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Thanks senti, no it’s clearly not based on thumbs up as it was previously, which is unfortunate. I’ve seen questionable posts there with 2 likes, while excellent posts with many likes (like yours) are left off, which made me wonder if moderators were involved. Anyway, thanks again for sharing your insights.
Why isn’t this post a “Most Liked Posts” at the bottom of the page? Do moderators control this?
BrightBoy, clearly you like to use bombastic language, and are a little looser with the truth to get your point across, but to me, misinformation is misinformation, whether it’s negative or positive. Your post appeared to be misinformed, so I clarified the issue. This was not intended to diminish this significant milestone, or any of the accomplishments that Northwest Bio has achieved thus far.
For the past couple of years, Northwest Bio has been almost exclusively focused on completing all of the prerequisites for the marketing application, but now that the application has been submitted, and is in the hands of the MHRA, Northwest Bio can catch their breath, bask in the glory of their accomplishment, while they wait for the application to be validated, (which is more than a few days btw) and then they will have to get right back to work.
Another significance of validation, or “official acceptance” of the application by the MHRA, is that when that occurs, Northwest Bio can finally turn their attention to other matters that have been in the periphery, such as; preparing for a commercial launch, re-engaging with NICE, preparing to file the application in other jurisdictions, finalizing new partnerships, preparing for new clinical trials, obtaining regulatory approval for the Flaskworks' system, and holding an annual shareholder meeting, just to name a few.
Once DCVax is approved, Northwest Bio is going to have a whole other set of tasks heaped on their plate, so yes, I think it actually does matter whether it takes 5, 6 or 7 months for approval, especially for a company that still has a tremendous amount of work to do, and has a history of missed timelines.
That’s incorrect BrightBoy. “Days To Acceptance” has everything to do with when the MHRA’s 150-day-assessment clock will actually start on Northwest Bio’s marketing application. And “what this has to do with approval,” is to attempt to more closely predict the approximate timing of the approval.
The MHRA’s assessment (and clock) does not start until the application has been validated. Regulatory Agencies first perform a technical validation of the marketing application to ensure that all of the essential elements that are required for scientific assessments are included, and that these elements are all organized and located according to the standard electronic Common Technical Document (eCTD) format. While it is true that the marketing application has been submitted by Northwest Bio, and received by the MHRA, it has not been “officially accepted” yet. And by the way, no they don’t “hand it back to the company” or “throw it in the trash” (it’s digital) but if the MHRA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a certain deadline.
Huh. Whatayaknow dennisdave? Would you like to apologize and admit that YOU were wrong? Do you recall this post of mine when many here were claiming approval is likely within 80 days?
Hallelujah! They sure packed a lot of information into that press release. And congrats to all posters who were correct in stating their belief that Northwest Bio would submit the application before the end of the year. Happy Holidays Everyone!
XMaster, the FDA’s “Submission Times” link I posted, shows the average submission size, and the upload duration for BLA’s and NDA’s, so you shouldn’t have to “imagine how long it would take to transfer.” Maybe I should have taken the time to just posted this:
https://www.fda.gov/industry/about-esg/submission-times
Doc, your guess is in the ball park. I’m not as familiar with the MHRA, but the FDA lists their submission times here:
Submission Times
The following transaction times are generated quarterly based on PDUFA submissions. Your company submission times may be above or below these transaction averages, sometimes by a significant amount. There are a number of factors that affect submission upload and processing times. Below are some of these factors:
Internet connection bandwidth: The bandwidth your Internet Service Provider (ISP) provides to your company
Internet connection bandwidth consumption: The amount of available bandwidth is currently in use by the company. Upload speed can be determined by going to: http://beta.speedtest.netExternal Link Disclaimer
Geographic proximity to FDA (Washington DC): The farther your location from FDA, the more network hops are required for your connection to reach FDA. The more hops your connection takes to get to FDA, the longer your submission will take to get to FDA
Data compression ratio (for multi-file submissions) and submission composition: The number of files and folders/directories and the type of data you are sending will affect the speed at which the submission makes it to FDA
End client/user infrastructure: Capacity of end user's machine (processor and memory), network storage performance, and shared vs dedicated machine might also affect the speed of signing the submission and upload
Uploading a submission during infrastructure maintenance (end user's and/or FDA)
Submission traffic during the specific period: Multiple, very large submissions (e.g., over 10 GB) being received concurrently, then the ACK times will vary.
https://www.fda.gov/industry/about-esg/submission-times
About ESG
What is ESG?
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. The FDA ESG enables the FDA to process regulatory information automatically, functioning as a single point of entry for receiving and processing all electronic submissions in a highly secure environment. The FDA ESG complies with secure Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for secure communication. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing and notification (to a receiving Center or Office) of the delivery of an electronic submission.
FDA ESG provides two methods, WebTrader (WT) and AS2, for making submissions to FDA. FDA ESG has been in production since 2006 and is used by 100s of users to send 1,000s of submissions every day.
* WT: A web portal designed for low volume submitters. WT allows users to login, digitally sign and submissions, and view responses through a simple web interface.
* AS2: A system-to-system connection to exchange submissions with FDA. AS2 requires a Gateway software implementation on submitters end.
Where do Submissions Go?
The FDA ESG is the central receipt point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. The FDA ESG does not open or review submissions, but automatically routes them to the proper FDA Center or Office. Industry Partners can send a receive documents from the Gateway via a web interface or server to server communications.
https://www.fda.gov/industry/electronic-submissions-gateway/about-esg
ski, I understand what you are saying about unnecessary and overly burdensome regulations, and I agree only to an extent. I think what you’re suggesting is extreme, and potentially would lead to unsafe and ineffective treatments being approved. I believe the amount of information that is necessary to prove that a medication or treatment, (that sick people ingest, and has the potential to kill them) is safe and effective, and can be manufactured at high quality, should be quite rigorous. I for one, am grateful that I live in a country that has high standards and regulations that attempt to protect its consumers and citizens from harm due to corporate greed and malfeasance. I appreciate the cautious approach that the FDA has taken in recent years (after the affordable care act was passed) to cut through some of the unnecessary red tape, and speed the drug development and approval processes.
While I think the JAMA article provided clear evidence that the addition of DCVax to the standard of care, is safe, and did increase survival meaningfully, no I don’t think that alone provides enough information for regulators to approve DCVax. For one thing, the article did not include the manufacturing data and analysis which proves that DCVax can be manufactured to meet commercial specifications, (which could account up to half of the pages in the marketing application) and there’s a significant amount of evidence outside of the clinical trial, (confirming DCVax is safe and efficacious) which I think regulators should also consider.
ski, it’s a team of reviewers. Many of the “1.7 million pages” are supporting documents, such as the clinical case records, manufacturing development work, the statistical, and scientific analysis methods, etc., that the reviewers may want to examine to aid them in their assessments. You’re right though, much like lengthy court electronic documents, the relevant files are searchable. And no, regulators don’t “demand such a document.” They require companies that want to sell a product to the public to provide sufficient evidence to demonstrate that it’s safe and efficacious, the scientific methods used to prove that are adequate, and that it can be manufactured to meet high standards. It would be impossible to do that in 1000 pages.
