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Bought additional 50k shares today, further averaged up my share base price.
NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]
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GlobeCitizen
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For those of you who want to start a new position or those who want to add to their positions, now is the time.
GlobeCitizen
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"
1 有望獲批上市-新診斷膠質瘤DCVax-L疫苗
2018年5月29日，西北生物披露了其個性化的自體樹突狀細胞疫苗DCVax-L的III期中期數據：個性化的膠質母細胞瘤疫苗可能會延長某些患者的長期生存期，這種名為DCVax-L的疫苗是通過患者自身的樹突狀細胞來幫助激活免疫系統，從而對抗癌症的。
試驗中近30％的患者從臨床入組到現在，生存期已達到至少三年(接下來，患者將繼續接受隨訪)。值得一提的是，該研究是迄今為止，定製化疫苗在被診斷的致命腦癌患者中進行的最大規模的臨床試驗。
2007年7月至2015年11月期間，該疫苗在全球80個地點的新診斷的膠質母細胞瘤患者中進行施用，且所有患者在參加試驗前都接受標準治療(手術切除腫瘤，然後進行放化療)。
由於試驗的交叉設計，最終接近90％的患者接受了疫苗治療。
此前公布的III期臨床研究的中期試驗數據。入組臨床超過三年的患者中，67例(30％)存活超過30個月，44例(24.2％)存活超過36個月。預計這些患者的中位生存期為46.5至88.2個月。在分析時，參加試驗的331名患者中有108名(32.6％)仍然保持存活。
至今，DCVax-L的臨床試驗已經進行了長達12年，這是非同尋常的，第一名患者入組於12年前，最後一名患者入組於5年前。大家都在期待這款療法的最終數據，也期待其早日獲批成為腦瘤的首款免疫療法！"
1 有望獲批上市-新診斷膠質瘤DCVax-L疫苗
2018年5月29日，西北生物披露了其個性化的自體樹突狀細胞疫苗DCVax-L的III期中期數據：個性化的膠質母細胞瘤疫苗可能會延長某些患者的長期生存期，這種名為DCVax-L的疫苗是通過患者自身的樹突狀細胞來幫助激活免疫系統，從而對抗癌症的。
試驗中近30％的患者從臨床入組到現在，生存期已達到至少三年(接下來，患者將繼續接受隨訪)。值得一提的是，該研究是迄今為止，定製化疫苗在被診斷的致命腦癌患者中進行的最大規模的臨床試驗。
2007年7月至2015年11月期間，該疫苗在全球80個地點的新診斷的膠質母細胞瘤患者中進行施用，且所有患者在參加試驗前都接受標準治療(手術切除腫瘤，然後進行放化療)。
由於試驗的交叉設計，最終接近90％的患者接受了疫苗治療。
此前公布的III期臨床研究的中期試驗數據。入組臨床超過三年的患者中，67例(30％)存活超過30個月，44例(24.2％)存活超過36個月。預計這些患者的中位生存期為46.5至88.2個月。在分析時，參加試驗的331名患者中有108名(32.6％)仍然保持存活。
至今，DCVax-L的臨床試驗已經進行了長達12年，這是非同尋常的，第一名患者入組於12年前，最後一名患者入組於5年前。大家都在期待這款療法的最終數據，也期待其早日獲批成為腦瘤的首款免疫療法！"
GlobeCitizen
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GlobeCitizen
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GlobeCitizen
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GlobeCitizen
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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Powerful Run Brewing as Sawston, UK Manufacturing Facility Completed & Phase III Top Line Data Looms
Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) continues to move forward with power over its $1.50 base averaging well over a million dollars a day in dollar volume as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that NWBO is on the verge of...
microcapdaily.com
Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Powerful Run Brewing as Sawston, UK Manufacturing Facility Completed & Phase III Top Line Data Looms
By Boe Rimes
June 24, 2021
Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) continues to move forward with power over its $1.50 base averaging well over a million dollars a day in dollar volume as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names recently who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numerous times as many recovered patients have come forward crediting DCVax®-L for saving their lives. The stock represents easily among the highest risk-reward opportunities in the market today and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range.
NWBO is also making rapid progress on other fronts recently reporting the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority (“MHRA”). To date, the Company’s production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 – 6 patients per month. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually, subject to regulatory approval.
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 is now completed and locked down, with announcement of top line data expected in the coming months. The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, is preparing for 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.
