Saturday, July 22, 2023 5:45:51 PM
In the 7/12/23 Les Goldman Big Biz interview (https://www.biztalkradio.com/players/individuals/) what does his "27 modules" imply as to the timing of the filing of RA (regulatory authority ) applications ? The FDA might account for 5-9 of the 27 modules.
"we are in the process of finalizing our applications. First one will be to MHRA, UK, which has a Specialist program even before we file, but we're getting much closer to being finished up 1.7 million pages long. It's got 27 modules. It's been double check now and to make sure that it's completely consistent. We'll be applying there will be applying them to the other places they gave us permission to do the trial. That was for different countries, including the UK, including Canada, including Germany, and we'll be filing in order in each of those places where commercial approval and then we will go into operation on a completely commercial basis."
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ATLnsider
Re: None
Friday, July 21, 2023 4:51:51 PM
Post#
612474
of 612753
Les recently mentioned that NWBio was in the final stages of double-checking the 27 modules of the BLA / MAA submission.
I, and other posters noticed that 27 modules is a lot more modules than any 1 single regulatory authority (RA) requires for a new BLA / MAA submission.
So, I thought that maybe this number of 27 modules is the combined total number of all the modules that will be submitted to all the RAs.
I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
ae kusterer
Re: None
Saturday, July 15, 2023 4:38:00 PM
Post#
610145
of 612753
My transcription machine generates alot of errors.Anyone have a machine that cab correct what I have below ? It's Les Goldman's Big Biz interview published yesterday, 7/14/23 . Thanks if you are able to clean it up .
https://www.biztalkradio.com/players/individuals/
So you're here to be treated and veryexcited. Our next guest His name is Lesgolden and has been a longtimecontributor. To the program is SenioSoyou're here to be treated and very excited.Our next guest His name is Les golden andhas been a longtime contributor. To theprogram is Senior Vice President andGeneral Counsel for NorthwestBiotherapeutics essentials and Web. Doyou hear me talking about them? almostconstantly because it's one of thosecompanies, which are DC Vax technology,and where they are in the clinical trialstory. Less Great to have you on today.Let's talk about this topic. Can you give usan overview the CBM is a horrible diseasetalk about that.
15:41
It is the most lethal or quickest growingkilling of any solid tumor cancer, and sono more cancers make up about 80% of allcancers with melanoma. So it's reallyimportant but But additionally, theplatform that we've developed, which isexplain the way it works in a couple ofseconds here for events, accordingrevelation that came from a presentationthat Dr. Monix Bosch T Chief TechnicalOfficer made an amazing conference justabout four or five weeks ago.
16:21
And what what we discovered with a studycalled proteomics, which is the study ofproteins.
16:33
We've been selling the genome for 20years that the genome is made up of cells,strands of DNA, which are made up of of,of various components.
16:50
Proteins are part of those components,many proteins in each strand, and eachprotein has as individual parts of it, thatare called peptides. And that's a very smallfragment of a protein, protein. And Dr.Ralph Steinman working at NYU as amolecular and cellular research doctor in1993 actually was the first person toidentify when until then nobody knewwhat had been good Excel even did forand and what we presented just about fouror five weeks ago, confirms that it's areally unbelievably bigger thing than evenour potential realized at the time, which isit is basically we're putting on today'sParliament's it's the artificial intelligenceof our immune system, which has evolvedover many, many years of humanevolution and what the dendritic cell doesit is and and Simon one, we Nobel Prize in2011. It usually takes 30 years from thediscovery, but it was so significant that hewanted just about 18 years 16 years.
18:13
And and what it does and what I'm goingto explain to everybody I'm gonna giveyou just a little bit more background isthere are two components to making ourvaccine.
18:26
One is the the antigens, which is the samesame meaning as a peptide that you find inyour own tumor tissue. And we either getthe tumor tissue by operating it's going tooperate, or we do the same technique byby putting our invention into the tumor ifyou're doing the body what we do in thelab, but let's just keep it separate for asecond and talk about the the operableapproach. And if we've got time toapproach it, it's the same principle.
19:02
The dendritic cell is one of thecomponents of the vaccine.
19:07
The other component is the tumor tissueitself, treated in a proprietary way.
19:14
Which rates all of the peptides that are inthat particular use cases.
19:22
And in the lab, we do a blood draw to getthe baby dendritic cells and needs to befresh. So we try and get that done nearwhere the manufacturing facilities andexpose the peptides in the tumor tissue tothe to the dendritic cells, and here's wherethe magic starts. I mean, it's exquisite, it'selegant, it's non toxic, and it works prettywell based on the results we've got now.We've got our ideas about why it works.What happens because when they theydrink cells meet these peptides that were inthe tumor tissues. They select the ones tobe targets for the weapons of the immunesystem. Well listen to how this works.
20:17
They they choose the ones that are allrelevant to that particular cancer and theythey hold on to him on the surface of thedendritic cell.
20:32
And then we take the result of thatcombination which we we do what I justdescribed in the lab, where this selectionprocess of the dendritic cells occur, thenthat becomes the vaccine which weshipped in the doctor's offices and and thedoctors give a shot right in the upper armright near your lymph nodes. And thereason for that is the lymph nodes are theconference center of the immune system.And one of these AI type nobody everheard of it millions of years ago and saydeveloper, whatever. What do they do?They carry on their service, these varioustargets, many more than anybody can pickup in a lab. Because it's, it knows when itsees what was in the tumor tissue, what togo after. And it presents those to theweapons of the immune system andbecause it's elegant and complicated, I'mjust gonna focus on one of the bestweapons in the immune system called theT cells.
21:42
And what it does, is it hands off in theconference room in your lymph nodes. Itsays, Here's here are the targets for you togo after. And and identify and find these inthe in the body and then go attack themand kill and and not only does it presentthese targets we before we did this, wereally were maybe about 30 by 40 of theantigens out of 50,000 in the body thatneeded to be identified.
22:15
The dendritic cell, figures it out, mounts itoutside of the cell holds on to it, hands itoff to the T cell and the order to the T celland this is just one of the many weapons inthe immune system, all of which areorganized and given orders by the debititself. And if you've got to sign up, go getinvoice and and not only do the T cells,pick up all those targets and now gohunting for them in the body withoutleaving cancer cells. But they are alsoencouraged to multiply to chronal to createmore of them as they are loaded. And oneof the findings in this probably happenedstudies was that normally in the humanbody if you're healthy, you'd havesomething like between five and 20. Asyou measure the volume of blood of theseT cells.
23:16
After four months of the vaccine beingadministered, it's like halfway through theformer regime which is a six shots in thefirst year.
23:29
It was discovered that that the cloning ofthat original 520 It resulted in 400 400new T cells that multiply from the banksgo not only are they going after numerouspartners, but there's a whole bunch of themthat are doing the same thing. And thataccounts for the fact that everything elseon GBM has pretty much failed, addingjust weeks of toxic life. And we rexine isnon toxic, because this is nature's way ofhandling it and we're just re educating theimmune system by getting on the back ifyou will, of the dendritic cells andutilizing them to go tell the immunesystem that the killer cells, the T cells, allof it what to do, and amazing discoveries,how viciously they're doing it when itcomes to just following their orderssomehow, that tells you how it works. Andit's almost like before we had a black boxbased on Stein standards, invention, andnow we know how it works and why itworks and why it's better than anythingelse out there. So let's My question isbased upon it being a vaccine from yourown immune system or your own cells,can i Is it possible that this could thiscould be a therapy for other cancers?because the way it multiplies and such is Imean, is it specific to GBM? is it possiblethat it could go towards other cancers?
25:02
It we've already shown it to work in theTibetan and treatment Specialist programthat we are currently running in the UKand building up, but we made it work on15 different solid tumor cancer. Wow.Most of them blockbuster drugs, there'sless gold is
25:16
Most of them blockbuster drugs, there'sless gold
25:25
companies obviously some of theirspecialty, horrible, you're going to end upyour bio.com the stock symbol webservices. r Vice President and GeneralCounsel for Northwest Biotherapeuticsessentials and Web. Do you hear metalking about them? almost constantlybecause it's one of those companies, whichare DC Vax technology, and where theyare in the clinical trial story. Less Great tohave you on today. Let's talk about thistopic. Can you give us an overview theCBM is a horrible disease talk about that.
15:41
It is the most lethal or quickest growingkilling of any solid tumor cancer, and sono more cancers make up about 80% of allcancers with melanoma. So it's reallyimportant but But additionally, theplatform that we've developed, which isexplain the way it works in a couple ofseconds here for events, accordingrevelation that came from a presentationthat Dr. Monix Bosch T Chief TechnicalOfficer made an amazing conference justabout four or five weeks ago.
16:21
And what what we discovered with a studycalled proteomics, which is the study ofproteins.
16:33
We've been selling the genome for 20years that the genome is made up of cells,strands of DNA, which are made up of of,of various components.
16:50
Proteins are part of those components,many proteins in each strand, and eachprotein has as individual parts of it, thatare called peptides. And that's a very smallfragment of a protein, protein. And Dr.Ralph Steinman working at NYU as amolecular and cellular research doctor in1993 actually was the first person toidentify when until then nobody knewwhat had been good Excel even did forand and what we presented just about fouror five weeks ago, confirms that it's areally unbelievably bigger thing than evenour potential realized at the time, which isit is basically we're putting on today'sParliament's it's the artificial intelligenceof our immune system, which has evolvedover many, many years of humanevolution and what the dendritic cell doesit is and and Simon one, we Nobel Prize in2011. It usually takes 30 years from thediscovery, but it was so significant that hewanted just about 18 years 16 years.
18:13
And and what it does and what I'm goingto explain to everybody I'm gonna giveyou just a little bit more background isthere are two components to making ourvaccine.
18:26
One is the the antigens, which is the samesame meaning as a peptide that you find inyour own tumor tissue. And we either getthe tumor tissue by operating it's going tooperate, or we do the same technique byby putting our invention into the tumor ifyou're doing the body what we do in thelab, but let's just keep it separate for asecond and talk about the the operableapproach. And if we've got time toapproach it, it's the same principle.
19:02
The dendritic cell is one of thecomponents of the vaccine.
19:07
The other component is the tumor tissueitself, treated in a proprietary way.
19:14
Which rates all of the peptides that are inthat particular use cases.
