ATLnsider
@ATLnsider
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Investor with over 25 years experience specializing in the biotech & pharmaceutical industries. My tweets are my own opinions. Please do your own research.
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Congratulations $NWBO & Advent for obtaining MIA from MHRA that authorizes commercial manufacturing of
#DCVax
-L. This is another major milestone accomplished. We’re surrounded by negative voices on social media 24/7/365. It’s important to focus on milestones not daily stock price
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I think it's time to take a comparative look at the qualifications & credentials of who thinks $NWBO
#DCVax
trial was an overwhelming success & it met both its Primary & Secondary endpoints versus those who think the DCVax-L Phase III failed. Any critical-thinking person can see:
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More good news for $NWBO &
#DCVax
-L. According to the American Society of Gene & Cell Therapy (ASGCT), the DCVax-L MAA submitted to the MHRA was not just for newly diagnosed and recurrent Glioblastoma (GBM). It includes all malignant gliomas. This will significantly increase the
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Dr. Linda Liau will teach up to 1,000 SNO-EANO neurologists, neuro-oncologists, oncologists, neurosurgeons & other KOLs in the US & Europe about the $NWBO
#DCVax
-L Phase 3 trial results on 2/14/23 (Valentine’s Day):
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#murcidencel
$NWBO: I have updated my Table (with the 50 abstract signers) that compares background, experience & credentials of experts who believe
#DCVax
-L Phase 3 was successful & it met both its Primary & Secondary Endpoints with statistical significance, with those who don’t
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$NWBO
#DCVax
-L trial results picked by the editorial board as 1 of the top / best advances - “News That Mattered”- during 2022 in the 1/19/2023 edition of Neurology Today:
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$NWBO will be able to treat Grade IV newly diagnosed & recurrent GBM with
#DCVax
-L & also Grade III malignant brain tumors. This will effectively double addressable market size. Also biomarker & proteomics analysis is good for tissue agnostic approvals:
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$NWBO
#DCVax
news: “This therapy has been in development for a long time and it is finally getting closer to reaching the people who can potentially benefit”: - Page 20
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It was very encouraging to see that $NWBO allowed their attorneys to include evidence in the MTD response to show that NWBio will be filing for imminent
#DCVax
-L regulatory approval with the FDA soon:
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Congratulations Dr. Linda Liau for being named by Women in Neurosurgery (WINS) a 2023 Woman of the Month during the month of December. This is well-deserved honor. The world will know more about your outstanding accomplishments after $NWBO
#DCVax
-L is approved by regulators in
We can't think of a better person to close out our 2023 WINS Woman of the Month features than Dr. Linda Liau!
Dr. Liau is
#MD
,
#PhD
,
#MBA
,
#DepartmentChair
, & Executive Medical Director of
@UCLANsgy
😱👏
#Neurosurgery
#WINSxWOM
#WomenInNeurosurgery
#WomenInSTEM
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I believe when $NWBO
#DCVax
-L is approved by all regulatory authorities soon, the approval will automatically include poly-ICLC as the maturation & activation agent. Extraordinary results have achieved with this combination (DCVax-L + poly-ICLC) DCVax 2.0:
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$NWBO is close to getting
#DCVax
-L approved in US, UK, Canada, Germany & rest of EU. There are forces with conflicting financial interests. $NWBO must stay focused on getting regulatory approvals & don’t worry about naysayers & detractors. As Dr. Liau said “the data is the data”.
