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Wednesday, October 30, 2024 9:12:21 AM
1) REGARDING US CITIZENS BEING ABLE TO IMPORT DCVAX-L FOR PERSONAL USE.
2. REGARDING SUBLEASE. WHO OWNS SAWSTON? WHAT IS THE RELATIONSHIP BETWEEN NWBO AND ADVENT BIOSERVICES?
3. FUN FUD REGARDING HYGRO
We start with
1) REGARDING US CITIZENS BEING ABLE TO IMPORT DCVAX-L FOR PERSONAL USE.
Exwannabe insinuated the following in several postings about US citizens NOT being able to import DCvax-L from the UK.
That is not correct. Because FDA has a ruleset called PERSONAL IMPORTATION, under which citizens and NWBO HAS the possibility of creating a logistical pathway for importing cells into the UK, make DCVax-L and ship back.
Let's look at that in the following ChatGPT correspondance
(Full: https://chatgpt.com/share/67212a3b-8074-8010-9fd4-2f404df5c4b0)
Nwbo has mia certification through advent bioservices for manifactoring of dcvax-l
https://nwbio.com/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-u-k-facility/
"Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (e.g., immune cells) may also be imported into the U.K. for production or release of cell therapy products under the facility’s licenses.
Linda Powers, CEO of NW Bio, commented “We are very excited to reach this major milestone, as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax®-L. It is especially exciting to be able to operate globally from this base in the U.K.”
With this FDA document
https://www.fda.gov/industry/import-basics/personal-importation
Can NWBO under the FDA Personal Importation rules, sell dcvax-l to or ship to residents of the US, when dcvax-l is approved in the uk by mhra?
ChatGPT wrote
The FDA's Personal Importation policy allows individuals to import certain drugs that are not approved in the U.S., provided they meet specific conditions. These include:
The drug is for personal use, not for sale.
The drug treats a serious condition for which no comparable FDA-approved drug exists.
The individual importing the drug cannot have any commercial interest in its importation.
Generally, a supply of no more than three months is allowed at once.
For NWBO's DCVax-L, if it is approved by the MHRA in the U.K. but not yet by the FDA, U.S. residents could potentially import it under this personal importation rule, provided they meet these criteria. It would be for personal use and likely for patients with serious conditions such as glioblastoma, where few treatment options exist. However, patients would need to work through the proper channels, including obtaining a doctor's statement, and NWBO would need to handle the global logistics for personal use shipments.
This would not be the same as NWBO commercially selling DCVax-L in the U.S., but it could offer a pathway for individuals to access the treatment. NWBO would need to clarify the logistics of meeting FDA requirements and U.S. Customs regulations for such imports.
I Asked ChatGPT:
And it would be possible to import dcvax-l under this personal importation rule, provided they meet these criteria?
ChatGPT wrote
Yes, it would be possible for U.S. residents to import DCVax-L under the FDA's Personal Importation rule if they meet the necessary criteria. Specifically, this means:
Personal Use: The treatment must be for individual, non-commercial use.
Serious Condition: DCVax-L treats glioblastoma, a serious condition with limited approved options, which aligns with FDA considerations for personal importation.
No FDA-Approved Alternatives: If there is no FDA-approved equivalent, this rule can apply.
Documentation: Patients typically need a doctor's statement confirming the treatment's necessity and that it’s for personal use.
Quantity Limits: Generally limited to a three-month supply.
As long as these criteria are met, and assuming DCVax-L is approved by the MHRA, it could be imported into the U.S. for personal use under these guidelines. NWBO would need to work with patients to ensure compliance with FDA and U.S. Customs requirements for individual shipments.
I would like to be sure so asked again
I submit the FDA ruleset for personal importation and ask again.
NWBO announced this last year
https://nwbio.com/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-u-k-facility/
"BETHESDA, MD, March 20, 2023 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, and Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly announce that a MIA license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K."
"Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Linda Powers, CEO of NW Bio, commented “We are very excited to reach this major milestone, as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax®-L. It is especially exciting to be able to operate globally from this base in the U.K.”
With this in mind MAY US citizens with glioblastoma be able to get DCVax-L exported to the US to get treated?