19:22
And in the lab, we do a blood draw to getthe baby dendritic cells and needs to befresh. So we try and get that done nearwhere the manufacturing facilities andexpose the peptides in the tumor tissue tothe to the dendritic cells, and here's wherethe magic starts. I mean, it's exquisite, it'selegant, it's non toxic, and it works prettywell based on the results we've got now.We've got our ideas about why it works.What happens because when they theydrink cells meet these peptides that were inthe tumor tissues. They select the ones tobe targets for the weapons of the immunesystem. Well listen to how this works.
20:17
They they choose the ones that are allrelevant to that particular cancer and theythey hold on to him on the surface of thedendritic cell.
20:32
And then we take the result of thatcombination which we we do what I justdescribed in the lab, where this selectionprocess of the dendritic cells occur, thenthat becomes the vaccine which weshipped in the doctor's offices and and thedoctors give a shot right in the upper armright near your lymph nodes. And thereason for that is the lymph nodes are theconference center of the immune system.And one of these AI type nobody everheard of it millions of years ago and saydeveloper, whatever. What do they do?They carry on their service, these varioustargets, many more than anybody can pickup in a lab. Because it's, it knows when itsees what was in the tumor tissue, what togo after. And it presents those to theweapons of the immune system andbecause it's elegant and complicated, I'mjust gonna focus on one of the bestweapons in the immune system called theT cells.
21:42
And what it does, is it hands off in theconference room in your lymph nodes. Itsays, Here's here are the targets for you togo after. And and identify and find these inthe in the body and then go attack themand kill and and not only does it presentthese targets we before we did this, wereally were maybe about 30 by 40 of theantigens out of 50,000 in the body thatneeded to be identified.
22:15
The dendritic cell, figures it out, mounts itoutside of the cell holds on to it, hands itoff to the T cell and the order to the T celland this is just one of the many weapons inthe immune system, all of which areorganized and given orders by the debititself. And if you've got to sign up, go getinvoice and and not only do the T cells,pick up all those targets and now gohunting for them in the body withoutleaving cancer cells. But they are alsoencouraged to multiply to chronal to createmore of them as they are loaded. And oneof the findings in this probably happenedstudies was that normally in the humanbody if you're healthy, you'd havesomething like between five and 20. Asyou measure the volume of blood of theseT cells.
23:16
After four months of the vaccine beingadministered, it's like halfway through theformer regime which is a six shots in thefirst year.
23:29
It was discovered that that the cloning ofthat original 520 It resulted in 400 400new T cells that multiply from the banksgo not only are they going after numerouspartners, but there's a whole bunch of themthat are doing the same thing. And thataccounts for the fact that everything elseon GBM has pretty much failed, addingjust weeks of toxic life. And we rexine isnon toxic, because this is nature's way ofhandling it and we're just re educating theimmune system by getting on the back ifyou will, of the dendritic cells andutilizing them to go tell the immunesystem that the killer cells, the T cells, allof it what to do, and amazing discoveries,how viciously they're doing it when itcomes to just following their orderssomehow, that tells you how it works. Andit's almost like before we had a black boxbased on Stein standards, invention, andnow we know how it works and why itworks and why it's better than anythingelse out there. So let's My question isbased upon it being a vaccine from yourown immune system or your own cells,can i Is it possible that this could thiscould be a therapy for other cancers?because the way it multiplies and such is Imean, is it specific to GBM? is it possiblethat it could go towards other cancers?
25:02
It we've already shown it to work in theTibetan and treatment Specialist programthat we are currently running in the UKand building up, but we made it work on15 different solid tumor cancer. Wow.Most of them blockbuster drugs, there'sless gold is
25:16
Most of them blockbuster drugs, there'sless gold
25:25
companies obviously some of theirspecialty, horrible, you're going to end upyour bio.com the stock symbol webservices.
Are we? Are we to continue the research? Are we gonna do an FDA sort of archivists story there where we're getting close to this obviously exciting you suddenly get a million emails, asking when can we get this here in the US? So talking about that? Well, we think we do have this advantage during my program, and you may need to go to UK to initially get it made. But a recent license, we've got to use our, our facility that we built for, for commercial operation and it's been licensed to do that allow us to ship anywhere now in the world. So if you call our office if there is a bathroom, but you can still get a hold of that away at this point, but but more significantly, we are in the process of finalizing our applications. First one will be to MHRA, UK, which has a Specialist program even before we file, but we're getting much closer to being finished up 1.7 million pages long. It's got 27 modules. It's been double check now and to make sure that it's completely consistent. We'll be applying there will be applying them to the other places they gave us permission to do the trial. That was for different countries, including the UK, including Canada, including Germany, and we'll be filing in order in each of those places where commercial approval and then we will go into operation on a completely commercial basis. And I think the prognosis is very exciting. During that we've shown the positive results and compassionate treatment specialists program and we're also dealing with issues relating to our are not as high as we believe we deserve. value in the marketplace, because you're interested would rather see us not succeed. We're we're cheaper. We're more efficient. We're not in toxic, I mean, and I will have to add, it's already been shown that in combination with certain other products that have been produced which have no effect than solid human cancers. We enhance the result of of what we get when we put it in combination with others and and we'll be doing plenty of that as well. We also have a product of inoperable tumors where we take the magic formula for well, and and together with MD Anderson. In 2015. We ran a phase one phase two trial where we developed a MRI guidance or or good scan guidance of being able to take a very thin needle and inject it to find the mothership tumor in a given body and then put the stuff into the tumor with this very thin tube which is quite non invasive, but it can be guided by by by by just you know the things that you can scope and one of the ways you could do X rays or whatever. And we got very good results on that and then we got the same safety results, which is basically no kind of side effects. And we'll be developing that product as well with further trials. So there's a lot of activities wanting to have to move this first one which was our leap I am because frankly, these trials are cost a fortune. And for example, if you're gonna do CrossFit, you have to do a phase three trial for six, seven years and costs $800 million.
4:06
And unfortunately, it's a lot quicker and you can measure themselves much quicker in the air. So we picked TBM to be our lead. And we're getting we're getting near the end others are working with less last of all will you take this to the finish line or well this is just one of those risk aversion models where a bigger pharma company will come in and take it to the market you guys intend on taking the market yourselves once you get done?
4:32
Well, if you're asking for absolutely everything. That would be a really big menu. I think with our seven minutes without 90 sites and 73 doctors, we have a pretty established infrastructure for GBM, the fact that it works and other things I mean, I think it all depends who might want to team up what they want, might want to say and I feel good stuff. Les Coleman, thank you so much. It was
5:04
a big lesson tonight. Holy moly.
ae kusterer
Re: None
Saturday, July 22, 2023 2:37:37 PM
Post#
612692
of 612753
ATLnsider : Your NWBO IHUB post 612474 (07/21/2023 05:08:59 PM ) kicked off the cacophony below. I am trying to pluck out the one sentence which sums up the essence of the RA first approval for DC VAX L .Thanks .A.E.K.
a) Contributing to a scientific programme focusing on developing better tools to analyse the microbiome, to improve patient access to personalised treatments
b)New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
c)$NWBO 27 modules ready to go and being checked for consistency, said Les Goldman on the Big Biz show. Considering the FDA application needs 5-9 depending on the source, 27 is enough for 4-6 regulators… fireworks coming…
d)"Very exciting update from MHRA, yet again demonstrating their status as Regulatory leaders"- mike scott
e)I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
f)So it would seem there is a new pathway separate from the ILAP one being developed … and it’s moving to the pilot stage. Will a personalised cancer vaccine be one of the first to use that pilot pathway?
1:48 AM · Jul 22, 2023
Saturday, 07/22/2023 1:57:28 PM
Creating a cross-agency team to rapidly deliver an end-to-end regulatory pathway for personalised cancer vaccines
Re: pgsd post# 612569
Saturday, July 22, 2023 7:39:25 AM
Post#
612581
of 612680
Thanks pgsd for sharing.
Dr June M Raine DBE
Chief Executive’s perspective on the year.
During this year of agency organisational evolution, we have not taken our eye off the ball. We have maintained as a top priority our strategy to facilitate patient access to innovative healthcare products, in full alignment with the Life Sciences Vision. A new pathway for access to innovative medical technology has been devised and is moving to the pilot stage, building on the learnings of the Innovative Licensing and Access Pathway for medicines. New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
MHRA Annual Report and Accounts
2022-2023
We have continued to support rapid and safe patient access to innovative medicines, by:
¦ Launching our Innovation Accelerator service, following consultation with stakeholders, to help provide innovators better access to our scientific expertise and regulatory guidance
¦ Continued operation and development of the Innovative Licensing Access Pathway (ILAP). The ILAP was recognised at The Organisation for Professionals in Regulatory Affairs (TOPRA) Human Medicines Symposium 2022 as a good example of how to create an end-to-end approach from discovery to deployment, involving both the regulator and health technology assessment bodies
¦ Creating a cross-agency team to rapidly deliver an end-to-end regulatory pathway for personalised cancer vaccines
¦ Developing guidelines, via an NHS programme, for acute myeloid leukaemia detection and creating better informatics tools for analysing patients’ genomic data
¦ Contributing to a scientific programme focusing on developing better tools to analyse the microbiome, to improve patient access to personalised treatments
¦ Developing a proposal and strategy for a risk-based approach to batch release testing to assure the quality of biological medicines, while maintaining the capability to independently monitor the quality of biological medicines not traceable by the risk-based approach
Innovative Licensing and Access Pathway
https://www.gov.uk/government/publications/medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-2022-to-2023
The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the approval process for new medicines and repurposed medicines for life threatening or seriously debilitating conditions, so that patients can access them faster. This is achieved in partnership with other health bodies, supporting the manufacturer through the licensing process, while still ensuring these are safe and fit for purpose.
Our partners in ILAP are All Wales Therapeutic and Toxicology Centre (AWTCC), the National Institute for Clinical Excellence (NICE), and the Scottish Medicines Consortium (SMC).
Medicines on the ILAP pathway, which fulfil the criteria, are awarded an Innovation Passport designation initially. They can then progress to a Target Development Profile, if they are intending to progress to market, which sets out a regulatory roadmap for delivery to patients.
To date we have received 178 applications from a range of pharmaceutical companies and awarded 129 Innovation Passports, including one for a ground-breaking immunotherapy for the treatment of Alzheimer’s disease. 40 products have progressed to a TDP with 26 TDP regulatory roadmaps issued.
Project Orbis
Project Orbis is a collaborative programme, led by the US Food and Drug Administration (FDA), which reviews and approves promising cancer drugs, enabling patients to access these treatments more rapidly. MHRA is a partner in Project Orbis alongside regulatory authorities from Australia, Canada, Singapore, Switzerland, and Brazil.