Northwest has an integrated strategy for protection of its technology through both patents and other mechanisms, such as Orphan Drug status. Currently the Company holds 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Of these, 191 issued patents and 52 pending patent applications directly relate to its DCVax products. In the United States and Europe, some of its patents and applications relate to compositions and the use of products, while other patents and applications relate to other aspects such as manufacturing and quality control. In addition to its patent portfolio, Northwet has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.
There have been indications that the top line date for DCVax®-L will be overwhelmingly positive; according to date published from 2018 at the Society for Neuro-Oncology Annual Meeting in New Orleans shows the following: Median overall survival (OS) from surgery in the intent-to-treat population at data cutoff was 23.1 months, the same OS benefit identified in 2017. The survival rate at year 2 was 46.4%, on par with 46.2% in 2017. In patients with methylated MGMT genes, median OS after surgery was 35.1 months, slightly better than 34.7 months observed in 2017. This represents a vast improvement over the median OS of only 14.6 months. “The survival rate is quite remarkable compared to what would be expected for glioblastoma,” said lead author Dr. Linda Liau, professor of neurosurgery at the David Geffen School of Medicine at UCLA and a member of the UCLA Jonsson Comprehensive Cancer Center. “The 20 to 30 percent of long-term survivors in immunotherapy clinical trials are the people in whom we think there may be a particularly strong immune response against their cancer that is protecting them from getting tumor reoccurrence.”
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NWBO is pursuing an intensive program of manufacturing preparations and planning as the Company approaches top line data from its Phase III trial of DCVax®-L. The Company recently announced development of the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority (“MHRA”). To date, the Company’s production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 – 6 patients per month. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually, subject to regulatory approval.
An intensive recruitment program has been underway for well over a year, and has successfully hired and trained the necessary 30 senior technical managers, scientists and staff technicians and operators for manufacturing, quality control and other operations of the first two production suites. The recruitment process for experienced personnel with these types of expertise is highly competitive because the cell therapy and immunotherapy fields are growing rapidly and the pool of experienced specialists is very limited. With the initial team of 30 specialists on board and trained, the recruitment and training are now continuing to expand the team. When the Sawston facility is fully built out and in full operation, it is estimated that it will employ in excess of 300 highly skilled personnel, including many who may be trained through apprenticeships in the Sawston facility.
Since the initial dendritic cell vaccine production capacity will occupy only a small fraction of the total space in the Sawston facility, it is anticipated that additional capacity for third party production of other cell therapy products may be developed in some of the other space. GMP facilities are capital intensive both to develop and to operate. Third party production of other products will help support the Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility. The capacity for production of other products will also be an important resource for the region. Development of the Sawston facility has been under way for more than two years, and has progressed on parallel tracks in multiple areas, including physical buildout of the first two production suites, equipment procurement and validation, specialized operating systems, drafting of regulatory documents, and recruitment and training of key scientific and technical personnel for the first two production suites. All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.
The facility is now in the Performance Qualification (PQ) stage, following completion of the Design Qualification (DQ), Installation Qualification (IQ), and Operations Qualification (OQ) stages. Each of these stages has taken many months of work. In the PQ stage, practice runs are conducted for months and the performance data is collected to show that the operations meet all of the applicable regulatory requirements (sterility, quality control testing, etc.). Those data then form a major part of the application to MHRA for certification of the first phase of the facility. The Company currently anticipates that the PQ stage will be completed and the certification application will be submitted to MHRA within approximately the next six to eight weeks.
As previously reported, the Company has also been moving forward on optimization of the Flaskworks system for manufacturing of dendritic cell vaccines. The buildout of the Sawston facility is purposefully being done in phases, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. It is anticipated that implementation of the Flaskworks system will enable the buildout of some or all of the rest of the 88,345 square foot facility, beyond the initial manufacturing suites, to be simplified and streamlined at reduced cost.
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NWBO continues to move forward with power over its $1.50 base averaging well over a million dollars a day in dollar volume as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names recently who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numerous times as many recovered patients have come forward crediting DCVax®-L for saving their lives. The stock represents easily among the highest risk-reward opportunities in the market today and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range. NWBO is also making rapid progress on other fronts recently reporting the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority (“MHRA”). To date, the Company’s production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 – 6 patients per month. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually, subject to regulatory approval. Microcapdaily first reported on NWBO in 2018 and continues today. We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with NWBO.