ChatGPT wrote:
Given NWBO’s MIA (Manufacturing and Import Authorization) license from the MHRA, which allows the Sawston facility to manufacture and export DCVax-L globally, U.S. citizens with glioblastoma could potentially access DCVax-L through the FDA’s Personal Importation policy. Under this policy, patients may import certain non-FDA-approved drugs if specific criteria are met:
Serious Condition: DCVax-L is aimed at treating glioblastoma, a serious condition with limited treatment options, meeting the “serious condition” requirement.
Lack of FDA-Approved Alternatives: If no FDA-approved treatments are directly comparable to DCVax-L, the policy could permit its import.
Personal Use and Non-Commercial Intent: Patients must confirm that the treatment is strictly for personal use, not resale or commercial distribution.
Supply Limitations: Typically, a three-month supply can be imported at a time for personal use, with a physician’s statement supporting the necessity of the treatment.
While these guidelines offer a pathway, they would require NWBO to facilitate individual export logistics to ensure compliance with both MHRA and FDA requirements. U.S. patients could then, under these FDA rules, potentially import DCVax-L for personal, life-threatening treatment in cases like glioblastoma.
Additional excerpts from Smith on Stocks regarding the MIA certification and its implications
2. REGARDING SUBLEASE. WHO OWNS SAWSTON? WHAT IS THE RELATIONSHIP BETWEEN NWBO AND ADVENT BIOSERVICES?
Exwannabe wrote this (see image)
I wanted to somehow "get to the bottom of this" and input the sublease, the british medias that have written about the relationship about NWBO and Advent, the NWBO answer to the Sawston Local Plan and asked ChatGPT to shed some light of it all.
The original post:
I Asked ChatGPT
A poster on the Investorshub Northwest Biotherapeutics board claims this sublease proves that NWBO does not own the cleanrooms or the freezers.
He continues:
One can easily verify the truth on the SEC website where you can find the sublease agreement contact with Advent
It clearly shows a sublease for 20 years. It shows the portions subleased to Advent including cryo, cleanrooms, future clenarooms and labs. It also shows the space subleased to Advent as in agreement with the first 2 phases of the buildout (as PR'd by NWBO).
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824000133/nwbo-20231231x10k.htm
He continues
From the contract:
2.4 Term. The term of this Sub-Lease (the “Term”) shall begin on the Effective Date of this Agreement, and shall end on the same date as the Lease term ends. [20 years]
? Finished and equipped interior space: ? ____________________________________ ? Hotel Suite 1 (including C lab extension) ... 2,238 ft2 ? Hotel suite 2 .............................. 2,012 ft2 ? Labs (PD and QC) .............................. 830 ft2 ? Corridors ................................... 1,420 ft2 ? Computer room .................................. 75 ft2 ? ? Sub-Total .................................... 6,575 ft2 ? ? Unfinished and/or un-equipped interior space: ? _____________________________________________ ? Hotel Suite 3 ................................. 2,012 ft2 ? Hotel Suite 2 ................................. 2,012 ft2 ? Nitrogen cryostorage area ..................... 2,560 ft2 ? Plant room + electrical cupboard ...............1,300 ft2 ? ? Sub-Total: .....................................7,884 ft2
And he ends up claiming
"NWBO does not own the cleanrooms or the freezers as you assert. They do not own the "manfacturing" in the sense of an implemented GMP approved facility"
Can you shed some light on this whole ordeal?
I have looked into british medias and found these articles mentioning the NWBO and Advent Bioservices relationship
https://www.cambridgeindependent.co.uk/business/sawston-business-park-becomes-world-class-facility-producing-9242093/
https://www.cambridgeindependent.co.uk/business/advent-bioservices-gains-mhra-certification-for-sawston-bus-9237342/
https://www.businessweekly.co.uk/news/biomedtech/us-cancer-company-fast-tracks-cambridge-facility
https://www.businessweekly.co.uk/news/biomedtech/northwest-biotherapeutics-creating-300-cambridge-uk-jobs
https://www.businessweekly.co.uk/news/biomedtech/us-cancer-tech-ramping-towards-cambridge-production
https://www.businessweekly.co.uk/tech-trail/tech-profiles/sawston-cell-and-gene-therapy-hothouse-exponential-growth-curve
I have gathered these 29 statements from these articles
1 )
"Linda Powers, CEO of Northwest Biotherapeutics (NW Bio), has paid tribute to the clinical development team at Sawston Business Park – and contractor Advent BioServices"
2)
"The Maryland-based biotechnology company has been developing personalised immunotherapy products designed to treat solid tumour cancers, with input from its R&D team at Sawston"
3)
"Production of the first NW Bio dendritic cell cancer vaccine for a compassionate use patient at the licensed production facility in Sawston"
4)
"That Northwest Biotherapeutics, together with our contractor Advent BioServices..."