In 2022/23, through Project Orbis, the MHRA approved four new medicines and new uses for three existing cancer medicines, including nivolumab (Opdivo) for use in non-small cell lung cancer in adults, darolutamide (Nubeqa) for the treatment of certain prostate cancers and durvalumab (Imfinzi) for the treatment of metastatic biliary tract cancer.
Medicines intended for use in Great Britain must meet the qualifying criteria for ILAP in order to be considered for Project Orbis.
Northwest Biotherapeutics (OTCQB: NWBO) is amoung the most exciting stories in small caps trading right over 52 week lows and established support levels that has been shorted into oblivion and is looking for a major reversal northbound here. In November of last year NWBO reported positive top-line results from its phase 3 trial on DCVax®-L for Glioblastoma, the most aggressive type of brain cancer representing a potential market expected to top $1.4 billion by 2025. DCVax®-L has succeeded where well over 400 clinical trials for glioblastoma having failed in the past. In the Phase 3 clinical trial both median survival and the “long tail” of extended survival showed a significant increase in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. Treatment with DCVax-L is associated with statistically significant and clinically meaningful extended survival, both in newly diagnosed and recurrent GBM.
Investors sentiment is high as countless medical professionals and Doctors have gotten behind DCVax®-L who believe the approval by the MHRA is imminent and will come this summer. In two UCLA combo trials it currently has 50-65% efficacy against brain cancer, works against all solid tumors and is 100% non toxic. NWBO’s partner, Advent Bioservices is continuing their hiring spree now with 10 open positions. Another major factor here is the Company’s lawsuit in Manhattan alleging Citadel Securities, Susquehanna and “other Wall Street firms including Canaccord Genuity, G1 Execution Services, GTS Securities, Instinet, Lime Trading and Virtu Americas drove down the price of NWBO through a series of illicit trading tactics. Representing the case for NWBO is Laura Posner, a partner at Cohen Milstein and a member of the securities litigation & Investor protection and ethics & Fiduciary Counseling practices; a hot shot securities attorney and a Harvard Law School grad who was recently instrumental negotiating the settlement of a historic $1B class action against Wells Fargo for alleged securities fraud. Most are expecting a settlement from Citadel here, long before the case progresses to discovery.
NWBO’s lawsuit aledges that market makers engaged in a deceptive market manipulation tactic known as spoofing, which involves placing large quantities of sell orders to fool the market into devaluing the company’s stock so the market makers can buy back in at a lower price. The market makers then immediately cancel the sell orders so they can reap big profits, in this case to the dismay of current and future cancer patients, as well as at the expense of Northwest Biotherapeutics and its investors. This alleged illegal trading behavior has made it significantly more difficult for the company to raise the money necessary to bring its cancer treatment to market, where the company believes it has the potential to extend the lives of thousands of patients. NWBO’s attorney, Laura Posner said: “It’s already underhanded to engage in market manipulation, but to do so at the expense of cancer patients, some of whom have no other treatments to place their hopes on, is unconscionable.”
In November of last year NWBO reported that in its Phase III clinical trial both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial met both the primary and the secondary endpoint under the Statistical Analysis Plan. The trial results were reported in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology, entitled “Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma”. This is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma. Despite the presentation of significant positive data and a steadily rising stock price prior to the TLD, there was a $1.6 billion loss in market cap value, with the share price dropping from the $2.05 high on May 9 to a low of 36.4 cents on May 10, 2022—a staggering decline of 82%.
NWBO’s enormous base of investors includes many medical professionals who are passionate in their support of DCVax®-L and its ability to completely disrupt the global market for Glioblastoma worth billions starting in the UK where MHRA approval is expected to come this year and then on to the EME, a much larger market, which is believed the best way for eventual approval in the United States. The MHRA has made DCVax a top priority to review and the review process could move forward very quickly if NWBO utilizes the rolling review submission process. Revenue just in the UK for GBM would be at least $200 million per year. NWBO also has a significant short position with over 39 million shares sold short that continues to mount attacks against the Company. A good example of this is the yahoo message board for NWBO where the shorts, using multiple fake aliases and accounts have upvoted negative posts on NWBO such that the top 10 posts on yahoo message boards are from the bashers themselves.
Northwest Biotherapeutics is a biotech that is focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer. The Company operates in the United States, the UK, Germany and Canada and is incorporated in Delaware, USA and is led by CEO Linda Powers, a Harvard law school graduate with years of experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. The Company owns a valuable Intellectual Property portfolio of at least 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families as of January 1, 2022. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products. NWBO lead product DCVax-L is a fully personalized immune therapy made from a patient’s own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient’s own tumor. A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days. The product is then stored frozen in individual doses, and is “off the shelf” throughout the treatment regimen. The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient’s next treatment. The Company’s manufacturing partner is Advent Biosciences.
The Company’s manufacturing facility in Sawston, Uk spans 88,345 square feet over 2 floors and an initial production capacity spanning two manufacturing suites, occupying 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 around 40 to 45 patients per month, or approximately 450 to 500 patients annually. Production of the first NW Bio dendritic cell cancer vaccine for a compassionate use patient at the licensed production facility in Sawston started a while ago. Since the issuance of the MHRA license, Advent Bioservices has conducted the required post-approval re-validations and testing, and the facility is now ready to scale up the manufacture of cell therapy products for clinical use.
Earlier this year the Company was at this year’s American Society of Clinical Oncology (ASCO) meeting. The ASCO annual meeting is the pre-eminent conference focused on clinical treatment of cancer, attended by over 25,000 oncologists and other medical professionals. Glioblastoma is the most common and most lethal form of primary brain cancer and the standard of care (SOC) treatments have been virtually unchanged for nearly 20 years. With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Five-year survival from diagnosis is only about 5%.
Saturday, 07/22/2023 1:39:25 PM
$NWBO 27 modules ready to go and being checked for consistency, said Les Goldman on the Big Biz show. Considering the FDA application needs 5-9 depending on the source, 27 is enough for 4-6 regulators… fireworks coming…
1:48 AM · Jul 22, 2023
·
2,903
Views$NWBO Read the MHRA annual report released yesterday.
Besides now being the chair of the ACCESS consortium, they declare that they’ve “created a cross-agency team to rapidly deliver an end-to-end regulatory pathway for personalized cancer vaccines”. Gosh wonder what that’s for.
6:22 AM
Post #612,573
Replying To: @Horseb4CarT - Didn’t someone post that there’s some sort of
ae kusterer
Re: None
Tuesday, 05/30/2023 9:01:15 AM
“MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners
From:
Medicines and Healthcare products Regulatory Agency
Published
26 May 2023
https://www.gov.uk/government/news/mhra-announces-new-recognition-routes-to-facilitate-safe-access-to-new-medicines-with-seven-international-partners?s=08
New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, the Medicines and Healthcare products Regulatory Agency has announced today.
This means that patients will have access to safe and effective medicines that have been approved by trusted regulatory partners in other countries. The new international recognition routes will sit alongside the MHRA’s own unique innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice.
These recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024.
The new framework will allow the MHRA to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products. As a result, cutting-edge medicines that have been approved in other countries will get to UK patients more quickly, with cost reductions and streamlined regulatory processes for industry.
As a sovereign regulator, the UK regulator will still be responsible for approving all ‘recognition route’ applications under the new framework, ensuring that all products are safe and of sufficient quality to be licensed in the UK. The MHRA will maintain rigorous scrutiny and retain the authority to reject applications if the evidence provided is considered insufficiently robust.
At the time of the UK’s exit from the European Union, the MHRA introduced temporary routes to market for European approved products in Great Britain, known as EU ‘reliance’ routes, to ensure that patients could continue to have timely access to new treatments. These temporary routes are due to expire at the end of 2023.
While the international recognition routes announced today focus on medicines, work is underway to establish similar routes for medical devices. As part of this ongoing work, the MHRA will launch a new targeted consultation on medical devices that will gather views on a wide range of topics, including recognising conformity assessments or approvals from international regulatory partners.
Dr June Raine, MHRA Chief Executive, said:
We are focused on providing UK patients faster access to the absolute best, most cutting-edge, and safest medical treatments. By fast-tracking access to approved products from other countries, we’re ensuring that innovative healthcare solutions reach those in need without delay.
The introduction of the new routes will complement the work being done through the MHRA’s Innovative Licensing and Access Pathway (ILAP), establishing an additional avenue for accelerated access to life-saving new medicines. Combining MHRA’s globally recognised high standards with improved flexibility and a sustained collaborative approach across the healthcare system, the ILAP is helping reduce the time to market for innovative treatments by developing medicines that are both regulatory and access ready.
Through this new dual approach, we will contribute to the UK’s ambition to be a global science superpower, by making the UK one of the best places in the world to bring life-changing healthcare products to patients safely.
A £10m funding from HM Treasury was announced earlier this year to support the development of this new recognition framework.
Find out more
Follow us on Twitter: @MHRAgovuk
Follow us on LinkedIn: Medicines and Healthcare products Regulatory Agency
Notes to editors
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
For media enquiries, please contact the newscentre@mhra.gov.uk. “
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172014475
"Very exciting update from MHRA, yet again demonstrating their status as Regulatory leaders"- mike scott
dennisdave
5:38 AM
ATLnsider
Re: Lykiri post# 612511
Friday, July 21, 2023 8:21:12 PM
Post#
612523
of 612675
I agree Lykiri, there is a lot of overlap between the various RAs. Although, as stated by the presenter in the presentation you posted, the various RAs have a lot of discretion, and they reserve the right to ask for additional information or modules.
As you may know, ChatGPT has only been updated through 2021, so there could be some additional requirements that we are not aware of. Also, in the case of a personalize cellular vaccine therapy, the RAs may have some additional requirements.
However, my main point was and still is, 27 modules is enough to meet the requirements of multiple RAs and not just 1 RA. In fact, 27 modules could be enough to meet the requirements of all 4 of the RAs included in the DCVax-L clinical trial, and maybe at least 1 additional RA not included in the clinical trial.
Bullish
BULLISH
Thanks pgsd for sharing.
Dr June M Raine DBE
Chief Executive’s perspective on the year.
During this year of agency organisational evolution, we have not taken our eye off the ball. We have maintained as a top priority our strategy to facilitate patient access to innovative healthcare products, in full alignment with the Life Sciences Vision. A new pathway for access to innovative medical technology has been devised and is moving to the pilot stage, building on the learnings of the Innovative Licensing and Access Pathway for medicines. New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
NWBO Detailed Quote Many fudsters have been working very hard for the past year or two . Is it just for daily profitable trading manipulation , or is there a material short position ?
dstock07734
Re: exwannabe post# 612662
Saturday, July 22, 2023 2:14:21 PM
Post#
612685
of 612685
EX,
Another post full of nonsense. A cunning one though since you packed with a bunch of jargon making it look like you know a thing or two.
