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For anybody paying attention there are very good reasons why the trial has taken so long and why we have not had accelerated approval YET. What is evident is the importance the UK assigns to this technology as shown by their designations and recent approval (PIP). The 'writing is on the wall' with approval pending.
that's a good one!
So you’re saying that JP Morgan, Goldman and others don’t have specialists that understand what’s going on the science industry. That they’re not looking for the next game changer.
Not sure I get your point. Very few on this board may not understand but major investment firms sure do and I’m just surprised that they’re not following or buying.
Just my opinion.
When you combine the fact that our trial was adopted as a national priority trial in the UK, designated "A promising innovative medicine" (PIM), along with the filing of application for licence for commercial manufacturing and approval of Pediatric investigation plan by MHRA, IMO really not a question IF DCVax is approved by MHRA, only WHEN
2013 was 9 years ago so if DCVax-L was a priority for the UK I’d hate to see how long something that was not a priority would take.
The reason that these great sounding announcements get forgotten is that the passage of time reveals their truth worth and bringing them up again elicits embarrassment or annoyance.
Ironically this isn’t management’s fault.
Ultimately all these government shortcuts meant to expedite stuff for companies, patients or both like EAMS, HE, or Right to Try never amount to much.
Until you see what it means in terms of increases speed, on the ground you have to assume it’s fluff.
We’ll it’s been 9 years and the trial was well along in 2013 so the jury has come in:
This was fluff.
SALIENT RESEARCH :
pgsd
Re: None
Monday, October 03, 2022 2:20:43 AM
Post#
518586
of 518592
???? The Danish Dude ???? (Madam/Your highness)
@FlemmingBruce
$NWBO
What did Linda Liau say in an interview, 2 years ago?
Comment 1:
https://twitter.com/FlemmingBruce/status/1576557919042093057
DONE. Flaskworks has managed to do, what Liau means is lacking.
https://billmalloy.info/qa-with-linda-liau/
pgsd
Re: None
Monday, October 03, 2022 6:42:59 AM
Post#
518590
of 518593
Excellent post, in the passage of time some key and positive factors are forgot or overlooked.
NW Bio’s Phase III Trial With DCVax®-L For Brain Cancer “Adopted” As A National Priority Trial In UK
Cred54675419C's avatar
c red @Cred54675419C
1h
Replying to @TodosInvestor @FlemmingBruce @WayneLee1983
The UK government has set a goal of making the UK a world leading innovator in medicines.
FlemmingBruce's avatar
???? The Danish Dude ???? (Madam/Your highness)
@FlemmingBruce
Replying to @Cred54675419C @TodosInvestor @WayneLee1983
Great info @Cred54675419C ??
The NIHR maintains a “portfolio” of clinical trials that have
been “adopted” as high priorities for the UK. In order to be
selected for the NIHR Portfolio, a proposed clinical trial must go
through multiple layers of review and evaluation. The
evaluation includes the potential significance of the new medical
technology being tested, the quality of the trial design, the
feasibility of the trial, and numerous other factors.
Trials that are selected (“adopted”) for inclusion in the NIHR Portfolio are monitored closely by
the NIHR and the trial sites receive several types of financial and operational support. For
example, the NIHR provides resources and funding for additional staff (e.g., nurses) at the trial
sites to help accelerate the trial. The NIHR also oversees the performance of the sites, and
imposes penalties on the sites for shortfalls such as lags in enrollment.
“We understand that it is relatively rare for a small biotech company to have its clinical trial
‘adopted’ into the NIHR portfolio, especially a Phase III trial,” noted Linda Powers, CEO of NW
Bio. “This important validation of our trial is an exciting development, and the extra resources
and support from the NIHR to the trial sites will be very helpful in accelerating our trial.
https://nwbio.com/nw-bios-phase-iii-trial-with-dcvax-l-for-brain-cancer-adopted-as-a-national-priority-trial-in-uk-2/
SkyLimit2022
Re: dr_lowenstein post# 518567
Sunday, October 02, 2022 10:39:01 PM
Post#
518569
of 518593
Maybe you’re right—and maybe DCVax patients are paid to be alive too.
