The deck is stacked against the avg Andres...Just trying to beat the odds.
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MartyDg's post scares the shit out of me because it is possible that nefarious forces which have been at play for a long time, may have won. When money talks, BS walks and given the disruptive nature of DCVax, BS would run at world-record speed.
MartyDg's statement, It wouldn’t take this long to approve a “revolutionary vaccine” if the MHRA were truly in favor of it, seems reasonable to me though, I don't think if this delay means DCVax will not be approved.
So when do you suppose LP should have partnered with BP? Before the trial was over and manufacturing was in place? Do you think BP would have ever paid a fair price, given (1) that their profit model is one pill for millions of patients and (2) DCVax was/is yet to be approved and (3) no buyout/partnership offers were made after Merck was privy to the details of DCVax trial data via Keytruda Research Scientific Director, Dr. Kevin Duffy. It's easy to post about what LP should have/could have done. No one has the info to make those decisions but NWBO management. I'm
I don't know why it is taking so long to get DCVax pass the finish line but, in spite of my frustrations, I recognize LP and others have way more at stake and assume they have their best interest in mind (which I too will derive benefit). LP's modus operandi is NOT selfishness. LP is on a mission. DCVax is her life's work. Clearly something other than selfishness is motivating her for 20 years now.
(yes I'm saying it:) "Stay tuned"!
I get what you are saying. I agree.
Jtorence, I may from time to time get a bit frustrated wrt to the time it is taking for DCVax to get pass the finish line. Though there are some things that I disagree with LP, I recognize that I don't have the insight that they do nor am I privy to the details of all the numerous variables that go into their decisions. In general, I SUPPORT NWBO, LP and management and believe what they have accomplished is absolutely phenomenal.
No doubt, you and I are on opposite sides regarding NWBO. Even though at times I may have some concerns and frustration about the timing of some of their decisions, I recognize they have accomplished what BPs, despite their massive resources, didn't have the foresight to accomplish.
If NWBO pull DCVAX off, they will be the GOAT!
Correct, just freaked-out a bit...
DocLogic, I hear what you are saying about NWBO's manufacturing/FLASKWORKS and combos (and I know this is a phase 1 trial) but... if this treatment gets FDA approval before DCVAX, this would not be good for NWBO or US longs. I am a long... a patient long... but if we keep fucking around, we'll find out someone else will cross the finish line before NWBO, seriously diminishing if not eliminating our investment.
How can this be?!?!?!?! NWBO doesn't have dendritic cells on lock-down after all? Did NWBO/LP fuck around and let someone else beat them to the finish line? Did NWBO make an error by not applying to the FDA?!?!?! WTF is going on!
NWBO doesn't have fast track status:
"The time required to obtain regulatory approval varies between countries. In the U.S., for products without "Fast Track" status, it can take up to eighteen (18) months after submission of an application for product approval to receive the FDA's decision. Even with Fast Track status, FDA review and decision can take up to twelve (12) months. At present, we do not have Fast Track status for our lead product, DCVax-L for GBM. We plan to apply for Fast Track status, but there can be no assurance that FDA will grant us such status for DCVax-L".
FDA Grants Fast Track Designation to DOC1021 for Glioblastoma
Author(s):
Ashling Wahner
The FDA has granted a fast track designation to the dendritic cell vaccine DOC1021 for use as a potential therapeutic option in patients with glioblastoma multiforme.
The designation is based on preliminary safety and efficacy findings from a phase 1 trial (NCT04552886).
DOC1021, which was developed at the Texas Medical Center in Houston, mimics a viral infection with the patient’s cancer markers and harnesses the body’s ability to find and kill infected cells. The vaccine uses a “double-loading” technique that stimulates a novel viral recognition and response pathway. DOC1021 uses patients’ dendritic cells to load unique cancer markers internally and externally into the immune cells, as would occur in a viral infection.
Patients’ individualized DOC1021 treatments are prepared and administered through 3 injections that target the deep cervical lymph node chains. This treatment leads to immune responses that target the central nervous system directly.