Here’s the FDA’s review members and their responsibilities:
Review Team Responsibilities
The review teams analyze new drug applications (NDAs) and biologic licensing applications (BLAs). During drug development, the teams also review Investigational New Drug Applications (INDs). Each team member uses their expertise to answer these key questions:
* Is it reasonably safe to study an investigational drug in humans and will proposed studies provide data needed to show safety and efficacy?
* Is the drug safe and effective in its proposed use and do the benefits of the drug outweigh the risks?
* Is the proposed labeling appropriate and if not what should it contain?
* Are the methods used in manufacturing the drug and the controls adequate?
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/review-team-responsibilities
CDER 21st Century Review Process Desk Reference Guide
Pre-submission Activities
Ensure Readiness for Application through Pre-Submission Activities
During this phase, applicants are strongly encouraged to request a meeting with the appropriate FDA review division prior to the submission of an NDA/BLA, particularly in the case of NMEs and BLAs covered under the PDUFA V “Program,” to discuss the planned content of their application. Meetings include the traditional pre-NDA/BLA meeting and other meetings such as the electronic pre-submission meeting, if necessary. Ideally, good FDA-industry IND interactions and use of pre-NDA/BLA meetings will help to ensure that all submitted applications are complete and fileable.
1.1 Pre-NDA/BLA Meeting (Pre-Submission Meeting)
Meeting Purpose: The purpose of a pre-NDA/BLA meeting is to discuss format and content of the anticipated application, including labeling and REMS (if applicable), presentation of data, dataset structure, acceptability of data for submission, as well as the projected submission date of the application. The meeting should be held sufficiently in advance of the planned submission of the application to allow for meaningful response to FDA feedback and should generally occur not less than two months prior to the planned submission. In cases where the FDA anticipates conducting an expedited review of the application and communicates this to the applicant, the pre-submission meeting may be held closer to the submission date.
Preparing for the Pre-Submission Meeting: In preparation for a pre-NDA/BLA meeting, the OND RPM evaluates the meeting request and meeting package, schedules the meeting with pertinent reviewers and provides them with the pre-meeting background package. The Office of Surveillance and Epidemiology (OSE) RPM is also given the meeting package and informs the OND RPM of the OSE reviewer assigned (as necessary) who should be invited to the meetings. The identified OSE staff members are invited to meetings if issues relating to a REMS, postmarketing safety study, or other safety concern(s) are identified.
The information to be provided by the applicant for the meeting includes:
* A timeline and list of prior FDA meetings and agreements, prior FDA advice, and any development changes. This would include meeting minutes and letters sent earlier, regulatory history, issues raised at the end-of-phase 2 meeting, etc.
* A summary of technical information to be submitted in the NDA/BLA, including the results of the pivotal trials, if they are available, and the proposed dataset structure.
* Highlights of any potential problems, including product quality issues, data integrity concerns, safety signals, etc.
* Proposed draft labeling.
* The proposed format for organizing the submission, including methods for presenting the data and a draft index if available.
* A discussion of the need for a REMS or post-marketing study/trial for any safety issue(s) that has emerged during development or during foreign marketing.
CDER 21st Century Review Process Desk Reference Guide Page 10
* Other information/issues that require discussion.
* List of questions for FDA. ?Reviewers should review the meeting package and also be prepared to discuss internally the potential need for an Advisory Committee meeting, REMS, and PMRs. The reviewers draft responses to the pertinent questions submitted by the applicant. The project manager assembles reviewers’ comments and sends them to the applicant at least 48 hours prior to the meeting. ?Holding the Meeting: At the pre-NDA/BLA meeting, the FDA and the applicant will agree on the content of a complete application for the proposed indication(s), including preliminary discussions on the need for REMS or other risk management actions. Reviewers also describe how data should be presented in the NDA/BLA to facilitate its review. The agreement and discussions are summarized at the conclusion of the meeting and reflected in the FDA meeting minutes. ?For “Program” applications, during the pre-submission meeting the FDA and the applicant may reach agreement on submission of a?limited number of application components not later than 30 calendar days after the submission of the original application. These?components must be of a type that would not be expected to materially impact the ability of the review team to begin its review.?Examples of application components that may be appropriate for delayed submission include updated stability data (e.g., 15-month data?to update 12-month data submitted with the original submission) or the final audited report of a preclinical study (e.g., carcinogenicity) where the final draft report is submitted with the original application. Major components of the application (e.g., the complete study report of a Phase 3 clinical trial or the full study report of required long-term safety data) are to be submitted with the original application and are not subject to agreement for late submission. Any agreement that is reached on delayed submission of application components will be summarized at the conclusion of the meeting and reflected in the FDA meeting minutes. (See also: http://inside.fda.gov:9003/ProgramsInitiatives/Drugs/21stCenturyReview /ucm034190.htm) ?For applications where an expedited review is anticipated, FDA will communicate during the pre-submission meeting that the review team plans to conduct an expedited review and has targeted earlier timelines for certain review activities, including “Program” activities. These expedited timelines will be communicated during the course of the review provided no significant unexpected review issues arise and there are no unexpected changes to the workload priorities or staffing for the review team. FDA and the applicant may discuss at the meeting the applicant’s readiness to launch should an action occur early. ?FDA should request that the applicant submit information on all manufacturing facilities and/or preliminary data on pivotal clinical trials or bioequivalence study(ies) that would be useful in early determination of sites for inspection. ?Meeting discussions may include what data will be submitted to support sought-after labeling or how labeling annotations should be linked to the primary supporting information in the eCTD. Container and carton labels can also be addressed during pre-submission meetings. Review teams should direct applicants to the website for the new requirements for prescribing information. (See New Requirements for Prescribing Information) ?Applicants may request that an application be designated for fast-track review; applicants may also request to submit completed sections of the marketing application for review by FDA (rolling review). (See Fast Track, Accelerated Approval, and Priority Review). ?CDER 21st Century Review Process Desk Reference Guide Page 11
Pre-submission Activities
Minutes from the Pre-NDA/BLA meeting are prepared and archived by the RPM.
1.2 Electronic Pre-Submission Meeting
If technical aspects of the submission have not been adequately addressed with the sponsor (e.g., at the pre-NDA/BLA meeting), an electronic pre- submission meeting may be held at the discretion of the review division 30-60 days prior to the submission of the application. The FDA may recommend this meeting for some applications. The focus of the NDA/BLA electronic pre-submission meeting is on navigation, formatting of electronic files, and layout of the application.