So many of these survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
https://m.youtube.com/watch?v=K9azZaIwOH8&feature=youtu.be
SkyLimit2022
Re: HyGro post# 518554
Sunday, October 02, 2022 9:54:46 PM
Post#
518560
of 518594
NVCR made some specific statements too in their February 24th 2022 SEC filing. Their risk disclosures start on page 26 of the NovoCure filing posted below. You stated that SEC filings are submitted under penalty of perjury and should be considered by investors. I tend to believe that the documents as a whole are important, but we could follow your lead and pluck out some interesting risk statements to publish in isolation. What do you think?
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001645113/c5eca622-306f-417f-931b-c2ab018fa6b6.pdf#page25
SkyLimit2022
Re: HyGro post# 518556
Sunday, October 02, 2022 9:57:01 PM
Post#
518561
of 518594
Thank you for again again again reminding us about Pazdur’s position on this point:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
"Novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug.”
—Richard Pazdur, MD
Richard Pazdur, M.D. is the director of the FDA's Oncology Center of Excellence (OCE), which leverages the combined skills of the FDA's regulatory scientists and reviewers with expertise in drugs, biologics and devices to expedite the development of novel cancer products. In his role as director of the OCE, Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.
Pazdur previously served as the director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research and will continue to serve in OHOP as acting director. This Office was formed in 2005 to consolidate the review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer, as well as the review of drugs and therapeutic biologics for hematologic diseases and for medical imaging. As director of OHOP, Pazdur facilitated coordination of oncology activities across all FDA Centers and ensured an ongoing outreach and collaboration between the FDA, the National Cancer Institute, and other cancer-related organizations within and outside of the government. Pazdur was the director of the Division of Oncology Drug Products from September 1999 to May 2005.
Prior to joining the FDA, Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. Pazdur was on the faculty of the M. D. Anderson Cancer Center from 1988 to 1999. During his tenure at the M. D. Anderson Cancer Center, Pazdur held administrative positions of assistant vice president for academic affairs, associate director of clinical trials administration (Division of Medicine) and director of educational programs (Division of Medicine). Pazdur served on the faculty of Wayne State University, Detroit, Michigan from 1982 to 1988.
Pazdur received his bachelor’s degree from Northwestern University (Evanston, Illinois), his M.D. from Loyola Stritch School of Medicine (Maywood, Illinois), and completed clinical training at Rush-Presbyterian St. Luke’s Medical Center (Chicago, Illinois) and the University of Chicago Hospitals and Clinics.
Pazdur has published more than 400 articles, book chapters and abstracts. In 2015, Fortune magazine named Pazdur as one of the 50 World’s Greatest Leaders. The American Association for Cancer Research recognized Pazdur with its Distinguished Public Service Award (2015) and the American Society of Clinical Oncology recognized him with the Service Recognition Award (2009) and the Public Service Award (2013). In 2015, Pazdur also received the Public Service Leadership Award from the National Coalition for Cancer Survivorship and also the Face of Hope Award from the LUNGevity Foundation. Most recently, in 2016, Pazdur was named to Massachusetts General Hospital Cancer Center’s “The One Hundred” list.
https://virtualtrials.org/dcvax.cfm
SkyLimit2022
Re: HyGro post# 518555
Sunday, October 02, 2022 9:59:12 PM
Post#
518562
of 518594
Thank you for again highlighting the exemplary trial design—compassionate, clinically appropriate, adaptive, and representative of DCVax as an innovative new platform technology.
The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.
Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
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://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://nwbio.com/press-releases/
More recent news and events:
https://m.youtube.com/watch?v=h_tev1qm1ZE&feature=youtu.be
Dr. Ashkan, a world-renowned clinical trial expert and an advisor to the U.K. government, presents DCVax P3 data.
https://soc-neuro-onc.org/
Autologous tumor lysate-loaded dendritic cell vaccination improves survival in patients with newly diagnosed and recurrent glioblastoma: survival results from a phase 3 trial Plenary Abstract Presenter: Linda M. M. Liau, MD PhD
- University of California, Los Angeles
https://youtu.be/Oq39FFUwKug
UCLA Presentaion
DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40
Other Relevant Links:
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://virtualtrials.org/dcvax.cfm
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
SkyLimit2022
Re: HyGro post# 518555
Sunday, October 02, 2022 10:03:48 PM
Post#
518563
of 518594
Dubious you say? Your postings would be less dubious if you included this disclosure about your investment in NovoCure:
I can’t imagine what it must be like for folks that bought a ton 8-9 years ago when NWBO was trading over $5. They got diluted like hell.
There are still bigger losers namely the buy and hold shareholders who support DCVax-L with our wallets.
Excellent post, in the passage of time some key and positive factors are forgot or overlooked.
NW Bio’s Phase III Trial With DCVax®-L For Brain Cancer “Adopted” As A National Priority Trial In UK
Cred54675419C's avatar
c red @Cred54675419C
1h
Replying to @TodosInvestor @FlemmingBruce @WayneLee1983
The UK government has set a goal of making the UK a world leading innovator in medicines.
FlemmingBruce's avatar
???? The Danish Dude ???? (Madam/Your highness)
@FlemmingBruce
Replying to @Cred54675419C @TodosInvestor @WayneLee1983
Great info @Cred54675419C ??
The NIHR maintains a “portfolio” of clinical trials that have
been “adopted” as high priorities for the UK. In order to be
selected for the NIHR Portfolio, a proposed clinical trial must go
through multiple layers of review and evaluation. The
evaluation includes the potential significance of the new medical
technology being tested, the quality of the trial design, the
feasibility of the trial, and numerous other factors.
Trials that are selected (“adopted”) for inclusion in the NIHR Portfolio are monitored closely by
the NIHR and the trial sites receive several types of financial and operational support. For
example, the NIHR provides resources and funding for additional staff (e.g., nurses) at the trial
sites to help accelerate the trial. The NIHR also oversees the performance of the sites, and
imposes penalties on the sites for shortfalls such as lags in enrollment.
“We understand that it is relatively rare for a small biotech company to have its clinical trial
‘adopted’ into the NIHR portfolio, especially a Phase III trial,” noted Linda Powers, CEO of NW
Bio. “This important validation of our trial is an exciting development, and the extra resources
and support from the NIHR to the trial sites will be very helpful in accelerating our trial.
https://nwbio.com/nw-bios-phase-iii-trial-with-dcvax-l-for-brain-cancer-adopted-as-a-national-priority-trial-in-uk-2/
Great summary TDD !
Thank you.
GLTU
Replying to
@FlemmingBruce
Comment 3:
Comment 3:
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) October 2, 2022
On Novocures Optune.
Don't like it. Don't understand it. Lot of us don't believe it works. Lot of problems with the clinical trial. pic.twitter.com/vkxmxLaXwT
???? The Danish Dude ???? (Madam/Your highness) $NWBO
@FlemmingBruce
$NWBO
What did Linda Liau say in an interview, 2 years ago?
Comment 1:
What did Linda Liau say in an interview, 2 years ago?
Comment 1:
DONE. Flaskworks has managed to do, what Liau means is lacking.https://t.co/4wzzL2rqTB pic.twitter.com/bCZS8JoXhB
DONE. Flaskworks has managed to do, what Liau means is lacking.
https://billmalloy.info/qa-with-linda-liau/
Mav,
I believe that revenue is highly overrated, anticipation of future growth and revenue is far more important. As you probably know, I'm an investor in IMGN essentially since it's been public, I've watched SGEN grow to many times the market cap of IMGN but still believe IMGN the better investment. SGEN has more approved, but has had very few profitable quarters. Merck did have the sense not to overpay for SGEN, as had been anticipated, but their market cap remains a huge multiple of IMGN's. I believe IMGN's approval of MIRV will make a dent in this, but they'll need a few more drugs to be approved to approach SGEN's market cap, I think it will take a few years, but it will happen.