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Thanks
@metacollectiveG
, This Nature article has been peer-reviewed. I really like this part about $NWBO & it confirms that
#DCVax
= ATL-DC. $NWBO has licensed the DC Vaccine technology from UCLA under the trademark name of DCVax: “Linda M. Liau is a member of the Scientific
$NWBO Nature just published Dr Liau’s landmark work
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If you know a family member, friend or anyone who has been diagnosed with newly diagnosed or recurrent Glioblastoma (GBM), Houston Methodist Hospital has put together a good summary of what $NWBO
#DCVax
-L is & how it works. Please share it with them:
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$NWBO sounds very optimistic & bullish in its email to shareholders today, which announced that the
#DCVax
-L MAA has been submitted to the MHRA. They indicate that more positive news should be released soon, in early 2024. I am hoping for some or all of these announcements: (1)
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Great news for GBM patients. UCLA says $NWBO
#DCVax
-L will be submitted for FDA approval soon: “As the therapy awaits submission for approval to the U.S. FDA, it is one of the latest examples of UCLA Health research moving from the bench to the bedside”:
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Great news for $NWBO &
#DCVax
. It appears that Dr. Linda Liau and her team at UCLA have successfully used CRISPR technology to change unmethylated cancer patients into methylated patients. This will help enable more solid tumor cancer patients to be cured:
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Dr. Marnix Bosch from $NWBO will be presenting
#DCVax
-L trial results & manufacturing info at the 4th Annual Glioblastoma Drug Development Summit on 3/15/23 at 11:30AM. The trial results were the 1st to have positive results for both nGBM & rGBM:
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This Neuro-Oncology Nurse Navigator is anxious for
#DCVax
-L to be approved soon by
@FDAOncology
so that it will be available to help more Glioblastoma patients live longer. I hope $NWBO will get it approved in US, Canada, UK, Germany & rest of EU soon :
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What does Brad Silver (18-Year survivor), Jeannine Walston (8-Year survivor) & Jamil Newirth (9-Year survivor) have in common? They were diagnosed with GBM & treated with
#DCVax
at UCLA by Drs. Linda Liau & Timothy Cloughesy. $NWBO will release TLD soon:
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According to Al Musella at the Musella Foundation for Brain Tumor Research, the $NWBO
#DCVax
clinical trial results “look very good!” “This is a major advance in the treatment of not only brain tumors but it is applicable to all solid tumors”:
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Unfortunately, IHub keeps removing this post I made today about $NWBO and
#DCVax
. So, I am posting it here to preserve it:
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Now we have 2nd slide that says UCLA combination trial that includes
#DCVax
-L & poly-ICLC + Pembrolizumab (Keytruda) is now in Phase 2. 1st slide was shown on 5/14/23 & 2nd slide was on 6/17/23 by Dr. Liau at 37:20 time stamp. This is good for $NWBO:
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2024 is setting up to be a special year of recognitions & awards for Dr. Linda Liau. This will continue with the imminent approval of $NWBO
#DCVax
in the UK & the eventual approval of DCVax in the US, Canada, Germany & the rest of the EU:
This past weekend, our Chair Dr. Linda Liau won the prestigious Winn Prize at the 2024
@SNS_Neurosurg
Annual Conference. This award recognizes outstanding, continuous commitment to research in the neurosciences by a neurological surgeon. Congratulations to Dr. Liau!
#Neurosurgery
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Here’re reasons I believe when $NWBO
#DCVax
is approved soon in US, Canada, UK, Germany & rest of EU, this means poly-ICLC will also be approved as a maturation & activation agent. This means 5-Year survival rate for GBM could increase from 13% to 50+%+:
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$NWBO: The federally-funded Patient-Centered Outcomes Research Institute (PCORI) selected
#DCVax
as 1 of the new & emerging health care technologies & innovations with high potential for disruption to the current standard of care (SOC). See Page 36:
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I believe $NWBO & Dr. Liau believe
#DCVax
-L regulatory approval in US, UK, Canada, Germany & rest of EU to treat newly diagnosed & recurrent Glioblastoma is a done deal. Focus has now moved to combination trials + basket trials trials to treat all/most other solid tumor cancers.
$NWBO gee why would this happen? Hmmm…looks like Dr Liau has some big work upcoming….
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Very interesting photo of a vial of $NWBO
#DCVax
-L on this article in the BNN in the UK. This article is about King Charles’ cancer diagnosis, but we still do not know what type of cancer the King has. If it is a solid tumor cancer, DCVax could be an option. DCVax is awaiting
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This is great news for newly diagnosed & recurrent Glioblastoma patients & eventually / hopefully all or most solid tumor cancer patients worldwide. The UK will be the first country to approve $NWBO
#DCVax
-L. Now we await news about regulatory submissions in US, Canada, Germany &
Northwest Biotherapeutics Announces That A Marketing Authorization Application Has Been Submitted To The UK MHRA For DCVax®-L For Glioblastoma $NWBO
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Yesterday, the National iInstitute of Health (NIH) National Cancer Institute (NCI) Neuro-Oncology Journal Club discussed $NWBO
#DCVax
-L Phase 3 trail led by Dr. Linda Liau & the results published in
@JAMAOnc
. The word is getting around to all oncology Key Opinion Leaders (KOLs).
