skitahoe
5 minutes ago
Marty, of course I don't know when we'll get an announcement from the Brits, perhaps the Annual Report will hint on it, if it doesn't come before then. While I think the Annual Report could be out any day, I gather the company can take until the end of the month, rather than the first week of the month, which applied previously. I'd hope we'd see some guidance on how the EDEN's advancing as well, we'll see.
The company can't make anything happen, but I believe they do communicate with the regulators, and hopefully they have a feeling of how much longer it will be.
I wish I could say we'll go no lower, but I can't. Can I imagine below $.20, no, but I couldn't imagine where we are today 6 months ago either.
I would hope that nearly all longs here have managed to at minimum bring their average price under $1. I think that most of us are at the $.50 or less range.
By the end of this year I believe that we'll be well in excess of $1. The end of the year equates to 18 months after the last Annual Meeting in which LP said we'd be a very different company. I would hope that means that we're at least far enough along with the EDEN that we've applied with the other regulators, if by that time we don't already have EDEN approval. With regulatory filings and approvals anticipated by second half or 2026, or sooner, along with building sales in the UK, I cannot see us trading for under about a $3 billion market cap, and probably $5 billion, or more. If I'm right about that by then, I would hope that all current longs would have at least twice what they invested in their accounts.
Gary
skitahoe
54 minutes ago
If we have major investors who're currently out of the stock, but planning on returning when they feel certain the time is right, the question is, will there always be a tell. Most technicians I've knows always believe they'll see an indication that something is coming, a tell, before anything of substance happens. If the UK is about to approve, anticipation is thought to start moving the share price up for days, to weeks, before the actual event.
I frankly don't know that will be the case here, to date both company and UK have done nothing that's really hinted at when an announcement will come, but perhaps it's because it's not that soon. If there is a clear tell, anyone out may pay slightly more than current prices, but still will be able to get in at these bargain basement prices. Without a tell, given the current price, I don't know that we won't gap up to triple or more of the current price taking our market cap to the 1 billion or greater range.
Previously I thought we'd see a substantially higher price in anticipation of approval, I simply don't know that is going to happen. If no one at either the company, or in the UK in any way leaks what's happening, no tell may be seen. If that's the case, much will be determined by how the news comes out.
If we not only get a press release from the company, but if they've also been working on the story with the mass media, if major stories hit the network news, newspapers, etc. about a new paradigm in cancer treatment, the gap up might be far greater than taking the share price to the billion dollar market cap level. While I don't think more than $5 billion is sustainable without bigger news, no telling what's possible on a real news blitz.
For now, I'd be satisfied to see anything above $1 or more in the immediate future, it won't be that long before it should grow on additional news, but if mass media picked up the story or a new paradigm in cancer treatment, no telling how high we could go. Much might also depend on just what the British said in labeling DCVax-L, does it read GBM, or Brain Cancer, or does it read Tumor Agnostic. That may tell the story of how mass media portrays it assuming we get noticed by the mass media.
I don't see any way that an approval doesn't lead to a gap up that will never be filled. The only question is, what will the price be before the news, and how high will it go after. With no tell, we might be about where we are today.
Gary
The Danish Dude
3 hours ago
With your latest drivel in mind regarding NWBO and Advent Bioservices and you obviously haven't quite come to terms with the debunk of your prior BS nonsense, let's have a stroll down dementia lane.
Exwannabe’s claims about NWBO’s ownership, control, and financial relationship with Advent Bioservices contain multiple misleading and incorrect assumptions. Below is a clear, well-documented refutation based on verified sources.
?
1. Claim: “NWBO does not own the 1A (original) and 1B buildout. That property is under long-term sublease to Advent, and all NWBO gets from it is $145K/year.”
Refutation:
✔ NWBO Retains Control Through Lease & Buildout Ownership
• NWBO sold the Sawston property in 2019 but retained a 20-year lease on 87,000 sq. ft. of the facility, ensuring its long-term control over manufacturing infrastructure (SEC Filings, NWBO Investor Statements).
• The 1A and 1B buildout includes cleanrooms, cryostorage, and Flaskworks automation that NWBO funded and directed for DCVax-L manufacturing.