In preparation for an electronic submission meeting, the RPM evaluates the meeting request and works with the Division of Regulatory Review Support (email: esub@fda.hhs.gov) to load any provided (mock) data sets on the FDA computer system that support review of electronic applications. The review division prepares draft responses to any questions submitted by the applicant and sends them to the applicant prior to the meeting. Meeting minutes are prepared and archived by the RPM. . . .
https://www.fda.gov/media/78941/download
Haha senti, you’re “confident that the company is still strongly hoping?” Sounds like you’ve been reading the company’s PR’s so long that you could probably write them!
BTW - I’m strongly confident that the company is strongly hoping that too! :)
pgsd, there was so much misleading information about the DCVax trial because the authors referenced the outdated “First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma” from the Journal of Translational Medicine in 2018. See the footnote:
80.Liau LM, Ashkan K, Tran DD, et al. . First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma. J Transl Med. 2018;16(1):142. https://doi.org/10.1186/s12967-018-1507-6
This deception was likely intentional because when you look at the history of this article, it shows:
Article history
Received: 24 August 2023
Accepted: 15 November 2023
Published: 04 December 2023
It seems extremely difficult to believe that the authors did not know about the final results of the trial published in JAMA Oncology in November 2022, which would make the deception particularly egregious in my opinion.
Yet another misleading article bashing DCVax and immunotherapy, in “The Oncologist,” which not surprisingly, notes this about the DCVax trial:
“These data should be interpreted with caution considering the high crossover rate, the statistical design, and the absence of information regarding the stated primary endpoint of the study which was PFS,”
and concludes,
“the role of immunotherapy in GBM remains a challenge,”
Not surprising, because Novocure is listed in the “conflict of interest” by multiple authors multiple times. (I will give them credit for disclosing it though)
Autologous Vaccines
In the context of autologous vaccines as a possible treatment in patients with GBM, there are several early-phase studies in the literature that have evaluated the use of vaccines based on dendritic cells (DCs).78,79 These cells have the task of presenting antigens to naïve T cells to ensure the activation of an adaptive immune response.
DCVax-L is the most studied DC vaccine to date, composed of autologous dendritic cells pulsed with autologous tumor lysate that was evaluated in a phase III study in newly diagnosed GBM patients, in combination with maintenance temozolomide after surgery and combined chemoradiotherapy.80 Patients were randomized 2:1 to receive DCVax-L plus temozolomide vs Placebo plus temozolomide; in case of disease progression/relapse during treatment, crossover was allowed. For the intent-to-treat (ITT) population of 331 patients, the mOS was 23.1 months (evaluated from the date of surgery). Due to the possibility of crossover, approximately 90% of all patients in the ITT population received DCVax-L during the study. Treatment was well tolerated with only 2.1% of patients reporting grade 3-4 adverse events possibly related to vaccine treatment. These data should be interpreted with caution considering the high crossover rate, the statistical design, and the absence of information regarding the stated primary endpoint of the study which was PFS.75
A phase III randomized open-label study (NCT04277221)81 is evaluating the use of Autologous Dendritic Cell/Tumor Antigen (ADCTA) immunotherapy in combination with a standard treatment (bevacizumab) in patients with first recurrence of GBM after the Stupp protocol. The primary endpoint was OS whereas the secondary endpoints were PFS, 6-month PFS, and 1- and 2-year survival rates. Another active but not currently recruiting phase II/III study (NCT03548571)82 is evaluating the use of dendritic cell immunotherapy against cancer stem cells in newly diagnosed IDH-wt, MGMT-promoter methylated GBM patients receiving concomitant radiochemotherapy with temozolomide as first-line treatment. The primary endpoint is PFS, whereas secondary endpoints include OS, assessment of patient-reported quality of life, immunological response by analysis of delayed type hypersensitivity reaction in skin and lymphocyte clonal analysis, and safety
Conclusions
Immunotherapy is clearly a revolution in the treatment of solid tumors. However, the role of immunotherapy in GBM remains a challenge because of the immunosuppressive nature of this tumor and its unique immune environment. Further studies will be needed to better understand possible strategies to overcome the mechanisms of immunosuppression. Data from clinical trials will show the future path, likely combination strategies may play a role.
Conflict of Interest
M.C. declares consulting from Health4U. M.P. declares consulting from Novocure and Health4U. A.I, reports research grants from Carthera, Transgene, Sanofi, Nutritheragene; travel funding from Enterome and Carthera; personal fees for advisory board from Leo Pharma, Novocure, Novartis, and Boehringer Ingelheim outside the submitted work. G.L. declares consulting or advisory role funding from ABBVIE, Bayer, Novartis, Orbus Therapeutics, BrainFarm, Celgene, CureTeq, Health4U, Braun, Janssen, BioRegio Stern, Servier, Novocure, and travel funding from Roche and Bayer.The other authors declare no financial relationships.
https://academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyad321/7458630?searchresult=1
abeta, the MHRA has fixed submission dates for marketing applications, that corresponds with a meeting by the Commission on Human Medicines, who advise ministers on the safety, efficacy, and quality of medicinal products. So once Northwest Bio missed the November 27th submission deadline, the next one is December 25th.
Submission dates for 150-days assessment procedure for national marketing authorisation applications containing new active substances.
The MHRA will operate a 150-day Assessment route for high-quality marketing authorisation applications (MAAs).
For applications containing new active substances, submissions should be received by the following dates in order to align with the meeting dates of the Commission on Human Medicines (CHM).
The Marketing authorisation application dossier should be submitted through the MHRA Submissions portal on or before the deadline as detailed below:
CHM meeting ----------------- Submission deadline
25 and 26 January 2024 —-- 30 October 2023
22 and 23 February 2024 — 27 November 2023
21 and 22 March 2024 ——- 25 December 2023
25 and 26 April 2024 ———- 29 January 2024
30 and 31 May 2024 ———- 04 March 2024
https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures
How to Sue Short Sellers: by Citadel’s law firm, Quinn Emanuel:
“That Is Not An Opinion”: How to Sue Short Sellers
JUNE 25, 2021
FIRM MEMORANDA
Short sellers capitalizing on illegal “short and distort” schemes can, and do, wreak havoc on a company’s stock price, reputation, and the reputation of senior officers and directors. All too often, with just a single tweet. When this happens, companies find themselves playing defense—i.e., responding to a sudden drop in market capitalization, as well as (i) regulatory investigations, (ii) securities class actions, and (iii) derivative lawsuits that often follow a “short attack”.
Many companies are sick of playing defense. Increasingly, clients want to stop “short and distort” schemes before they find themselves the victims of unfair, repeat attacks that can act as a drag on share price for years—even if the attacks are baseless. Common law claims such as defamation, unfair competition, and intentional interference with contracts, as well as claims for market manipulation, RICO violations, and securities fraud under federal and state securities laws all sound like appealing avenues for relief. But in practice, few companies decide to bring claims against offending short sellers.