“The FDA’s decision acknowledges the potential of this new treatment approach for a very challenging disease,” Mike Wicks, chief executive officer of Diakonos, stated in a news release. “Our protocol represents a first for cancer immunotherapy and could be viable for many types of cancers beyond glioblastoma multiforme.”
“The vaccine's mechanism of action and its unique route of administration showcase the potential of harnessing the body's immune system to combat glioblastoma,” Joseph Georges, DO, PhD, assistant professor of neurosurgery at the University of Arizona College of Medicine — Phoenix, added in the press release.
The single-arm, open-label, first-in-human phase 1 trial is evaluating the safety and feasibility of delivering DOC1021 in 9 to 24 adult patients with glioblastoma who have undergone neurosurgical tumor resection and in whom a neuropathological diagnosis has been established.2 Eligible patients include those with potentially resectable glioblastoma who are deemed good candidates for adjuvant chemotherapy and radiation therapy, including those with tumors deemed suitable for gross total resection or partial resection. Patients must have adequate liver, kidney, immune, and bone marrow function and have an ECOG performance status of 2 or lower.
Patients will be excluded if they have locally advanced tumors deemed unresectable and/or recurrent tumors after prior vaccination; used a nonstandard adjuvant treatment regimen of chemoradiation and temozolomide (Temodar); have any uncontrolled or severe condition that could affect study participation, including hyperthyroidism, hypothyroidism, systemic autoimmune disorders, untreated viral hepatitis, or autoimmune hepatitis; need or are expected need for concurrent therapy with corticosteroids during the trial’s vaccination phase; received prior treatment with another investigational drug or intervention beyond the prespecified standard of care for glioblastoma; or have active HIV.
The phase 1 trial planned to treat 3 to 6 patients with a starting dose of 3.5 x 106 of DOC1021. If this dose was associated with unacceptable adverse effects (AEs), no further patients would be enrolled at this dose, and a de-escalation cohort of 3 to 6 patients would receive the vaccine at a dose of 1.75 x 106 cells. If the starting dose was not associated with unacceptable AEs, a dose-escalation cohort of 3 to 6 patients would receive a dose of 7.0 x 106 cells. If no unacceptable AEs were associated with the vaccine at 7.0 x 106 cells, a second dose-escalation cohort of 3 to 6 patients would receive a dose of 1.4 x 107 cells.
The primary end point of this trial is the safety and potential toxicity of DOC1021. Secondary end points include overall survival and progression-free survival.
“Because phase 1 clinical trials are generally not statistically powered to demonstrate efficacy, detection of a statistically significant efficacy signal is very promising,” William Decker, PhD, an associate professor of immunology at Baylor College of Medicine and the inventor of the DOC1021 technology, stated in the press release.1
The phase 1 trial is ongoing at the MD Anderson Cancer Center at Cooper University Health Care in Camden, New Jersey, and at the University of Texas Health Science Center, and it is expected to complete in 2023.
“Historically, glioblastoma outcomes have been notoriously challenging to improve upon,” Georges said in the press release. “From a clinical and scientific standpoint, the results we are observing with DOC1021 are encouraging.”
WTF!!! Could the FDA jump-frog another treatment ahead of DCVAX?
And this is what that means. FDA must be getting comfortable with dendritic cells. https://t.co/KFF1qhG1yN
— Jman4956 (@jman4956) July 19, 2024
You are mad at LP for financial decisions you made! Take responsibility for YOUR financial decisions! Hindsight is ALWAYS 20-20!
It- when my friend told me what he did it was like someone struck a knife in my heart. Here this guy increase his share count to close to million while I hold to my position believing in LP. Yep . LP knows exactly what she is doing. A dangling carrot in front retail investors.
And your comment... ROTFLMAO!!!!
Your entire comment is simply no more than a speculative wish list, akin to a child writing to santa, in the hope of getting a new bike 🚲 ☝️🥴
First, I put my $$$ where my money is and have been on this board for more than a decade... and up over 150%! I wouldn't be here if I didn't believe in the company. Also, NWBO doesn't have the money to pay all of the longs, many of whom have been here for a decade and a half.
Stop projecting...
By the way, if I am getting paid to post by NWBO, providing links to bash NWBO wouldn't be prudent now, would they? You don't believe your own bs... LMAO.
