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That is also NOT TRUE.
NWBio is currently treating the DCVax-L revenue from the Specials Program as R&D expenses, because DCVax-L has not been commercially approved by the MHRA yet.
As such, NWBio is currently allowing Advent Bioservices to invoice patients directly for their DCVax-L vaccines, under the Specials Progam. The bulk of the revenue from the Specials Program are being used to cover the cost of producing DCVax-L for patients, and to help Advent cover other costs related to preparing for commercialization readiness.
But, after DCVax-L is commercially approved by the MHRA, all of the invoicing will be done by NWBio, and all the commercial revenue from DCVax-L will go directly to NWBio.
Then, NWBio will pay Advent Bioservices at an agreed upon cost + rate, for each batch of DCVax-L vaccine produced. I believe that + rate was around 15% to 20%..
It has nothing to do with improper controls. It would be a simple purchase of Advent Bioservices at fair value.
Advent Bioservices does not own any equipment, does not own or control any facilities, does not have or own any commercially approved drug or biologic treatments.
It is a “false bear talking point” that alleges that Advent Bioservices is worth hundreds of millions or even billions of dollars. This simply is not true.
You may want to go back and review one of my previous posts, where I explained that Advent Bioservices does not own any assets of value at the Sawston facility. NWBio own and control all of the following assets at the Sawston facility:
1. All of the equipment at the Sawston facility.
2. The lease to the Sawston facility.
3. The DCVax-L soon to be issued, commercial license and Marketing Authority (MA) for all of the UK.
4. All of the Class B and Class C clean rooms at the Sawston Facility.
5. All of the cryo-storage freezers at the Sawston facility.
6. All of the Flaskworks equipment and IP at the Sawston facility.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174958843
I have 3 questions for you. Please answer these questions honestly:
(1) Who owns Toucan Capital?
(2) How many shares of NWBO does Linda Powers beneficially own?
(3) Would Linda Powers vote in favor of a transaction that would significantly increase her shareholder value in NWBO?
Similar to how NWBio bought Flaskworks outright for a few million dollars, NWBio can do the same with Advent Bioservices. Advent does not own any equipment or facilities. They primarily have production, manufacturing and operational expertise and employees.
NWBio can also purchase Oncovir outright for a few more million. Oncovir is worth more when Hiltonol (poly-ICLC) is combined with DCVax, than they are worth as a stand-alone company.
Poly-ICLC is not approved to treat any cancers or other diseases as a monotherapy. But, if the new formulation of DCVax along with poly-ICLC is approved on a tumor / tissue agnostic basis, to treat all or most solid tumor cancers, along with the combination of Keytruda + CSF-1R inhibitor, then tens of billions in value will be created by becoming a part of NWBio.
Amplifybio would be the most expensive part of this proposed transaction. But the additional value created, because you will be able to meet DCVax production demand in all of North America (US, Canada and Mexico), will be worth the price.
Again, because of excess and extreme demand for Ozempic and Wegovy, Novo Nordisk paid $16.5 billion in cash for the CDMO Catalent, so they could meet exceptional demand for its products.
I would love to see a merger between NWBio + AmplifyBio + Advent Bioservices + Oncovir, then an uplist and a new ticker symbol for NWBO:
There are a lot of interconnections & past relationships. J. Kelly Ganjei used to also work for Toucan Capital & Cognate Bioservices. Cognate manufactured #DCVax-L for the Phase 3 trial. Toucan Capital owned Cognate & now owns Advent Bioservices. $NWBO owns the Sawston facility.… https://t.co/hMP2Q3lRh7 pic.twitter.com/LKdjq6rikj
— ATLnsider (@ATLnsider) September 10, 2024
You’re right barnstormer, I keep adding more and more NWBO shares.
I will continue to add more and more cheap shares, as long as the collusive 7 Market Makers, Hedge Funds, Short Sellers, and their army of social media surrogates, continue to illegally manipulate NWBO share price.
By the way, it looks like my Braves are battling your Diamondbacks for a wildcard spot in the MLB playoffs.
Thanks dstock07734, it’s good to see J. Kelly Ganjei again in that video.
As you know J. Kelly Ganjei is the current CEO of AmplifyBio, and he is the past President and CEO of Cognate Bioservices.
He is also listed as 1 of the inventors on the DCVax-L + Checkpoint Inhibitors combination patents, along with the people at UCLA and NWBio.
Ganjei was the CEO of Cognate Bioservices when the DCVax-L Phase III trial was enrolling GBM patients, and when Cognate Bioservices was making all of the DCVax-L vaccines for patients in the US and Canada.