One reason companies shy away from bringing claims against short sellers is because, frankly, the claims often fail. The short sellers’ modus operandi is to publish negative statements about companies they hold short positions in (be it through short reports, social media, podcasts, etc.) while describing their statements as “opinions.” Because opinions are protected by anti-SLAPP (strategic lawsuit against public participation) statutes and the First Amendment, some companies believe that short sellers seem to operate as if they are untouchable. But they are not: companies can and have succeeded on offense.
HOW TO SUE A SHORT
First, carefully vet short sellers’ statements to identify all actionable statements.
The First Amendment and anti-SLAPP statutes do not give short sellers cart blanche to knowingly or recklessly publish false information about a company. To that end, step one in preparing claims against a short seller is to painstakingly review and vet all of their public statements and identify those that cross the line from opinion to fact and which can be disproved. This may require reviewing social media posts, interviews, podcasts, and short reports – all of which are common mediums of short sellers. It may be that the only good news for a company being attacked on all fronts by short sellers is that the more statements the short sellers make, the more likely it is that some of them will be actionable.
The importance of identifying actionable statements is demonstrated through the recently-announced settlement agreement in Farmland Partners, Inc. v. Rota Fortunae. In Farmland Partners, FPI, a publicly traded real estate investment trust, sued a research firm and its owner, Quintin Mathews, as well as the hedge fund that backed the research, after Mathews published an article online that caused FPI’s stock to fall 39 percent in one day. At the motion to dismiss stage, the Court rejected Mathews’ argument that his publication as a whole was a non-actionable opinion, explaining that the use of disclaimers throughout the article such as “I think” and “I believe” “does not lend to automatic protection under the First Amendment.”[1] The Court held that statements such as FPI was “artificially increasing revenues by making loans to related-party tenants” and “neglected to disclose that over 70% of its mortgages have been made to members of the management team” were objectively verifiable and thus not opinions.[2]
On June 20, 2021, Mathews tweeted a settlement press release—a mea culpa wherein he admitted to reporting a litany of “inaccuracies and false allegations based on those inaccuracies.”[3] The press release states that the inaccuracies were made apparent through “the benefit of evidence from years of litigation, including deposition testimony and documents, and also as evidenced by the recovery of FPI’s share price despite the persistence of expensive shareholder litigation against FPI resulting from my article.” Mathews, who held a short position in FPI, agreed to pay FPI “a multiple” of the profits he earned from his short position.[4] FPI’s claims against the hedge fund defendant are still pending.
In Amira Nature Foods, Ltd. v. Prescience Point LLC, Amira, brought claims in the Southern District of New York against short seller Prescience Point stemming from Prescience Point’s short reports stating that Amira’s financial statements were false.[5] As expected, Prescience Point moved to dismiss the complaint, raising the scepter of the First Amendment as a defense. The Court analyzed that defense under New York’s three-factor test, which considers “[one,] whether the specific language in issue has a precise meaning which is readily understood; two, whether the statements are capable of being proven true or false; and, three, whether either the full context of the communication in which the statement appears or the broader social context and surrounding circumstances are such as to signal readers or listeners that what is being read or heard is likely to be opinion not fact.”[6] The Court went on to explain that “[t]his examination does not parse the individual words or statements but instead considers the publication as a whole, asking whether a reasonable listener is likely to have understood the statements as conveying verifiable facts about the plaintiff.” . . . .
https://www.quinnemanuel.com/the-firm/publications/that-is-not-an-opinion-how-to-sue-short-sellers/
HOW QUINN EMANUEL CAN HELP
Quinn Emanuel is one of the few firms that have successfully sued malicious short sellers, and we are not afraid to do so. We frequently advise clients in navigating the muddy waters of short attacks, and we work with the best investigators and economists in the industry in applying the above playbook.
No firm is better suited to guide companies dealing with short attacks than us.
Quinn Emanuel was ranked #1 in the BTI Consulting Fearsome Foursome for 2021, earning the title of “Most Feared” law firm in the world for the second year in a row. Quinn Emanuel was also included in the list of “Top 20 Trial Law Firms” by Benchmark Litigation USA 2021 and received a global ranking of Tier 1 for securities. The Wall Street Journal called us “a Global Force in business litigation”, and The American Lawyer says we are “Better. Faster. Tougher. Scarier.”
***
If you have any questions about the issues addressed in this Client Alert, or if you would like a copy of any of the materials we reference, please do not hesitate to contact us.
yes flipper, I believe that half-truths have been used to string investors along. They know quite well that their current shareholder base is retail.
Thoughts on Northwest Bio’s marketing application:
It’s a massive undertaking to develop a drug and bring it to market, even for a well-resourced, experienced pharmaceutical company that has commercialized many drugs. The difficulty is magnified tenfold, for a small company like NW Bio, that doesn’t have the resources or experience of Big Pharma, and is applying for its very first commercial marketing approval, for a novel cell therapy, that may not be well understood by regulators. It’s not only necessary to run clinical trials to prove the product’s safety and efficacy, but they must also prove their ability to manufacture the product consistently to meet very strict commercial standards in high volumes.
Northwest Bio owns ground-breaking, disruptive technology that one day may help to change the way cancer is treated, and I think It’s managed by some well-intentioned, accomplished people who truly care about helping cancer patients. But it would be a huge understatement to say that Northwest Bio’s management has underestimated the problems and opposition that confronts companies when bringing a disruptive cell therapy to market, as well as the time it takes to counter and overcome them. In my view, their credibility has been damaged by their numerous, inaccurate, often-extended timeline forecasts, half-truths, and repeated delays. I don’t think that necessarily makes them incompetent as some suggest, but the repeated attacks have probably made them wary of the slightest mis-step, and exposure to potential future attacks, which probably affects their actions and communication.
Northwest Bio has navigated and overcome numerous hurdles, and has many accomplishments. As a reminder, they: 1. produced positive clinical trial results, (from a trial with flaws) 2. got those results published in JAMA, 3. gathered evidence, and brought a suit against malicious stock market criminals who repeatedly manipulate their stock, 4. developed crucial manufacturing data, (which is necessary for a successful marketing application) 5. developed an automated, digitized system to manufacture their product, (which is necessary to overcome commercial bottlenecks) 6. gathered and analyzed data from decades-long clinical trials, and converted and digitized that data into a common marketing application, (that will also be used in the US and other jurisdictions) and are now very close to filing an application for their first regulatory approval.
The company had a pre-submission meeting with the MHRA, and is in contact with other regulators, as well as being advised by informed consultants and scientific board members, so if, based on the expert advice they received, they concluded that it was prudent to take an extra month or two, just prior to submitting the application, in order to gather additional data or evidence, that will strengthen the marketing application, (possibly required by the FDA) then how can I (or anyone else) disagree?
I think some of the wording used in the previous, Oct. 13th press release, (and their past history) made it seem unlikely, that NW Bio was going to achieve that very optimistic timeline of submitting the application by mid to late November. Last week’s update, that the publisher now has (most of) the key final section, the publisher’s work has begun, and it may take them several weeks to complete the application, is very positive news. (despite the “distorting” on social media, and coordinated stock “shorting” by hedge funds)
The next MHRA submission deadline is December 25th, which aligns with a CHM meeting on March 21st or 22nd. I’m fairly confident that they will submit the application next month, and beat this deadline.