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I love this slide that suggests that $NWBO
#DCVax
vaccine platform is tumor & tissue agnostic & should work on all or most solid tumor cancers such as: lung, prostate, colon, pancreatic, breast, etc. Once efficacy is validated by regulators $NWBO would be worth $100s of billions:
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$NWBO
#DCVax
trial results were positive. Met both primary & secondary endpoints. Results are approvable by regulatory authorities. Market needs time to understand & appreciate the results. Panic selling among retail investors fueled by short attack. More patience is required.
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I had a chance to listen to Dr. Linda Liau’s presentation at the University of Pittsburgh on 11/3/2022. I have a few comments & observations about
#DCVax
-L & $NWBO:
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Be very careful $NWBO shareholders. Shorts, Hedge Funds, MMs & other manipulators are working together to take out Stop Losses & accumulate some cheap shares. They are desperate & they know that soon
#DCVax
-L will soon be approved in US, UK, Canada, Germany & the rest of the EU.
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$NWBO
#DCVax
-L: Dr. Linda Liau has been named the honored guest lecturer for the 16th Annual Stuart Rowe Society Lectureship and Resident Research Day, set for October 26th at the University of Pittsburgh Department of Neurological Surgery:
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$NWBO With imminent TLD release & peer-reviewed journal article & eventual approval of
#DCVax
in US, UK, Canada, Germany & rest of the EU, we’re close to a paradigm shift in the way GBM patients will be treated. Current survival numbers are dismal. Patients need a better option:
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More proof that $NWBO
#DCVax
-L external control arms (ECAs) were accepted by FDA. Here is Code of Federal Regulations (CFR) statue that gives FDA the right & authority to ask any Sponsor for access to patient-level data for any IND application that was FDA approved & authorized:
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Hopefully, $NWBO will have the
#DCVax
-L MAA approval from the MHRA by ASCO 2024. ASCO 2024 would be the perfect setting for NWBio to take some victory laps among its peers, including BPs like Merck, Regeneron, Pfizer, AstraZeneca, etc.:
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$NWBO
#DCVax
: sounds like Dr. Linda Liau lecture on Friday, 4/19/2024, at the University of Nebraska Medical Center (UNMC), titled: “Immunotherapy for the treatment of Glioblastoma”, was well received. I look forward to getting more information & for Glioblastoma & other solid
To be standing with these two giants tonight was inspiring. If I can have one tenth of the career or impact of these two, my career will be a huge success. Thank you, Dr. Liau, for visiting us here in Omaha and sharing your insight with us.
@UNMC_NeuroSurg
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The ground swell of advocacy is starting & building momentum for
@FDAOncology
approval of $NWBO
#DCVax
-L in the US ASAP for the benefit of patients with malignant brain tumors:
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After 400+ failed trials, $NWBO
#DCVax
-L is first successful trial to show statistical significant & clinically meaningful results in treating newly diagnosed & recurrent Glioblastoma. Early combo results show 50% survival rate @ 10 years:
#CancerResearch
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These 49 million short shares will act as an accelerant when the $NWBO &
#DCVax
-L fuel is lit soon. Should make for some exciting fireworks soon. I hope all of the short sellers are wearing flame retardant underwear:
$NWBO from Aug 15 to 31st, short interest INCREASED by approx 1.5M shares. This means that the increase in share price has been due to new money and not due to a short covering rally. Dangerous for shorts particularly as borrow fees continue to increase.
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I've updated my $NWBO Table to include the exact same external control arms (ECAs) Dr. Liau used in her presentation. There isn't a 3-month randomization timing difference between
#DCVax
trial & the 5 ECAs. DCVax results are significantly better than SOC:
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I am excitedly looking forward to a productive & eventful 2024 for $NWBO & all of our future
#DCVax
combinations partners who will help further develop the DCVax dendritic cell vaccine platform into a global tissue agnostic treatment option for all or most solid tumor cancers
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Fortunately
@adamfeuerstein
, FDA & other regulatory authorities in UK, Canada, Germany & the rest of EU will not be duped by your false claims of $NWBO
#DCVax
trial failure. They will look at the fact that trial met its Primary & Secondary endpoints & GBM patients lived longer.