He was also involved in the transfer of the DCVax-L manufacturing technology to the labs in London and Germany, for patients in the DCVax-L Phase III trial in London and Germany .
The Amplify Manufacturing Enablement Center (AMEC) in New Albany, Ohio will be about 350,000 S.F., and it has Grade B and Grade C clean rooms, and it will be over 3.5 times larger than NWBio’s Sawston facility.
No thank you D-Mike, I would rather buy NWBO shares at the current illegally manipulated share prices of about $0.30.
I recently bought an additional 300,000+ shares of NWBO at these illegally manipulated prices. I will continue to look for future opportunities to continue accumulating NWBO shares at these illegally manipulated share prices.
This opportunity was created by the collusive 7 Market Makers, Hedge Funds, Short Sellers, and their vast army of surrogates who are posting FUD 24/7/365 across all social media platforms.
I am a long-term NWBO investor. Now, I will continue to wait for NWBio to continue accomplishing its significant milestones, including:
(1) Regulatory approvals in the UK, US, Canada, Germany and the rest of the EU.
(2) Partnership(s) with Big Pharma(s) to further develop combination treatments with DCVax-L and DCVax Direct
(3) Regulatory clinical trials, and subsequent global approvals for both DCVax-L and DCVax Direct, to treat all or most solid tumor cancer.
(4) Uplisting NWBO to a major exchange, away from the OTC.
Accomplishing all of these milestones may take 5 years or longer, but I will wait until the true value of NWBO shares, and the DCVax dendritic cell vaccine platform, is truly and more accurately reflected by the market.
However, you and anyone else o this board, are free to sell all your NWBO today, tomorrow, next week, next month, or next year for $1, $3, $5, etc. I will not try to stop you from selling your NWBO shares.
In fact, I personally prefer to have fellow long-term investors, who truly believe in the long-term prospects of NWBio, and who trust the NWBio senior management team, and understand the true value of the DCVax platform technology, invest in NWBO shares.
Not, short-term investors who are anxious to sell their shares at low, illegally manipulated prices.
Thanks Lykiri, unfortunately there are not many neuro-oncologists and neurosurgeons, who have treated newly diagnosed (nGBM) and recurrent Glioblastoma (rGBM) patients, and can truthfully make this statement below.
But, Dr. Linda Liau, who has treated hundreds of nGBM and rGBM patients, with DCVax-L from NWBio can make this statement:
Thanks VikingInvest, I am hoping to see you in Vegas in December.
Thanks, depending on how long the manipulators continue to manipulate NWBO’s share price, I may get additional chances to add even more shares. 😀👍
Over the past couple of weeks, I have purchased another 300,000+ NWBO shares.
Now, I will just sit back and wait for more milestones to be achieved by NWBio.
Thanks dstock07734, so that is only a little over 3 months from now.
I am looking forward to seeing the updated results from this DCVax-L along with poly-ICLC + Keytruda (Pembrolizumab) trial.
In my opinion, a lot of money is being wasted on ADCs.
Thanks Doc logic. Unfortunately, I see ADCs as a last ditch effort by Big Pharma (BP) to keep treating cancer patients with highly toxic chemo.
ADCs, in theory, are a more precise and targeted form of delivering chemo, and should be less toxic to healthy cells. But, they come with a long list of toxic side-effects, similar to traditional chemo.
https://my.clevelandclinic.org/health/treatments/antibody-drug-conjugates
As you know, the ADCs only target 1 or 2 tumor associated antigens (TAAs), biomarkers or genes, that are over-expressed in specific cancers.
On the other hand, DCVax targets all of the cancer patients’s TAAs, biomarkers, and genes, that are over-expressed on solid tumor cancer patient’s tumors. Unlike ADCs, DCVax helps to ensure that the cancer does not escape.
In my opinion, ADCs, and traditional chemo, weakens a cancer patient’s immune system, and reduces the effectiveness of true immunotherapy, like DCVax. It also lessens the body’s ability to fight cancer, and prevents a patient from being truly cured.
Unfortunately, chemo is very profitable for BP. They will fight “tooth and nail” to hold on to these profits. Curing cancer patients is not as profitable.