With a little positive news on DCVax's being the new paradigm in the treatment of cancer I believe we'll see prices between at least $5 and well into double digits. Once shareholders authorize more share whether we get an equity partner or not it won't take that many share to cover operations and clinical trial growth while revenue is growing. Bringing in $100 million is a big deal when you're trading for under $1, it's not so much when you're trading for over $10. While I'd hope they get that equity partnership, but if not as long as the news is what we believe it to be, it won't be a problem.
Gary
A lot of us that bought from $3 up to $12 also backed up the truck between $0.14-$0.50.
I had reduced my average cost to about $0.68 but since I’ve continued adding whenever I have loose change I have raised the average to about $0.75 now.
I regret limiting the buying at $0.14 because of perceived level of risk.
Most of the risks have since been taken out, but hindsight is 20/20
Gary, I have been in this for 7 odd years now. I am a bit fortunate that I sold a little over 50% of my personal investment in NWBO this spring. I am playing with house money at this point and yet I am frustrated given the opportunity cost during these years. I can’t imagine what it must be like for folks that bought a ton 8-9 years ago when NWBO was trading over $5. They got diluted like hell.
I am convinced that 2023 will be disappointing from a revenue perspective. So we ain’t going anywhere for a while unless there is a major partnership announcement soon and that seems unlikely at the rate they are diluting us.
that would be interesting ;)
There was never a dubious NWBO Phase 3 trial. NWBO is on the right path and that is all that matters.
Once again, NWBO SEC filings are as clear as day, but perhaps you are in a dark place unable to read the true NWBO SEC filings. Recommend a new pair of glasses.
NWBO's SEC filings are all in order and in accordance with the SEC regulation standards.
No, not at all, I mean the real OS data, case closed since the OS data is valid and real.
HyGro,
You appear to be reading the risk section of SEC filings for NWBO like there is a boogeyman trying to attack investors then post here warning us that we will be attacked too. I am very certain that almost all the longs on this board have moved well along from that particular stage of human development and are quite aware of the risks here and of getting out of bed in the morning and heading out. It’s an apple not the sky or in Poor Man’s case it might just be a pigeon ; ). Best wishes.
The reality is, why stretch out a trial? To get 5,7, and perhaps 10 year OS data. I am certain they did not plan this originally, but when they realized how good DCVAX can be, it makes sense. Good luck to competition running a trial long enough to get the long OS data.
Most biotechs fail, they follow the same strategy. A path never traveled is always GROUNDBREAKING... and your get GROUNDBREAKING results.
abeta,
Thanks. That’s quite a few patient lives that are going to have a good chance to be significantly extended with L, Direct and adjuvants and or combos. Looking forward to another step towards the better day. Best wishes.
No question on the applause. Corrected
Maybe you’re right—and maybe DCVax patients are paid to be alive too.
So many of these survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
the experts are all paid to say it was a success, and then there is a podiatrist LOL LOL
Confounding after a highly successful P3 trial is an impossible task. The helmet will be obsolete.
Wow. All your investment dollars are being wasted.
Thank you for again highlighting the exemplary trial design—compassionate, clinically appropriate, adaptive, and representative of DCVax as an innovative new platform technology.
The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.
Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
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://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://nwbio.com/press-releases/
More recent news and events:
Thank you for again again again reminding us about Pazdur’s position on this point:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
"Novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug.”
—Richard Pazdur, MD
Richard Pazdur, M.D. is the director of the FDA's Oncology Center of Excellence (OCE), which leverages the combined skills of the FDA's regulatory scientists and reviewers with expertise in drugs, biologics and devices to expedite the development of novel cancer products. In his role as director of the OCE, Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.
Pazdur previously served as the director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research and will continue to serve in OHOP as acting director. This Office was formed in 2005 to consolidate the review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer, as well as the review of drugs and therapeutic biologics for hematologic diseases and for medical imaging. As director of OHOP, Pazdur facilitated coordination of oncology activities across all FDA Centers and ensured an ongoing outreach and collaboration between the FDA, the National Cancer Institute, and other cancer-related organizations within and outside of the government. Pazdur was the director of the Division of Oncology Drug Products from September 1999 to May 2005.