Why is another investor's wife a concern, thought or topic? If you like NWBO's stock, you invest. If you don't, you state your case and find another stock that you do like. But it is strange to hate a stock/management and stick around 24/7 badgering a company on a message board... unless there is a hidden agenda (where you derive some type of benefit) that propels you.
How much are they paying you?
Again...
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https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174669305
Only a clueless (uniformed) person would use the term "clueless" to define NWBO management who:
1. Created and patented a credible, efficacious cancer treatment, DCVax-L (not to mention DC-Direct, which has been described as DCVax-L with the brakes off) that has been peer-reviewed and validated by a top-tier journal and 50+ renowned oncologists;
2. Created/submitted an SAP and MAA that will lead not only to being able to treat GBM and other brain tumor types but also to a potential "agnostic" designation (for lack of a better word), opening DCVax-L to the broadest possible market of ALL tumor-based cancers;
3. Created its own manufacturing process of DCVax-L in parallel to conducting its clinical testing/trial, while naysayers complained about LP focusing on manufacturing even before the drug was validated;
3. Forged a relationship with Charles River Labs (who, over the past three years, have supported the development of more than 80% of the drugs approved by the FDA) with operations in 20 countries in preparation for worldwide scalability and distribution;
4. Purchased a company renowned for its dendritic cell research to further its dominance by continuing research in using dendritic cells against cancer, ultimately, in addition to its extensive patents (including the latest EPO "combination" patent), effectively creating an impenetrable barrier of entry to this space as well as an insurmountable protective moat around the entire DCVax platform.
Given what NWBO's management has accomplished-- despite the onslaught of attacks by wall-street, SHFs, BP and others, it is absurd to opine that NWBO management is "clueless" concerning communications when the effectiveness of their communications was directly responsible for the above (and more) accomplishments!
You are majoring in the minors, my friend. You're trying to piss in the wind that is blowing in your face. But... if you must... carry on.
Correct. Robot's objective is absurdly impossible to accomplish. Given that most longs have been here for a decade and know what we hold and why we hold it, we will NEVER sell until approval. Most will not sell until full commercialization. If we didn't sell when NWBO fell from $12 to 14 cents (BEFORE the last SAP and MAA, patents, JAMA-validated (along with 50+ oncologists) journal article, automated manufacturing (Flaskwork) almost in place), why in the name of God would he waste his time trying to get us to undermine our own long-held, convictions.
The most likely explanation is he's a paid shill.
Only a clueless (uniformed) person would use the term "clueless" to define NWBO management who:
1. Created and patented a credible, efficacious cancer treatment, DCVax-L (not to mention DC-Direct, which has been described as DCVax-L with the brakes off) that has been peer-reviewed and validated by a top-tier journal and 50+ renowned oncologists;
2. Created/submitted an SAP and MAA that will lead not only to being able to treat GBM and other brain tumor types but also to a potential "agnostic" designation (for lack of a better word), opening DCVax-L to the broadest possible market of ALL tumor-based cancers;
3. Created its own manufacturing process of DCVax-L in parallel to conducting its clinical testing/trial, while naysayers complained about LP focusing on manufacturing even before the drug was validated;
3. Forged a relationship with Charles River Labs (who, over the past three years, have supported the development of more than 80% of the drugs approved by the FDA) with operations in 20 countries in preparation for worldwide scalability and distribution;
4. Purchased a company renowned for its dendritic cell research to further its dominance by continuing research in using dendritic cells against cancer, ultimately, in addition to its extensive patents (including the latest EPO "combination" patent), effectively creating an impenetrable barrier of entry to this space as well as an insurmountable protective moat around the entire DCVax platform.
Given what NWBO's management has accomplished-- despite the onslaught of attacks by wall-street, SHFs, BP and others, it is absurd to opine that NWBO management is "clueless" concerning communications when the effectiveness of their communications was directly responsible for the above (and more) accomplishments!
You are majoring in the minors, my friend. You're trying to piss in the wind that is blowing in your face. But... if you must... carry on.
NWBO cannot be defined as "clueless" given what they have accomplished. Obviously you know this..