This article published in 2017, by researchers at UCLA, including Drs. Linda Liau, Robert Prins, Timothy Cloughesy, et al, was about an animal (mice) study that combined NWBio’s DCVax-L + Keytruda (Pembrolizumab, Merck).
https://www.pnas.org/doi/full/10.1073/pnas.1706689114
It was 1 of the first studies to show that ATL-DC (autologous tumor lysate-pulsed DC vaccination) is the same as DCVax-L, and the researchers at UCLA used the terms interchangeably:
This article published in 2017, by Drs. Linda Liau, Robert Prins, Timothy Cloughesy & et al, was about an animal (mice) study that combined $NWBO #DCVax-L + Keytruda (Pembrolizumab, Merck). It was 1 of the first studies to show that ATL-DC (autologous tumor lysate-pulsed DC… pic.twitter.com/Z0rlaj3MFW
— ATLnsider (@ATLnsider) August 26, 2024
More blatant illegal spoofing and NWBO stock price manipulation this afternoon:
@SEC_Enforcement @GaryGensler @TheJusticeDept In my opinion, this appears to be more illegal & blatant spoofing & illegal manipulation of $NWBO shares by Market Maker OTCN. At 3:52 PM on Level 2, OTCN put 250,000 NWBO shares on the Ask @ $0.3488. At that time, there was a total… pic.twitter.com/TtdisKKRn7
— ATLnsider (@ATLnsider) August 21, 2024
CaptainObvious, we (NWBio) don’t own the weekly, monthly and annual overhead and payroll costs at Advent Bioservices.
But, we (NWBio) do own the following:
1. All of the equipment at the Sawston facility.
2. The lease to the Sawston facility.
3. The DCVax-L soon to be issued, commercial license and Marketing Authority (MA) for all of the UK.
4. All of the Class B and Class C clean rooms at the Sawston Facility.
5. All of the cryo-storage freezers at the Sawston facility.
6. All of the Flaskworks equipment and IP at the Sawston facility.
Thanks for posting that excerpt from the ASM. But, that does not say that NWBio will submit the BLA to the FDA in 12 to 18 months.
When Linda Powers was talking about the coming 12 to 18 months, she was referring to working with specialized consultants to develop the health economics model to present to NICE, the cost benefits analysis of the DCVax-L treatment.
After she talked about working with NICE, she went on to talk about submitting DCVax-L applications to other countries:
No where does she say it will be 12 to 18 months before we submit applications to other countries.
But, that being said, no one knows when NWBio will submit DCVax-L applications to other countries. You are free to believe that it will be Q4 2025, I will not try to change your mind on that.
However, I have not seen enough definitive evidence to rule out a BLA submission in late 2024 or early 2025. I will continue to hold out hope that it will happen. But, I will adjust my beliefs if more evidence or guidance in disclosed by NWBio.
We still have over 4 months remaining in 2024. Also, even if a regulatory submission is submitted to the FDA in early 2025, and the FDA agrees to an accelerated approval pathway for DCVax-L, it could still be approved in 2025.
However, I do believe that NWBio will probably wait until after DCVax-L is approved by the MHRA in the UK, before they apply to the FDA.
But, I don’t recall Linda Powers definitively saying that they will wait until 2025 before they submit a BLA to the FDA for approval in the US.
If you have a link confirming that Linda Powers said they will wait until 2025 to submit to the FDA, please share it.
Please tell that to the children, spouses, families, loved ones, and friends of long-term Glioblastoma (GBM) survivors:
Unfortunately, that statement says more about you, and your lack of humanity, empathy and caring, than it does about the efficacy of DCVax-L.
By the way, do you know what 13.0% of 232 equals? I’ll help you out, DCVax-L helped over 30 nGBM (newly diagnosed) patients live 5+ years.
Plus, an additional 11.1% of rGBM (recurrent) patients lived 30+ months.
In fact, these long-term survival numbers do not count the hundreds of other long-term survivors of solid tumor cancer patients treated in other clinical trials (Phase I & Phase II), Compassionate Use, Specials, expanded access, etc.
You may laugh and snicker at cancer patients surviving long-term, and you may feel callous and cavalier about these long-term survival numbers. But, most of us do not feel that way.
At the UCLA Visionary Ball, Dr. Linda Liau was able to introduce 2 patients who were treated with $NWBO #DCVax-L & are now long-term survivors of Glioblastoma (GBM).
Shenell Malloy has survived for 5 years & Brad Silver has survived for 21 years.