Prior to joining the FDA, Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. Pazdur was on the faculty of the M. D. Anderson Cancer Center from 1988 to 1999. During his tenure at the M. D. Anderson Cancer Center, Pazdur held administrative positions of assistant vice president for academic affairs, associate director of clinical trials administration (Division of Medicine) and director of educational programs (Division of Medicine). Pazdur served on the faculty of Wayne State University, Detroit, Michigan from 1982 to 1988.
Pazdur received his bachelor’s degree from Northwestern University (Evanston, Illinois), his M.D. from Loyola Stritch School of Medicine (Maywood, Illinois), and completed clinical training at Rush-Presbyterian St. Luke’s Medical Center (Chicago, Illinois) and the University of Chicago Hospitals and Clinics.
Pazdur has published more than 400 articles, book chapters and abstracts. In 2015, Fortune magazine named Pazdur as one of the 50 World’s Greatest Leaders. The American Association for Cancer Research recognized Pazdur with its Distinguished Public Service Award (2015) and the American Society of Clinical Oncology recognized him with the Service Recognition Award (2009) and the Public Service Award (2013). In 2015, Pazdur also received the Public Service Leadership Award from the National Coalition for Cancer Survivorship and also the Face of Hope Award from the LUNGevity Foundation. Most recently, in 2016, Pazdur was named to Massachusetts General Hospital Cancer Center’s “The One Hundred” list.
https://virtualtrials.org/dcvax.cfm
NVCR made some specific statements too in their February 24th 2022 SEC filing. Their risk disclosures start on page 26 of the NovoCure filing posted below. You stated that SEC filings are submitted under penalty of perjury and should be considered by investors. I tend to believe that the documents as a whole are important, but we could follow your lead and pluck out some interesting risk statements to publish in isolation. What do you think?
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001645113/c5eca622-306f-417f-931b-c2ab018fa6b6.pdf#page25
Poor Man, Include me in the loser group. Sold 50k shares last year at $1.50 and bought back from 1.23 to 92 cents. Thought I was doing good - WRONG!!!
should have waited to buy under 50 cents - oh well, probably should have sold 500k shares instead then could have had some meaningful $
You are referring to the old endpoints of PFS. Can't confound beating hearts, which is the gold standard endpoint and exactly what NWBO switched to!
have a good one hygro
You mean using confounded naive OS data??
"What is confounding?
Confounding is often referred to as a “mixing of effects”1,2 wherein the effects of the exposure under study on a given outcome are mixed in with the effects of an additional factor (or set of factors) resulting in a distortion of the true relationship. In a clinical trial, this can happen when the distribution of a known prognostic factor differs between groups being compared.
Confounding factors may mask an actual association or, more commonly, falsely demonstrate an apparent association between the treatment and outcome when no real association between them exists."
Has nothing to do with the dubious NWBO Phase 3 trial.
So NWBO making very specific statements in their SEC filings, under penalty of perjury is now "manufacturing disinformation?" They are stating the facts as they are obligated too. NWBO wants to avoid investor class action suits and SEC investigations, so they reveal for facts, even it is buried pages deep in their SEC filings.
2014 Ovarian STUDY:
https://www.prnewswire.com/news-releases/nw-bio-making-a-joint-poster-presentation-on-its-dcvax-direct-trial-at-the-29th-annual-sitc-meeting-281912681.html
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3583933/?report=reader
MISCELLANEOUS:SkyLimit2022
Re: HyGro post# 518269
Sunday, October 02, 2022 3:42:57 PM
Post#
518504
of 518553
HyGro, I wonder why you don’t go over to the NVCR message board and post cherry-picked SEC disclosures from their February 24th 2022 SEC filing. Their risk disclosures start on page 26 of the NovoCure filing posted below. You stated that SEC filings are submitted under penalty of perjury and should be considered by investors. I tend to believe that the documents as a whole are important, but we could follow your lead and pluck out some interesting risk statements to publish in isolation. What do you think?