GlobeCitizen
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Re-review what CEO Linda said during annual shareholder meeting taken place on 18 May:
"
The following may contain forward-looking statements.
Linda Powers: "We received a number of questions from various questions from shareholders. Not surprisingly they grouped into several main categories of subject matter about five subject matter categories and one question about ASCO.
"The subject matter categories were: The process for the Phase III trial results; Question about whether we’ll be presenting at ASCO; Questions about the DC-Vax Direct program; Question about a patents; Questions about Sawston; and about Flaskworks.
"We have bundled the questions into these subject-matter categories in order to make it feasible to walk through some informal discussion of them and I will walk through that discussion now. And we appreciate the shareholders sending in these questions."
1. Phase III trial Results
"So first of all is the process for Phase III trial results. We know everyone is very anxious to see the results of the trial. As I think everybody knows, back on October 5th [2020] we outlined the process that we would be going through to get to the stage where the results can be announced. And I want to assure everyone that the Phase III trial and the analysis of the data are the most important topic that everyone in this company is focusing on. It has the full focus and attention of our management and our Board as well. Every resource we have has been and is being brought to bear on it. As we say, ‘it is our number one, number two, and number three priority.’ There’s nothing more important to the company. I’d like to be able to go into the details that we know everybody is craving, and understandably so, but we are in a quiet period now, while the data are being reviewed and analyzed. We’ve explained the process that we’re going through, it’s six stages of various analyses and reviews by various parties. And I can assure everyone that we are committed to completing this full process that we outlined at the outset, back when we did data lock. And we are doing so with great care. To put this in context, this is a fourteen-year long, Phase III trial. It’s really important that the review process be of the highest quality. We really appreciate the patience of our long-term investors. We do understand how hard it is to be patient after all this time. But we do ask that you continue to be patient because we serve you best by moving carefully and thoroughly through all the stages of the process that we’ve outlined. So that’s what we have been doing and we will finish doing. That’s really all I can say at this moment about the Phase III trial process."
2. ASCO
"The next subject that came up relates to ASCO, the big ASCO conference, big annual conference. And I think everybody knows that the ASCO conference will be virtual this year. We plan to be a sponsor and exhibitor again this year, we have been for a good number of years now. Seven or eight or nine, something like that, anyway a good number of years. But it’s come to our attention that rumors and even some claims have been circulating that we would be presenting the Phase III results at ASCO. And that’s simply not the case. It’s not accurate and those rumors and claims are unfounded. And we think it’s very important to clarify this. We’re not presenting the Phase III trial results at ASCO."
3. DC-Vax Direct
"Third subject, DC-Vax Direct. We were quite pleased to receive several questions about our DC-Vax Direct technology. And about whether we plan to do anything further with that. The short answer is ‘Definitely, Absolutely, Yes.’ We certainly do plan to. At present, as I just explained a few minutes ago, our whole intense focus is on DC-Vax L and the Phase III trial results, as you would want it to be. But it’s worth remembering that the extended survival results that we saw in the Phase I trial with DC-Vax Direct, which if you remember was thirteen different types of advanced, solid-tumor, inoperable cancers in that trial. And those extended-survival results in that trial were quite encouraging. We reported those, that information at ASCO several years ago. So, we’ve been mentioning in our quarterly and annual reports, we do plan to proceed with Phase II trials with DC-Vax Direct after the Phase III results, the process of getting to the Phase III results is completed and as soon as time and resources permit. ‘Cause as I just said, first the focus is DC-Vax L. But there is a tremendous need for new treatments and approaches for inoperable metastatic cancers. There’s so many treatments in development for cancer but there’s so little for patients who are at that kind of a stage of advanced, inoperable cancer. Definitely ‘yes’ we will be reactivating the DC-Vax Direct program."
4. Patents
"Next question was about patents. We received a question and we are pleased to report that ‘yes we did receive a new patent’ relating to our DC-Vax Direct process that’s recently been approved in the US. What’s very nice is the US was the first country to approve it. So we’re excited about that. That patent covers certain aspects of optimizing DC-Vax Direct, the DC-Vax Direct product for enhanced potency. That’s what that’s about. So the answer is ‘yes we did receive that patent, it was approved in the US.’"