When you hear and read the constant lies, distortions & deceit by collusive & manipulative Market Makers, Hedge Funds, Short Sellers and their vast army of social media surrogates, all over Twitter (X) and other social media platforms, you should think about these long-term cancer survivors & keep listening to their stories:
https://www.instagram.com/reel/C0kqFdpJpBN/?utm_source=ig_web_copy_link
I agree, but don’t forget about Canada. That would make it a one, two, three, four punch. 😀
It is very encouraging to see that the American Society of Gene & Cell Therapy (ASGT) predicts that the MHRA will approve DCVax-L in the UK by 9/30/2024, and EverNorth (Cigna Health) predicts that the FDA will approve DCVax in the US in 2025.
This is very good news, and it provide hope for solid tumor cancer patients, including Glioblastoma (GBM):
At the 2024 UCLA Visionary Ball, Dr. Linda Liau was able to introduce 2 patients who were treated with DCVax-L, and are now long-term survivors of Glioblastoma (GBM).
Shenell Malloy has survived for 5 years and Brad Silver has survived for 21 years.
When you hear and read the constant lies, distortions & deceit by collusive & manipulative Market Makers, Hedge Funds, Short Sellers & their vast army of social media surrogates, all over Twitter (X) & other social media platforms, you should think about these long-term cancer survivors, and keep listening to their first-hand stories:
At the 2024 UCLA Visionary Ball, Dr. Linda Liau was able to introduce 2 patients who were treated with $NWBO #DCVax-L & are now long-term survivors of Glioblastoma (GBM). Shenell Malloy has survived for 5 years & Brad Silver has survived for 21 years. When you hear & read the… pic.twitter.com/ekniResfOm
— ATLnsider (@ATLnsider) August 19, 2024
EverNorth Health Services is a division of Cigna & it provides nationwide health benefit management services including pharmacy benefit services. They believe DCVax-L will be FDA approved in 2025:
EverNorth Health Services is a division of Cigna & provides nationwide health benefit management services including pharmacy benefit services. They believe $NWBO #DCVax-L will be FDA approved in 2025: https://t.co/JjwqTM6yRD pic.twitter.com/jPs9p49Slb
— ATLnsider (@ATLnsider) August 19, 2024
Thanks Horseb4CarT. I agree with you.
I look forward to meeting up with you when you move to your new home in the Atlanta metro area
Thanks dstock07734, it is also noteworthy that in the description of this trial, UCLA and Dr. Robert Prins, do not mention that poly-ICLC is also included in this trial.
Poly-ICLC is not mentioned separately as 1 of the combination treatments. The only combination treatments that are specifically mentioned are: Pembrolizumab (Keytruda, Merck), and CSF-1R inhibiitor (PLX3397, Daiichi-Sankyo):
The reason for this is, poly-ICLC has been included as a component in the new DCVax-L (ATL-DC) formulation. Poly-ICLC is not considered to be a separate combination treatment, like Pembrolizumab and the CSF-1R inhibitor. Even though poly-ICLC is a separate intramuscular injection, and the DCVax-L is a separate intradermal injection.
There are no current DCVax-L clinical trials, nor are there any future planned DCVax-L clinical trials, that do not include poly-ICLC as a component in the DCVax-L formulation.
We can clearly see from this slide below, which has been presented by Dr. Linda Liau and by Dr. Robert Prins, poly-ICLC is included in this trial, but it is not mentioned separately from DCVax-L (ATL-DC):
Sounds good, I’d be very interested in their response.
Thanks branster
branster, do you think that the Ask at $0.36 on Level 2 for 110,000 NWBO shares, by NITE is real, or do you think this is more spoofing as usual by them?
I took a screenshot, just in case it is needed.
Thanks DJPele, it's also interesting that the source of this data is the American Society of Gene & Cell Therapy (ASGCT), and ASGCT is sticking with their prediction that the MHRA approval of DCVax-L will not only be for newly diagnosed GBM (nGBM) and recurrent GBM (rGBM), but the approved label indications will also include all malignant gliomas (Grade III & Grade IV).
Hopefully, we will know definitively soon.
Steady_T, that is not true. Let’s look at some facts instead of message board misinformation.
All NWBio needs to do is, keep achieving all of its milestones, and successfully execute its strategic and operational business plans. The stock price will take care of itself in time, after more milestones are achieved.
Here are the total number of shares outstanding as of 6/30/2024. As you can see, NWBio outstanding share count is significantly less than these other pharmaceutical / biotech companies:
NWBio (NWBO) = 1.21 Billion
Merck (MRK) = 2.53 Billion
Bristol Myers Squibb = 2.03 Billion
Pfizer (PFE) = 5.57 Billion
Bayer (BAYRY) = 3.93 Billion
Abbvie (ABBV) = 1.77 Billion
Johnson & Johnson (JNJ) = 2.41 Billion
Roche (RHHBY) = 5.52 Billion
Sanofi (SNY) = 2.51 Billion
AstraZeneca (AZN) = 3.12 Billion
Novartis (NVG) = 2.02 Billion
skitahoe, I agree. That will be the primary purpose of each cohort (basket) group in future DCVax basket clinical trials.