• Advent does not own this infrastructure—it operates as a contract service provider under NWBO’s control.
✔ Sublease ? Ownership
• NWBO subleased parts of its leased space to Advent, but this does not mean Advent owns or controls the facility.
• The buildout is NWBO’s capital investment and remains an NWBO asset regardless of Advent’s operational role.
✔ Financial Misrepresentation
• The $145K/year sublease revenue is a misleading focal point because NWBO benefits primarily from DCVax-L production at Sawston, not from lease income.
• The true value lies in the commercial manufacturing capabilities of DCVax-L, which Advent operates exclusively for NWBO’s benefit.
?
2. Claim: “Advent controls the GMP facility’s use, not NWBO.”
Refutation:
✔ Regulatory Filings Confirm NWBO’s Control
• NWBO funded the buildout and its regulatory compliance (e.g., MHRA’s MIA licensing).
• MHRA’s approval of Sawston for DCVax-L manufacturing was a strategic milestone for NWBO, not Advent independently.
✔ Statements from Advent’s COO, Dr. Mike Scott, Confirm NWBO’s Primacy
• “The Sawston hothouse – run by Advent BioServices under a service contract for US-based Northwest Biotherapeutics, which owns the long-term facility lease.” (Business Weekly, 2022).
• “Advent’s work is primarily for NWBO and DCVax-L.”
✔ Advent Operates, NWBO Dictates
• Advent is a contract manufacturer (CDMO), meaning it executes NWBO’s strategy.
• NWBO determines what gets produced, when, and how.
• If NWBO required 100% capacity for DCVax-L, Advent would comply.
?
3. Claim: “The MIA license is Advent’s, proving their control.”
Refutation:
✔ Operational License ? Ownership or Control
• The MHRA MIA license was issued to Advent because it is the GMP-certified operator, but this does not give it ownership or independent control.
• NWBO remains the strategic beneficiary and regulatory applicant for DCVax-L manufacturing approvals.
✔ Industry Standard: License Goes to Operator, Not Asset Owner
• Many biopharma firms outsource GMP operations to CDMOs while retaining ownership and oversight.
• The MIA’s issuance to Advent is a procedural necessity, not proof of independent authority.
?
4. Claim: “NWBO only leases office/warehouse space, not manufacturing areas.”
Refutation:
✔ Fact: NWBO Leased Space Includes GMP Cleanrooms & Cryostorage
• NWBO’s lease covers GMP manufacturing suites, not just administrative areas.
• NWBO funded the facility buildout for DCVax production (10-K Filings).
✔ Regulatory & Property Documents Confirm Production Priority
• The Cambridge Planning Submission explicitly states:
“The Mill Lane Site, Sawston is owned by Northwest Biotherapeutics (NW Bio), a biotechnology company developing novel immune therapies to treat cancer.”
• This directly contradicts the claim that NWBO only has an office lease.
?
5. Claim: “How did they pay for the expansion?” (Implying Advent funded it, not NWBO).
Refutation:
✔ NWBO Funded the Expansion, as Confirmed in Filings
• NWBO paid Advent $2.4M in Q4 2024 for facility operations (SEC Filings).
• These payments are part of NWBO’s contractual agreement with Advent to run its manufacturing.
• No evidence suggests Advent “shifted” NWBO funds elsewhere.
✔ Expansion was Part of NWBO’s Long-Term Manufacturing Strategy
• NWBO’s phased GMP expansion was planned since 2019.
• Flaskworks Automation and comparability studies were anticipated for scaling production.
• NWBO’s payments to Advent are for contracted work, not independent Advent business activity.
?
Final Verdict: NWBO Controls, Advent Operates
✔ NWBO owns the lease, the buildout, and the core manufacturing infrastructure.
✔ Advent is a contractor executing NWBO’s manufacturing needs, not an independent decision-maker.
✔ Regulatory approvals, SEC filings, and public statements confirm NWBO’s strategic control.
✔ The long-term value for NWBO lies in commercial DCVax production, not lease revenue.