5)
"NW Bio plans to continue developing the Sawston facility in phases..."
cambridgeindependent.co.uk/business/adven…
6)
"Northwest Biotherapeutics has secured MHRA certification for its cancer vaccine trials in the Sawston Business Park, sparking delight for site developer Advent BioServices."
Advent BioServices’ gains MHRA certification for Sawston Business Park site
Northwest Biotherapeutics’ R&D team progress cancer vaccine using cutting-edge facilities
7)
"Advent, which is based on the Park, has completed the laboratory facilities to UK regulatory standards on behalf of Northwest Biotherapeutics..."
8)
"NW Bio’s Sawston R&D team is working on a cancer vaccine for glioblastoma multiforme..."
9)
"Last month, the company’s (NWBO) state-of-the-art manufacturing facility on Sawston Business Park received MHRA approval for the manufacture..."
10)
"Advent BioServices began as a cell therapy contract development and manufacturing organisation (CDMO) in 2016. Currently there are 40 staff working on the site, of whom about 40 per cent are scientists."
11)
"Dr Mike Scott, who joined Advent as COO in April 2019, has overseen the design."
“Advent was contracted to build out the facility in 2019..."
12)
"The MHRA manufacturing approval is connected to the site at Sawston Business Park,” Mike says, “and Advent is contracted to put together everything for that licensing, which was granted in mid-December."
13)
businessweekly.co.uk/news/biomedtec…
14)
"A US company personalising immune therapies for solid tumour cancers has raised further money to complete the Phase 1 buildout of a UK manufacturing facility in Sawston, Cambridge"
15)
"Northwest Biotherapeutics, a Maryland-based company developing personalised cancer vaccines, has finished initial buildout of a plant in Sawston, Cambridge which it intends to be a centre of excellence for manufacturing advanced therapies."
16)
"The primary goal is to prepare for production of Northwest Biotherapeutics’ lead candidate, DCVax-L, the first medicine to be awarded the UK’s ‘Promising Innovative Medicine’ (PIM) designation"
17)
"US cancer technology company Northwest Biotherapeutics is hopeful of rolling out transformational product from its new Cambridge UK facility in Q3 of this year."
18)
"...development of a Cambridge team of nearly 40 people with all of the required types of expertise for production of Advanced Therapy Medicinal Products and training in regard to the DCVax® technology and processes".
19)
"COO Dr Mike Scott, who previously enjoyed 28 years with Cambridge University Hospitals, says the Sawston hothouse – run by Advent BioServices under a service contract for US-based Northwest Biotherapeutics which owns the long-term facility lease..."
20)
"Its various laboratories, GMP clean rooms, cold room storage – to cryostorage temperatures – and biobank are already being used to good effect by Advent on behalf of NW Bio and various external clients – and the partners haven’t even started any external marketing as yet."
21)
"Advent and NW Bio, who are developing the facility were buoyed and are already exploiting the recent award of specialist manufacturing and tissue handling approvals that should boost demand and productivity."
22)
"The transatlantic owners of the facility anticipate..."
23)
"To maximise overall potential capacity of the Sawston facility, Advent is actively recruiting third party clients interested in production of bespoke and personalised cell therapy products."
24)
"The capacity for production of other products will also be an important resource for the region, helping to fulfil NWBio’s commitments to the Cambridgeshire and Peterborough Development Authority."
25)
"Scott has identified from major players in the Bio industry that there is huge and growing international demand for exactly the type and variety of facilities Advent and NW Bio can supply – over and above the manufacture of their own product portfolio. "
26)
"It is clearly a very good space for us to be in as market demand accelerates globally,” Scott remarks. “It is an exciting time for Advent BioServices and NW Bio and validates the decision to build and expand the Sawston facility.”
27)
"Business Weekly reported in early February that production was set to get underway at the company’s Sawston facility."
28)
"Since the licence was issued, Advent Bioservices – NW Bio’s contract manufacturer in the UK..."