“The most important thing to do if you find yourself in a hole is to stop digging.”
— Warren Buffett
exwannabe
Re: TTsr post# 612645
Saturday, July 22, 2023 12:40:22 PM
Post#
612662
of 612686
BTW why don’t you EVER give your opinion on the other data that’s available, like combos?
I will chirp in on that one.
The adjuvant trial often discussed is for grade 3 and 4 gliomas with 23 patients reported on across 3 arms in the interim data presented.
DC + plaecebo : 11m mOS
DC + PolyICLC : 54m mOS
DC + Resquimid: 17m mOS
It was noted that grade 3 lived longer than grade 4 (GBM). Not a surprise.
We have no data on how many grade 3 patients were in the trial or how they were distributed across the arms. They did randomize on it, but with 23 patients that means little.
Was the result pure luck? Very possible with the small N, 3 arms to pick positive results from and an non-homogeneous population. Can you explain why DC alone did so poorly in a trial including grade 3 gliomas? Probably pure luck there also, but good for the goose, good for the gander.
As far as the CI combo trial, did you hear LL saying how the results early so must be taken with caution? Did you also not hear both LL and Prins saying CIs may well work in GBM when used neo-adjuvant? How does the provide evidence that Dc contributes anything to the PolyICLC+CI combo when used neoadjuvant?
ae kusterer
Re: None
Saturday, 07/22/2023 1:07:37 PM
muee88
11:43 AM
Post #612,644
Replying To: @ATLnsider - muee88, as I told you before, I know
ATL, I don’t disagree with you regarding the 27 modules and how it correlates to four different regulatory authorities. What I take issue with is when you post a table with the number of modules per country and present it as fact. It’s not fact. I tried to do my own research, at least for the FDA, and could only find that they require 5 modules (as Lykiri pointed out too). And that is my whole point — ChatGPT appears just to make this stuff up. Anything g you’re getting from ChatGPT should be researched separately before being presented as fact. Here are some good articles explaining why ChatGPT cannot be relied on as a trustworthy source:
https://www.scribbr.com/ai-tools/is-chatgpt-trustworthy/
https://fortune.com/2023/07/19/chatgpt-accuracy-stanford-study/amp/
https://www.makeuseof.com/does-chatgpt-lie/
Look, I value and appreciate your DD, but reliance on ChatGPT unfortunately cuts into your credibility and the credibility of longs more generally on this MB, which is completely avoidable. We constantly challenge the shorts to provide sources for their information and we should be doing the same — we should strive to want to put out accurate information as it only backs the shorts into a corner. In my opinion, when we start relying on non-reliable sources, it only gives them ammunition to attack our credibility and, more generally, the credibility of this MB and NWBO.
Dr BalaATLnsider
Re: hyperopia post# 612607
Saturday, July 22, 2023 9:52:25 AM
612608
Thanks hyperopia, I do believe that NWBio will be filing a BLA submission for DCVax-L in the US soon.
Although Les did not specifically mention the US, he did say that they plan to file for approval in all 4 countries where the clinical trial was held.
As we all know, the original DCVax-L Phase III trial started in the US first, and the FDA was the first RA to approve the IND to start the trial. The FDA has always been, and still is the lead RA for the trial.
Bullish
612474
of 612669
Les recently mentioned that NWBio was in the final stages of double-checking the 27 modules of the BLA / MAA submission.
I, and other posters noticed that 27 modules is a lot more modules than any 1 single regulatory authority (RA) requires for a new BLA / MAA submission.
So, I thought that maybe this number of 27 modules is the combined total number of all the modules that will be submitted to all the RAs.
I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
Friday, July 21, 2023 4:51:51 PM
Post#
612474
of 612669
Les recently mentioned that NWBio was in the final stages of double-checking the 27 modules of the BLA / MAA submission.
I, and other posters noticed that 27 modules is a lot more modules than any 1 single regulatory authority (RA) requires for a new BLA / MAA submission.
So, I thought that maybe this number of 27 modules is the combined total number of all the modules that will be submitted to all the RAs.
I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
Bullish
BULLISH
NWBO
Northwest Biotherapeutics Inc (QB)
ATLnsider
Re: muee88 post# 612571
Saturday, July 22, 2023 8:36:49 AM
Post#
612593
of 612666
muee88, as I told you before, I know that ChatGPT is not 100% correct all of the time. In fact, there are very few, if any sources that are 100% correct all of the time.
ChatGPT is only 1 source of information I use in my research and due diligence. I am not going to stop using it..
Each investor should do their own research and due diligence. If you are not comfortable using ChatGPT, then you should not use it. I will not try to force you to use it, or stop anyone else from using it.
I can not say with 100% absolute certainty, that the exact number of modules required by all 4 of the participating DCVax-L clinical trial countries is exactly 23. It could be anywhere from 20 to 25. But, the main points are: (1) 27 modules is more than what is required for 1 single RA, and (2) 27 modules would be more than enough for all 4 regulatory authorities, in all 4 countries.
If you disagree with my main points, please express your disagreement and show me your sources. I am open to different opinions on this subject, especially those backed up with sources.
Also, you should read some of my previous posts regarding this subject, including this one:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172407924
I agree Lykiri, there is a lot of overlap between the various RAs. Although, as stated by the presenter in the presentation you posted, the various RAs have a lot of discretion, and they reserve the right to ask for additional information or modules.
As you may know, ChatGPT has only been updated through 2021, so there could be some additional requirements that we are not aware of. Also, in the case of a personalize cellular vaccine therapy, the RAs may have some additional requirements.
However, my main point was and still is, 27 modules is enough to meet the requirements of multiple RAs and not just 1 RA. In fact, 27 modules could be enough to meet the requirements of all 4 of the RAs included in the DCVax-L clinical trial, and maybe at least 1 additional RA not included in the clinical trial.
ae kusterer
Re: None
Saturday, 07/22/2023 1:24:03 PM
ATLnsider
9:52 AM
Post #612,608
Replying To: @hyperopia - ATLnsider, that’s an interesting theory on the number
Thanks hyperopia, I do believe that NWBio will be filing a BLA submission for DCVax-L in the US soon.
Although Les did not specifically mention the US, he did say that they plan to file for approval in all 4 countries where the clinical trial was held.
As we all know, the original DCVax-L Phase III trial started in the US first, and the FDA was the first RA to approve the IND to start the trial. The FDA has always been, and still is the lead RA for the trial.
hyperopia
9:35 AM
Post #612,607
Replying To: @ATLnsider - Les recently mentioned that NWBio was in the
ATLnsider, that’s an interesting theory on the number of modules required for a BLA/MAA. Maybe you saw my reply to the question senti asked about the odd number of modules Les mentioned here. While there are exceptions, generally for a marketing authorization application like the one Northwest Bios is likely submitting, there are 5 modules, which are standard and harmonized for most of the wold, and submitted in what’s known as an electronic Common Technical Document (eCTD) format. Modules 2-5 are exactly the same for all regions, and module 1 is region specific. This harmonization is how regulators around the world in consortiums like Project Orbis, are able to collaborate.
As I said in my reply to senti, it only makes sense to me if Les is counting sub-modules. (and that may be why you say there are 9 for the BLA?) I didn’t spell all this out in my reply to senti, but this is my best guess (see CTD Triangle below):
If you were to add module 1, and the 5 sub-modules of module 2, and modules 3-5, they total 9. So possibly, Les was saying that they are now preparing to file applications in 3 countries, which would add up to the 27 modules. And he did specifically mention 3 places: the UK, Canada, and Germany (EMA) . . . which all potentially could be handled now from Sawston.
Perhaps they plan to file next in the US, when commercial manufacturing/tech transfer (or partner) is established there. (maybe after approval in the UK) Comparability will need to be established in any new manufacturing facility, for the semi-automated commercial manufacturing process that Advent developed at Sawston. This should be relatively quick though, (a few months) since the change protocol from manual to semi-automated, has already been established, and it’s automated procedures.
The Common Technical Document
The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.
The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States.
https://www.ich.org/page/ctd
vator
9:35 AM
Post #612,606
Replying To: @Poor Man - - Almost 99.9% of peer reviewed climates scientists across
So tell me. How was that number derived? Not one reporter had the stones to question a statement like that when the grand pooba at the podium put it out.
The survey from the University of (if I recall correctly) Illinois that the number is based on was very flawed. They claim it is the world scientific community that came up with that derived number but when they didn’t like the response they used a predominance of scientists from California.
They went out with a survey with over 3000 mailings. They got back about 1000 responses and when they wanted a number that would knock your socks off they whittled it down to about 83 scientists. Mostly from California. You call that a proper screening of the world’s scientific community involved with climate?
norisknorewards
9:30 AM
Post #612,605
Replying To: @aesop1 - If you are concerned about shorts, why stay
Oh please do, that would be very fun to discuss after you have your findings
Bullish
BULLISH
sentiment_stocks
10:52 AM
Post #612,631
Replying To: @Lykiri - Thanks pgsd for sharing.
A new pathway for access to innovative medical technology has been devised and is moving to the pilot stage, building on the learnings of the Innovative Licensing and Access Pathway for medicines. New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
So it would seem there is a new pathway separate from the ILAP one being developed … and it’s moving to the pilot stage. Will a personalised cancer vaccine be one of the first to use that pilot pathway?
SkyLimit2022
Re: iclight post# 612639
Saturday, 07/22/2023 2:25:09 PM
iclight,
You repost and repost the same misinformation over and over. You need to seek full-context credible sources of independently verifiable information. Please do some research before posting meaningless statements recklessly again and again.
The clinical data in total include data beyond the trial with the ECA, and the ECA included over a thousand well-matched contemporaneous patients.
