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I know everyone is frustrated, but stay calm and don't let your emotions get the best of you right now. I watched this group go from excitement and optimism in the last two weeks, to anxiety and frustration in a matter of days. I get it, the frustration and anxiety, because when management says end of September, you take their word for it and expect it. But hear me out. Ground breaking and profound treatments for cancer naturally will be if anything, questioned, simply because of the imminent paradigm shift that they can cause in the treatment of cancer, which is ultimately disruptive. Think about what DCVAX is....it's a vaccine that uses the human body to fight defects within the human body. It has virtually zero side effects. What is game changing about those two things? Well, do I really need to talk about how much of a poison temozolomide is? Do I really need to talk about the side effects of chemo and radiation? With the amount of cancer in our country, we probably have all lost someone close to us or know someone who has experienced the negative outcomes and hardships involved. This treatment offers a breakthrough. A novel form of immunotherapy not yet brought about and delivered to the masses. I say the masses because it has the potential to surpass GBM, and the potential to treat ALL solid tumors. The management of this company know this. They know it's capabilities, and the paradigm shift it could cause. They will be attacked at all angles from anyone or any entity that either cannot capitalize on it, or own it... because if TLD shows statistically significant overall survival we are in the midst of a game changing biotechnology that is far reaching towards life extension and even profoundly significant in a search for the cure! This is one of those stocks that has the potential to skyrocket suddenly, because of what it ultimately represents. Every T must be crossed and every i must be dotted. Stay strong longs. DCVAX's destiny is imminent.
Don't get discouraged now longs! TLD is coming whether the pessimistic turds on this board like it or not!!!
You should change your handle to cantankerous2020
Some guys on another group I'm in were investigating this. They contacted SNO site reps. The reps said that the title is still there and that they would bring back the details closer to SNO. The group I'm in theorized that SNO site was getting an onslaught of emails, so they removed it for now. As far as we have concluded everything is still fine and I still personally have the screenshot of the details of the page.
1. Brick and mortar in play with Sawston build out
2. Manufacturing streamlined with flaskwork's microden
3. Good Science showing blinded positive results.
4. SNO late breaking Plenary scheduled NOV20
Come on TLD!!!
Tell us more about your experience with this. I would love to hear some examples of pullbacks just before a binary event that you have witnessed so I can go look at the tickers!
No volume, everybody holding, not much movement....waiting....
Is that even possible?
Day of TLD ....$5-7, but that is only the starship launching
I have a feeling this is going to be an exciting week!!!!
Need big PRs that are timely and strategic, solid positive irrefutable data, and impeccable management decisions for a steady and timely rise in share price.
Yes exactly, and I believe Linda unofficially notified us of datalock at ABTA. Datalock has already taken place.
Learn more about the science and eventual application to all solid tumors before making such a statement.
Doesn't seem to have the same late day momentum as it did yesterday. Not likely. Things are still looking good however, with no news.
Not likely
Not likely, but I'm still glad we are sitting comfortably in high .80 low .90 range still on no new news.
Good show about brain cancer: The Most Dangerous Game, on Quibi. You're welcome.
I almost feel like announcing data lock at this point in time would be detrimental to the share price because we are only 10 trading days away from the end of September which is the month that we were promised top line data. This pps increase is a result of crunch line buying.. In not so many words, it has been assumed by most investors based on the rhetoric of the company (Linda's words last weekend) that we are past data lock and about to reveal TLD within 10 days at this point.
Thanks Captain obvious. Many of us have been here for years. Try to keep up.
Exactly
" Results of our 13 year long International phase 3 trial of DCvax-L for GBM are expected to be unblinded and announced later this month"
-LP at ABTA presentation
Linda Powers expects TLD before end of September per the ABTA conference.
Anyone know how to listen or watch Linda Powers tomorrow? Please share
Same old crap from you....
Looking forward to 9/12 and 11/20
10Q in August said statistical analysis would take "several" weeks after datalock, and that SAB meetings would also take "several weeks" after results were reported by statisticians. Several weeks + Several weeks = at the least, 6 weeks, and at most, 8 weeks. I'm hoping for TLD release last week of September, but expecting it no later than mid October. It is very possible Linda will announce datalock has occurred on 9/12 to keep momentum as they steadily start to PR leading up to TLD. GLTA longs!
Cures Act implications for DCVAX direct if DCVAX-L is approved...
The provision under drug development section subtitle C ->
Enables drug manufacturers to submit real-world evidence (RWE) instead of randomized control trial (RCT) data to seek new indications for existing medications. RWE is clinical practice and utilization data collected outside of the RCT setting and is regarded for its comprehensive patient
perspective under circumstances that reflect real-life experiences. Under the Cures Act, permissible sources of RWE
include ongoing surveillance data, observational studies, registries, claims, and patient-centered outcomes research activities. he costs to generate RWE for the approval of new indications will be substantially lower than the costs for traditional RCT evidence generation. Thus, manufacturers are positioned to achieve higher returns on investments when their overhead is reduced by observational studies.
https://pubmed.ncbi.nlm.nih.gov/29952706/
So according to the law, if DCVAX-L is approved and is efficacious, new indications like DCvax direct can be submitted for approval without the need for long phased RCT clinical trials because They could just use the successful data from L trials as well as whatever data is collected after it is in use. I think we could see approval for DCvax direct within 1 to 2 years.
