revenue and potential revenue. NWBO at present falls in the latter category. I expect this to change in 2022 for NWBO but until then the comparisons between Bios with a MC of of 10/15/20 x their actual revenue can not yet be made. Still NWBOs MC after the certification is heavily undervalued.
Ooh dear. I pray and wish you will recover soon and wish for you to have the strenght to overcome this. God speed Irdpdx77 I hope that DCVAX can help you in you treatment
and my wife is excited too as we all are waiting for topline data + the publication
I added 20,000 shares this morning and will add more depending on price movements (my wife is getting a bit nervous so I need to time future purchases to continued good news).
the Duffy man again…LOL .. he ran away screaming after seeing how LP works ..
But the case is being made that publication can be delayed at the request of the authors/company. My sense of real world dynamics, that’s probably true if you have enough street cred.
100% agree
Stocks however react to revenue mostly less to assets and IP inflation by a listed company
now that at least compassionate use could bring in well over 50 million per year in 2022 it would be just to see a 2 billion MC.
This stock is way way undervalued.,
I think they are trying to convey its their manufacturing partner in the UK. To suggest its their subsidiary would be too much of a blunt lie
I dont understand what you are getting at you mean to hint/say that NWBO is referring to Advent specifically as their GMP for the UK or do you mean to say that it is THEIR entity as in subsidiary (which would be a falsehooid its Toucan’s)?
other than that your post was the most redicolous remark ever made on this board shorty ;) ;) hahaha lol
The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK's supply of unlicensed medicinal products ('Specials') regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme.
most people are confusing missed timelines with failed trials. Funny thing is that in general its the other way around failed trial often means successful trials... I mean how much time does it take to rap up a failed trial when concluded as such? It take much, much more time to communicate and commercialize a successful trial.
The certification is not ONLY to produce DCVAX products but to produce Human Investigational Medicinal Products Under which DCVax falls, correct.
What I dont understand is some asserting that Advent would not be enough to get FDA approval but only EMA/Uk. The production facilty will be good enough for the FDA under certain circumstances.
Statements made by life science and medical device companies are thoroughly scrutinized by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), since investors rely heavily on these disclosures when making their investment decisions. Mistakes made while disclosing events of the clinical trial lifecycle can cause a serious crisis for your company: analysts may downgrade your stock, investors may dispose of your shares, and your stock price may plummet. Such errors will also harm management’s credibility and reputation, your company’s most valuable attributes.
The bad news: Failing to properly disclose material events regarding clinical trial data may result in more than harm to company’s reputation. It could lead to an investigation by the SEC and/or DOJ if the agencies believe that the company has intentionally deceived investors. The FDA may assist these inquiries, and in fact, the FDA and SEC now have a specified mechanism in place that facilitates FDA reporting to the SEC if they come to believe that a company may have made a false or misleading statement to the investors. SEC and DOJ investigations pose a much graver risk than ordinary commercial litigation, as consequences may include substantial fines for the company and its executives, bars on serving as an officer at a publicly traded company for a period of time, and, in extreme cases, criminal prosecution including potential jail time.
https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
Public companies scream it out loud when they have a winner. Not pass out tote nags.