Yes, the DOJ is exploring RICO charges, and potentially racketeering, in their investigation of illegal short sellers and the “research” firms they pay to manipulate stocks. The DOJ is particularly focused on “spoofing” which most NWBO investors have witnessed firsthand when making trades. I wonder if any information obtained during discovery, in their case against the market makers, will assist in this investigation . . .
The Department of Justice is reportedly exploring if they can charge stock market short-sellers with the same law used to take down the mafia
Feb 24, 2022
Matthew Fox
- The Department of Justice is exploring if they can charge stock market short-sellers with the same law used to prosecute the mafia, according to a Reuters report.
- Several short-selling research firms have been on the DOJ's radar as they investigate illegal trading tactics.
- Subpoenas have been sent to dozens of firms, including Citron Research and Muddy Waters.
An ongoing investigation into the practices of several stock market short-sellers is heating up, and the Department of Justice is exploring if it can use a federal law that was originally enacted to prosecute the mafia, according to a Reuters report.
The Justice Department already sent subpoenas to dozens of short-selling firms last year, including high-profile activists Andrew Left of Citron Research and Carson Block of Muddy Waters.
While no final decision has been made by prosecutors, potential charges under the Racketeer Influenced and Corrupt Organizations Act, or RICO, remain an option "on the table," Reuters reported, citing two sources familiar with the situation.
This wouldn't be the first time RICO charges were leveled against Wall Street participants. In the 1980s, Michael Milken was charged with racketeering, though he reached a plea deal that did not include those charges. And in 2019, JPMorgan executives were charged with racketeering related to the price manipulation of precious metals.
The current investigation into short-sellers revolves around their trading practices, specifically whether manipulative tactics were employed around the same time a negative report was published.
According to prior reports, the DOJ seized hardware, trading records, and private messages from various short-sellers and is focused on the act of "spoofing" and "scalping," two practices that could lead to big gains for traders.
Spoofing is an illegal practice banned in 2010 in which a trader floods the market with fake orders to influence a stock price. Scalping is related to activist short-sellers selling out of their position for profits without disclosing it.
Short-sellers are an unloved group of market participants that get a lot of blowback from the companies they target and the investors of those companies. Some see their tactics as predatory, as they often have the power to move a stock that they might have a position in by releasing a critical report. Critics say these reports use misleading information that doesn't give a complete picture of the situation at hand.
But some short-sellers also have a proven track record of identifying and exposing fraudulent companies that sometimes go bankrupt. Such companies that were the target of short-seller research included Enron, Sino-Forest, and Wirecard AG, among others.
One person who is happy with the Justice Department's investigation is Tesla CEO Elon Musk.
"I am greatly encouraged by the Justice Department investigating short sellers. This is something the SEC should have done, but, curiously, did not," Musk said in an e-mail to CNBC. "They will short a company, conduct a negative publicity campaign to drive the stock price down temporarily and cash out, then do it all over again many times."
Musk's position against short-sellers is not surprising given that Tesla stock was a popular target among short-sellers for many years until it broke out to record highs in late 2019 as the EV maker turned a profit. While 25% of Tesla's shares were sold short in 2019, that figure now stands at just 2%, according to data from Koyfin.
So far, the investigation by the Justice Department has reached nearly 30 investment and research firms that engage in short-selling. No one has been accused of wrongdoing, and the investigation may not lead to charges being brought.
https://markets.businessinsider.com/news/stocks/stock-market-short-sellers-doj-investigation-mafia-law-rico-racketeering-2022-2
flipper, the JTM article says differently:
Patients in both arms continued to receive monthly adjuvant temozolomide (150–200 mg/m2/day×?5 days every 28 days), interspersed with the DC vaccine or placebo treatments administered on Days 0, 10 and 20, then Months 2, 4 and 8, and thereafter at 6-month intervals starting at month 12. Each DCVax-L treatment involved a dose of 2.5 million autologous tumor lysate-pulsed DCs administered intradermally in the upper arm, alternating arms between injection visits. . .
In general, approximately 2 g of tumor tissue was needed to produce the full ten doses for the 36-month treatment and follow-up schedule. The vaccine was aliquoted in individual doses and cryopreserved ?https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
murcidencelum
murcidencel
autologous dendritic cells (DCs) derived from peripheral blood mononuclear cells (PBMCs) obtained from glioblastoma patients. A sample of the same patients' glioblastoma is also collected, and a tumour lysate prepared. The purified adherent monocytes isolated from PBMCs are initially grown in media containing granulocyte-macrophage colony-stimulating factor (GM- CSF) and interleukin 4 (IL-4) to induce differentiation into dendritic cells, followed by loading of the dendritic cells with the tumour lysate in culture media supplemented with GM-CSF and IL-4. The final cell suspension contains =60% dendritic cells (MHC Class II+, CD86+; CD14-), with =40% of the cells in the suspension being other autologous cells, such as T lymphocytes, B lymphocytes, and natural killer cells. The dendritic cells induce T cell proliferation in a co-stimulation assay cell therapy (antineoplastic)
https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl128.pdf?sfvrsn=889fe54b_3&download=true
DocLee, you’re unlikely to see a number specifically for total DCVax development costs. The accumulated deficit is generally accepted as a reasonable public number for the costs spent by the company to date, since revenues have been extremely minimal, but it does include other expenses to run the company, in addition to the specific drug development costs.
Thanks ATLnsider, so that proves it was for the trial.
So this is the controversial post by Bio99. Unfortunately, this is not the first time that he’s been completely wrong, and he lost credibility with me long ago because of it. There are no “facts” or “many different sources” that “Advent has been running at greater than maximum capacity since May. (hundreds of patients per month potentially)” It’s complete nonsense.
thanks abc, but I'm not so sure that 20221 is a date.
DocLee, the accumulated deficit is close to $1.3B, according the most recent 10Q.
flipper, I believe that label indicates the minimum number of viable cells, so that likely means at least 1.25M dendritic cells in that dose. I wonder if it’s actually the same cell count listed for the clinical trial (2.5M), but the dose actually contains a minimum 50% viable dendritic cells. (another source indicated that number was 60%)
Interesting pic. Sharpie, do you or anyone else know for sure where and when it was actually taken? I see the “Specimen” description of the JPEG and Mail/Create date when the trademark was updated Nov 10, 2023, but the original application filing date was June 3, 2014, so that's my guess.
It looks like “NWBio Gm” and “ipzig” can be read. So I’m guessing that says “NW Bio Gmbh, Leipzig,” which means that it was manufactured by Fraunhofer Izi. (which would have been manufacturing in 2014)
Thanks Viking, I know Kuehne Nagel, but your link only shows tangential relevance. What’s your source?
