Doc, Thanks for your attention to the 100,000s of deaths caused by Citadel delaying DC VAX L getting to market by 5 years.
Wednesday, March 22, 2023 3:15:56 PM
11) Absent the short side activities of the past 10- year , DC VAX L could have come to market 5 years ago. 3 million cancer deaths have occurred during the last 5 years. DC VAX L could gave prevented 5%, or 150,000 . At a damage award of $ 5 million per patient , the total damage award is $750 billion. Settlement: Citadel et al pay $ 5 billion to NWBO; $ 5 billion to cancer research.
12) As to criminal charges (murder 1), federal agencies sue Citadel et al principals .Since they are bankrupted by the civil suit settlement , the penalty becomes 10 years in jail.Doc logic
Re: ae kusterer post# 579489
Wednesday, March 22, 2023 2:43:49 PM
Post# 579496 of 579505 ae kusterer,
That is correct and this is why I constantly clamor against “the process” which is so entrenched in law and helped by the kind of work Citadel and others are being accused of. This works strongly against patient access to safe, transformative medical advances. NWBO has run the gauntlet and survived with dilution that pales in comparison to the potential of the DCVax platform but how many patients have been sacrificed on the altar of the status quo? I would suggest a minimum of 7 years times up to 50% of all solid tumor cancer patient deaths during that period for any jurisdictions you want to include in the estimate and all because chemo, radiation and things like the Optune device were supported over access to this treatment on a reasonable pre approval basis. NIH did what they could but what about all the so called charitable organizations besides the one or two that have contributed? Self preservation is a powerful motivator for some of them it seems. Best wishes. ae kusterer
Re: None
Wednesday, March 22, 2023 2:29:21 PM
Post# 579489 of 579507 So no way to ramp DC VAX L revenues in the U.S. until final FDA approval? 12/31/23?
"They could only do it under a compassionate use designation. Anyone can get compassionate use in the US but under US laws the company has to almost create a clinical trial for each patient and can’t charge for the Vaccine. Via UK Specials that gets bypassed."
ae kusterer
Re: None
Tuesday, March 21, 2023 7:56:47 PM
Post# 579200 of 579507 SUMMARY AND CONCLUSION: On 3/20/23, NWBO received the MHRA's MIA certificate. This provides authorization that DC VAX L can be made at the Company's Sawston (UK-Cambridgeshire) manufacturing facility for patient use in the U.K.and globally.In effect, the MHRA has made DC VAX L fully commercial on a global basis; this, all before formal approval to do so . AVC expects the MAA (formal approval of DC VAX L as a drug to be given to GBM and other solid tumor cancer patients) to be filed about 4/5/23 , and approved 45 days later. NICE patient cost coverage for the U.K. would then come 60 days later. FDA approval we estimate to come before yearend '23.
Prior to formal final RA commercial sale approvals, DC VAX L would be sold on a compassionate use basis with the cost ( $200,000) born by the patient. There are 50,000 new GBM cases , and 1.5 million new solid tumor cancer cases annually .Of these , AVC estimates 4% can afford to self pay.These 6,200 possible patients for Sawston are within the Sawston facility's 12,000 annual dosage capacity.
AVC believes the commercial ramp implications deriving from NWBO's 3/20/23 MIA approval are generally not understood.
1) Post# 578985 of 579013 Gregory Zivic, MD @metacollectiveG $NWBO People don’t understand the weight of what just occurred. As a Physician I can now send a patient’s frozen tumor to Sawston as well as a Leukapheresis. A “treating Physician” in the UK signs off for the Specials Program. the patient’s vaccine dose shipped to me, I inject it 1:38 PM · Mar 21, 2023
NWBO 3/20/23 PR: "Under this commercial manufacturing license(MIA), 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."
Dr. Mike Scott, President of Advent BioServices, commented, "It is always challenging to be one of the trailblazers. The field of personalised cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape. We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license."