5. Sawston
"The next category of subject matter that was asked about was the Sawston, UK facility. I think probably a number of the questions came before our announcement, our press release last week which was on this subject. And I hope everybody had a chance to see our press release last week. Because it was announcing that a quite important milestone was reached. The milestone was the completion and the submission to the UK regulatory authority, the FDA of the UK, of the whole application package for the initial licensing of the Sawston facility. I think everyone knows, but just to provide the background, all facilities that produce medical products for human patients are required to be licensed by the regulator in that country. Every facility has to go through this. And the application that was submitted and that we announced last week as we said in the announcement, was the culmination of more than two years of work by a large team and a whole lot of expert consultants. So that was a quite important step, a quite important milestone. Looking ahead, looking forward, we are hopeful that the process, the next steps are for the regulatory authority to make an on-site inspection, in person of the facility. There’s some lead-time for scheduling that, there’s some time involved in the regulatory authority writing up the results after the inspection and if there is anything to address then having that be addressed. So we are hopeful that that process those steps will proceed quickly over the coming months. And we hope to have the initial license for the Sawston facility by around the end of the third quarter this year. Something in that time frame. Once we have the initial license, then we expect to begin producing vaccine products for our existing programs as we’ve been doing at the small facility in London that we’ve been using up ‘til now. So that’s the update on the Sawston facility and the discussion related to the questions we got on that."
6. Flaskworks
"Our last subject for discussion today relates to questions we received about Flaskworks. As we have described in various announcements and filings, we believe the Flaskworks system has the potential to significantly enhance our product economics and our production capacity. So at present, DC-Vax products, like other immune cell therapies, CAR-Ts, cell therapies, and others, NK, CAR-NKs, all these immune cell therapies, they’re made in extremely costly, specialized facilities that are called GMP facilities, which stands for Good Manufacturing Practice, and they’re made by hand by specialized technicians. The GMP facilities require all sorts of specialized infrastructure, all of the air has to be sterile, goes through so many air changes per minute, per hour the technicians who work there have to wear space suits. It’s very expensive to develop these facilities in the first place and to operate them on an ongoing basis. The Flaskworks system is designed to make two fundamental improvements. First of all, it closes the manufacturing process, which means that the steps of the process take place inside machines and since they’re not exposed to the air, there’s not a need for sterile air, the space suits, and all that special infrastructure. So that takes a whole lot of cost, a huge cost out of the equation for the product cost of the DC-Vax products, or it is anticipated that it will, it should. Second, the Flaskworks system automates the steps so that the machines are doing it so it is not being done by hand by specialized technicians. This is really important to enable scale-up to large production quantities for large numbers of patients. So that’s a little recap of, you know we’ve had some questions about what the Flaskworks system will do, how will it benefit us and I think those are very significant benefits. So in terms of progress or status, the Flaskworks teams has been working intensively toward some key milestones, which we built into the acquisition agreement last year when we acquired Flaskworks. And the initial focus of the milestones is on applying the Flaskworks system to the production of DC-Vax L products. So, once again, that’s a reflection of that’s and a part of our company-wide priority focus on the DC-Vax L program for the time being. As we announced last week, we anticipate that the initial practice runs with the Flaskworks system for the DC-Vax L product may begin at the Sawston facility during this summer. And what’ll happen after that is that after sufficient practice runs have been done and any optimization work has been completed, then the Flaskworks system will go through a similar validation process and regulatory process as what our existing manufacturing is currently going through. So it will be the same type of process, that was another question that we got."
Conclusion
"That brings me in conclusion to the end of our subject grouping categories for informal discussion today. I hope this discussion has been interesting and helpful. I will say on behalf of the whole Northwest Bio team, we’d really like to express again our appreciation for everyone’s patience and understanding and I’ll just conclude by assuring everyone again that we will continue to press forward to complete the six-stage process of . . . or multi-stage process that we originally outlined that the Phase III trial results need to go through to be reviewed and analyzed in a high-quality process. So I’d like to thank everyone for attending and wish everyone a nice day and that brings our meeting to an end.
"
"
The following may contain forward-looking statements.
Linda Powers: "We received a number of questions from various questions from shareholders. Not surprisingly they grouped into several main categories of subject matter about five subject matter categories and one question about ASCO.
"The subject matter categories were: The process for the Phase III trial results; Question about whether we’ll be presenting at ASCO; Questions about the DC-Vax Direct program; Question about a patents; Questions about Sawston; and about Flaskworks.