We’ve never seen definitive proof, (like Cognate’s subcontracts) posted. I believe the actual dry shippers for DCVax that were posted here, were for a compassionate-use patient, and there may have been more than one logistics company.
Viking, you are correct that Cognate had the services contract for cryopreservation and shipping for the clinical trials, but I believe they did subcontract the cryopreservation protocol to Biolife Solutions, and the shipping logistics to Cryoport.
There were pictures posted many years ago on Facebook of the shipping containers for DCVax, (which Linda Powers called R2D2) that were the exact containers that Cryoport used.
1.2 Cryopreserved Storage
In addition to the Manufacturing Services, Cognate will undertake the cryopreserved storage of DCVax® Products including, without limitation, the initial freezing of DCVax® Products, bar coding or other inventory identification, preparation for shipment and preparation for tracking as provided in Section 1.5 (collectively, the “Storage Services”), provided that NWBT pays for such services in accordance with Section 2 hereof.
1.3 Shipping and Distribution
Cognate will identify and work with shipping companies for the collection and shipping of leukapheresis liquids and tumor tissue to Cognate, and the delivery of finished DCVax® Products from Cognate to the applicable medical facility or physician (collectively, the “Shipping Services”), provided, that NWBT pays or reimburses all costs relating to such shipping and distribution, and provided that NWBT pays for such services in accordance with Section 2 hereof.
No, the hedge-fund wolf pack who bet against Northwest Bio, like John Hempton (Bronte), and Chris Brown (Artistides) are not stupid. They are arrogant bullies, who prey on small companies that depend on their stock to raise capital to stay in business. Even when they are wrong, these hedge funds are able to use their significant capital and connections, to short stocks (both legally and illegally) to force these vulnerable companies to fail, simply due to their inability to raise enough capital to survive the year’s-long attacks.
Well the wolf pack finally met their match in Linda Powers and Northwest Bio, who would not submit to their seemingly insurmountable pressure campaign. They may not have known the company wasn’t a scam when they started their campaign many years ago, or about Northwest Bio’s management’s will to survive, but it has become evident to EVERYONE now.
These hedge funds won’t go away without a fight, but they are in a very competitive business, and will use all means necessary to minimize their losses, as evidenced by the monthly increasing legal short interest, fail’s-to-deliver, and other not-so-evident means. Despite Chris Brown’s whining about Northwest Bio in his letter the other day, (at 85 cents it was his biggest loser) he does leave a hint at the end that he knows what he must do:
“Ultimately, being right about high conviction shorts is important, but what is even more important is the willingness and ability to manage risk around them, and I think we’ve done a pretty good job of that over the years, and that is something we’ll continue to strive for.”
Actually, Chris Brown’s fund, Aristides Capital, has had a 15% annualized return since its launch in 2008, and I think it was the top long-biased equity hedge fund last year, based on risk-adjusted performance, so maybe it’s not that surprising that he has a number of investors. Hedge fund managers aren’t stupid, but they can certainly be wrong. Will see what 2023 brings . . .
Hedge Fund Manager With 10 Straight Years Of Positive Returns Says Stay Away From These Sectors
Nathaniel Baker Former Contributor
I've spent my career covering investing, hedge funds and economics.
May 18, 2020
Christopher Brown of Aristides Capital joined the Contrarian Investor Podcast recently to discuss his investment strategy, which has produced positive returns every calendar year since 2008.
In Brown’s view, healthcare and information technology stocks should not be treated as defensive investments that will protect portfolios in times of stress — especially after their recent run-up. There are reasons many companies in this sector are overvalued and could see their shares drop as the economy begins to see further difficulties from coronavirus.
“I have nothing against healthcare broadly,” Brown said. Companies like Gilead and large cap pharmaceutical companies “that actually make money and trade at 10- to 25-times earnings are fine.” But there are many companies “that are just total frauds.” Many are small- or micro-cap stocks that started with a market capitalization of $20 million or less but are currently valued between $600 million and $2 billion.
“Seeing that kind of stuff is pretty insane,” Brown said. It makes it challenging for short sellers who have seen even their high conviction ideas rally. But the biopharma sector has a lot of interesting short targets that should sell off within two years. Aristides Capital does have some short bets against these companies in its portfolio and Brown names some of them on the podcast.
The IT names bring to mind the late 1990s tech bubble when dot-coms with barely the promise of revenues saw their stocks rally to astronomical highs. The business prospects of today’s tech darlings are much more reasonable, but in Brown’s view the market has been too happy to reward revenue growth. “Just holding the Tesla’s of the world and the things that have revenue growth attached to them,” he says. “Enterprise software is...the epicenter for us where we see just really difficult valuations on things that are hard to justify.”
https://www.forbes.com/sites/nathanielbaker/2020/05/18/hedge-fund-manager-with-10-straight-years-of-positive-returns-says-stay-away-from-these-sectors/
The SEC’s "Fails-To-Deliver" data hasn’t been updated for September, but the first half should be out next week. It was definitely increasing at the end of August - the last 4 days went from 1,625 on the 28th, to 90,000 on the 29th, to 540,000 on the 30th, to 989,000 on the 31st, so it should be interesting.
Fails-To-Deliver
The values of total fails-to-deliver shares represent the aggregate net balance of shares that failed to be delivered as of a particular settlement date. Fails to deliver on a given day are a cumulative number of all fails outstanding until that day, plus new fails that occur that day, less fails that settle that day. The figure is not a daily amount of fails, but a combined figure that includes both new fails on the reporting day as well as existing fails. In other words, these numbers reflect aggregate fails as of a specific point in time, and may have little or no relationship to yesterdays aggregate fails. Thus, it is important to note that the age of fails cannot be determined by looking at these numbers. If all shares were delivered on a particular day, then there will be no entry in the table.
Update Frequency: SEC publishes daily data in batches that are delivered twice monthly and lagged about two weeks. So, for example, daily data for the month of March would arrive on our around mid April.
https://fintel.io/sftd/us/nwbo
What fantastic news!! Northwest Bio could not have added a more qualified person to their scientific board. Anyone who knows Linda Liau’s credentials and has seen her presentations, understands that she is the most eminently qualified person in the world to offer advice and guidance on designing clinical trials with DCVax.
Linda Powers’ quote says it all:
Linda Powers, NWBio CEO, commented: "We are delighted to have Dr. Liau join our existing distinguished SAB. Her experience as a leader in the neuro-oncology field, her decades of research and knowledge of both brain cancer biology and immunotherapies, and her extensive experience with DCVax-L as the Principal Investigator of the Phase 3 trial, will be invaluable as we work together on DCVax-L approval and on future clinical programs building on that."
Yes, Northwest Bio’s first agreements with UCLA started with the phase I trial in 2001, and continued with the phase II trial, which turned into the phase III trial. If anyone thinks that Linda Powers would draft agreements that do not allow licensing rights to anything associated with DCVax, they would be wrong and foolish.
