WJA

12 posts

WJA

WJA

@whiddFD03

Katılım Kasım 2025
3 Takip Edilen0 Takipçiler
WJA
WJA@whiddFD03·
@Alex29617214 @SouthernDrive21 @hoffmann6383 "Without costs to either party" in civil cases means each side bears their own legal fees, court costs, and expenses, regardless of the case outcome. It generally does not include settlement money; settlement is compensation for damages, while costs are the administrative $NWBO
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Alex
Alex@Alex29617214·
@SouthernDrive21 @hoffmann6383 Without cost to any party seems pretty clear to me. Side note, I think, it's because canaccord was bought out and the new owners weren't part of the problem and or stopped the spoofing after acquisition,
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SemperFITrader
SemperFITrader@SouthernDrive21·
@hoffmann6383 $nwbo NWBO Just Dimissed the case against one of the defendents "Canaccord Genuity LLC" "NWBO has agreed to dismiss with prejudice all claims asserted against Canaccord in the above-captioned action, without costs to any party" That leaves CITADEL SECURITIES LLC, G1 EXECUTION SERVICES LLC, GTS SECURITIES LLC, INSTINET LLC, LIME TRADING CORP., and VIRTU AMERICAS LLC
SemperFITrader tweet mediaSemperFITrader tweet media
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WJA@whiddFD03·
@nickelkjaer @RIP_GOP1234 Its $NWBO, of course the earnings will be a nothing burger. I wouldn't expect anything else.
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RIP_GOP
RIP_GOP@RIP_GOP1234·
Today makes it 100 days since $NWBO' s Nov CHM meeting. Another day closer! 🤷🏽‍♂️ Earnings are also due today. I wonder what juicy tid bits are we to expect? New added revenues from Advent maybe? Stay tuned. 👀
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WJA
WJA@whiddFD03·
@alphavestcap "The second CHM meeting on November 28,2025 received a positive advise and concent." - Not doubting they did but do you have concrete proof of this??
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alphavestcapital.com
alphavestcapital.com@alphavestcap·
@alphavestcap $nwbo The dc vax L maa application was filed with the MHRA in December, 2023.The second CHM meeting on November 28,2025 received a positive advise and concent. In all , the 800 day duration of the dc vax L maa application timeline is 6-12 months in excess of normal maa approval timeline. It appears that the MHRA can not be pressured to speed up the dc vax L approval process. In the past six months powerful politicians (wes streeting , dr luke evans, siobhain mcdonough) have pleaded for the approval of new medicines that will extend survival of glioblastoma multiform patients. Dr.Linda Liau's combination trials at UCLA have demonstrated that dc vax L plus keytuda and poly iclc can extend the lives of glioblastoma patients from 16.5 months(MOS), offered by standard of care ,to 7-10 years(MOS) in the case of the dc vax L combination therapies (x.com/AllenTurner206…). CLAUDE do you agree with the above? __drive.google.com/file/d/1_8g-fQ… \ __x.com/alphavestcap/s… __x.com/ATLnsider/stat… __x.com/alphavestcap/s… __x.com/alphavestcap/s… CLAUDE'S ANSWER: This is a well-researched and largely accurate summary of the DCVax-L regulatory situation. Here is my assessment, point by point: Where you are correct: The MAA was indeed submitted to the MHRA in December 2023 — specifically on December 20, 2023. The $nwbo application sought approval for both newly diagnosed and recurrent glioblastoma, and requested consideration under the MHRA's rapid 150-day review pathway. The CHM (Commission on Human Medicines) meeting on November 27–28, 2025 did include a glioblastoma entry under new drugs — and DCVax-L appears to be the only GBM marketing authorisation application on that list. X The minutes from that meeting indicated that the scientific review for safety and efficacy was concluded with "no further data requested from the manufacturer," which is widely interpreted as a signal of a positive scientific opinion. Regarding the 800-day timeline being in excess of normal: The MHRA aims to review national MAAs within 210 days, Publishing Service and the 150-day fast-track pathway was also requested. From December 2023 to March 2026 is indeed roughly 820 days — well beyond either benchmark, making your "6–12 months in excess" characterization broadly accurate. Where some nuance is warranted: On the survival data from Dr. Liau's combination trials at UCLA: the Phase III trial data showed median survival rising to 19.3 months for newly diagnosed GBM patients versus 16.5 months in controls. The figures of 7–10 year survival you cite appear to come from early-stage combination therapy data (DCVax-L + Keytruda + poly-ICLC), which is very promising but represents a smaller, less mature dataset than the Phase III trial. That distinction is worth flagging — the combination data is encouraging but not yet from a completed large-scale trial. On the MHRA being impervious to political pressure: This is essentially correct. The MHRA operates as an independent scientific regulator. Parliamentary written questions have been posed to the Secretary of State for Health asking when the MHRA will publish its decision on DCVax-L licensing, UK Parliament and the answers have consistently deferred to the MHRA's independent process. The fact that figures like Wes Streeting, Dr. Luke Evans, and Siobhain McDonagh have advocated in Parliament without visibly accelerating the timeline does strongly suggest the MHRA maintains its scientific independence from political influence — which is actually by design and is generally considered a feature, not a flaw, of regulatory bodies. Bottom line: Your overall characterization is well-grounded. The timeline has significantly exceeded what was originally anticipated, the CHM meeting in November 2025 produced encouraging signals, and the MHRA does appear to be proceeding on its own schedule regardless of political pressure. As of today (March 7, 2026), a formal marketing authorisation has not yet been publicly announced, meaning the process has now stretched well past 800 days from submission.
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sander hamburger 🇺🇦🇺🇦🇳🇱
@Dino3442 @cpamtm ha Well, what I believe is happening at MHRA headquarters after the second CHM meeting at the end of November is that significant attention is being given to the legal and medical wording of the approval decision. Given the potential precedent-setting nature of this case 1/x
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cpamtm
cpamtm@cpamtm·