Don't know if this is a good thing or bad... but I feel EXACTLY the same. I'm in it until the end!
My wife asked me again why not sell so we can pay some expenses, and I responded as usual that I would rather lose my investment than to sell it after all these years and watch the sp ramp up on and after approval.
What does NWBO's poor communications have to do with approval? Their communications, even if poor, has no impact on MHRA's decision to approve DCVax-L?
Settlement agreement discussion?
LMAO, what about you...
they are reading and posting on this crap message board
To those who say NWBO management can't do anything right... read it and weep!
MAA Application. As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.
MAA Application. As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.
Could it possibly be NWBO already got what it wanted?
Abstract
Nature, Science, and PNAS are the three most prestigious general-science journals, and Nature and
Science are among the most influential journals overall, based on the journal Impact Factor (IF).
Or... perhaps management knows what they have and are so confident in their plans that they do not care about the daily stock swings, knowing the true value of the company WILL eventually be accurately reflected in its stock. Management has way more to lose than you and I, for sure.
This point is particularly true given where NWBO is in commercializing the dcvax platform: ALL HANDS ON DECK TO GET APPROVAL, FLASKWORKS AUTOMATION, PARTNERSHIPS, ADDITIONAL TRIALS, ETC.
Keep a record of the conversation, just in case. I wouldn't believe a word they say.
Could this possibly count?
Northwest Biotherapeutics Provides Update on Near Term Plans for Submission of Marketing Authorization Application
"The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators."
Thanks BB
Did anyone see Maverick's tweet, linked below? I don't know what to make out of the attached email screen shot (below)
Is he implying, via the email snapshot, that there's a Memorandum of Understanding between NWBO and Oncovir (POLY-ICLC)?
#DISRUPTOR #CANCER $NWBO Collabs: $MRK $AZN $AMGN $REGN $TAK $BMY $JNJ $GILD $RHHBY
— maverick_1 (@maveric92283613) March 21, 2024
Update day after sequel
Funding SET
4 BIG ANGEL Investor Briefing reviewed by Brian Golf: Excellent
Tweeted:https://t.co/88opUNnCa5$NWBO 4 Generational Wealth pic.twitter.com/E88CcV4inX
biosectinvestor is posting garbage? ROTFLMAO.... You just can't make this shit up.
I don't like the formatting of the twitter (X) posting feature. I always take a screen shot and paste it, with the URL link, in X... FWIW.
I don't think that's going to happen...
Of course, no response...
The MHRA will approve DCVax-L around mid-March, give or take two weeks!
Not odd at all. They simply don't want to pay the asking price! They'll he and haw, stop their feet like petulant children but at he end of the day, they have Keytruda revenues to lose because whoever partners or buys NWBO wins with a more effective treatment and everyone else loses, imho... but what do I know?
Vator, Vator, Vator, I know you don't understand why I am so upbeat... just like I don't understand why you've been on this board for more than a decade, not invested in NWBO and hating the management WHILE ADMITTING THAT "THE VACCINE WILL GET APPROVED". Imho, this is tantamount to LP/NWBO creating the main ingredient to THE cure for all tumor based cancers and you complaining about ... (fill-in your bullshit here)! If DCVax-L gets approved, as you think they will, LP won't need defending (she doesn't need it now).
R.I.D.I.C.U.L.O.U.S.
I hear you. Although sometimes I think Merck will buy NWBO (can you say, "MURCidencel"), I question whether Merck can afford the true value of the DCVax-L platform treating all tumor-based cancers. Then, again, at other times I think NWBO will construct numerous partnerships with BP. But, also, on occasion, I thought/think NWBO would/will go it alone, given the Charles River Labs and Advent in Sawston, UK. Perhaps, the answer is all that LP is letting BP know PAY-UP! or I will take all of your cancer revenues! How else can you explain Merck STARTING a mRNA cancer vaccine trial in August 2023 which will not be completed until 2019! Good luck!
By the way, I am not 'stuck' on any of these positions because I think however it plays out NWBO, cancer patients and investors will, imho, tremendously benefit. DCVax may very well pan out to be THE main ingredient to THE cure for all tumor-based cancer! That's all I focus on, frankly.... not the route but the destination.