I doubt that Northwest Bio will license the Flaskworks’ process, at least for the foreseeable future. It’s a HUGE competitive advantage, and it’s what will separate Northwest Bio from the multitudes who will attempt to copy-cat DCVax. Look how many companies are attempting CAR-T therapy now. It’s pennies compared to dollars, so it makes little sense to me at this point.
Wonder no more Gary; knowledge is power. Of course Northwest Bio has license rights in its agreements with UCLA:
9. Patents and Inventions
Inventorship of developments or discoveries first conceived and actually reduced to practice in the performance this Agreement ("Subject Inventions") will be determined in accordance with U.S. Patent Law and this Agreement. Except as stated below, all rights to. Subject Inventions made solely by employees of University will belong solely to University and all rights to Subject Inventions made solely by employees of Sponsor will belong solely to Sponsor. All rights to Subject Inventions made jointly by employees of University and employees of Sponsor and any developments or discoveries conceived and actually reduced to practice as part of the Investigational New Drug work described in Exhibit A, Paragraph 2A and 2B, will belong jointly to University and Sponsor.
To the extent that Sponsor pays all direct and indirect costs set forth in Article 4 above, and to the extent that the University is legally able, Sponsor will be granted a time-limited first right to negotiate an option or license under University's rights in any Subject Invention that belongs either solely to University or jointly to University and Sponsor. With respect to filing patents where University and Sponsor are co-inventors, University is obligated to file such patent application upon Sponsors request and will allow Sponsor the opportunity, if it so elects, to review and have right to make reasonable changes to all documents prior to filing. University will promptly disclose to Sponsor any Subject Inventions. Sponsor will hold such disclosure on a confidential basis and will not disclose the information to any third party without consent of University.
Sponsor will advise the University in writing within sixty (60) days of such disclosure to Sponsor whether or not it wishes to secure an option or commercial license ("Election Period"). Sponsor will have ninety (90) days from the date of election to conclude an option or license agreement with University ("Negotiation Period").
Said license will contain reasonable terms, will require diligent performance by Sponsor for the timely commercial development and early marketing of Subject Inventions, and include Sponsor's obligation to reimburse University's patent costs for all Subject Inventions subject to the license. In the event it is necessary in the opinion of University to file any patent applications to protect a Subject Invention during the Election or Negotiation Periods, University will promptly notify Sponsor in writing of such decision and Sponsor will reimburse patent costs incurred by University during such period.
If such option or license is not concluded within the Negotiation Period, neither party will have any further obligations to the other with respect to such Subject Invention. If Sponsor does not elect to secure such option or license, rights to such Subject Invention will be disposed of in accordance with University's policies, with no further obligation to Sponsor with respect to such Subject Invention.
Nothing contained in this Agreement shall be deemed to grant either directly or by implication, estoppel, or otherwise, any rights under any patents, patent applications or other proprietary interests, whether dominant or subordinate, or any other invention, discovery or improvement of either party, other than the specific rights covering Subject Inventions under this Agreement.
Here we go again. At the most recent Annual Shareholder Meeting, Linda Powers addressed the issue of re-listing the stock on a national exchange, and said it’s something that she’s given a lot of thought to, and she did not want to do a reverse split. I believe that when Linda Powers puts her brilliant mind to something, she will figure out the best solution. I think this would likely occur in conjunction with significant news, such as a partnership, or marketing approval, and will have the support of backing of analysts, and institutional investors. The clock is ticking, and the time is getting shorter for those who have held the price of NWBO down by shorting.
I think it’s important to note that Northwest Bio VOLUNTARILY DELISTED their stock, and complied with the required rules for voluntary delisting; Northwest Bio was not the subject of a decision by an Adjudictory Body to deslist.
I will let you figure out why this is important . . .
NW Bio Announces Decision to Voluntarily Withdraw from Nasdaq Listing and Begin Trading on OTC Market
07 Dec, 2016, 08:00 ET
BETHESDA, Md., Dec. 7, 2016 /PRNewswire/ -- Northwest Biotherapeutics (Nasdaq: NWBO) ("NW Bio" or the "Company"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the Nasdaq Staff has not accepted the Company's plan of remediation for certain violations of Listing Rules previously reported, and the Company has notified Nasdaq of its intention to voluntarily withdraw the Company's common stock from listing on Nasdaq. Upon withdrawal from Nasdaq, the Company plans to begin trading on the over-the-counter (OTC) market.
Pursuant to Nasdaq Listing Rule 5840(j), the Company is required to give Nasdaq ten days' notice of the voluntary withdrawal, and this period cannot be shortened. As a result, trading on Nasdaq is expected to be suspended on or about December 19, 2016, and trading in the Company's stock on the OTC is expected to begin the same day, as the Company anticipates a seamless transition.
The Company will file a Form 25 with the Securities and Exchange Commission on December 19. The delisting is expected to become effective 10 calendar days later. During this 10-day period, the Company's stock is anticipated to be trading on the OTC market.
The Company has had discussions with the Staff of OTC Markets Group Inc. and believes that it currently satisfies all requirements for trading on The OTCQB Venture Market (the "OTCQB"). Accordingly, the Company plans to promptly file an application to be traded on that market.
The Company desires to proceed with multiple Phase 2 trials in addition to completing its current Phase 3 trial. The Company believes that it will have enhanced ability to raise the funding required for these programs on the OTC as compared with the Nasdaq as the Company will not be subject to the type of the restrictions on its ability to accept financing on the OTC that it has been subject to on Nasdaq. If the Company were to remain listed on Nasdaq, the Company's understanding is that the aggregation of the financings completed by the Company since May of this year would likely be deemed to preclude any substantial further fundraising until at least sometime in Q1 of 2017.
As previously reported, on November 7, 2016 the Company received a letter from the Nasdaq Staff indicating that the Staff had determined to aggregate a series of financing transactions that were completed between May 15, 2016 and October 13, 2016, although the transactions were in many cases small and diverse, and involved a number of unrelated parties. Based upon the aggregation, the Nasdaq Staff determined that the transactions did not comply with Nasdaq's Listing Rule 5635(d) since, in the aggregate, they exceeded 20% of the number of shares outstanding prior to May 15, 2016. The Company engaged in remediation discussions with the Nasdaq Staff. However, the Nasdaq Staff ultimately determined not to accept the Company's proposed plan of remediation. As noted above, given that the Nasdaq Staff determined to aggregate these transactions and that the last transaction did not occur until October 13, 2016, the Company's understanding is that it would likely be foreclosed from completing further significant financings until at least sometime in Q1 2017.
Due to the fact that the Nasdaq Staff has not accepted the Company's plan of remediation, the Nasdaq Staff would have issued a letter (the "Staff Determination") indicating that, unless the Company requested a hearing before an independent Nasdaq Listing Qualifications Panel (the "Panel") to review the Staff Determination, the Company's common stock would be subject to delisting from Nasdaq. If the Company requested such a hearing, it would likely have taken place in February, 2017. A request for a hearing would stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel. The Panel would have the discretion to grant the Company an extension period of up to 180 calendar days from the date of the Staff Determination within which the Company would be required to demonstrate compliance with all applicable listing requirements.