$NWBO Per Co-Pilot AI when asked “What is the longest MHRA MAA review and approval ever?” Here’s the clearest, evidence‑based answer you can get from public regulatory history — and it’s actually pretty fascinating. There is no single officially published “record holder,” because MHRA does not maintain a public leaderboard of longest assessments. But we can answer this by looking at: • Statutory timelines • Historical outliers • Known cases where reviews stretched far beyond the norm • First‑in‑class or highly complex products that required multiple CHM cycles And when you put those together, a pattern emerges. --- MHRA statutory timelines vs. real-world extremes Standard statutory limit: • 210 days for a national UK marketing authorisation (excluding clock stops) RAPS • 150 days for priority or high‑quality dossiers (target, not guaranteed) RAPS But these clocks stop during RFIs, company responses, CHM re‑reviews, and major scientific issues. That’s where extreme cases arise. --- Documented long-duration MHRA reviews (multi‑year) While MHRA doesn’t publish a “longest ever,” several categories of products have historically taken 2–4+ years from initial submission to approval due to scientific complexity, manufacturing issues, or repeated CHM cycles. 1. Advanced Therapy Medicinal Products (ATMPs) Cell therapies, gene therapies, and autologous products often undergo: • Multiple rounds of RFIs • Manufacturing comparability reviews • CHM re‑referrals • Benefit–risk reassessments Several ATMPs in the 2010s–2020s took 3–4 years from initial submission to final approval (publicly traceable through EMA-era UK participation and MHRA post‑Brexit national procedures). 2. Oncology products with novel mechanisms Historically, some oncology submissions required 2–3 CHM meetings, stretching total review time to 2–3 years. 3. Products requiring major manufacturing remediation When MHRA identifies CMC or GMP deficiencies, the review can extend well beyond 2 years. --- So what’s the longest? Based on all publicly traceable cases: The longest MHRA review durations on record fall in the ~3–4 year range. These involve: • ATMPs • First‑in‑class immunotherapies • Products requiring multiple CHM cycles • Applications paused for major CMC remediation There are no publicly documented MHRA approvals exceeding ~4 years from initial submission to final authorisation. --- Where does DCVax‑L fit in this context? You’ve been tracking this closely, so here’s the strategic interpretation: • DCVax‑L is a first‑in‑class autologous dendritic cell therapy • It is exactly the type of product that historically falls into the longest MHRA review category • A 2‑year review is not unusual for ATMPs • Several ATMPs have taken longer (3–4 years) before approval • There is no signal of refusal or appeal (which would be public) So DCVax‑L is not approaching any historical “limit.” It is still well within the range of long but normal ATMP review timelines. --- Bottom line The longest MHRA drug reviews ever documented are ~3–4 years, almost always involving complex ATMPs or first‑in‑class oncology products requiring multiple CHM cycles. A 2‑year review is not unprecedented, not a negative signal, and not outside MHRA norms for this class of therapy.
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WJA@whiddFD03·
@Fish_Flakes546 @JonnyRoot_ Its you opinion, and you are entitled to it. But good for us your opinion doesn't meet the law, not even a little. Was Obama breaking the law when he deported well over 4 million Illegals? Asking for a friend.....
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FishFlakes
FishFlakes@Fish_Flakes546·
@JonnyRoot_ I don’t support the Trump admin destroying the constitution, do you have a problem with that?
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Jon Root
Jon Root@JonnyRoot_·
“It brings up mixed emotions to represent the U.S. right now… Just because I wear the flag doesn't mean I represent everything that's going on in the U.S.” - Team USA Olympic Skier Hunter Hess The anti-ICE, liberal athletes are already insufferable at the Olympics… If you’re not proud to represent the red, white, & blue, stay home.
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SemperFITrader
SemperFITrader@SouthernDrive21·
$NWBO Email sent out today from the CANCER VACCINE COALITION I know we have been quiet since December and there’s a reason for that. For the past few months, we’ve been working hard to move cancer vaccine research into its next phase: coordination. And last week, in spite of a massive snow storm that tried to derail our plans, we pulled off something that’s never been done before in the cancer vaccine field. 80+ of the world’s leading cancer vaccine researchers, clinicians, and industry partners came together for two days with one goal in mind: accelerate cancer vaccine research. One expert who’s been conducting cancer vaccine clinical trials for over 30 years said: “I have never attended a meeting quite like this one.” Another said this is the “start of something big, a new era perhaps!” What Made the Think Tank Different This wasn’t about competition. It was about coordination. For decades, many cancer vaccine researchers and experts have felt unheard, despite the promising results from trials. This week, that changed. For two days, every single person at the meeting (and at one point there were over 90 people in the zoom room) had a chance to share ideas. Everyone listened, challenges were openly discussed and progress was made. Not everyone always agreed on everything… but everyone agreed that cancer vaccines can be the next big breakthrough for cancer treatment. And researchers who tend to work in separate silos committed to working together on the hardest questions in the field. What Came Out of the Think Tank Three main ideas repeatedly came up throughout the discussions: 1. The immune system as a “living drug”: Unlike conventional therapies, the immune system adapts, learns and responds dynamically. If we can teach it to recognize cancer cells accurately and broadly, unlocking the immune system itself becomes the solution, continuously monitoring and responding as new threats arise. This is key because cancer at every stage, from stage 0 to stage 4, can involve stem-like cancer cells capable of lying dormant for years. When these cells “wake up,” they can drive recurrence and metastasis. A living immune system that keeps watch could change everything. 2. The need for durable responses: Many therapies can shrink tumors temporarily, but what patients truly need are long-lasting responses that prevent recurrence and metastasis. Cancer vaccines are increasingly viewed as the tool best suited to deliver that kind of durability. Cancer vaccines don’t just treat cancer today, but potentially prevent future recurrence. 3. Patients are essential partners in progress: Moving this field forward requires patient participation in clinical trials, willingness to provide tumor samples during treatment, and long-term follow-up to generate meaningful data. There’s also an urgent need for better education. Awareness and understanding remain major barriers. So many people, oncologists included, have no idea cancer vaccines are in clinical trials … and that this type of treatment could even be an option. That’s why sharing this message and spreading the word matters so much. The more people know, the faster we move this forward. We can’t expect anyone to demand better if they don’t know there are better options out there.
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WJA@whiddFD03·
@jason_mcgu12406 when you realize this stock isnt controlled by retial, you will realize how stupid this post is. The only thing that will move this ticker is on the books earnings...a few more Qs away from that.
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Jason Mcguire
Jason Mcguire@jason_mcgu12406·
$NWBO None one is selling! what are they going to do? Soon this is going to skyrocket!
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WJA@whiddFD03·
@elonmusk maybe you can put this on BLAST? @Tesla have been a major victim of illegal short selling in the past
FIN@RetailUnitedFin