Regarding the ECA/crossover design and the SAP, please review the video recording of Dr. Ashkan at ASCO 2022 and the JAMA Oncology podcast recording of Dr. Liau. Both recordings are included at the links below.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048;
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254756;
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.
https://clinicaltrials.gov/ct2/show/NCT04201873
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
June 13, 2023 Interview:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
https://www.braintumourresearch.org/stories/in-hope/in-hope-stories/kat-charles
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.uclahealth.org/news/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
September 2023
https://www.cns.org/annualmeeting
"we are in the process of finalizing our applications. First one will be to MHRA, UK, which has a Specialist program even before we file, but we're getting much closer to being finished up 1.7 million pages long. It's got 27 modules. It's been double check now and to make sure that it's completely consistent. We'll be applying there will be applying them to the other places they gave us permission to do the trial. That was for different countries, including the UK, including Canada, including Germany, and we'll be filing in order in each of those places where commercial approval and then we will go into operation on a completely commercial basis."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172406629
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172350272
ATLnsider
Re: None
Friday, July 21, 2023 4:51:51 PM
Post#
612474
of 612753
Les recently mentioned that NWBio was in the final stages of double-checking the 27 modules of the BLA / MAA submission.
I, and other posters noticed that 27 modules is a lot more modules than any 1 single regulatory authority (RA) requires for a new BLA / MAA submission.
So, I thought that maybe this number of 27 modules is the combined total number of all the modules that will be submitted to all the RAs.
I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
ae kusterer
Re: None
Saturday, July 15, 2023 4:38:00 PM
Post#
610145
of 612753
My transcription machine generates alot of errors.Anyone have a machine that cab correct what I have below ? It's Les Goldman's Big Biz interview published yesterday, 7/14/23 . Thanks if you are able to clean it up .
https://www.biztalkradio.com/players/individuals/
So you're here to be treated and veryexcited. Our next guest His name is Lesgolden and has been a longtimecontributor. To the program is SenioSoyou're here to be treated and very excited.Our next guest His name is Les golden andhas been a longtime contributor. To theprogram is Senior Vice President andGeneral Counsel for NorthwestBiotherapeutics essentials and Web. Doyou hear me talking about them? almostconstantly because it's one of thosecompanies, which are DC Vax technology,and where they are in the clinical trialstory. Less Great to have you on today.Let's talk about this topic. Can you give usan overview the CBM is a horrible diseasetalk about that.
15:41
It is the most lethal or quickest growingkilling of any solid tumor cancer, and sono more cancers make up about 80% of allcancers with melanoma. So it's reallyimportant but But additionally, theplatform that we've developed, which isexplain the way it works in a couple ofseconds here for events, accordingrevelation that came from a presentationthat Dr. Monix Bosch T Chief TechnicalOfficer made an amazing conference justabout four or five weeks ago.
16:21
And what what we discovered with a studycalled proteomics, which is the study ofproteins.
16:33
We've been selling the genome for 20years that the genome is made up of cells,strands of DNA, which are made up of of,of various components.
16:50
Proteins are part of those components,many proteins in each strand, and eachprotein has as individual parts of it, thatare called peptides. And that's a very smallfragment of a protein, protein. And Dr.Ralph Steinman working at NYU as amolecular and cellular research doctor in1993 actually was the first person toidentify when until then nobody knewwhat had been good Excel even did forand and what we presented just about fouror five weeks ago, confirms that it's areally unbelievably bigger thing than evenour potential realized at the time, which isit is basically we're putting on today'sParliament's it's the artificial intelligenceof our immune system, which has evolvedover many, many years of humanevolution and what the dendritic cell doesit is and and Simon one, we Nobel Prize in2011. It usually takes 30 years from thediscovery, but it was so significant that hewanted just about 18 years 16 years.
18:13
And and what it does and what I'm goingto explain to everybody I'm gonna giveyou just a little bit more background isthere are two components to making ourvaccine.
18:26
One is the the antigens, which is the samesame meaning as a peptide that you find inyour own tumor tissue. And we either getthe tumor tissue by operating it's going tooperate, or we do the same technique byby putting our invention into the tumor ifyou're doing the body what we do in thelab, but let's just keep it separate for asecond and talk about the the operableapproach. And if we've got time toapproach it, it's the same principle.
19:02
The dendritic cell is one of thecomponents of the vaccine.
19:07
The other component is the tumor tissueitself, treated in a proprietary way.
19:14
Which rates all of the peptides that are inthat particular use cases.
19:22
And in the lab, we do a blood draw to getthe baby dendritic cells and needs to befresh. So we try and get that done nearwhere the manufacturing facilities andexpose the peptides in the tumor tissue tothe to the dendritic cells, and here's wherethe magic starts. I mean, it's exquisite, it'selegant, it's non toxic, and it works prettywell based on the results we've got now.We've got our ideas about why it works.What happens because when they theydrink cells meet these peptides that were inthe tumor tissues. They select the ones tobe targets for the weapons of the immunesystem. Well listen to how this works.
20:17
They they choose the ones that are allrelevant to that particular cancer and theythey hold on to him on the surface of thedendritic cell.
20:32
And then we take the result of thatcombination which we we do what I justdescribed in the lab, where this selectionprocess of the dendritic cells occur, thenthat becomes the vaccine which weshipped in the doctor's offices and and thedoctors give a shot right in the upper armright near your lymph nodes. And thereason for that is the lymph nodes are theconference center of the immune system.And one of these AI type nobody everheard of it millions of years ago and saydeveloper, whatever. What do they do?They carry on their service, these varioustargets, many more than anybody can pickup in a lab. Because it's, it knows when itsees what was in the tumor tissue, what togo after. And it presents those to theweapons of the immune system andbecause it's elegant and complicated, I'mjust gonna focus on one of the bestweapons in the immune system called theT cells.
21:42
And what it does, is it hands off in theconference room in your lymph nodes. Itsays, Here's here are the targets for you togo after. And and identify and find these inthe in the body and then go attack themand kill and and not only does it presentthese targets we before we did this, wereally were maybe about 30 by 40 of theantigens out of 50,000 in the body thatneeded to be identified.
22:15
The dendritic cell, figures it out, mounts itoutside of the cell holds on to it, hands itoff to the T cell and the order to the T celland this is just one of the many weapons inthe immune system, all of which areorganized and given orders by the debititself. And if you've got to sign up, go getinvoice and and not only do the T cells,pick up all those targets and now gohunting for them in the body withoutleaving cancer cells. But they are alsoencouraged to multiply to chronal to createmore of them as they are loaded. And oneof the findings in this probably happenedstudies was that normally in the humanbody if you're healthy, you'd havesomething like between five and 20. Asyou measure the volume of blood of theseT cells.
23:16
After four months of the vaccine beingadministered, it's like halfway through theformer regime which is a six shots in thefirst year.
23:29
It was discovered that that the cloning ofthat original 520 It resulted in 400 400new T cells that multiply from the banksgo not only are they going after numerouspartners, but there's a whole bunch of themthat are doing the same thing. And thataccounts for the fact that everything elseon GBM has pretty much failed, addingjust weeks of toxic life. And we rexine isnon toxic, because this is nature's way ofhandling it and we're just re educating theimmune system by getting on the back ifyou will, of the dendritic cells andutilizing them to go tell the immunesystem that the killer cells, the T cells, allof it what to do, and amazing discoveries,how viciously they're doing it when itcomes to just following their orderssomehow, that tells you how it works. Andit's almost like before we had a black boxbased on Stein standards, invention, andnow we know how it works and why itworks and why it's better than anythingelse out there. So let's My question isbased upon it being a vaccine from yourown immune system or your own cells,can i Is it possible that this could thiscould be a therapy for other cancers?because the way it multiplies and such is Imean, is it specific to GBM? is it possiblethat it could go towards other cancers?
25:02
It we've already shown it to work in theTibetan and treatment Specialist programthat we are currently running in the UKand building up, but we made it work on15 different solid tumor cancer. Wow.Most of them blockbuster drugs, there'sless gold is
25:16
Most of them blockbuster drugs, there'sless gold
25:25
companies obviously some of theirspecialty, horrible, you're going to end upyour bio.com the stock symbol webservices. r Vice President and GeneralCounsel for Northwest Biotherapeuticsessentials and Web. Do you hear metalking about them? almost constantlybecause it's one of those companies, whichare DC Vax technology, and where theyare in the clinical trial story. Less Great tohave you on today. Let's talk about thistopic. Can you give us an overview theCBM is a horrible disease talk about that.
15:41
It is the most lethal or quickest growingkilling of any solid tumor cancer, and sono more cancers make up about 80% of allcancers with melanoma. So it's reallyimportant but But additionally, theplatform that we've developed, which isexplain the way it works in a couple ofseconds here for events, accordingrevelation that came from a presentationthat Dr. Monix Bosch T Chief TechnicalOfficer made an amazing conference justabout four or five weeks ago.
16:21
And what what we discovered with a studycalled proteomics, which is the study ofproteins.
16:33
We've been selling the genome for 20years that the genome is made up of cells,strands of DNA, which are made up of of,of various components.
16:50
Proteins are part of those components,many proteins in each strand, and eachprotein has as individual parts of it, thatare called peptides. And that's a very smallfragment of a protein, protein. And Dr.Ralph Steinman working at NYU as amolecular and cellular research doctor in1993 actually was the first person toidentify when until then nobody knewwhat had been good Excel even did forand and what we presented just about fouror five weeks ago, confirms that it's areally unbelievably bigger thing than evenour potential realized at the time, which isit is basically we're putting on today'sParliament's it's the artificial intelligenceof our immune system, which has evolvedover many, many years of humanevolution and what the dendritic cell doesit is and and Simon one, we Nobel Prize in2011. It usually takes 30 years from thediscovery, but it was so significant that hewanted just about 18 years 16 years.
18:13
And and what it does and what I'm goingto explain to everybody I'm gonna giveyou just a little bit more background isthere are two components to making ourvaccine.
18:26
One is the the antigens, which is the samesame meaning as a peptide that you find inyour own tumor tissue. And we either getthe tumor tissue by operating it's going tooperate, or we do the same technique byby putting our invention into the tumor ifyou're doing the body what we do in thelab, but let's just keep it separate for asecond and talk about the the operableapproach. And if we've got time toapproach it, it's the same principle.
19:02
The dendritic cell is one of thecomponents of the vaccine.
19:07
The other component is the tumor tissueitself, treated in a proprietary way.
19:14
Which rates all of the peptides that are inthat particular use cases.
19:22
And in the lab, we do a blood draw to getthe baby dendritic cells and needs to befresh. So we try and get that done nearwhere the manufacturing facilities andexpose the peptides in the tumor tissue tothe to the dendritic cells, and here's wherethe magic starts. I mean, it's exquisite, it'selegant, it's non toxic, and it works prettywell based on the results we've got now.We've got our ideas about why it works.What happens because when they theydrink cells meet these peptides that were inthe tumor tissues. They select the ones tobe targets for the weapons of the immunesystem. Well listen to how this works.