In that regard, as previously announced on June 24, 2016, the Company is currently under a grace period for compliance with the $1.00 per share bid price requirement, as set forth in Listing Rule 5550(a)(2), which expires on December 21, 2016. The Company had planned to conduct a Special Meeting shortly after the upcoming Annual Meeting, to obtain shareholder approval for the reverse split and the plan of remediation proposed to the Nasdaq Staff. However, since the plan of remediation was not accepted, the Company is not currently proceeding with the Special Meeting or the reverse stock split.
Notwithstanding the right to a hearing before the Panel, there can be no assurance that the Panel would determine to maintain the listing of the Company on The Nasdaq Capital Market.
The Company's Board of Directors considered a variety of factors and reached a unanimous decision for the Company to voluntarily withdraw its listing on Nasdaq and undertake the actions necessary to trade on the OTCQB, rather than seeking to remain on Nasdaq and go through the hearing process. Such factors include the likely expenses and uncertainty associated with the hearing process and seeking to regain compliance with Nasdaq Listing Rules, the value to the Company of being able to raise and accept financing to proceed with multiple Phase 2 trials while also completing the Phase 3 trial, the potential availability of such financing on the OTCQB, the Company's obligations with respect to its outstanding convertible notes as discussed in the next paragraph, and other perceived potential advantages and drawbacks of seeking to maintain the Company's Nasdaq listing as compared to moving the trading to the OTCQB at this time.
Ceasing to be listed or quoted on Nasdaq will constitute a "Fundamental Change" under the terms of the Company's Convertible Senior Notes that were issued in August, 2014 and are otherwise due in August, 2017. Following this change, the Company will have a period of 20 business days, ending in January, within which the Company is obligated to make an offer to repurchase the Notes in accordance with the terms of the indenture relating to the Notes. There is approximately $11.0 million in aggregate principal amount outstanding. The Company believes that it has several options for addressing this obligation, and will be evaluating those options over the coming weeks, although there can be no assurance that such options will be available or will be on acceptable terms. If the Company fails to satisfy its obligation, that would result in an event of default under the Notes.
https://www.prnewswire.com/news-releases/nw-bio-announces-decision-to-voluntarily-withdraw-from-nasdaq-listing-and-begin-trading-on-otc-market-300374967.html
Re-Listing of a Company
A Company that has been the subject of a Decision by an Adjudicatory Body to delist such Company shall be required, prior to re-listing, to comply with the requirements for initial listing. A Company that has been suspended but that has not been the subject of such a Decision shall be required, prior to re-listing, to comply with requirements for continued listing.
(j) Voluntary Delisting
(1) A Company may voluntarily terminate its listing upon compliance with all requirements of Rule 12d2-2(c) under the Act. In part, Rule 12d2-2(c) requires that the Company may delist by filing an application on Form 25 with the Commission, provided that the Company: (i) complies with all applicable laws in effect in the state in which it is incorporated and with the applicable Nasdaq Rules; (ii) provides notice to Nasdaq no fewer than 10 days before the Company files the Form 25 with the Commission, including a statement of the material facts relating to the reasons for delisting; and (iii) contemporaneous with providing notice to Nasdaq, publishes notice of its intent to delist, along with its reasons therefore, via a press release and on its web site, it if has one. Any notice provided on the Company's web site pursuant to Rule 12d2-2(c) must remain available until the delisting has become effective. The Company must also provide a copy of the Form 25 to Nasdaq simultaneously with its filing with the Commission. Nasdaq will provide notice on its web site of the Company's intent to delist as required by Rule 12d2-2(c)(3).
(2) A Company that seeks to voluntarily delist a class of securities pursuant to Rule 5840(j)(1) that has received notice from Nasdaq, pursuant to the Rule 5800 Series or otherwise, that it fails to comply with one or more requirements for continued listing, or that is aware that it is below such continued listing requirements notwithstanding that it has not received such notice from Nasdaq, must disclose this fact (including the specific continued listing requirement that it is below) in: (i) its statement of all material facts relating to the reasons for withdrawal from listing provided to Nasdaq along with written notice of its determination to withdraw from listing required by Rule 12d2-2(c)(2)(ii) under the Act; and (ii) its press release and web site notice required by Rule 12d2-2(c)(2)(iii) under the Act.
(k) Disclosure of Public Reprimand Letter
A Company that receives an Adjudicatory Body Decision that serves as a Public Reprimand Letter must make a public announcement by filing a Form 8-K, where required by SEC rules, or by issuing a press release disclosing the receipt of the Decision, including the Rule(s) upon which the Decision was based. As described in Rule 5250(b)(1) and IM-5250-1, the Company must notify Nasdaq's MarketWatch Department about the announcement through the electronic disclosure submission system available at www.nasdaq.net, except in emergency situations when notification may instead be provided by telephone or facsimile. If the public announcement is made during Nasdaq market hours, the Company must notify MarketWatch at least ten minutes prior to the announcement. If the public announcement is made outside of Nasdaq market hours, the Company must notify MarketWatch of the announcement prior to 6:50 a.m. ET. The Company should make the public announcement as promptly as possible but not more than four business days following receipt of the Decision.
(l) Disclosure by Nasdaq
In order to maintain the quality of and public confidence in its market and to protect investors and the public interest, Nasdaq may, at any level of a proceeding under this Rule 5800 Series, make a public announcement, including by press release, describing a notification, Public Reprimand Letter, Staff Delisting Determination, Adjudicatory Body Decision, or other event involving a Company's listing or trading on Nasdaq.
Adopted March 12, 2009 (SR-NASDAQ-2009-018); amended Jan. 29, 2010 (SR-NASDAQ-2009-077); amended Mar. 15, 2010 (SR-NASDAQ-2010-006); amended Mar. 26, 2010 (SR-NASDAQ-2010-041); amended Dec. 3, 2012 (SR-NASDAQ-2012-118).
https://listingcenter.nasdaq.com/rulebook/nasdaq/rules/Nasdaq%205800%20Series
ilovetech, I would really like to believe that. I’m familiar with the regulatory system, and unfortunately it rarely works the way some here think. Believe me, I would LOVE to be wrong on this, and hope that I am - the MHRA did pull a rabbit out of its hat with the Covid vaccine, so we know that they are capable of it. Regardless, the important thing to me, is that Northwest Bio is close to submitting the application, and receiving marketing approval. Whether that approval happens in four months, or seven months, is irrelevant to me.
Thanks for the kind wishes JTORENCE. I have dennisdave on ignore, and his post appears to demonstrate limited math and comprehension abilities. If you think he blew my theory, then perhaps you do as well. Good day to you sir.
Senti, I think you are one of the most astute critical thinkers on this board, so that’s good to know. ;)