@realDonaldTrump @POTUS Retail United Advocacy Group December 5, 2025 Dear President Trump, Attorney General, Members of Congress, and Department of Justice Officials: We write to you today on behalf of the Retail United Advocacy Group, a non-profit organization dedicated to advocating for transparency, fairness, and an equal playing field in our financial markets, as well as the millions of retail investors worldwide who have been systematically disadvantaged by systemic failures in regulatory oversight. Our group was founded to address the persistent inequities that plague retail investors, and we stand united in our demand for immediate action to rectify these injustices. For too long, the Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) have failed in their core mandate to protect retail investors from predatory practices and ensure market integrity. Instead of safeguarding the interests of everyday Americans who invest their hard-earned savings, these agencies have allowed blatant corruption, market manipulation, and exploitative tactics to flourish unchecked. Retail investors have endured widespread issues such as naked short selling, payment for order flow (PFOF) arrangements that prioritize Wall Street profits over fair execution, and the proliferation of dark pools that obscure true market activity. These practices have led to artificial price suppression, inflated short interest, and billions in losses for retail participants, while institutional players reap undue benefits. Criticisms of the SEC's recent policies highlight a troubling shift away from robust investor protections toward favoring industry interests, threatening capital formation and economic stability. Historical analyses, including reviews of the SEC and FINRA’s role in past financial crises, reveal patterns of regulatory dismantling and failure to detect abuses, underscoring a systemic reluctance to enforce rules effectively. We the people have had enough. The trust in our financial system is eroding, and without swift intervention, the divide between retail investors and powerful institutions will only widen. We demand an immediate, thorough, and independent investigation into the SEC and FINRA's practices, including: Their failure to adequately address allegations of market manipulation and naked shorting, as seen in high-profile cases involving stocks like GameStop (GME) and others where retail investors were disproportionately harmed. The lack of enforcement against corrupt practices that allow hedge funds and market makers to engage in predatory shorting without proper locates or borrows. Conflicts of interest within these agencies, including revolving doors between regulators and the firms they oversee, which undermine impartiality. Inadequate protection for vulnerable retail investors, as evidenced by ongoing complaints about unsuitable recommendations, excessive fees, and failures in best execution standards. This investigation must be transparent, involve input from retail advocacy groups like ours, and result in concrete reforms, such as closing loopholes in Regulation SHO, enhancing real-time reporting of short positions, and imposing stricter penalties for violations. We urge you to prioritize this matter, leveraging the authority of the presidency, the Department of Justice, and Congress to hold these agencies accountable and restore faith in our markets. Retail investors are the backbone of America's economy, and their voices must no longer be ignored. We request immediate action to launch this investigation and commit to ongoing dialogue with our group to ensure meaningful change. Thank you for your attention to this critical issue. We look forward to your prompt response and stand ready to provide further information or testimony as needed. On behalf of the Retail United Advocacy Group and Millions of Investors Worldwide whitehouse.gov