No not simultaneous approval. That would be irresponsible. However, according to the Cures Act, this dendritic cell vaccine can get a kind of expedited approval for all solid tumors without phase 3 studies via the success of dcvax-L and cheaper and faster non RCT studies amongst other approved real world evidence gathered from Dcvax-L.
Cures Act implications for DCVAX direct if DCVAX-L is approved...
The provision under Subtitle C ->
Enables drug manufacturers to submit real-world evidence (RWE) instead of randomized control trial (RCT) data to seek new indications for existing medications. RWE is clinical practice and utilization data collected outside of the RCT setting and is regarded for its comprehensive patient
perspective under circumstances that reflect real-life experiences. Under the Cures Act, permissible sources of RWE
include ongoing surveillance data, observational studies, registries, claims, and patient-centered outcomes research activities. he costs to generate RWE for the approval of new indications will be substantially lower than the costs for traditional RCT evidence generation. Thus, manufacturers are positioned to achieve higher returns on investments when their overhead is reduced by observational studies.
https://pubmed.ncbi.nlm.nih.gov/29952706/
Cures Act implications for DCVAX direct if DCVAX-L is approved...
The provision under Subtitle C ->
Enables drug manufacturers to submit real-world evidence (RWE) instead of randomized control trial (RCT) data to seek new indications for existing medications. RWE is clinical practice and utilization data collected outside of the RCT setting and is regarded for its comprehensive patient
perspective under circumstances that reflect real-life experiences. Under the Cures Act, permissible sources of RWE
include ongoing surveillance data, observational studies, registries, claims, and patient-centered outcomes research activities. he costs to generate RWE for the approval of new indications will be substantially lower than the costs for traditional RCT evidence generation. Thus, manufacturers are positioned to achieve higher returns on investments when their overhead is reduced by observational studies.
https://pubmed.ncbi.nlm.nih.gov/29952706/
So according to the law, if DCVAX-L is approved and is efficacious, new indications like DCvax direct will have streamlined approval without the need for clinical trials.
Am I interpreting this wrong? I urge everyone to read the cures act part about this particular area in approvals for new indications of existing medications so we can have a better understanding of implications for direct if L is approved. I'll see what else I can find.
21st Century Cures Act was passed in 2016:
Cures Act Implications for DCVAX Direct if DCVAX-L is approved:
Additional wording in the Act allows for the approval of new indications for existing medications to be based only on “data summaries".
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5424829/
President Obama praised its final passage. “?We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need,”
___________________________
Former FDA head Gottlieb on cures act:
"Known as “in silico” testing, the use of computer modeling to supplement drug and device development is a promising avenue for evaluating safety and moving new therapeutics through the approvals process.
“FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms".
____________________________
21st Century Cures Act.1
Broadly, this $6.3 billion law provides funding for accelerating cancer research through the so-called Cancer Moonshot, increasing the understanding of the human brain through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, and extending precision medicine to all diseases through the Precision Medicine Initiative (PMI).
Plus, the Act allocates substantial support to the US Food and Drug Administration (FDA) in order to streamline the process for drug and medical device approvals, promote increased use of electronic health records, eliminate bureaucratic red tape, and advance the implementation of telehealth services.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5424829/
One thing is for sure... If DCVAX-L is efficacious, DCVAX direct phase 3 will not take 10+ years for approval. I look for the stock price to surprise us all after release of positive topline data. Especially if we are on the verge of a new potential SOC, not just for GBM but also for all solid tumors. Once the world catches on to the potential benefit to all cancer patients, with it's safety profile included, we are looking at a game changer. Consequently, we should anticipate a share price to increase in the next year to at least double digits if we low ball it. However, I will never discount a share price up to and over $100 per share if this is a banger!
I'm sitting here wondering about all of the off label uses that could bring revenue from direct....
I wonder how long approval would take for direct, if L is proven efficacious? Isn't direct just out of phase 1? Are we talking years?
I think they have "x" amount of days to report a failed trial to shareholders. I remember reading something about it not long ago. I tried to find it again online but no luck. Not sure if it is an SEC rule or not but I think they must disclose a failed trial within a certain time frame after learning the results. I want to say 72 hours but don't quote me on that.
Thank you to all the long posters on this board who have given such a vast array of insight for all these years on this company. Your knowledge and analyses of available data about this trial and company has solidified my staying in this investment with every penny to my name. Some of you do not know how valuable you have been to others, and I want to sincerely thank you.
That drop this morning to 0.05 needs to be investigated. That should be reported to the SEC.
Someone had an opportunity to buy at that share price....
Wowsers!!
Losing momentum with no DL. Need DL