20:17
They they choose the ones that are allrelevant to that particular cancer and theythey hold on to him on the surface of thedendritic cell.
20:32
And then we take the result of thatcombination which we we do what I justdescribed in the lab, where this selectionprocess of the dendritic cells occur, thenthat becomes the vaccine which weshipped in the doctor's offices and and thedoctors give a shot right in the upper armright near your lymph nodes. And thereason for that is the lymph nodes are theconference center of the immune system.And one of these AI type nobody everheard of it millions of years ago and saydeveloper, whatever. What do they do?They carry on their service, these varioustargets, many more than anybody can pickup in a lab. Because it's, it knows when itsees what was in the tumor tissue, what togo after. And it presents those to theweapons of the immune system andbecause it's elegant and complicated, I'mjust gonna focus on one of the bestweapons in the immune system called theT cells.
21:42
And what it does, is it hands off in theconference room in your lymph nodes. Itsays, Here's here are the targets for you togo after. And and identify and find these inthe in the body and then go attack themand kill and and not only does it presentthese targets we before we did this, wereally were maybe about 30 by 40 of theantigens out of 50,000 in the body thatneeded to be identified.
22:15
The dendritic cell, figures it out, mounts itoutside of the cell holds on to it, hands itoff to the T cell and the order to the T celland this is just one of the many weapons inthe immune system, all of which areorganized and given orders by the debititself. And if you've got to sign up, go getinvoice and and not only do the T cells,pick up all those targets and now gohunting for them in the body withoutleaving cancer cells. But they are alsoencouraged to multiply to chronal to createmore of them as they are loaded. And oneof the findings in this probably happenedstudies was that normally in the humanbody if you're healthy, you'd havesomething like between five and 20. Asyou measure the volume of blood of theseT cells.
23:16
After four months of the vaccine beingadministered, it's like halfway through theformer regime which is a six shots in thefirst year.
23:29
It was discovered that that the cloning ofthat original 520 It resulted in 400 400new T cells that multiply from the banksgo not only are they going after numerouspartners, but there's a whole bunch of themthat are doing the same thing. And thataccounts for the fact that everything elseon GBM has pretty much failed, addingjust weeks of toxic life. And we rexine isnon toxic, because this is nature's way ofhandling it and we're just re educating theimmune system by getting on the back ifyou will, of the dendritic cells andutilizing them to go tell the immunesystem that the killer cells, the T cells, allof it what to do, and amazing discoveries,how viciously they're doing it when itcomes to just following their orderssomehow, that tells you how it works. Andit's almost like before we had a black boxbased on Stein standards, invention, andnow we know how it works and why itworks and why it's better than anythingelse out there. So let's My question isbased upon it being a vaccine from yourown immune system or your own cells,can i Is it possible that this could thiscould be a therapy for other cancers?because the way it multiplies and such is Imean, is it specific to GBM? is it possiblethat it could go towards other cancers?
25:02
It we've already shown it to work in theTibetan and treatment Specialist programthat we are currently running in the UKand building up, but we made it work on15 different solid tumor cancer. Wow.Most of them blockbuster drugs, there'sless gold is
25:16
Most of them blockbuster drugs, there'sless gold
25:25
companies obviously some of theirspecialty, horrible, you're going to end upyour bio.com the stock symbol webservices.
Are we? Are we to continue the research? Are we gonna do an FDA sort of archivists story there where we're getting close to this obviously exciting you suddenly get a million emails, asking when can we get this here in the US? So talking about that? Well, we think we do have this advantage during my program, and you may need to go to UK to initially get it made. But a recent license, we've got to use our, our facility that we built for, for commercial operation and it's been licensed to do that allow us to ship anywhere now in the world. So if you call our office if there is a bathroom, but you can still get a hold of that away at this point, but but more significantly, we are in the process of finalizing our applications. First one will be to MHRA, UK, which has a Specialist program even before we file, but we're getting much closer to being finished up 1.7 million pages long. It's got 27 modules. It's been double check now and to make sure that it's completely consistent. We'll be applying there will be applying them to the other places they gave us permission to do the trial. That was for different countries, including the UK, including Canada, including Germany, and we'll be filing in order in each of those places where commercial approval and then we will go into operation on a completely commercial basis. And I think the prognosis is very exciting. During that we've shown the positive results and compassionate treatment specialists program and we're also dealing with issues relating to our are not as high as we believe we deserve. value in the marketplace, because you're interested would rather see us not succeed. We're we're cheaper. We're more efficient. We're not in toxic, I mean, and I will have to add, it's already been shown that in combination with certain other products that have been produced which have no effect than solid human cancers. We enhance the result of of what we get when we put it in combination with others and and we'll be doing plenty of that as well. We also have a product of inoperable tumors where we take the magic formula for well, and and together with MD Anderson. In 2015. We ran a phase one phase two trial where we developed a MRI guidance or or good scan guidance of being able to take a very thin needle and inject it to find the mothership tumor in a given body and then put the stuff into the tumor with this very thin tube which is quite non invasive, but it can be guided by by by by just you know the things that you can scope and one of the ways you could do X rays or whatever. And we got very good results on that and then we got the same safety results, which is basically no kind of side effects. And we'll be developing that product as well with further trials. So there's a lot of activities wanting to have to move this first one which was our leap I am because frankly, these trials are cost a fortune. And for example, if you're gonna do CrossFit, you have to do a phase three trial for six, seven years and costs $800 million.
4:06
And unfortunately, it's a lot quicker and you can measure themselves much quicker in the air. So we picked TBM to be our lead. And we're getting we're getting near the end others are working with less last of all will you take this to the finish line or well this is just one of those risk aversion models where a bigger pharma company will come in and take it to the market you guys intend on taking the market yourselves once you get done?
4:32
Well, if you're asking for absolutely everything. That would be a really big menu. I think with our seven minutes without 90 sites and 73 doctors, we have a pretty established infrastructure for GBM, the fact that it works and other things I mean, I think it all depends who might want to team up what they want, might want to say and I feel good stuff. Les Coleman, thank you so much. It was
5:04
a big lesson tonight. Holy moly.
ae kusterer
Re: None
Saturday, July 22, 2023 2:37:37 PM
Post#
612692
of 612753
ATLnsider : Your NWBO IHUB post 612474 (07/21/2023 05:08:59 PM ) kicked off the cacophony below. I am trying to pluck out the one sentence which sums up the essence of the RA first approval for DC VAX L .Thanks .A.E.K.
a) Contributing to a scientific programme focusing on developing better tools to analyse the microbiome, to improve patient access to personalised treatments
b)New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
c)$NWBO 27 modules ready to go and being checked for consistency, said Les Goldman on the Big Biz show. Considering the FDA application needs 5-9 depending on the source, 27 is enough for 4-6 regulators… fireworks coming…
d)"Very exciting update from MHRA, yet again demonstrating their status as Regulatory leaders"- mike scott
e)I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
f)So it would seem there is a new pathway separate from the ILAP one being developed … and it’s moving to the pilot stage. Will a personalised cancer vaccine be one of the first to use that pilot pathway?
1:48 AM · Jul 22, 2023
Saturday, 07/22/2023 1:57:28 PM
Creating a cross-agency team to rapidly deliver an end-to-end regulatory pathway for personalised cancer vaccines
Re: pgsd post# 612569
Saturday, July 22, 2023 7:39:25 AM
Post#
612581
of 612680
Thanks pgsd for sharing.
Dr June M Raine DBE
Chief Executive’s perspective on the year.
During this year of agency organisational evolution, we have not taken our eye off the ball. We have maintained as a top priority our strategy to facilitate patient access to innovative healthcare products, in full alignment with the Life Sciences Vision. A new pathway for access to innovative medical technology has been devised and is moving to the pilot stage, building on the learnings of the Innovative Licensing and Access Pathway for medicines. New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
MHRA Annual Report and Accounts
2022-2023
We have continued to support rapid and safe patient access to innovative medicines, by:
¦ Launching our Innovation Accelerator service, following consultation with stakeholders, to help provide innovators better access to our scientific expertise and regulatory guidance
¦ Continued operation and development of the Innovative Licensing Access Pathway (ILAP). The ILAP was recognised at The Organisation for Professionals in Regulatory Affairs (TOPRA) Human Medicines Symposium 2022 as a good example of how to create an end-to-end approach from discovery to deployment, involving both the regulator and health technology assessment bodies
¦ Creating a cross-agency team to rapidly deliver an end-to-end regulatory pathway for personalised cancer vaccines
¦ Developing guidelines, via an NHS programme, for acute myeloid leukaemia detection and creating better informatics tools for analysing patients’ genomic data
¦ Contributing to a scientific programme focusing on developing better tools to analyse the microbiome, to improve patient access to personalised treatments
¦ Developing a proposal and strategy for a risk-based approach to batch release testing to assure the quality of biological medicines, while maintaining the capability to independently monitor the quality of biological medicines not traceable by the risk-based approach
Innovative Licensing and Access Pathway
https://www.gov.uk/government/publications/medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-2022-to-2023
The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the approval process for new medicines and repurposed medicines for life threatening or seriously debilitating conditions, so that patients can access them faster. This is achieved in partnership with other health bodies, supporting the manufacturer through the licensing process, while still ensuring these are safe and fit for purpose.
Our partners in ILAP are All Wales Therapeutic and Toxicology Centre (AWTCC), the National Institute for Clinical Excellence (NICE), and the Scottish Medicines Consortium (SMC).
Medicines on the ILAP pathway, which fulfil the criteria, are awarded an Innovation Passport designation initially. They can then progress to a Target Development Profile, if they are intending to progress to market, which sets out a regulatory roadmap for delivery to patients.
To date we have received 178 applications from a range of pharmaceutical companies and awarded 129 Innovation Passports, including one for a ground-breaking immunotherapy for the treatment of Alzheimer’s disease. 40 products have progressed to a TDP with 26 TDP regulatory roadmaps issued.
Project Orbis
Project Orbis is a collaborative programme, led by the US Food and Drug Administration (FDA), which reviews and approves promising cancer drugs, enabling patients to access these treatments more rapidly. MHRA is a partner in Project Orbis alongside regulatory authorities from Australia, Canada, Singapore, Switzerland, and Brazil.
In 2022/23, through Project Orbis, the MHRA approved four new medicines and new uses for three existing cancer medicines, including nivolumab (Opdivo) for use in non-small cell lung cancer in adults, darolutamide (Nubeqa) for the treatment of certain prostate cancers and durvalumab (Imfinzi) for the treatment of metastatic biliary tract cancer.
