Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
kund,
It sounds like you need some better sources of information—I believe you’re misinformed.
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.
https://www.fda.gov/media/120721/download
https://clinicaltrials.gov/ct2/show/NCT04201873;
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.
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/
HyGro,
Exactly!
I agree 100% that the peer-reviewed landmark P3 will draw the majority of the focus duing regulatory review and advisory. The other clinical data simply provide extra confirmation of safety and efficacy and provide additional evidence of a broader range of use.
The data were peer reviewed by independent physicians and qualified statisticians (JAMA Oncology).
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.
https://www.fda.gov/media/120721/download
https://clinicaltrials.gov/ct2/show/NCT04201873
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.
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/
exwannabe,
Thanks for requesting more information.
For information about the ECA/crossover design, endpoints, 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.
Skip to timestamp 13:00 of the ASCO video to hear about the ECA and the SAP.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254756
iclight,
It is not accurate to suggest that there have not been any submissions to regulators. Most notably, the MIA was approved and is evidence of a regulatory filing plan that has begun to unfold. Further applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
March 2023
https://cms.mhra.gov.uk/mhra/mia/uk-mia-54923
The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
HyGro,
Thanks for reposting that again, but your information is outdated and out of context. Furthermore, the P3 is not the only DCVax-L trial/trial design relevant to the DCVax-L cell-based technology.
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172268944
BNOS 2023 Begins! Official welcome from our President @BrainTumourSurg to #BNOS2023 pic.twitter.com/4IT0frA4NY
https://www.bnosconference.co.uk/bnos-conference/programme/
iclight,
Thanks for the reply, but you are mixed up.
If you don’t like the ECA or other aspects of the landmark P3, then you have other DCVax-L clinical trials to consider.
All clinical data are relevant to the FDA whenever they must make a decision about the safety and efficacy of any drug.
DCVax-L has been studied in placebo trials too if you like internally controlled trials. DCVax-L is currently being studied in combo with Keytruda at UCLA in an internally controlled study supported by Merck and the NIH (NCI).
Don’t miss the two conferences where Northwest Biotherapeutics is scheduled to participate—BNOS in July (the conference starts today!) and CNS in September!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172204891
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172268944
HyGro,
Thanks for reposting your opinion again, but you are misinformed about the P3 and the FDA.
The 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.
https://www.fda.gov/media/120721/download
https://clinicaltrials.gov/ct2/show/NCT04201873
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.
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/
HyGro,
Are you referring to the independent peer review of the landmark P3 study that was published in JAMA Oncology?
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
HyGro
Thank you for posting about the MHRA. The forthcoming regulatory developments will be quite significant. Commercialization and value measured in dollars requires RA approval.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171785690
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
HyGro,
Thanks for asking about the landmark P3! The data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. Always seek credible full-context sources.
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.
https://www.fda.gov/media/120721/download
https://clinicaltrials.gov/ct2/show/NCT04201873
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.
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/
iclight,
I think your posts are mixed up and inaccurate. Seek credible full-context sources. Perhaps consider the independent peer review that was published in JAMA Oncology.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171785690
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
iclight,
It is not accurate to suggest that there have not been any submissions to regulators. Most notably, the MIA was approved and is evidence of a regulatory filing plan that has begun to unfold. Further applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
March 2023
https://cms.mhra.gov.uk/mhra/mia/uk-mia-54923
The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
July 2023
https://www.bnosconference.co.uk/bnos-conference/
September 2023
https://www.cns.org/annualmeeting
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
iclight,
The data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. I believe that your post is baseless and you might consider researching credible 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.
https://www.fda.gov/media/120721/download
https://clinicaltrials.gov/ct2/show/NCT04201873
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.
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/
JTORENCE,
There are two upcoming conferences where Northwest Biotherapeutics is scheduled to participate—BNOS in July and CNS in September.
Conferences convened by world-renowned organizations such as ASCO, SNO, BNOS, NYAS, or CNS are never “nothing burgers” and conferences are never about any single company or any single presentation.