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001645113/c5eca622-306f-417f-931b-c2ab018fa6b6.pdf#page25
The Danish Dude
Re: None
Sunday, October 02, 2022 5:53:24 AM
Post#
518358
of 518553
I have compiled a "what has happened in 2022" guide or in other terms "Let's pump it" for those who haven't heard of the phenomenons of reason, rationality, logic, that makes it possible to put forth information and thesis that are qualified with regards to being either uncompromising facts, or very probable.
Let's take a stroll down the 2022 memory lane and sum up, why the NWBO stock currently is the best stock investment since Gamestop around new years eve 2020, at this ridicolous price level.
Facts
January 9th.
The use of the external control arms trial design gets thumbs up by FDA, as the article "External Control Arms in Oncology: Current Use and Future Directions", gets printed in Annals of Oncology. 12 co-authors, among these dr. Richard Pazdur, ALL affiliated with U.S. Food and Drug Administration, also known as FDA.
January 11th.
AdventBio announces their new Cryostore and Freezer facility at Sawston.
January 23rd.
It is found out, that dr. Roger Stupp, the man behind The Stupp protocol, which became standard of care for the treatment of glioblastoma (GBM) since its publication in 2005, became an advisor to NWBO BEFORE September 26th. 2020.
January 27th, February 17 and 26th.
3 articles in british newspapers specifying the NWBO and AdventBio connection, with the later dedicated to do NWBO's bidding as a CDMO in terms of manufactoring and production.
When reading, one is not in doubt of the "mother-child" setup and what is AdventBio's main purpose.
"Northwest Biotherapeutics has secured MHRA certification for its cancer vaccine trials in the Sawston Business Park, sparking delight for site developer Advent BioServices. Advent, which is based on the Park, has completed the laboratory facilities to UK regulatory standards on behalf of Northwest Biotherapeutics, which is headquartered in Bethesda, Maryland. NW Bio’s Sawston R&D team is working on a cancer vaccine for glioblastoma multiforme, the most aggressive type of brain cancer."
Article reveals that AdventBio are now 40 employees. Most hired within a year.
February 6th.
A Global Glioblastoma Multiforme Drug Forecast and Market Analysis expect DCvax-L to be one of three pipeline agents to have highest sales in the GBM market till 2030.
February 17th.
Advent Bioservices – NW Bio’s contract manufacturer in the UK – has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use.
The first vaccine production for compassionate use treatment is for a glioblastoma patient.
March 2nd.
Dr. Marnix Bosch speaks at the Brain Tumour North West Retreat, a yearly cancer symposium, which is attended by british gbm clinicians. It seems he gets registered late for a 2 hours session, where he is to speak of “Dendritic Vaccine”.
The news is not in any way published. A participant tries to delete his tweet revealing this and blocking anyone writing about it. In vain.
March 31st. 2022
Linda Liau speaks about “Therapy induced resistance in glioblastoma” at University of Miami. She talks about the UCLA Spore 1 project, which directly mentions the use of DCVax-L in conjunction with PD-1 inhibitors.
She also talks about the combo trial that started in 2010, that has run for 12 years, combo'ed with Resquimod and nt least Poly-ICLC:
"That’s actually another project, we’re working on getting collaboration with Mark Gilbert and NCI. We’re actually trying to collect all these people, because even in our immunotherapy trials, I think we have about 50 of them now, that are over 5 years going on 10 years"
“The group that got dendritic cell vaccination plus poly-ICLC had a 50% survival rate and now the majority of these patients are reaching 100 months and with not only survival but really no tumor recurrence.”
May.
Dr. Linda Liau is in the UK.
May 10th.
Results of the P3 DCvax-L trial is presented at NYAS. All endpoints met, statistic significance. Landmark results, the best seen in 3 decades.
June 5th.
Northwest Biotherapeutics Announces Presentations On DCVax®-L Personalized Vaccines, Manufacturing and Scale-Up, and DCVax®-L Clinical Program. They are now able to scale to 1.000 patients pr. month. 12.000 pr. year.
June 6th.