Medicines intended for use in Great Britain must meet the qualifying criteria for ILAP in order to be considered for Project Orbis.
Northwest Biotherapeutics (OTCQB: NWBO) is amoung the most exciting stories in small caps trading right over 52 week lows and established support levels that has been shorted into oblivion and is looking for a major reversal northbound here. In November of last year NWBO reported positive top-line results from its phase 3 trial on DCVax®-L for Glioblastoma, the most aggressive type of brain cancer representing a potential market expected to top $1.4 billion by 2025. DCVax®-L has succeeded where well over 400 clinical trials for glioblastoma having failed in the past. In the Phase 3 clinical trial both median survival and the “long tail” of extended survival showed a significant increase in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. Treatment with DCVax-L is associated with statistically significant and clinically meaningful extended survival, both in newly diagnosed and recurrent GBM.
Investors sentiment is high as countless medical professionals and Doctors have gotten behind DCVax®-L who believe the approval by the MHRA is imminent and will come this summer. In two UCLA combo trials it currently has 50-65% efficacy against brain cancer, works against all solid tumors and is 100% non toxic. NWBO’s partner, Advent Bioservices is continuing their hiring spree now with 10 open positions. Another major factor here is the Company’s lawsuit in Manhattan alleging Citadel Securities, Susquehanna and “other Wall Street firms including Canaccord Genuity, G1 Execution Services, GTS Securities, Instinet, Lime Trading and Virtu Americas drove down the price of NWBO through a series of illicit trading tactics. Representing the case for NWBO is Laura Posner, a partner at Cohen Milstein and a member of the securities litigation & Investor protection and ethics & Fiduciary Counseling practices; a hot shot securities attorney and a Harvard Law School grad who was recently instrumental negotiating the settlement of a historic $1B class action against Wells Fargo for alleged securities fraud. Most are expecting a settlement from Citadel here, long before the case progresses to discovery.
NWBO’s lawsuit aledges that market makers engaged in a deceptive market manipulation tactic known as spoofing, which involves placing large quantities of sell orders to fool the market into devaluing the company’s stock so the market makers can buy back in at a lower price. The market makers then immediately cancel the sell orders so they can reap big profits, in this case to the dismay of current and future cancer patients, as well as at the expense of Northwest Biotherapeutics and its investors. This alleged illegal trading behavior has made it significantly more difficult for the company to raise the money necessary to bring its cancer treatment to market, where the company believes it has the potential to extend the lives of thousands of patients. NWBO’s attorney, Laura Posner said: “It’s already underhanded to engage in market manipulation, but to do so at the expense of cancer patients, some of whom have no other treatments to place their hopes on, is unconscionable.”
In November of last year NWBO reported that in its Phase III clinical trial both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial met both the primary and the secondary endpoint under the Statistical Analysis Plan. The trial results were reported in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology, entitled “Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma”. This is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma. Despite the presentation of significant positive data and a steadily rising stock price prior to the TLD, there was a $1.6 billion loss in market cap value, with the share price dropping from the $2.05 high on May 9 to a low of 36.4 cents on May 10, 2022—a staggering decline of 82%.
NWBO’s enormous base of investors includes many medical professionals who are passionate in their support of DCVax®-L and its ability to completely disrupt the global market for Glioblastoma worth billions starting in the UK where MHRA approval is expected to come this year and then on to the EME, a much larger market, which is believed the best way for eventual approval in the United States. The MHRA has made DCVax a top priority to review and the review process could move forward very quickly if NWBO utilizes the rolling review submission process. Revenue just in the UK for GBM would be at least $200 million per year. NWBO also has a significant short position with over 39 million shares sold short that continues to mount attacks against the Company. A good example of this is the yahoo message board for NWBO where the shorts, using multiple fake aliases and accounts have upvoted negative posts on NWBO such that the top 10 posts on yahoo message boards are from the bashers themselves.
Northwest Biotherapeutics is a biotech that is focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer. The Company operates in the United States, the UK, Germany and Canada and is incorporated in Delaware, USA and is led by CEO Linda Powers, a Harvard law school graduate with years of experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. The Company owns a valuable Intellectual Property portfolio of at least 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families as of January 1, 2022. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products. NWBO lead product DCVax-L is a fully personalized immune therapy made from a patient’s own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient’s own tumor. A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days. The product is then stored frozen in individual doses, and is “off the shelf” throughout the treatment regimen. The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient’s next treatment. The Company’s manufacturing partner is Advent Biosciences.
The Company’s manufacturing facility in Sawston, Uk spans 88,345 square feet over 2 floors and an initial production capacity spanning two manufacturing suites, occupying 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 around 40 to 45 patients per month, or approximately 450 to 500 patients annually. Production of the first NW Bio dendritic cell cancer vaccine for a compassionate use patient at the licensed production facility in Sawston started a while ago. Since the issuance of the MHRA license, Advent Bioservices has conducted the required post-approval re-validations and testing, and the facility is now ready to scale up the manufacture of cell therapy products for clinical use.
Earlier this year the Company was at this year’s American Society of Clinical Oncology (ASCO) meeting. The ASCO annual meeting is the pre-eminent conference focused on clinical treatment of cancer, attended by over 25,000 oncologists and other medical professionals. Glioblastoma is the most common and most lethal form of primary brain cancer and the standard of care (SOC) treatments have been virtually unchanged for nearly 20 years. With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Five-year survival from diagnosis is only about 5%.
Saturday, 07/22/2023 1:39:25 PM
$NWBO 27 modules ready to go and being checked for consistency, said Les Goldman on the Big Biz show. Considering the FDA application needs 5-9 depending on the source, 27 is enough for 4-6 regulators… fireworks coming…
1:48 AM · Jul 22, 2023
·
2,903
Views$NWBO Read the MHRA annual report released yesterday.
Besides now being the chair of the ACCESS consortium, they declare that they’ve “created a cross-agency team to rapidly deliver an end-to-end regulatory pathway for personalized cancer vaccines”. Gosh wonder what that’s for.
6:22 AM
Post #612,573
Replying To: @Horseb4CarT - Didn’t someone post that there’s some sort of
ae kusterer
Re: None
Tuesday, 05/30/2023 9:01:15 AM
“MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners
From:
Medicines and Healthcare products Regulatory Agency
Published
26 May 2023
https://www.gov.uk/government/news/mhra-announces-new-recognition-routes-to-facilitate-safe-access-to-new-medicines-with-seven-international-partners?s=08
New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, the Medicines and Healthcare products Regulatory Agency has announced today.
This means that patients will have access to safe and effective medicines that have been approved by trusted regulatory partners in other countries. The new international recognition routes will sit alongside the MHRA’s own unique innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice.
These recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024.
The new framework will allow the MHRA to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products. As a result, cutting-edge medicines that have been approved in other countries will get to UK patients more quickly, with cost reductions and streamlined regulatory processes for industry.
As a sovereign regulator, the UK regulator will still be responsible for approving all ‘recognition route’ applications under the new framework, ensuring that all products are safe and of sufficient quality to be licensed in the UK. The MHRA will maintain rigorous scrutiny and retain the authority to reject applications if the evidence provided is considered insufficiently robust.
At the time of the UK’s exit from the European Union, the MHRA introduced temporary routes to market for European approved products in Great Britain, known as EU ‘reliance’ routes, to ensure that patients could continue to have timely access to new treatments. These temporary routes are due to expire at the end of 2023.
While the international recognition routes announced today focus on medicines, work is underway to establish similar routes for medical devices. As part of this ongoing work, the MHRA will launch a new targeted consultation on medical devices that will gather views on a wide range of topics, including recognising conformity assessments or approvals from international regulatory partners.
Dr June Raine, MHRA Chief Executive, said:
We are focused on providing UK patients faster access to the absolute best, most cutting-edge, and safest medical treatments. By fast-tracking access to approved products from other countries, we’re ensuring that innovative healthcare solutions reach those in need without delay.
The introduction of the new routes will complement the work being done through the MHRA’s Innovative Licensing and Access Pathway (ILAP), establishing an additional avenue for accelerated access to life-saving new medicines. Combining MHRA’s globally recognised high standards with improved flexibility and a sustained collaborative approach across the healthcare system, the ILAP is helping reduce the time to market for innovative treatments by developing medicines that are both regulatory and access ready.
Through this new dual approach, we will contribute to the UK’s ambition to be a global science superpower, by making the UK one of the best places in the world to bring life-changing healthcare products to patients safely.
A £10m funding from HM Treasury was announced earlier this year to support the development of this new recognition framework.
Find out more
Follow us on Twitter: @MHRAgovuk
Follow us on LinkedIn: Medicines and Healthcare products Regulatory Agency
Notes to editors
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
For media enquiries, please contact the newscentre@mhra.gov.uk. “
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172014475
"Very exciting update from MHRA, yet again demonstrating their status as Regulatory leaders"- mike scott
dennisdave
5:38 AM
ATLnsider
Re: Lykiri post# 612511
Friday, July 21, 2023 8:21:12 PM
Post#
612523
of 612675
I agree Lykiri, there is a lot of overlap between the various RAs. Although, as stated by the presenter in the presentation you posted, the various RAs have a lot of discretion, and they reserve the right to ask for additional information or modules.
As you may know, ChatGPT has only been updated through 2021, so there could be some additional requirements that we are not aware of. Also, in the case of a personalize cellular vaccine therapy, the RAs may have some additional requirements.
However, my main point was and still is, 27 modules is enough to meet the requirements of multiple RAs and not just 1 RA. In fact, 27 modules could be enough to meet the requirements of all 4 of the RAs included in the DCVax-L clinical trial, and maybe at least 1 additional RA not included in the clinical trial.
Bullish
BULLISH
Thanks pgsd for sharing.
Dr June M Raine DBE
Chief Executive’s perspective on the year.
During this year of agency organisational evolution, we have not taken our eye off the ball. We have maintained as a top priority our strategy to facilitate patient access to innovative healthcare products, in full alignment with the Life Sciences Vision. A new pathway for access to innovative medical technology has been devised and is moving to the pilot stage, building on the learnings of the Innovative Licensing and Access Pathway for medicines. New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
NWBO Detailed Quote Many fudsters have been working very hard for the past year or two . Is it just for daily profitable trading manipulation , or is there a material short position ?
dstock07734
Re: exwannabe post# 612662
Saturday, July 22, 2023 2:14:21 PM
Post#
612685
of 612685
EX,
Another post full of nonsense. A cunning one though since you packed with a bunch of jargon making it look like you know a thing or two.