"We have bundled the questions into these subject-matter categories in order to make it feasible to walk through some informal discussion of them and I will walk through that discussion now. And we appreciate the shareholders sending in these questions."
1. Phase III trial Results
"So first of all is the process for Phase III trial results. We know everyone is very anxious to see the results of the trial. As I think everybody knows, back on October 5th [2020] we outlined the process that we would be going through to get to the stage where the results can be announced. And I want to assure everyone that the Phase III trial and the analysis of the data are the most important topic that everyone in this company is focusing on. It has the full focus and attention of our management and our Board as well. Every resource we have has been and is being brought to bear on it. As we say, ‘it is our number one, number two, and number three priority.’ There’s nothing more important to the company. I’d like to be able to go into the details that we know everybody is craving, and understandably so, but we are in a quiet period now, while the data are being reviewed and analyzed. We’ve explained the process that we’re going through, it’s six stages of various analyses and reviews by various parties. And I can assure everyone that we are committed to completing this full process that we outlined at the outset, back when we did data lock. And we are doing so with great care. To put this in context, this is a fourteen-year long, Phase III trial. It’s really important that the review process be of the highest quality. We really appreciate the patience of our long-term investors. We do understand how hard it is to be patient after all this time. But we do ask that you continue to be patient because we serve you best by moving carefully and thoroughly through all the stages of the process that we’ve outlined. So that’s what we have been doing and we will finish doing. That’s really all I can say at this moment about the Phase III trial process."
2. ASCO
"The next subject that came up relates to ASCO, the big ASCO conference, big annual conference. And I think everybody knows that the ASCO conference will be virtual this year. We plan to be a sponsor and exhibitor again this year, we have been for a good number of years now. Seven or eight or nine, something like that, anyway a good number of years. But it’s come to our attention that rumors and even some claims have been circulating that we would be presenting the Phase III results at ASCO. And that’s simply not the case. It’s not accurate and those rumors and claims are unfounded. And we think it’s very important to clarify this. We’re not presenting the Phase III trial results at ASCO."
3. DC-Vax Direct
"Third subject, DC-Vax Direct. We were quite pleased to receive several questions about our DC-Vax Direct technology. And about whether we plan to do anything further with that. The short answer is ‘Definitely, Absolutely, Yes.’ We certainly do plan to. At present, as I just explained a few minutes ago, our whole intense focus is on DC-Vax L and the Phase III trial results, as you would want it to be. But it’s worth remembering that the extended survival results that we saw in the Phase I trial with DC-Vax Direct, which if you remember was thirteen different types of advanced, solid-tumor, inoperable cancers in that trial. And those extended-survival results in that trial were quite encouraging. We reported those, that information at ASCO several years ago. So, we’ve been mentioning in our quarterly and annual reports, we do plan to proceed with Phase II trials with DC-Vax Direct after the Phase III results, the process of getting to the Phase III results is completed and as soon as time and resources permit. ‘Cause as I just said, first the focus is DC-Vax L. But there is a tremendous need for new treatments and approaches for inoperable metastatic cancers. There’s so many treatments in development for cancer but there’s so little for patients who are at that kind of a stage of advanced, inoperable cancer. Definitely ‘yes’ we will be reactivating the DC-Vax Direct program."
4. Patents
"Next question was about patents. We received a question and we are pleased to report that ‘yes we did receive a new patent’ relating to our DC-Vax Direct process that’s recently been approved in the US. What’s very nice is the US was the first country to approve it. So we’re excited about that. That patent covers certain aspects of optimizing DC-Vax Direct, the DC-Vax Direct product for enhanced potency. That’s what that’s about. So the answer is ‘yes we did receive that patent, it was approved in the US.’"