These events are global snapshots in time of the state of cancer care and new discovery. Medical conferences provide a glimpse, in momentary still frame, of the ever-evolving science toward better technologies and the future of oncology.
NWBO fits in the picture frame of world-renowned oncology conferences beautifully.
These events overall give some context to the emerging field of cell-based science and the future of cancer care. FDA officials are embracing the swift evolution of the science toward cell-based therapies and FDA officials are usually in attendance at global conferences.
Northwest Biotherapeutics is a small company on the cutting edge of science and innovation. The DCVax-L cell-based technology is on par with the biggest and best global blockbuster drugs. Consider the interim data of the pembrolizumab combo study at UCLA to illustrate why Northwest Biotherapeutics appears at worldwide conferences alongside companies like Merck and Bristol Myers Squibb.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172204891
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172194377
July 2023
https://www.bnosconference.co.uk/bnos-conference/
September 2023
https://www.cns.org/annualmeeting
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
HyGro,
Thanks for the response. Just to clarify: The MIA is a prerequisite of the MAA for DCVax-L.
The Specials License is referred to as “MS,” not MIA. The MIA is a commercial license that will allow DCVax-L to be manufactured commercially once it has its own approval. The MIA will apply to the DCVax-L product manufactured at Advent following the approval of DCVax-L.
https://nwbio.com/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-u-k-facility/
https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172038107
HyGro,
Thank you for highlighting the topic of the MHRA! I would like to add a reminder to this conversation about the highly significant recent developments:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172038107
HyGro,
Thanks for reosting your perspective again about the FDA and MHRA.
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.
https://www.fda.gov/media/120721/download
https://clinicaltrials.gov/ct2/show/NCT04201873
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.
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/
HyGro,
“Purgery” can only be found in a sugar factory.
Thank you for reposting that again, but the document you are referring to and your comments are outdated and out of context.
The NIH is the most significant player in this game if you are looking for “proof” or some kind of assurance. 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/
Foogie88,
Congratulations on your long position! We are always happy to welcome a long investor who recognizes the value to humanity of the DCVax-L cell-based platform technology!
You are 100% correct—NWBO has committed a lot of diligent work and resources to build a hefty BLA that has been under construction for a significant period of time and likely includes a voluminous catalogue of clinical data.
Just like the JAMA Oncology independent peer review, the regulatory filings will be executed with precision to ensure a favorable outcome.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172038107
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
BTW, have you met Poor Man? Any relation?
HyGro,
Thanks for reposting to ask about that again!
From my perspective, the NIH is the most significant player in this game if you are looking for “proof” or some kind of assurance as the NIH shares a common mission with the FDA. 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/
aesop1,
Yes, NWBO is the “tortoise.”
The independent peer review took a long time too, but it was successfully completed and published in JAMA Oncology, and it is a solid asset as we move further into the regulatory process.
Slow and steady wins the race!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172038107
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
Grip,
Good point! There always are two sides and opposing opinions…
Everyone must do their own research to determine for themselves which direction we’re likely going. Seek trustworthy full-context sources, and verify information found posted online.
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
Exactly.
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/how-clinical-trials-are-planned-and-organised/how-long-it-takes-for-a-new-drug-to-go-through-clinical-trials
https://www.drugs.com/fda-approval-process.html
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
iclight,
That does not make sense. The Expanded Access Program is specifically for drugs that have not yet been evaluated for approval.
Additionally, the FDA approved the PD1 combo study to commence, and that study is ongoing at UCLA today.
https://www.fda.gov/news-events/public-health-focus/expanded-access
https://www.uclahealth.org/departments/neurosurgery/expanded-access-protocol-treatment-glioblastoma-multiforme
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
Grip,
The company is still very small, but the leadership are formidable and tenacious. The independent peer review took a long time too, but it was successfully completed and published in JAMA Oncology, and it is an asset as we move further into the regulatory process.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172038107
iclight,
Excellent point! The fact that he is alive to have additional resections is significant. Patients who enjoy extended survival have the chance to try any number of additional medical treatments or wellness therapies.