“The most important thing to do if you find yourself in a hole is to stop digging.”
— Warren Buffett
exwannabe
Re: TTsr post# 612645
Saturday, July 22, 2023 12:40:22 PM
Post#
612662
of 612686
BTW why don’t you EVER give your opinion on the other data that’s available, like combos?
I will chirp in on that one.
The adjuvant trial often discussed is for grade 3 and 4 gliomas with 23 patients reported on across 3 arms in the interim data presented.
DC + plaecebo : 11m mOS
DC + PolyICLC : 54m mOS
DC + Resquimid: 17m mOS
It was noted that grade 3 lived longer than grade 4 (GBM). Not a surprise.
We have no data on how many grade 3 patients were in the trial or how they were distributed across the arms. They did randomize on it, but with 23 patients that means little.
Was the result pure luck? Very possible with the small N, 3 arms to pick positive results from and an non-homogeneous population. Can you explain why DC alone did so poorly in a trial including grade 3 gliomas? Probably pure luck there also, but good for the goose, good for the gander.
As far as the CI combo trial, did you hear LL saying how the results early so must be taken with caution? Did you also not hear both LL and Prins saying CIs may well work in GBM when used neo-adjuvant? How does the provide evidence that Dc contributes anything to the PolyICLC+CI combo when used neoadjuvant?
ae kusterer
Re: None
Saturday, 07/22/2023 1:07:37 PM
muee88
11:43 AM
Post #612,644
Replying To: @ATLnsider - muee88, as I told you before, I know
ATL, I don’t disagree with you regarding the 27 modules and how it correlates to four different regulatory authorities. What I take issue with is when you post a table with the number of modules per country and present it as fact. It’s not fact. I tried to do my own research, at least for the FDA, and could only find that they require 5 modules (as Lykiri pointed out too). And that is my whole point — ChatGPT appears just to make this stuff up. Anything g you’re getting from ChatGPT should be researched separately before being presented as fact. Here are some good articles explaining why ChatGPT cannot be relied on as a trustworthy source:
https://www.scribbr.com/ai-tools/is-chatgpt-trustworthy/
https://fortune.com/2023/07/19/chatgpt-accuracy-stanford-study/amp/
https://www.makeuseof.com/does-chatgpt-lie/
Look, I value and appreciate your DD, but reliance on ChatGPT unfortunately cuts into your credibility and the credibility of longs more generally on this MB, which is completely avoidable. We constantly challenge the shorts to provide sources for their information and we should be doing the same — we should strive to want to put out accurate information as it only backs the shorts into a corner. In my opinion, when we start relying on non-reliable sources, it only gives them ammunition to attack our credibility and, more generally, the credibility of this MB and NWBO.
Dr BalaATLnsider
Re: hyperopia post# 612607
Saturday, July 22, 2023 9:52:25 AM
612608
Thanks hyperopia, I do believe that NWBio will be filing a BLA submission for DCVax-L in the US soon.
Although Les did not specifically mention the US, he did say that they plan to file for approval in all 4 countries where the clinical trial was held.
As we all know, the original DCVax-L Phase III trial started in the US first, and the FDA was the first RA to approve the IND to start the trial. The FDA has always been, and still is the lead RA for the trial.
Bullish
612474
of 612669
Les recently mentioned that NWBio was in the final stages of double-checking the 27 modules of the BLA / MAA submission.
I, and other posters noticed that 27 modules is a lot more modules than any 1 single regulatory authority (RA) requires for a new BLA / MAA submission.
So, I thought that maybe this number of 27 modules is the combined total number of all the modules that will be submitted to all the RAs.
I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
Friday, July 21, 2023 4:51:51 PM
Post#
612474
of 612669
Les recently mentioned that NWBio was in the final stages of double-checking the 27 modules of the BLA / MAA submission.
I, and other posters noticed that 27 modules is a lot more modules than any 1 single regulatory authority (RA) requires for a new BLA / MAA submission.
So, I thought that maybe this number of 27 modules is the combined total number of all the modules that will be submitted to all the RAs.
I looked up the number of required modules for all of the 4 relevant RAs, and that total number of combined required modules is 23. So, it’s possible that Les number 27 is for all 4 RAs, plus 1 additional RA:
Bullish
BULLISH
NWBO
Northwest Biotherapeutics Inc (QB)
ATLnsider
Re: muee88 post# 612571
Saturday, July 22, 2023 8:36:49 AM
Post#
612593
of 612666
muee88, as I told you before, I know that ChatGPT is not 100% correct all of the time. In fact, there are very few, if any sources that are 100% correct all of the time.
ChatGPT is only 1 source of information I use in my research and due diligence. I am not going to stop using it..
Each investor should do their own research and due diligence. If you are not comfortable using ChatGPT, then you should not use it. I will not try to force you to use it, or stop anyone else from using it.
I can not say with 100% absolute certainty, that the exact number of modules required by all 4 of the participating DCVax-L clinical trial countries is exactly 23. It could be anywhere from 20 to 25. But, the main points are: (1) 27 modules is more than what is required for 1 single RA, and (2) 27 modules would be more than enough for all 4 regulatory authorities, in all 4 countries.
If you disagree with my main points, please express your disagreement and show me your sources. I am open to different opinions on this subject, especially those backed up with sources.
Also, you should read some of my previous posts regarding this subject, including this one:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172407924
I agree Lykiri, there is a lot of overlap between the various RAs. Although, as stated by the presenter in the presentation you posted, the various RAs have a lot of discretion, and they reserve the right to ask for additional information or modules.
As you may know, ChatGPT has only been updated through 2021, so there could be some additional requirements that we are not aware of. Also, in the case of a personalize cellular vaccine therapy, the RAs may have some additional requirements.
However, my main point was and still is, 27 modules is enough to meet the requirements of multiple RAs and not just 1 RA. In fact, 27 modules could be enough to meet the requirements of all 4 of the RAs included in the DCVax-L clinical trial, and maybe at least 1 additional RA not included in the clinical trial.
ae kusterer
Re: None
Saturday, 07/22/2023 1:24:03 PM
ATLnsider
9:52 AM
Post #612,608
Replying To: @hyperopia - ATLnsider, that’s an interesting theory on the number
Thanks hyperopia, I do believe that NWBio will be filing a BLA submission for DCVax-L in the US soon.
Although Les did not specifically mention the US, he did say that they plan to file for approval in all 4 countries where the clinical trial was held.
As we all know, the original DCVax-L Phase III trial started in the US first, and the FDA was the first RA to approve the IND to start the trial. The FDA has always been, and still is the lead RA for the trial.
hyperopia
9:35 AM
Post #612,607
Replying To: @ATLnsider - Les recently mentioned that NWBio was in the
ATLnsider, that’s an interesting theory on the number of modules required for a BLA/MAA. Maybe you saw my reply to the question senti asked about the odd number of modules Les mentioned here. While there are exceptions, generally for a marketing authorization application like the one Northwest Bios is likely submitting, there are 5 modules, which are standard and harmonized for most of the wold, and submitted in what’s known as an electronic Common Technical Document (eCTD) format. Modules 2-5 are exactly the same for all regions, and module 1 is region specific. This harmonization is how regulators around the world in consortiums like Project Orbis, are able to collaborate.
As I said in my reply to senti, it only makes sense to me if Les is counting sub-modules. (and that may be why you say there are 9 for the BLA?) I didn’t spell all this out in my reply to senti, but this is my best guess (see CTD Triangle below):
If you were to add module 1, and the 5 sub-modules of module 2, and modules 3-5, they total 9. So possibly, Les was saying that they are now preparing to file applications in 3 countries, which would add up to the 27 modules. And he did specifically mention 3 places: the UK, Canada, and Germany (EMA) . . . which all potentially could be handled now from Sawston.
Perhaps they plan to file next in the US, when commercial manufacturing/tech transfer (or partner) is established there. (maybe after approval in the UK) Comparability will need to be established in any new manufacturing facility, for the semi-automated commercial manufacturing process that Advent developed at Sawston. This should be relatively quick though, (a few months) since the change protocol from manual to semi-automated, has already been established, and it’s automated procedures.
The Common Technical Document
The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.
The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States.
https://www.ich.org/page/ctd
vator
9:35 AM
Post #612,606
Replying To: @Poor Man - - Almost 99.9% of peer reviewed climates scientists across
So tell me. How was that number derived? Not one reporter had the stones to question a statement like that when the grand pooba at the podium put it out.
The survey from the University of (if I recall correctly) Illinois that the number is based on was very flawed. They claim it is the world scientific community that came up with that derived number but when they didn’t like the response they used a predominance of scientists from California.
They went out with a survey with over 3000 mailings. They got back about 1000 responses and when they wanted a number that would knock your socks off they whittled it down to about 83 scientists. Mostly from California. You call that a proper screening of the world’s scientific community involved with climate?
norisknorewards
9:30 AM
Post #612,605
Replying To: @aesop1 - If you are concerned about shorts, why stay
Oh please do, that would be very fun to discuss after you have your findings
Bullish
BULLISH
sentiment_stocks
10:52 AM
Post #612,631
Replying To: @Lykiri - Thanks pgsd for sharing.
A new pathway for access to innovative medical technology has been devised and is moving to the pilot stage, building on the learnings of the Innovative Licensing and Access Pathway for medicines. New products which blur definitional boundaries are being presented, and technologies which support personalised treatments such as cancer vaccines challenge the traditional regulatory approaches
So it would seem there is a new pathway separate from the ILAP one being developed … and it’s moving to the pilot stage. Will a personalised cancer vaccine be one of the first to use that pilot pathway?
SkyLimit2022
Re: iclight post# 612639
Saturday, 07/22/2023 2:25:09 PM
iclight,
You repost and repost the same misinformation over and over. You need to seek full-context credible sources of independently verifiable information. Please do some research before posting meaningless statements recklessly again and again.
The clinical data in total include data beyond the trial with the ECA, and the ECA included over a thousand well-matched contemporaneous patients.
Regarding the ECA/crossover design and the SAP, please review the video recording of Dr. Ashkan at ASCO 2022 and the JAMA Oncology podcast recording of Dr. Liau. Both recordings are included at the links below.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048;
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254756;
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.
https://clinicaltrials.gov/ct2/show/NCT04201873
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
June 13, 2023 Interview:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
https://www.braintumourresearch.org/stories/in-hope/in-hope-stories/kat-charles
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.uclahealth.org/news/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
September 2023
https://www.cns.org/annualmeeting
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