Exwannabe’s claims conflate operational roles with ownership, misrepresent the significance of subleases, and ignore clear financial and regulatory documentation.
GROK
Ownership Structure of Advent Bioservices
Advent Bioservices was spun out from Northwest Biotherapeutics (NWBO) in 2019 to operate as a contract development and manufacturing organization (CDMO), primarily to support DCVax-L production at the Sawston facility (NWBO 10-K, 2019).
?
1. NWBO’s Stake in Advent
✔ No Direct Equity Ownership Post-Spin-Out
• The 2019 10-K does not confirm that NWBO retained an equity stake in Advent following its 2019 spin-off.
• NWBO does not list Advent as a subsidiary or affiliated entity in its financial statements, indicating no direct corporate ownership.
• However, NWBO’s influence over Advent remains significant through contractual agreements and control over the Sawston facility lease (NWBO 10-K, 2019).
✔ Strategic Dependence on NWBO
• Advent’s primary revenue source is NWBO, as its contract manufacturer for DCVax-L production.
• Financial dependency and contractual agreements ensure NWBO’s control over Advent’s operations, even without direct ownership.
?
2. Linda Powers’ Involvement
✔ Toucan Holdings as the Majority Owner
• Advent is owned by Toucan Holdings, which is controlled by Linda F. Powers, who is also NWBO’s CEO (UK Company House Filings, 2023).
• While Advent is an independent corporate entity, it operates within NWBO’s strategic ecosystem.
✔ Other NWBO Insiders Hold Personal Stakes
• The 2019 10-K states that certain NWBO insiders hold personal equity interests in Advent, but NWBO as a company does not.
• This structure ensures alignment of Advent’s operations with NWBO’s strategic priorities.
✔ Financial & Operational Influence
• Powers’ dual role as NWBO’s CEO and Toucan’s managing partner reinforces NWBO’s indirect control over Advent.
• Advent’s business remains tightly linked to NWBO’s success, limiting its true independence.
?
3. Operational Independence & Management
✔ Separate Corporate Entity, but Not Truly Independent
• Advent operates as a standalone CDMO, but its primary focus is NWBO.
• Dr. Mike Scott (COO) oversees Advent’s operations, but NWBO dictates manufacturing priorities (Business Weekly, 2022).
✔ Sawston Facility Lease Ensures NWBO’s Control
• NWBO leases the 87,000 sq. ft. Sawston facility, which Advent operates under a sublease.
• NWBO’s long-term lease guarantees control over all facility expansions and production activities (SEC filings, 2019–2023).
✔ Contractual Oversight from NWBO
• While Advent may serve other clients, its core regulatory and production framework is aligned with NWBO’s needs.
• The Business Weekly (2022) report confirms that Advent’s priority remains DCVax-L manufacturing under NWBO’s direction.
?
4. Assessment of “Owned by LP”
✔ Oversimplification of Ownership Structure
• The claim that Advent is “owned by LP” is misleading.
• Toucan Holdings owns Advent, and Linda Powers controls Toucan, but other NWBO insiders also hold stakes.
• NWBO as a corporate entity does not own Advent, but its CEO and key stakeholders maintain financial ties.
✔ Distributed Ownership Model
• Toucan Holdings is the majority owner, but the presence of NWBO insiders in Advent’s ownership structure reinforces NWBO’s strategic influence.
• Advent’s financial reliance on NWBO further ties it to NWBO’s success.
?
Final Verdict: Advent’s Ownership is Shared, But NWBO Retains Strategic Control
✔ NWBO does not own Advent directly but retains financial and operational leverage.
✔ Toucan Holdings (controlled by Linda Powers) is the majority owner.
✔ Advent operates independently on paper but remains dependent on NWBO’s manufacturing contracts.
✔ The claim that Powers “owns Advent” exclusively ignores the broader ownership and control structure.
✔ Through the Sawston lease and contractual agreements, NWBO dictates Advent’s primary operations.