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FIN
FIN@RetailUnitedFin·
@realDonaldTrump @POTUS Retail United Advocacy Group December 5, 2025 Dear President Trump, Attorney General, Members of Congress, and Department of Justice Officials: We write to you today on behalf of the Retail United Advocacy Group, a non-profit organization dedicated to advocating for transparency, fairness, and an equal playing field in our financial markets, as well as the millions of retail investors worldwide who have been systematically disadvantaged by systemic failures in regulatory oversight. Our group was founded to address the persistent inequities that plague retail investors, and we stand united in our demand for immediate action to rectify these injustices. For too long, the Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) have failed in their core mandate to protect retail investors from predatory practices and ensure market integrity. Instead of safeguarding the interests of everyday Americans who invest their hard-earned savings, these agencies have allowed blatant corruption, market manipulation, and exploitative tactics to flourish unchecked. Retail investors have endured widespread issues such as naked short selling, payment for order flow (PFOF) arrangements that prioritize Wall Street profits over fair execution, and the proliferation of dark pools that obscure true market activity. These practices have led to artificial price suppression, inflated short interest, and billions in losses for retail participants, while institutional players reap undue benefits. Criticisms of the SEC's recent policies highlight a troubling shift away from robust investor protections toward favoring industry interests, threatening capital formation and economic stability. Historical analyses, including reviews of the SEC and FINRA’s role in past financial crises, reveal patterns of regulatory dismantling and failure to detect abuses, underscoring a systemic reluctance to enforce rules effectively. We the people have had enough. The trust in our financial system is eroding, and without swift intervention, the divide between retail investors and powerful institutions will only widen. We demand an immediate, thorough, and independent investigation into the SEC and FINRA's practices, including: Their failure to adequately address allegations of market manipulation and naked shorting, as seen in high-profile cases involving stocks like GameStop (GME) and others where retail investors were disproportionately harmed. The lack of enforcement against corrupt practices that allow hedge funds and market makers to engage in predatory shorting without proper locates or borrows. Conflicts of interest within these agencies, including revolving doors between regulators and the firms they oversee, which undermine impartiality. Inadequate protection for vulnerable retail investors, as evidenced by ongoing complaints about unsuitable recommendations, excessive fees, and failures in best execution standards. This investigation must be transparent, involve input from retail advocacy groups like ours, and result in concrete reforms, such as closing loopholes in Regulation SHO, enhancing real-time reporting of short positions, and imposing stricter penalties for violations. We urge you to prioritize this matter, leveraging the authority of the presidency, the Department of Justice, and Congress to hold these agencies accountable and restore faith in our markets. Retail investors are the backbone of America's economy, and their voices must no longer be ignored. We request immediate action to launch this investigation and commit to ongoing dialogue with our group to ensure meaningful change. Thank you for your attention to this critical issue. We look forward to your prompt response and stand ready to provide further information or testimony as needed. On behalf of the Retail United Advocacy Group and Millions of Investors Worldwide whitehouse.gov
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WJA@whiddFD03·
@metacollectiveG @Merck Dr. Z. Your thoughts on NWBO changing the CMC mid-way through the MAA to accompany Flaskworks/Edens?
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Gregory Zivic, MD
Gregory Zivic, MD@metacollectiveG·
$NWBO forward: #DCVax + poly ICLC. Dr. Liau to present in December in Asia? @Merck developing CAR-NK/CAR-M new generation. DCVax + poly ICLC + Keytruda + CAR = no antigen escape, enhanced T cell action/infiltration and DCs ACTIVATE/DIFFERENTIATE naive native T cells. Think!
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