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Dr. Marnix Bosch confirmed that $NWBO
#DCVax
-L was successful in treating multiple other solid tumor cancers on a compassionate use basis & through a small pilot trial. Can you say "Tissue Agnostic"?:
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Great news for newly diagnosed & recurrent Glioblastoma patients in UK & soon worldwide. US, Canada, Germany & rest of EU initially. IMO $NWBO will conduct basket trials for
#DCVax
-L &
#DCVax
Direct to confirm both are tissue agnostic & effective for all solid tumor cancers.
8/29/23 - We are very happy to report that
#NWBio
has just announced their plans for submission of their Marketing Authorization Application within the next 30-45 days!
DCVax® is a platform technology that uses activated dendritic cells.
#hopeforgbm
#fightglioblastoma
#hope
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It is truly exciting that $NWBO will be able to manufacture
#DCVax
-L for solid tumor cancer patients around the world, on a compassionate use basis, before the MAAs & BLAs are commercially approved in US, UK, Canada, Germany & rest of the EU:
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I took another look at the potential valuation $NWBO in a buyout based on the
#DCVax
production scale guidance that they gave us over the weekend. According to my conservative calculations the buyout value of $NWBO shares are estimated to be $48 per share:
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It was good to hear $NWBO is in talks with CRL to update their CDMO agreement to manufacture
#DCVax
-L for North America out of Memphis. Also, MIA approval by MHRA for commercial manufacturing is imminent, then MAA regulatory submissions will be made to multiple regulators.
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On Friday, 4/19/2024, Dr. Linda Liau will give a lecture at University of Nebraska Medical Center (UNMC), titled: “Immunotherapy for the treatment of Glioblastoma”. Should include details about $NWBO
#DCVax
-L Phase 3 positive trial results:
Join us Friday, April 19, 2024 for the
@UNMC_NeuroSurg
42nd Annual J. Jay Keegan Memorial Lecture as we welcome internationally renowned neurosurgeon, Dr. Linda Liau! Details below!
@unmc
@UNMCCOM
@NebraskaMed
@UCLANsgy
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Dr. Steven Brem is also excited about
#DCVax
-L becoming a part of the standard of care treatment for both newly diagnosed & recurrent GBM patients. $NWBO is closer to getting regulatory approvals in the US, Canada, UK, Germany & the rest of the EU.
The complexity, heterogeneity of the overlapping pathways (redundancy) as well as the mutational drift (oncoplasticity) contribute to glioblastomas being resistant to therapy. Excited that the
#dendritic
cell vaccine could be part of the future solution.
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I’m thankful $NWBO licensed the DC Vaccine technology ATL-DC /
#DCVax
globally from UCLA so $NWBO can commercialize & make it available to solid tumor cancer patients worldwide, beginning with malignant brain cancer patients. $NWBO has global patent protection for DCVax as a
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Congratulations to Dr. Linda Liau for being awarded the 2024 Cloward Medal by the Western Neurosurgical Society (WNS). Soon $NWBO
#DCVax
will be available for malignant glioma cancer patients in the U.K. Then, in the US, Canada, Germany & the rest of the EU:
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Dr. Steven Toms of Brown University comments on Dr. Linda Liau
#DCVax
-L combo early trial results with PD-1 inhibitors, saying GBM patients survival rate at about 50%. This is great news for $NWBO:
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$NWBO: “Many Diseases, One Answer”. Harnessing the body’s natural immune system could be answer to curing autoimmune, neuro-degenerative & cancer diseases. Soon,
#DCVax
could become a foundational / core weapon to fight many types of solid tumor cancers:
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Good news for solid tumor cancer patients around the world, $NWBO
#DCVax
vaccine platform uses the patients own dendritic cells & immune system. DCVax is safe & non-toxic, unlike CAR-T therapies which use genetically modified T-cells & are very toxic, unsafe & very expensive
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On page 4 of the Winter 2022 edition of The Grey Matters, that was recently published by The Brain Tumor Charity in the UK, it stated the following regarding $NWBO
#DCVax
-L Phase III clinical trial:
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It’s good to see that both $NWBO & Merck $MRK are both prominently listed in Dr. Linda Liau disclosures. The
#DCVax
-L combo trial with Keytruda (Pembrolizumab) is showing extraordinary early results.