5. Sawston
"The next category of subject matter that was asked about was the Sawston, UK facility. I think probably a number of the questions came before our announcement, our press release last week which was on this subject. And I hope everybody had a chance to see our press release last week. Because it was announcing that a quite important milestone was reached. The milestone was the completion and the submission to the UK regulatory authority, the FDA of the UK, of the whole application package for the initial licensing of the Sawston facility. I think everyone knows, but just to provide the background, all facilities that produce medical products for human patients are required to be licensed by the regulator in that country. Every facility has to go through this. And the application that was submitted and that we announced last week as we said in the announcement, was the culmination of more than two years of work by a large team and a whole lot of expert consultants. So that was a quite important step, a quite important milestone. Looking ahead, looking forward, we are hopeful that the process, the next steps are for the regulatory authority to make an on-site inspection, in person of the facility. There’s some lead-time for scheduling that, there’s some time involved in the regulatory authority writing up the results after the inspection and if there is anything to address then having that be addressed. So we are hopeful that that process those steps will proceed quickly over the coming months. And we hope to have the initial license for the Sawston facility by around the end of the third quarter this year. Something in that time frame. Once we have the initial license, then we expect to begin producing vaccine products for our existing programs as we’ve been doing at the small facility in London that we’ve been using up ‘til now. So that’s the update on the Sawston facility and the discussion related to the questions we got on that."
6. Flaskworks
"Our last subject for discussion today relates to questions we received about Flaskworks. As we have described in various announcements and filings, we believe the Flaskworks system has the potential to significantly enhance our product economics and our production capacity. So at present, DC-Vax products, like other immune cell therapies, CAR-Ts, cell therapies, and others, NK, CAR-NKs, all these immune cell therapies, they’re made in extremely costly, specialized facilities that are called GMP facilities, which stands for Good Manufacturing Practice, and they’re made by hand by specialized technicians. The GMP facilities require all sorts of specialized infrastructure, all of the air has to be sterile, goes through so many air changes per minute, per hour the technicians who work there have to wear space suits. It’s very expensive to develop these facilities in the first place and to operate them on an ongoing basis. The Flaskworks system is designed to make two fundamental improvements. First of all, it closes the manufacturing process, which means that the steps of the process take place inside machines and since they’re not exposed to the air, there’s not a need for sterile air, the space suits, and all that special infrastructure. So that takes a whole lot of cost, a huge cost out of the equation for the product cost of the DC-Vax products, or it is anticipated that it will, it should. Second, the Flaskworks system automates the steps so that the machines are doing it so it is not being done by hand by specialized technicians. This is really important to enable scale-up to large production quantities for large numbers of patients. So that’s a little recap of, you know we’ve had some questions about what the Flaskworks system will do, how will it benefit us and I think those are very significant benefits. So in terms of progress or status, the Flaskworks teams has been working intensively toward some key milestones, which we built into the acquisition agreement last year when we acquired Flaskworks. And the initial focus of the milestones is on applying the Flaskworks system to the production of DC-Vax L products. So, once again, that’s a reflection of that’s and a part of our company-wide priority focus on the DC-Vax L program for the time being. As we announced last week, we anticipate that the initial practice runs with the Flaskworks system for the DC-Vax L product may begin at the Sawston facility during this summer. And what’ll happen after that is that after sufficient practice runs have been done and any optimization work has been completed, then the Flaskworks system will go through a similar validation process and regulatory process as what our existing manufacturing is currently going through. So it will be the same type of process, that was another question that we got."
Conclusion
"That brings me in conclusion to the end of our subject grouping categories for informal discussion today. I hope this discussion has been interesting and helpful. I will say on behalf of the whole Northwest Bio team, we’d really like to express again our appreciation for everyone’s patience and understanding and I’ll just conclude by assuring everyone again that we will continue to press forward to complete the six-stage process of . . . or multi-stage process that we originally outlined that the Phase III trial results need to go through to be reviewed and analyzed in a high-quality process. So I’d like to thank everyone for attending and wish everyone a nice day and that brings our meeting to an end.
"
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GlobeCitizen
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yet one more opportunity that you can take a new position or simply add more due to failure of CVM trial in meeting its primary endpoint (to the contrary, nwbo is highly likely to meet its primary endpoint of overall survival).
"
There is a huge and fundamental difference between cvm and nwbo in terms of MOA of cvm's failed Multikine and nwbo's dcvax-L.
Multikine is an immune booster designed to boost a patient's immune system before SOC treatment aimed to improve OS, quality of life, etc. just like grandma's chicken soup, while DCVax-L is not only an immune booster but more importantly "a cancer killing machine/system" loaded with patients' specific antigens, designed to seek, find and kill cancer cells.
CVM: CEO has constantly pumped the stock via social media and shareholder letters; the slim advantages (10% better than SOC) designed being very consistent to repeated failed previous trials for other indications (so aimed and fine-tuned to achieve "a lucky" success); one week before TLD a huge financing.
NWBO, CEO has behaved completely differently.