Professor Keyoumars Ashkan from Kings Hospital in London presents P3 DCvax-L results in a video.
June 8th.
Hugh Adams, Head of Stakeholders Releations from the british Brain Tumour Research organisation writes the following in an email:
"Thank you for your email, your information and your advice. We communicate directly with Linda Powers at NWBio and most recently facilitated her contributing to a meeting with UK politicians as part of an inquiry into the pathway to a cure for brain tumour patients."
May 16th.
NWBO submits annual OTCQB certification Michael Fox (new) and Sarah MacLeod (known) have been added as IR/PR service providers.
About Michael Fox:
With more than 25 years of experience in strategic communications at global PR agencies and in politics, Michael has advised leading global companies, promising start-ups, respected organizations and political candidates across the full range of communications, media and reputation management activities. He leads the Corporate Communications Group at ICR and specializes in corporate positioning, executive coaching, crisis, transactions and special situations.
Michael has provided communications counsel on more than 100 IPOs, scores of M&A transactions.
June 23rd.
Professor Keyoumars Ashkan yet again presents the P3 DCVax-L trial results at BNOS in Liverpool in England. At the presentation is Linda Powers CEO of NWBO. Mike Scott CEO of Advent Bioservices. Dr. Roger Stupp creator of the chemotherapy Standard-of-Care and now advisor to NWBO and Hugh Adams, the Head of Stakehold relations at british Brain Tumour Research organisation
July 1st.
Dr. Linda Liau presented the DCVax-L Phase III trial results in Prague, at The Society of University Neurosurgeons 2022 Annual Meeting.
July 6th.
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
August 17th.
Northwest Biotherapeutics receives final Approval of Pediatric Investigation Plan (PIP) by MHRA, green lighting the use of OS endpoint and external control arm trial design in the P3 Adult trial.
September 30th.
Advent Bioservices continues to hire and have now more than 60 employees. Their latest job roles includes a GMP Production Scientist in London, with the following job description (excerpt).
"The GMP Production Scientist will be responsible for performing batch manufacturing of the company’s contract manufacturing products to support the delivery, in the first instance, of Advanced Therapeutic Medicinal Products (ATMPs) as both ”Specials” and as Investigational Medicinal Products (IMPs). The post holder will work closely with GMP Production Scientists, Quality Assurance Scientists and facilitate the efficient delivery of cellular therapy products for clinical use."
Correlate that with NWBO press-release from 21st. December 2021, when they announced MHRA Approval Of License for GMP Manufacturing At Sawston, UK Facility and you can not miss how AdventBio are continually hiring people that fullfill NWBO's future plans.
"The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme."
It's only to congratulate those diamond hands, that wonders what the talk about the management not doing their shareholders bidding is all about, who are patiently awaiting the inevitable and who use the extra time to continue to load up.
Mav,
You're only a looser if you bought at $1 or even $2 if you've sold. If you've held and hopefully added at the lower price I believe you'll see days where NWBO is up $1, $2, or more in just a day, actually perhaps in minutes some day. Give it time, it can still be the best investment of your life.
Gary
Mav, I’m only human!
I suspect to realize a 60% compounded return over five years would also require some shorting of NWBO. Would be very difficult to simply buy and sell as a long as a trader’s only strategy.
Bruv , snovember 2022 is where it’s at! I been saying it for months but been randomly attacked by posters here saying it’s snonsense!
Considering the NWBO specifically listed the issues with their trials. it certainly is NOT cherry-picking. It is specifically relevant to the trial, was not included in any other press releases or presentations. They buried it in SEC filings that, they knew most investors wouldn't read. But it is the facts and regulators will certainly know it and it adds significant risk that they won't approve NWBO's application when they finally get around to filing it.
I feel ya homey!
Btw, I like squid every way it’s prepared. Stuffed and baked like my mom used to make them, sliced in pasta, and of course fried legs and all.
I also like octopus but now I feel guilty eating them after reading about how they’re intelligent feeling creatures.
Then again I’d have to go vegan thinking about pigs, birds, rabbits and the cute deer outside my house that no longer fear humans. And then there’s veal and lamb, oh no I’m so torn!