29)
"NW Bio plans to continue developing the Sawston facility in phases, both to calibrate the capital expenditures with the capacity needed and to leave room for implementation of new technologies. "
This is the whole text from one of the Cambridge Independent Articles here
https://www.cambridgeindependent.co.uk/business/advent-bioservices-gains-mhra-certification-for-sawston-bus-9237342/
Advent BioServices’ gains MHRA certification for Sawston Business Park site
By Mike Scialom
Published: 17:40, 27 January 2022
Northwest Biotherapeutics has secured MHRA certification for its cancer vaccine trials in the Sawston Business Park, sparking delight for site developer Advent BioServices.
Advent Biosciences’ COO Mike Scott at the Sawston Business Park facility. Picture: Richard MarshamAdvent Biosciences’ COO Mike Scott at the Sawston Business Park facility.
Advent, which is based on the Park, has completed the laboratory facilities to UK regulatory standards on behalf of Northwest Biotherapeutics, which is headquartered in Bethesda, Maryland. The US-based clinical stage biotechnology company is focused on the development of personalised cancer vaccines designed to treat a broad range of solid tumour cancers. Its dendritic cell-based cancer vaccine is a fully personalised immunotherapy treatment that mobilises the entire immune system to fight many types of solid tumour cancers.
NW Bio’s Sawston R&D team is working on a cancer vaccine for glioblastoma multiforme, the most aggressive type of brain cancer. Phase III data is expected in the near future. The treatment has been described as a ‘major breakthrough’ in the treatment of glioblastoma, following the publication of blinded interim results in the Journal of Translational Medicine.
This therapy has been in development for a long time and is finally getting closer to reaching the people who can potentially benefit. Last month, the company’s state-of-the-art manufacturing facility on Sawston Business Park received MHRA approval for the manufacture of GMP cell therapy products under the UK ‘specials’ regime (for their compassionate use programme, offered by Dr Paul Mulholland at UCL).
Fit for a global pharma business on Sawston Business Park. Picture: Richard MarshamFit for a global pharma business on Sawston Business Park.
The facility will have the capacity to produce therapies for 450-500 patients per year and is one of the most advanced cell and gene therapy manufacturing facilities in the world.
Advent BioServices began as a cell therapy contract development and manufacturing organisation (CDMO) in 2016. Currently there are 40 staff working on the site, of whom about 40 per cent are scientists.
Dr Mike Scott, who joined Advent as COO in April 2019, has overseen the design.
“Advent was contracted to build out the facility in 2019,” Mike says. “The warehouse was already at the site, and we’re further developing it – it’s about 90,000sq feet dedicated to cell therapies, officially referred to as ‘advanced therapy medicinal products’, or ATMPs. We’ve built out around one-fifth of the whole building. When fully built out, it will be one of the largest facilities of its kind in Europe or North America.”
The MHRA accreditation allows GMP (clinical grade) manufacturing of medical products to commence in the Sawston facility.
The converted warehouse on Sawston Business Park is really adding value to the site. Picture: Richard MarshamThe converted warehouse on Sawston Business Park is really adding value to the site. Picture: Richard Marsham
“The MHRA manufacturing approval is connected to the site at Sawston Business Park,” Mike says, “and Advent is contracted to put together everything for that licensing, which was granted in mid-December.
“So, from now, advanced cell therapy products can be manufactured in the building.”
Mike has impeccable credentials for overseeing the company’s development work, having been director of the cellular therapy facility at Cambridge University Hospitals NHS Foundation Trust for more than 20 years before arriving at Advent.
Advent Biosciences’ cryo-storage facilities on Sawston Business Park. Picture: Richard MarshamAdvent Biosciences’ cryo-storage facilities on Sawston Business Park.
“I really enjoy the job and the challenges,” he says of the role. “We now have a state-of-the-art facility here at Sawston in addition to a certificate received last year from the Human Tissue Authority which allows us to process and store cell and tissue for medical purposes. The facilities include GMP clean rooms for the production of human cell products, research and process development laboratories, and a large cryo-storage facility.”
He adds: “I came here thinking it would take much longer to obtain our regulatory licences, but my team has worked tirelessly and managed to get it done sooner despite being in the midst of a pandemic and despite serious supply chain difficulties especially for specialised equipment and materials.”
Advent BioSciences has developed the facilities on Sawston Business Park to MHRA standard. Picture: Richard MarshamAdvent BioSciences has developed the facilities on Sawston Business Park to MHRA standard.
The progress in bringing this facility together was supported in part by a £1.35m loan from the Cambridgeshire and Peterborough Economic Development Authority for the Phase 1a build-out and equipment.