For a thorough walkthrough of ownership etc, earlier posts about NWBO and Advent Bioservices relations.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175848158
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175756324
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175307408
pgsd
3 hours ago
Excellent post by Lykiri :
(Interesting Grok AI Analysis at the bottom)
"As of March 13, 2025, this development underscores a proactive strategy to capitalize on an anticipated approval, with significant implications for patients, investors, and the UK biotech landscape" - Grok AI Analysis (continued below)
The expansion of Advent Bioservices may signal a strategic preparation for the anticipated MHRA approval of DCVax-L, IMO.
Advent Bioservices joins Unity Campus cohort
13 Mar, 2025
Another thrusting life science company – cell therapy pioneer Advent Bioservices – has taken space at Howard Group’s Unity Campus just outside Cambridge.
Advent’s arrival means that following practical completion in May, 87 per cent of Phase 2 of the Sawston hub will have been let.
The company has committed to a 5+5-year lease of lab and office space within the Cadence building, joining an impressive roster of life science innovators at the campus. It intends to scale across the Cluster and further afield from the growth springboard.
Advent began activity as a cell therapy Contract Development & Manufacturing Organisation (CDMO) in 2016. It is currently managing the development of the state-of-the-art facility for multi-product Good Manufacturing Practice production at Cadence.
This reinforced base will allow scale up of current commercial production and initiate the provision of contract manufacturing services to meet the growing demand for such services in the UK.
At the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products, Advent Bioservices supports the development of complex, breakthrough therapies for a globally diverse market.
Mike Scott, President at Advent Bioservices, said: “This space will permit Advent to expand and diversify process development, microbiological testing and quality assurance and quality control services to Biotech and drug development companies working in the cell and gene therapy sector.”
Property investor and developer Howard Group is overseeing the delivery of a bespoke CL2 laboratory fit-out at the Unity Campus development, with Parkeray appointed as the contractor for this project, marking their comprehensive involvement in the fit-out of the entire Cadence building.
The professional team includes 3PM as project managers, CB3 as cost consultants, and Hive for mechanical and electrical services.
With the arrival of Advent and an additional letting also recently completed, the only remaining space in the BREEAM ‘Excellent’ Cadence building is the second floor, offering 10,825 sq ft of high-quality laboratory and office space.
Katherine Friend, Director – Investment and Asset Management, Howard Group, said: "We are thrilled to welcome Advent Bioservices to Unity Campus. Their groundbreaking work in cell therapy aligns perfectly with our vision for Unity Campus as a hub for world-class innovation, breakthroughs, and collaboration in the life sciences sector and further reinforces Unity Campus’ position as a prime destination for pioneering research and development."
Interesting Grok AI Analysis :
Advent Bioservices joining the Unity Campus cohort, as reported by Business Weekly, represents a significant development for the company and its operations, particularly in the context of its role in manufacturing DCVax®-L, a personalized immune therapy for solid tumor cancers developed by Northwest Biotherapeutics (NW Bio). Below, I’ll outline possible synergies, potential opportunities, and implications of this move, with a focus on its relevance to DCVax awaiting an imminent UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval decision as of March 13, 2025.
Possible Synergies
Collaboration with Life Science Innovators: Unity Campus, located just outside Cambridge, is a hub for life science companies. Advent Bioservices’ presence alongside other cutting-edge firms could foster collaborations in cell and gene therapy development, leveraging shared expertise in areas like process optimization, quality control, and regulatory compliance. This could enhance Advent’s capabilities in producing DCVax-L, potentially improving efficiency or scalability.
Access to Talent and Resources: The Cambridge area, part of the UK’s "golden triangle" for biotech, offers access to a skilled workforce and advanced research institutions. This synergy could strengthen Advent’s technical teams, which are critical for maintaining the high standards required for DCVax-L’s Good Manufacturing Practice (GMP) production.
Infrastructure Enhancement: The bespoke CL2 laboratory fit-out at Unity Campus, managed by Howard Group, aligns with Advent’s need for state-of-the-art facilities. This could complement its existing Sawston facility, providing additional capacity or specialized equipment to support DCVax-L manufacturing and related R&D.