I agree with you about NWBO only offering compassionate care in the U.K. Specials Program. It needs to be more available globally! Stay tuned!
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
iclight,
Great point! Thank you for reminding us about the brilliant compassionate use results. The compassionate use cases generated some astonishing data, and those data could be included in the regulatory filings!
https://t.co/082urSTQ0s
https://www.braintumourresearch.org/media/news/news-item/2022/11/18/astonishing-results-for-brain-tumour-vaccine-trial
HyGro,
Thanks for the reply and for reposting your perspective again. A little bit of research into the full picture can help to clear up the confusion. Here’s a quick review of some of the most relevant facts:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172139882
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172145669
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171927087
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171781313
exwannabe,
You raise a great point! When you’re looking at ECA data, you might wonder whether there would be proof of efficacy in a placebo study—you’re in luck! The DCVax-L cell-based technology has been under clinical investigation for a significant period of time using internal controls too! The overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from both external controls and placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
https://www.fda.gov/media/120721/download
https://clinicaltrials.gov/ct2/show/NCT04201873
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.
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 P3 was brilliantly executed and is more than adequate all by itself, but the application(s) for approval will require lots of paper clips and plenty of staples for all the extra pages that will be included—there is a voluminous catalog of supportive data that has been collected, analyzed, and validated.
All clinical data are relevant to a regulatory application including those data gathered from other studies, interim analyses, and compassionate use. All the DCVax-L trials have produced substantial safety and efficacy data, and two of the three clinical trials ran for over a decade with survivors alive today.
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
HyGro,
Thanks for reposting that again, but you are mixed up. Your information is out of context and outdated.
For information about the ECA/crossover design, endpoints, 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
HyGro,
I forgot about that! That approval is quite significant for anyone who doubted the P3 design. Yes, the P3 methodology was approved for a future clinical trial!
“The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company's Phase III trial in adult patients.”
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
Don’t forget that the MIA was also granted!
https://cms.mhra.gov.uk/mhra/mia/uk-mia-54923
The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
aesop1,
I think you’re mixed up. If I recall, Provenge was approved but the company did not have the capacity to produce the product. NWBO does not have that problem—NWBO has planned well to expand and scale manufacturing capacity to serve a global market.
Further studies can and should be required after commercialization. For example, Keytruda was commercialized years ago, but clinical studies involving Keytruda have continued ever since and will continue into the future. Safety and efficacy data should always be gathered and new combinations should be tested and investigated.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172029305
HyGro,
Thanks for asking! From my perspective, the NIH is the most significant player in this game if you are looking for “proof” or some kind of assurance. 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/
aesop1,
Thanks for the post—manufacturing capacity and RA approval for manufacturing are crucial. NWBO is on top of it!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171907111
The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
jondoeuk,
Your assertion is not from a reliable or verifiable source. The posting from the other message board is not credible and cannot be verified by looking at it.
Here is crystal clear proof directly from UCLA…
The article below was published just yesterday by UCLA where Dr. Prins is employed. At least examine the portion that I have excerpted above the full-context link — it clearly verifies that DCVax-L is same vaccine that was published in JAMA Oncology and it is the same vaccine that is being studied in combination with PD-1 blockade (pembrolizumab). Read the clear print of the article for yourself.
The UCLA article also embeds the link—click on the PD-1 portion inside the article and it directs you to: https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
HyGro,
Your post does not align with reality.
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.
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
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
jondoeuk,
Thanks for the reply. Your post is a distortion—it is missing crucial context and is misleading. The DCVax-L cell-based platform technology was analyzed by an independent peer review that was published in JAMA Oncology. Comments about the publication are not peer reviewed and are not part of the medical literature.
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://ceoworld.biz/2022/04/05/top-5-medical-journals-in-the-world-everyone-should-know-about/