2)Gregory Zivic, MD @metacollectiveG Replying to @hoffmann6383 I believe the recent MIA has a special license of some sort that allows import to the US; at least this is the case under the Specials Program right now since the MIA. NWBO would not have mentioned specifically global export capability if import not allowed on the other side 2:31 PM · Mar 21, 2023
3)The MIA license allows for global export of the vaccines and global import of immune cells/tumor resected material. Anyone in the entire world that is diagnosed with GBM can NOW ship their tumor samples to Northwest/Advent/Sawston to have their personal vaccine made and stored, all to be shipped back to the patient/doctor on a prescribed injection schedule. The beauty of this process is that patients everywhere can NOW receive their vaccine on a compassionate care basis. https://twitter.com/alphavestcap/status/1638149821004406786
Northwest Biotherapeutics and Advent BioServices Announce Receipt of License for Commercial Manufacturing at Sawston, U.K. Facility NEWS PROVIDED BY
Northwest Biotherapeutics Mar 20, 2023, 19:46 ET
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One of the First UK Licenses for Commercial Manufacturing of Cell Therapy Products;
Allows Global Delivery of the Products
BETHESDA, Md., March 20, 2023 /PRNewswire/ -- 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.
This MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. To the companies' knowledge, there are only two other such licenses, one of which was just granted as well.
This license is the culmination of more than 3 years' work, including development of the facility, the teams of specialized personnel, the Standard Operating Procedures (SOPs) and systems, well over 1,650 regulatory documents, and a successful operating history under the initial manufacturing licenses previously obtained to produce cell therapies in the Sawston facility for clinical trials and compassionate use. All of this work was carried out by Advent BioServices under contract with NW Bio.
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."
Dr. Mike Scott, President of Advent BioServices, commented, "It is always challenging to be one of the trailblazers. The field of personalised cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape. We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license."
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." This Phase III trial has been completed, and the results have been presented in scientific meetings and published in JAMA Oncology. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
About Advent BioServices
Advent BioServices is a contract development and manufacturing organization (CDMO) based in Sawston, U.K. The Company operates the 88,000 square foot GMP facility in Sawston, which includes a large, HTA licensed, cryostorage facility capable of storing several million vials of tissues and cells, and includes capabilities for all stages of cell therapy development and production. During the past three-plus years, the Company has recruited staff members with a wide spectrum of specialist skills in the cell therapy space. The Process Development and QC teams provide significant expertise in complex assay development, GMP manufacturing, product release and GMP-related monitoring which has underpinned the work leading to MHRA licensing for commercial manufacturing, as well as the prior licenses for manufacturing for clinical trials and compassionate use (Specials).
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will be viewed as demonstrating safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Dave Innes
Philippe Piré
804-513-4758
917-796-2426
dinnes@nwbio.com
ppire@adventbio.uk
Les Goldman
240-234-0059
lgoldman@nwbio.com
Bright Boy
Re: hoffmann6383 post# 578889 Tuesday, March 21, 2023 1:55:12 PM Post# of 579111 Go People, People, People!!! It's your friendly "hillbilly" here with some more great news!! Don't know if I can "one up" my earlier post about the "Dog eating the license", but I'll try. So here we go!!
I don't think everyone realizes how dynamic and important the manufacturing license really is so I'll take a shot at giving you my take on it. First of all, the marketing approval (MAA) and the government subsidy approval(NICE) are pretty much in the bag before the manufacturing team gets the "green light" to proceed. The MAA and NICE teams talk to the MIA team and say," This stuff looks really cool and we wanted to let you know before you run off and do a lot of work on something that we won't approve when you're finished!!" Okay! So that's the first part.
Now for the second part and this is the part that involves a lot of money so read very carefully!!! The MIA license allows for global export of the vaccines and global import of immune cells/tumor resected material. Anyone in the entire world that is diagnosed with GBM can NOW ship their tumor samples to Northwest/Advent/Sawston to have their personal vaccine made and stored, all to be shipped back to the patient/doctor on a prescribed injection schedule. The beauty of this process is that patients everywhere can NOW receive their vaccine on a compassionate care basis. No more waiting!! No more opportunities for the "dark forces" to delay or deny suffering cancer patients their desperately needed treatments !!!
People, as of yesterday, Northwest is now IN BUSINESS !!!! AND that opens the door for institutional investors and an uplist to the New York or Nasdaq exchanges!!!!
All of the above is as good as that first sip of ice cold buttermilk on a hot summer day!!!! AND for those unfortunate shorts and haters it adds a whole new description to the letters FTD and I'll let you guess what that might be!!!