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Had a chance to listen to Charles River Laboratories $CRL Q1 2023 call. They talked about expecting more cell therapy CDMO business in 2nd half of 2023 into 2024. My belief is $NWBO
#DCVax
-L is 1 of these new therapies to be approved soon in US, Canada:
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$NWBO: “interim analysis demonstrated a mean OS of 23.1 months, with 2 and 3 year survival of 46.2% and 25.4%, respectively, with a higher OS in patients with methylated MGMT of 34.7 months vs. 19.8 months. To date
#DCVax
has been safe and well tolerated”
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$NWBO news: Dr. Linda Liau presented the
#DCVax
-L Phase III trial results on 7/1/2022 in Prague, Czech Republic at The Society of University Neurosurgeons 2022 Annual Meeting:
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Dr. Ashkan Keyoumars, the Principal Investigator for the $NWBO
#DCVax
-L Phase III trial in Europe, will speak about the clinical trial results in London on Oct. 6th at 7:30 PM at the British Neuro-Oncology Society (BNOS) Patient and Carer Event:
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This should be a very interesting oral abstract on 6/23/22 in the UK, regarding $NWBO
#DCVax
-L Phase III clinical trial. Dr. Linda Liau and Dr. Marnix Bosch are both joining Dr. Keyoumars Ashkan. See page 13 of this pdf document:
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Dr. Steven Brem was a part of the $NWBO
#DCVax
-L Phase 3 trial & was an author on the JAMA paper. Dr. Brem graduated from the Harvard Medical School & is currently the Director of Medical Student Education, Department of Neurosurgery, University of Pennsylvania & Medical Director
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In October 2022, FDA released draft guidance: Tissue Agnostic Drug Development in Oncology. This should help $NWBO further develop its
#DCVax
vaccine platform to treat all or most other solid tumor cancers:
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Congrats Dr. Linda Liau et al
@UCLANsgy
who were named
@CastleConnolly
Top Doctors for 2024. Hopefully, for newly diagnosed & recurrent Glioblastoma (GBM) patients, soon $NWBO
#DCVax
-L, your dendritic cell cancer vaccine will be approved soon in the UK, then US, Canada, Germany &
Congratulations to the UCLA Neurosurgeons who were named
@CastleConnolly
Top Doctors for 2024! Learn more about each of these physicians, as well as the rest of our incredible
#neurosurgery
team, here:
@IsaacYangMD
@TheYangLab1
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@adamfeuerstein
tried to harass & intimidate Dr. Steven Toms & Brown University but his efforts failed & backfired. Brown’s neuro-oncology department held a public press conference in full support of
#DCVax
-L Phase 3 trial results & $NWBO:
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FDA agrees that if there’s a Phase 3 clinical trial like $NWBO
#DCVax
, that allows control (placebo) patients in the trial to crossover to the treatment drug being studied, then an External Control Arm can be used to help augment & interpret the results:
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It’s laughable & insane,
@adamfeuerstein
thinks he know more about neurosurgery & how to treat GBM patients than Dr. Steven Toms, a renown neurosurgeon who’s treated 1,000s of brain tumor patients & is Director of Brain Tumor Program for Lifespan Health:
@adamfeuerstein
1) DCVax trial was positive not failed with Increased OS. 2) The steps for producing a DCVax are a bit more complex than “waving around tumor lysate”. 3) Woukd be happy to share some single cell / methyl RNA Seq data to show you why the Moderna approach won’t work as well in GBM
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Dr. Linda Liau spoke 2 consecutive days (10/26 & 10/27) first @ University of Pittsburgh & then @ University of Pennsylvania. Soon a dendritic cell vaccine
#DCVax
-L will be an approved core / foundational tool for treating GBM & other solid tumor cancers.This bodes well for $NWBO
Superb lecture 10.27 by Dr. Linda Liau on targeting treatment-induced resistance in glioblastoma, organized by
@PennRadOnc
[Yi Fan], and
@PennNSG
[
@DanielYoshor
], elucidating the science behind the UCLA SPORE, glioblastoma treatment resistance, and exciting future clinical trials
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$NWBO
#DCVax
This patent is a BFD. This could be the start of worldwide patents issued for cancer treatments that combine DCVax with checkpoint inhibitors like Keytruda & Opdivo. This may be a mic drop moment:
$NWBO patent application with status "Acceptance of application" on April 30, 2022 by Israel: IL245337 - "Combinations of checkpoint inhibitors and therapeutics to treat cancer"
1.