Potential Opportunities
Scaling Production: Advent’s 5+5-year lease at Unity Campus signals a long-term commitment to growth. With DCVax-L nearing potential MHRA approval, this additional space could enable Advent to scale production beyond the Sawston facility’s current capacity (estimated at 450-500 patients annually in Phase 1A), meeting anticipated demand if approved.
Diversification of Services: Advent aims to expand process development, microbiological testing, and quality assurance/control services for the cell and gene therapy sector. Success with DCVax-L could position Advent as a leading Contract Development and Manufacturing Organization (CDMO), attracting new clients and diversifying revenue streams.
Strengthened MHRA Approval Case: Joining a prestigious innovation hub like Unity Campus could enhance Advent’s credibility with regulators. Demonstrating investment in advanced facilities and a collaborative ecosystem might bolster confidence in its ability to reliably manufacture DCVax-L at commercial scale, a key factor in MHRA’s decision-making process.
Possible Implications
Impact on DCVax-L Timeline: The move to Unity Campus, announced recently as of March 13, 2025, comes at a critical juncture with DCVax-L’s Marketing Authorization Application (MAA) submitted to MHRA in December 2023. The MHRA’s 150-day rapid review pathway, if granted, could conclude around mid-2024, though delays or additional data requests could push this into 2025. The new facility might signal to MHRA that Advent is preparing for immediate post-approval production, potentially influencing a favorable decision.
Market Perception and Investment: This expansion could signal to investors and the market that Advent and NW Bio anticipate MHRA approval and are gearing up for commercialization. Positive sentiment could drive interest in NW Bio (OTCQB: NWBO), though any delay in approval might temper enthusiasm given the high stakes of this milestone.
Competitive Positioning: If DCVax-L gains approval, Advent’s enhanced capabilities at Unity Campus could position it ahead of competitors in the UK cell therapy market, where only a handful of facilities hold commercial manufacturing licenses. However, failure to secure approval could strain resources invested in this expansion, impacting Advent’s growth trajectory.
Relevance to DCVax Awaiting MHRA Approval
The timing of Advent’s move to Unity Campus is highly relevant to DCVax-L’s imminent MHRA approval decision. Northwest Biotherapeutics submitted the MAA in December 2023, seeking approval for glioblastoma (GBM) treatment, supported by Phase III trial data showing significant survival benefits. The Sawston facility, operated by Advent, received its Manufacturer’s Importation Authorization (MIA) license in March 2023, enabling global commercial production—a prerequisite for MHRA’s consideration of the MAA. The Unity Campus expansion builds on this foundation, potentially addressing MHRA concerns about manufacturing capacity and reliability post-approval.
Moreover, the Cambridge location ties into the UK’s push to lead in life sciences, as seen with initiatives like the Early Access to Medicines Scheme (EAMS), under which DCVax-L was the first designated "Promising Innovative Medicine" in 2014. This history, combined with Advent’s strategic growth, could reinforce MHRA’s confidence in approving DCVax-L, especially if regulators view Unity Campus as a step toward meeting unmet medical needs in GBM treatment.
Conclusion
Advent Bioservices’ integration into Unity Campus offers synergies in collaboration, talent, and infrastructure that could enhance its DCVax-L manufacturing capabilities. The potential to scale production and diversify services aligns with the critical MHRA approval decision awaiting NW Bio. While the move strengthens Advent’s position and may positively influence regulators, the outcome hinges on MHRA’s final assessment of clinical data and manufacturing readiness. As of March 13, 2025, this development underscores a proactive strategy to capitalize on an anticipated approval, with significant implications for patients, investors, and the UK biotech landscape.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175923593
https://businessweekly.co.uk/posts/advent-bioservices-joins-unity-campus-cohort
#dcvax $nwbo #gbm
Excellent post by Lykiri :
(Interesting Grok AI Analysis at the bottom)
"As of March 13, 2025, this development underscores a proactive strategy to capitalize on an anticipated approval, with significant implications for patients, investors, and the UK…— Peter Davis (@peter_brit) March 13, 2025
maverick_1
4 hours ago
MRK new Durham, NC vaccine mfg for GARDASIL
Not for DC VAX L
Merck has opened a new manufacturing plant in Durham, NC which will make HPV vaccines, including its quadrivalent vaccine Gardasil and nine-valent vaccine Gardasil 9.