NWBIo will test and confirm that each combination component (checkpoint inhibitors, CSF-1R inhibitors, Roswell Park IP, etc.) combined with DCVax along with poly-ICLC, will add incremental overall survival (OS), and will provide additive benefits to solid tumor cancer patients.
The beauty of this is that NWBio will own and/or control all of these combination patents, including the combo patents that utilize the Roswell IP.
Investor082, I am glad you asked. I am happy to repost this below. It’s good to review this list of milestones, from time-to-time, to measure and gauge the progress NWBIo has made to-date. Thank you for the reminder. Let me know if you need anything else. 😀👍
As you can see from my milestone list below, NWBio has fully completed milestones 1, 2 and 3.
Also, NWBio has partially completed milestone 4 with a MAA submission and validation to the MHRA in the UK. According to NWBio, regulatory submissions to the US, Canada, Germany and the rest of the EU will be completed in the coming months or year.
Milestone 6 has been partially completed with the DCVax + Checkpoint Inhibitors combination patents being approved in all 29 EU states plus 2 additional countries in Europe. Also, the combination patent was approved in Israel and Mexico.
Milestones 7 and 8 are still pending. But, approval in the UK is imminent:
Nice post hyperopia. I also agree that NWBio will incorporate poly-ICLC in all future trials for the DCVax dendritic cell vaccine platform. In my opinion (IMO), that will include both DCVax-L and DCVax Direct.
We can see this future direction, by looking at the current DCVax-L (ATL-DC) trials that are being conducted at UCLA (DCVax-L along with poly-ICLC + Keytruda), and by looking at all of the future planned UCLA trials (DCVax-L along with poly-ICLC + Keytruda + CSF-1R inhibitor).
There are no (0) current trials, or future planned trials, at UCLA that do not include poly-ICLC.
The trial that begin in 2010 at UCLA, and the results were recently published in the Nature article, conclusively showed that the best TLR agonist to add as a component to the DCVax formulation, “to send the danger signal” and to help modulate a stronger immune response, to a cancer’s patient’s own cancerous tumors, is TLR3 (poly-ICLC).
IMO, NWBio will be able to conduct future basket trials for both DCVax-L and DCVax Direct. These basket trials will also be designed and powered to confirm that DCVax-L and DCVax Direct are both tumor / tissue agnostic. These trials will target multiple solid tumor cancers, such as: colon, ovarian, pancreatic, lung, breast, etc. These trials will also formally validate DCVax as a platform technology.
There will be several baskets (cohorts) of patients. The various baskets will include:
(1) control basket for the DCVax trials will be DCVax along with poly-ICLC.
(2) then the other cohort (basket) of patients will be treated with DCVax along with poly-ICLC + Keytruda.
(3) the next basket of patients will be treated with DCVax along with poly-ICLC + Keytruda + CSF-1R inhibitor.
(4) the last basket of patients will be treated with DCVax along with poly-ICLC + Keytruda + CSF-1R inhibitor + IP from Roswell.
The IP from Roswell is complimentary to both DCVax-L and DCVax Direct. This IP focuses on reprogramming the tumor microenvironment (TME) to make it less immunosuppressive, and to help make a personalized dendritic cell cancer vaccine (DCVax) more effective. The Roswell IP include a chemokine modulating regimen (CKM) such as interferon alpha (IFNa). Also, another positive for this Roswell IP is, it can be administered intratumorally, just like DCVax Direct.
beartrap12, I believe it was the University of Pittsburgh instead of U of Penn.
GoodGuyBill, the “inspections” that NWBio is referring to, are primarily related to the DCVax-L Phase III trial data, and all related parties involved in the conduct of the Phase III trial.
I recommend you read my previous post linked below:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174399935
Yes it is, I think it was intentional to sell these common stock options to another NWBio insider, instead of selling these in the open market, or selling these shares to “unfriendlies” .
This transaction keep the NWBO shares in friendly hands, and keeps these shares out of the hands of NWBO share manipulators, including collusive Market Makers, Hedge Funds, Short Sellers, etc.
Also, Malik Navid still beneficially owns over 23 million NWBO shares.