NW Bio originally owned the Sawston site, having bought it from previous owners Spicer in 2014. The 550-acre site was then sold to Chinese technology company Huawei for £37.5m in an off-market deal handled by Bidwells in 2019. As part of the transaction NW Bio entered into a leaseback agreement for 87,000sq ft of space at £500,000 per annum for 20 years. NW Bio currently has a contracted team of more than 40 staff on the site, which could expand to 300 when the project is fully completed.
Regarding the local plan of the area
This is a question on the Greater Cambridge Shared Planning site concerning the local plan in Sawston. A question to Northwest Biotherapeutics
Question 24. How important do you think continuing economic growth is for the next Local Plan?
It was answered by respondent NWBO here
https://oc2.greatercambridgeplanning.org/document/forms/37625/5
"Very important. Continued economic growth is vital for the next Local Plan in order ensuring that Greater Cambridge continues to be recognised as a centre for research and high technology employment, with the significant and varied employment opportunities that this creates for residents. The Mill Lane Site, Sawston is owned by Northwest Biotherapeutics (NW Bio), a biotechnology company developing novel immune therapies to treat cancer. NW Bio’s DCVax®-L immune therapy for Glioblastoma brain cancer is in the NIHR's Priority Portfolio and was the first product to receive PIM designation as a Promising Innovative Medicine by the Ministry of Health. NW Bio currently has offices in London but is planning to develop a head office in Sawston, where they are working together with Advent BioServices to develop the Vision Centre on the former Spicers site. Advent is one of only a small number of companies in the world that specializes in technology/process development and advanced manufacturing for cell and tissue therapies for cancer and other diseases. The Vision Centre is located across the A1301 (a 5 or 10 minute walk) from the proposed residential site on Mill Lane. The Vision Centre is an advanced manufacturing facility that will produce cell therapy products for the UK and for export to the European Union and worldwide. The development of the Vision Centre will involve the creation of up to 450 new high-value jobs across a wide range of skill levels in phases over the next few years. A key factor which will affect the pace at which personnel can be hired for these jobs will be the availability of housing nearby to the Vision Centre. A proportion of Vision Centre employees will have to live close to the site because producing and managing living cell products requires unpredictable and varied hours (e.g. when tissues are received from hospitals for processing at any time of the day or evening). The jobs at the Vision Centre will be for a range of employees, from school leavers through to PhD level, with a private apprenticeship programme also under development. This will result in increased employment and learning opportunities within Sawston and South Cambridgeshire as a whole which will have benefits for social inclusion. As a result of these requirements NW Bio are promoting the Mill Lane Site, Sawston for the development of up to 225 residential dwellings, some of which could provide the essential housing for key employees of the Vision Centre. The need that NW Bio have identified for adequate nearby housing for personnel who must be “on call” for the Vision Centre (similar to doctors being “on call” for a hospital), and the fact that this need will be a significant factor in the pace at which NW Bio and Advent BioServices can hire personnel and grow the operations in the Vision Centre, clearly highlight the intrinsic links that there are between economic and housing growth in Greater Cambridge."
With all the above in mind, can you shed some light on the relationship of NWBO and Advent Bioservices and about the ownership of the Sawston building and its interiorsm the cryo, cleanrooms, future clenarooms and labs?
ChatGPT
The poster’s claim that “NWBO does not own the cleanrooms or the freezers” and does not “own the manufacturing” in the sense of a GMP-approved facility reflects a nuanced reality of NWBO’s operational structure rather than a straightforward lack of ownership or control.
Breaking Down Ownership and Control
Ownership vs. Operational Control:
Lease Structure: NWBO originally owned the Sawston site but sold it and retained a long-term lease (20 years), which includes a sub-lease arrangement with Advent Bioservices. This sub-lease allows Advent to manage critical manufacturing spaces such as cleanrooms, labs, and cryo-storage on NWBO’s behalf.
GMP Approval: Although NWBO itself doesn’t directly manage these GMP-approved spaces, the approval applies to the Sawston site as a whole. This facility is specifically designed to produce NWBO’s DCVax-L and other cell therapies.
Role of Advent in Manufacturing:
Contracted CDMO (Contract Development and Manufacturing Organization): Advent Bioservices acts as a contract manufacturer, responsible for maintaining the facility’s compliance with GMP standards, managing equipment (such as freezers and cleanrooms), and handling daily operations. Advent’s management includes overseeing the facility’s build-out, certifications, and compliance, which aligns with UK MHRA regulatory standards.