Cheers,
BB
MISCELLANEOUS SPECULATIONS ON WHAT'SNEXT:
Since today's MIA manufacturing certificate puts NWBO on the road to commercial approval in the U.K by 8/1/23, and in the U.S. by 12/31/23 , let's list what might be in an S-1 to get institutional ownership up from the current zero. None of these top biotech funds have any ownership of NWBO.( https://www.fiercebiotech.com/special-report/top-7-life-sciences-public-investors). By '29, FCF should be $3.5 billion from $ 4 billion in revenues.
Therefore, let's speculate on what could be in the S-1:
1) MAA filing by 4/1/23.
2) NICE commitment letter for patient cost coverage by 6/1/23.
3) Full U.K. commercial approval by 8/1/23.
4) Full FDA approval by 12/31/23.
5) Stock priced at $4.00 .
6) 250 million shares for 5 institutions.250 million shares for retail.$ 2 billion in proceeds.
7) New COO announced.
8) Announced CRL global manufacturing agreement.
9) Uplist to NYSE when the S-1 goes effective.
10) Major bracket firm investment banker on board.
11) Absent the short side activities of the past 10- year , DC VAX L could have come to market 5 years ago. 3 million cancer deaths have occurred during the last 5 years. DC VAX L could gave prevented 5%, or 150,000 . At a damage award of $ 5 million per patient , the total damage award is $750 billion. Settlement: Citadel et al pay $ 5 billion to NWBO; $ 5 billion to cancer research.
12) As to criminal charges (murder 1), federal agencies sue Citadel et al principals .Since they are bankrupted by the civil suit settlement , the penalty becomes 10 years in jail.
NWBO Northwest Biotherapeutics Inc (QB) 0.647 0.012 (1.89%) Volume: 2,284,792 Day Range: 0.64 - 0.6749 Bid: 0.646 Ask: 0.647 Last Trade Time: 3:16:20 PM EDT Total Trades: 1,077 1D 1M 3M 6M 1Y 5Y Chart for Northwest Biotherapeutics Inc (QB) NWBO Detailed Quote Recent NWBO News Nightfood, Inc. (OTCQB: NGTF) now in Sonesta International Hotels Multiple Brands • InvestorsHub NewsWire • 03/13/2023 11:35:55 AM Annual Report (10-k) • Edgar (US Regulatory) • 02/28/2023 09:31:58 PM Annual Statement of Changes in Beneficial Ownership (5) • Edgar (US Regulatory) • 02/07/2023 10:55:54 PM Current Report Filing (8-k) • Edgar (US Regulatory) • 01/13/2023 09:34:51 PM Current Report Filing (8-k) • Edgar (US Regulatory) • 01/06/2023 09:42:13 PM Additional Proxy Soliciting Materials (definitive) (defa14a) • Edgar (US Regulatory) • 12/23/2022 10:24:51 PM Additional Proxy Soliciting Materials (definitive) (defa14a) • Edgar (US Regulatory) • 12/16/2022 06:40:40 PM Proxy Statement (definitive) (def 14a) • Edgar (US Regulatory) • 12/05/2022 12:01:37 PM Northwest Bio Accuses Market Makers of Share Price Manipulation • TipRanks • 12/01/2022 03:29:04 PM Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) • Edgar (US Regulatory) • 11/25/2022 10:30:31 PM Quarterly Report (10-q) • Edgar (US Regulatory) • 11/09/2022 09:31:44 PM Acquisition Completed: Endexx (EDXC)'s HYLA Secures 200k+ Unit Order; 4,500 Puffs per Unit • InvestorsHub NewsWire • 09/27/2022 01:33:31 PM Amended Annual Report (10-k/a) • Edgar (US Regulatory) • 06/30/2022 09:09:33 PM Quarterly Report (10-q) • Edgar (US Regulatory) • 05/10/2022 10:02:07 AM Amended Annual Report (10-k/a) • Edgar (US Regulatory) • 05/02/2022 09:05:06 PM TNS Issues New Reports on Stocks with Potential Near Term Catalysts and a Feature Green Energy NASDAQ Report • InvestorsHub NewsWire • 04/12/2022 12:30:00 PM More NWBO News InvestorsHub NewsWire FEATURED Lifecycle Assessment by Benchmark Shows TMC's NORI-D Nodule Project Could Outperform Land-Based Routes of Producing Nickel, Copper and Cobalt in Almost Every Impact Category Analyzed • Mar 22, 2023 1:44 PM
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