The opening of the factory comes at a time of heightened talks of reshoring manufacturing to the US as a way to sidestep President Donald Trump’s tariffs on products made overseas. Last month, Merck said it would pause shipments of Gardasil to China due to weakened demand there. CEO Rob Davis said there was higher demand for the vaccine outside of China.
The Durham vaccine site investment is one of several totaling more than $12 billion that Merck has poured into expanding its US manufacturing and R&D footprint since 2018. The drugmaker plans to spend a further $8 billion on these efforts by 2028.
https://endpts.com/merck-opens-billion-dollar-facility-to-make-bladder-cancer-immunotherapy/?utm_medium=email&utm_campaign=2159+-+Mercks+new+1B+vaccine+plant+Endo+divests+its+global+business+Basic&utm_content=2159+-+Mercks+new+1B+vaccine+plant+Endo+divests+its+global+business+Basic+CID_0e87a604efcd0f7dd08e5873ddb8ad06&utm_source=ENDPOINTS+emails&utm_term=Merck+opens+billion-dollar+facility+to+make+bladder+cancer+immunotherapy
Merck to Eliminate Nearly 500 Jobs in Early 2020 Due to Shifting R&D Focus
Published: Oct 18, 2019 By Alex Keown
Job Cuts
Halloween horror is descending on the Philadelphia suburbs. This horror is not in the form of a serial killer slasher, but rather in job cuts. Merck will slash about 500 jobs in early 2020 at two Montgomery County facilities, as well as in some other states, Pennsylvania’s Morning Call reported.
According to the report, the majority of the cuts will occur in the company’s Human Health Division and are expected to begin Jan. 3 and conclude Jan. 16, 2020. Merck spokesperson Pamela Eisele told Morning Call that the cuts are due, in large part, to a shifting R&D focus of the pharma giant. Many of the workers who will be eliminated are remote employees who are based outside of Pennsylvania but some office-based sales personnel will be affected by the cuts. Additionally, Eisele said a “small amount” of marketing employees will be cut,” Morning Call reported.
With about 12,000 employees in the area, Kenilworth, N.J.-based Merck is one of the largest employers in the Lehigh Valley region of Pennsylvania. That is about half of all Merck employees in the United States. There are approximately 25,400 employees in the United States and Puerto Rico, Morning Call noted, with about 69,000 global employees. Earlier this year Merck announced multiple expansions of some U.S. facilities, including a $1 billion expansion to its manufacturing facility in Elkton, Va. and plans to build a new manufacturing site in Durham, N.C. Both sites are aimed at supporting the production of Human Papillomavirus (HPV) vaccine GARDISIL.
While Merck is slashing those 500 employees, Eisele said the company is adding new positions in strong growth areas, such as oncology. Those employees who are impacted by the January cuts will be able to apply for the new positions. Eisele stressed that the expansions in oncology are not part of a restructuring for Merck, but are “part of ongoing companywide efforts to sharpen Merck’s focus on innovative research and development that addresses significant unmet medical needs and on our best opportunities for growth,” Morning Call reported.
Merck’s oncology focus has grown exponentially, particularly as its vaunted checkpoint inhibitor Keytruda continues to earn multiple indications from regulatory bodies across the globe. Last year, Keytruda generated $7.2 billion but its revenue projections are expected to grow exponentially. In fact, some analysts have pegged Keytruda to take over the spot of top-selling drug that is currently occupied by AbbVie's Humira. Sales of Keytruda are already forecast to hit $10 billion by the end of this year.
Keytruda has been approved more than 22 times since 2015. In August, BioSpace took a deep dive into Keytruda and the impact it has had on treating multiple types of cancer, including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck cancer, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel Cell Carcinoma, and renal cell carcinoma.
During an Investor’s Day conference in June, Merck's Chief Commercial Officer Frank Clyburn said in a short time, Keytruda has become a foundational cancer treatment. “We have activity across 25 different cancer types… and Keytruda is changing the way in which patients are being treated today,” Clyburn said at the time.
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