You buy nwbo -- a winning strategy
Don't touch cvm yet -- a winning strategy
"
"
Not really. Short-term (a few days) impact of the failure of cvm on nwbo price - everybody has seen it now
med-term (within week) impact -- favorable for nwbo price appreciation
Long-term impact - none
only explain the first one - sympathy price drop understandable as most investors particularly non-investors who are considering and about to take a position are ignorant and have not done their DD yet. after some digging and digesting, actually those undecided or those who may be panic and sold some shares will finally realize
1) Multikine and DCVax-L are actually two different beasts
2) NWBio will be most likely meeting its primary and key secondary endpoints
3) the worst scenario for nwbo price drop if ever it would fail in its trial not meeting its primary endpoint like CVM is in the worst case 40%, not really that much expected by most investors
As a matter of fact, NWBio will probably meet its primary and key secondary endpoints
[conclusion:} new blood will flow into nwbo within days]
"
"
| Dan88 | Tuesday, 06/29/21 09:30:44 AM |
| Re: Basin Street Blues post# 386901 | |
| Post # of 386943 |
There is a huge and fundamental difference between cvm and nwbo in terms of MOA of cvm's failed Multikine and nwbo's dcvax-L.
Multikine is an immune booster designed to boost a patient's immune system before SOC treatment aimed to improve OS, quality of life, etc. just like grandma's chicken soup, while DCVax-L is not only an immune booster but more importantly "a cancer killing machine/system" loaded with patients' specific antigens, designed to seek, find and kill cancer cells.
CVM: CEO has constantly pumped the stock via social media and shareholder letters; the slim advantages (10% better than SOC) designed being very consistent to repeated failed previous trials for other indications (so aimed and fine-tuned to achieve "a lucky" success); one week before TLD a huge financing.
NWBO, CEO has behaved completely differently.
You buy nwbo -- a winning strategy
Don't touch cvm yet -- a winning strategy
"
"
| Dan88 | Tuesday, 06/29/21 09:53:40 AM |
| Re: trocprofit post# 386924 | |
| Post # of 386943 |
Not really. Short-term (a few days) impact of the failure of cvm on nwbo price - everybody has seen it now
med-term (within week) impact -- favorable for nwbo price appreciation
Long-term impact - none
only explain the first one - sympathy price drop understandable as most investors particularly non-investors who are considering and about to take a position are ignorant and have not done their DD yet. after some digging and digesting, actually those undecided or those who may be panic and sold some shares will finally realize
1) Multikine and DCVax-L are actually two different beasts
2) NWBio will be most likely meeting its primary and key secondary endpoints
3) the worst scenario for nwbo price drop if ever it would fail in its trial not meeting its primary endpoint like CVM is in the worst case 40%, not really that much expected by most investors
As a matter of fact, NWBio will probably meet its primary and key secondary endpoints
[conclusion:} new blood will flow into nwbo within days]
"
GlobeCitizen
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GlobeCitizen
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Been adding weekly. The general biotech sector has been down about 30% so definitely that's some other pressure on the price in addition to no news
GlobeCitizen
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Sorry. Just saw your post Henri. NWBO had been steadily declined for about 3-months and had strangely go side-by-side with small biotech index XBI recently. Since the general trend for small biotech companies indicated by XBI had been down about 25-30% from the peak there is a lot pressure on nwbo as well. So why it started appreciation in price since last Thursday, 1) XBI appreciates somewhat in price and the sector tends to drop in price after annual ASCO meeting in late May and early June, and now it's time for investors to get in ; 2) despite repeated delay for tld release, NWBio must be really closer to the day when they have to release trial data.
In anticipation of data release, the stock price may continue to rise even if XBI doesn't.
I have to say there are some things which have supported stock's bullish future besides the known trial data (blinded), etc:
1) the new WHO definition of GBM
2) the company has not yet raised any funds yet contrary to other small biotech companies in the similar situations, faced with a binary event despite the company has been running on fume
3) no distractions such as initiate any other trials, etc.
In anticipation of data release, the stock price may continue to rise even if XBI doesn't.
I have to say there are some things which have supported stock's bullish future besides the known trial data (blinded), etc:
1) the new WHO definition of GBM
2) the company has not yet raised any funds yet contrary to other small biotech companies in the similar situations, faced with a binary event despite the company has been running on fume
3) no distractions such as initiate any other trials, etc.
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