Agree 100%. I am not making any judgment calls on management until this has played out. I am also not disturbed by the time it has taken. When we get some more info post Journal article, I will make my assessment, but holding on for now.
I’m convinced New Jersey is just another region of Italy, which I attribute to being why I’m also so fond of Italian food — except for squid. The ramen is more of an acquired taste and cheaper alternative for my life style.
I figure if I hold 20% of what I now own, and by some miracle this stock hits the mother load, that is still a beach front park bench. And if it goes to zero, I still have a bed and hot water.
The risk I’m taking is anything that goes south from now until November.
Anders, wow! Awesome share!
I understand your situation and at least keeping 20% in is a meaningful enough stake if “old Les’ a billionaire” happens.
To be honest, I could eat pasta every day (if I wasn’t so overweight and pre-diabetic practically) and enjoy it, but ramen not so much at all.
Pasta fagioli maybe yes
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“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”
~ Winston Churchill
Stylized Dendritic Cell featured on NWBO board since 2015
- Dr. Linda Liau, PhD, MBA, Professor and Chair, Department of Neurosurgery, David Geffen School of Medicine at UCLA
Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind)
UK (MHRA): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
DE (Germany - PEI): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III
Dendritic Cell Vaccine for Patients with Brain Tumors (NCT01204684) - Phase II - at UCLA - Randomized (Open Label) testing DCVaccine with Resiquimod and DC Vaccination with Adjuvant polyICLC
Pembrolizumab and a Vaccine (ATL-DC) for the treatment of Surgically Accessible Recurrent Glioblastoma - Phase 1 (NCT04201873)
Dendritic Cell-Autologous Lung Tumor Vaccine (DCVax-L) and Nivolumab in Treating Patients with Recurrent Glioblastoma - Phase 2 (NCT03014804)
Dendritic Cell Therapy for Brain Metastases From Breast or Lung Cancer (NCT0368765) - Phase 1 - Collaborator: Mayo Clinic
Announcement of DCVax-L and Anti-PD-1 Monoclonal Antibody (Pembrolizumab) for Patients with Liver Metastases of Primary Colorectal Carcinoma Phase 2 Trial - November 17, 2016 - University Medical Center (UMC) of the Johannes Gutenberg University of Mainz
Cognate Bioservices - Owned by Charles River Labs
Website
Company Contact Info
Investor Relations:
Les Goldman (Company) (202) 841-7909 lgoldman@nwbio.com
Sign up for Northwest email list here (hit the subscribe to email list button in the lower right)
Company Headquarters
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814 (240) 497-9024
NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs. NW Bio’s proprietary manufacturing technology enables them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines.
Their lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. This trial is currently underway at 69 locations thoughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.
Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.
They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
DCVAX Survival Stories & Testimonials
Alice - Metastic Merkel Cell patient from Florida - ASCO 2018
Brad Silver - GBM patient from Huntington Beach, California - ASCO 2018
Sarah Rigby - GBM patient from Hong Kong - ASCO 2018
Kristyn Power - daughter of GBM patient from Canada - ASCO 2018
Kat Charles - GBM patients from UK - ASCO 2018 - as related by her husband Jason (Kat's Cure)
Prospective patients may contact NW Bio at patients@nwbio.com
UCLA Jamil Newirth DCVax-Patient Video - 2015
Allan Butler Video - National Geographic Vice President - DCVax-Direct patient from Phase 1 Trial with Pancreatic Cancer
NWBO - Patients Sunday Dennis and Jami Newirth - Enrolled at UCLA - Vimeo, Uploaded approx. May 2015
NWBO - Vaccine Helps Keep Brain Cancer Patient Alive (Jennifer Sugioka) - NBC Channel 4, Southern California, February 24, 2015
NWBO - National Geographic's Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
Presentations
UCLA Agreements
Prostrate
DCVax-Phase II
DCVax-Booster
Upcoming Events
Videos
Linda M. Liau, MD, PhD, MBA - April 24, 2019 at University of Washington, Neurosciences Institute
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