Facility Operation and Development: NWBO’s arrangement with Advent means that Advent effectively operates the manufacturing facility, ensuring that NWBO meets GMP requirements without NWBO having to oversee daily operational management.
NWBO’s Control and Strategic Oversight:
Long-term Lease and Sub-Lease Agreements: NWBO’s strategic control of the facility through the lease and sub-lease allows it to direct production priorities and future expansions. The fact that NWBO plans phased developments at the Sawston facility shows NWBO’s role in shaping the facility’s capacity and production objectives.
Manufacturing Capabilities: NWBO controls the production pipeline and owns the technology for DCVax-L, using Advent’s GMP-certified facility for manufacturing. This setup is common in biotech, where companies outsource manufacturing to reduce operational complexity while retaining ownership of the IP and overall product.
I added ATLnsiders info
And asked ChatGPT if he is correct?
ChatGPT
Yes, the responder is mostly accurate in their interpretation of NWBO's arrangement with Advent and ownership structure at the Sawston facility, though the details are nuanced. Here’s a breakdown based on the available information:
Key Points Regarding NWBO’s Ownership and Control at Sawston
Facility Lease:
NWBO holds a long-term lease on a portion of the Sawston facility, spanning 87,000 square feet, as part of the terms from the sale of the site in 2019. This lease grants NWBO significant operational control over the leased space and allows it to designate that space for its purposes, which include housing Advent’s operations as a contract manufacturer.
Sub-Leased Space and Equipment:
Under the sub-lease to Advent, Advent manages the daily operations, including cleanrooms, cryo-freezers, and specialized equipment. Although Advent operates these spaces, NWBO's lease arrangement suggests that NWBO retains ultimate control over these facilities and assets to the extent required for its production needs. Thus, the responder’s assertion that NWBO “owns” the cleanrooms and cryo-freezers aligns with NWBO's control over these assets, even though Advent is responsible for their operational management.
Manufacturing Equipment and Intellectual Property:
NWBO owns the intellectual property for DCVax and related patents, as well as Flaskworks’ proprietary devices, which play a role in NWBO’s automated manufacturing processes. This includes any specialized equipment at the Sawston facility developed specifically for DCVax production or related research, further aligning with the responder’s statement.
Advent’s Role as CDMO:
Advent operates as a Contract Development and Manufacturing Organization (CDMO), meaning it is an external contractor NWBO relies on for manufacturing expertise, regulatory compliance, and production processes. Advent does not own the production rights or products themselves but fulfills these roles under NWBO’s direction.
Expansion and Ownership Scope:
NWBO’s phased plans for the Sawston facility imply ongoing expansion of the facility’s capacity and technology. As NWBO is directing these expansions, it suggests a level of strategic control over the future configuration and use of the cleanrooms, labs, and other specialized spaces, even as Advent remains responsible for operational compliance and daily management.
Summary
The responder is correct in stating that NWBO has a long-term lease with control over significant manufacturing resources, equipment, and intellectual property at Sawston. However, Advent, as the CDMO, is contracted to manage the facility’s cleanrooms, cryo-freezers, and GMP compliance for NWBO’s benefit. This setup is common in biotech partnerships, where companies like NWBO outsource facility management while retaining strategic control over the assets and production activities essential to their proprietary therapies, such as DCVax.
3. FUN FUD REGARDING HYGRO
HyGro making a fool of himself:
This was HyGro late 2023.
Oh no, ATL-DC is not DCVax-L. UCLA has their own special recipé.
Yeah we know how that went.
This is HyGro in present time.
Now the SPORE trial IS with DCVax-L, but a new fud narrative came up, with Merck acquiring another company, so we throw the old fud narrative out, which also made the fudders look pretty idiotic and ignorant anyway, and pick up anything new and try to create some new bullshit :)
This guy is all over Seeking Alpha also, with piles of fud comments, which should make him a target of Joshua Mitts research into manipulation of stocks and the use of pseudonyms doing it.
Recent NWBO News
- Form 8-K - Current report • Edgar (US Regulatory) • 01/15/2026 10:06:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2026 10:14:59 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2025 09:43:27 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/26/2025 05:15:34 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/20/2025 09:26:03 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/19/2025 09:15:48 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:44:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2025 04:28:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/14/2025 06:22:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2025 09:00:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/31/2025 09:23:24 PM
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