2.
@biggercapital
@rago_carlo
@ATLnsider
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In this video attorney Wes Christian, who is an expert in cases involving naked short selling & spoofing, talks about $NWBO &
#DCVax
-L around 1:30:00 & 1:47:15 marks. He said “these people are so crooked, they don’t mind killing people to make money:
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This timeline is great news for GBM patients & other solid tumor cancer patients worldwide‼️ One regulatory authority down (UK) & I look forward to hearing news about $NWBO submission plans for
#DCVax
-L US, Canada, Germany & rest of the EU soon.
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$NWBO was “thinking big” for a very long time. They know
#DCVax
-L will not only be used for brain cancer, it’s tissue agnostic & is effective in treating all or most solid tumor cancers. Listen to Dr. Bosch at ASCO 2022 at the 33:07 to 33:55 minute mark:
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Some don’t realize $NWBO
#DCVax
-L newly diagnosed & recurrent Glioblastoma patients overall survival improvements wasn’t only for 5-Year survivors but was across the board & more GBM patients survived 1, 2, 3, & 4 years & longer than patients treated with current standard of care
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Dr. Linda Liau says: “Two decades ago, no one thought immunotherapies would become mainstream in cancer treatment, but now we are seeing the potential to cure cancers that were incurable. There will be a huge growth in cancer immunotherapy” $NWBO
#DCVax
-L:
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That is very convenient for Dr. Linda Liau. The NCI Center for Cancer Research Neuro-Oncology branch is located at 31 Center Drive in Bethesda. $NWBO is also located in Bethesda less than 2 miles away. It’s easy to get together & talk about
#DCVax
& SAB:
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$NWBO has posted the
#DCVax
-L slides from Dr. Marnix Bosch presentation at the 4th Annual Glioblastoma Drug Development Summit in Boston yesterday, 3/16/2023:
#CancerResearch
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$NWBO
#DCVax
: Dr Linda Liau & Dr. Steven Brem (Director of Neurosurgery at UPenn) will participate in “New Science & Clinical Trials That Will
Change Glioblastoma Management in the Next Five Years” on 5/1/22:
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I’ve updated my estimated $NWBO value per share based on a potential increase in authorized shares to 1.7 billion. If
#DCVax
is approved by regulatory authorities worldwide to be tissue agnostic & the label is expanded to include most solid tumor cancer:
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I am thankful that this autologous tumor lysate dendritic cell (ATL-DC) cancer vaccine technology was licensed globally by $NWBO under trademark name
#DCVax
. Soon it will be available to treat malignant brain tumor patients in UK, then in US, EU, Canada & rest of the world. Then
Drs. Robert Prins, Linda Liau, Richard Everson, & team investigated the effectiveness of adding TLR agonists to autologous tumor lysatepulsed dendritic cell (ATL-DC) vaccination in patients with newly-diagnosed or recurrent
#gliomas
. Read the article here:
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Great news!! With this GMP certification from the MHRA in the UK, the finish line for $NWBO &
#DCVax
regulatory approvals & commercialization is much closer.
$NWBO
Cheers longs!!!!
MHRA certification approval!
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$NWBO: The new
#DCVax
Phase 3 trial Primary Endpoint is: "compare overall survival between patients randomized to DCVax-L & control patients from comparable, contemporaneous trials who received SOC, in patients with newly diagnosed Glioblastoma". I updated my comparison Table:
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