Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I hear you. Unfortunately, US mainstream media has a general policy to ignore penny stock breakthroughs. Limited science publications are not necessarily so limited.
Likely you'll see it in the news when there is a deal with Big Pharma, or there is news for UCLA's work on the vaccine. They won't cover NWBO unless it is no longer a penny stock, generally speaking.
$150,000 Initially, for manual production and for the second year can be either 50,000 or 100,000 additional, depending upon dose production. For 1 or 2 additional doses it is 50,000 and for 3 or more additional doses, it is 100,000. Total, $250,000. And depending on the number of doses produced, and assuming biannual shots, that can potentially last more than the second year. I would presume that they could produce no more doses, and they could produce another 6 doses. So doctors will want to get as much tumor as possible to save their patients costs.
$250,000. That puts them around $10, 416.66 per month. That is much cheaper than, for instance, Optune, at $21,000 per month. Other immunotherapies can also be more expensive per month. I did not include VAT for Optune. 21,000 x 12 = $252,000 + $50,400 for VAT = 302,400 per year out of pocket.
Looks like VAT (tax) is around $30,000, or 20%. I presume that is when it is out of pocket only.
Assuming DCVax-L extends survival and costs less per month by. substantial amount, it would be hard to believe a regulator would not think this is an advance over current other treatments.
Ohhh, thank you. Obviously acting on our behalf spreading your fake FUD.
There are no crickets here.
Learningcurve has responded to my response to his harangues and then “ignored” me so that I can’t respond to his response, which is so typical of a frightened short who cannot argue the issues and doesn’t want to keep discussion going for fear of losing the argument.
Well, then ignore the facts if you must and hide your head in the sand by repeating this falsehood.
I gave you the recent UCLA press release clearly indicating they are in fact the same. There are numerous posts with all the details as they were confirmed repeatedly by UCLA, numerous persons involved intimately including Dr. Liau, multiple times, the title of the Phase 3 JAMA article and countless other times.
But if you want to keep pretending longer so that your farce can continue, that’s up to you.
You have no idea what you’re talking about and can’t even point to the patents you’re trying to suggest are problematic. Bluffing won’t do. Sorry. You’ll just have to keep faking it.
Excellent post by Hoffmann, though generally I would not go off of a case for those timelines, even given the letters. But I think the timeline is reasonable in terms of the way he laid it out. You can derive much information from case filings though. As for the timing, the challenge is ultimately that the variables are so flexible, so it can happen even very rapidly if the regulator is very satisfied with the application. It is very reasonable to expect a decision this year.
It is clear though that the Phase 1 assessment can go as long as 80 days or even be faster… it is “up to” 80 days. If there are substantial questions and I do think those types of questions tend to be, then the clock off period might likely take the full 60 days or close to it, but that also can be shorter, or longer if it requires that, but I think more likely around 60, to ensure thoroughness of a response. Such things do not necessarily turn around fast when so much is riding on the answer and not missing anything. And of course, that period might not happen at all, further making it very difficult to estimate. The regulator could be very satisfied with the application package.
Then you have 150 days minus the time for phase 1 (and the clock off period), for the last phase. That is somewhat of an indeterminate period, not in maximum length but speed. Assuming it takes the full period, as he suggests, you look at these variables and you can really get a wide range of decision dates. As H suggests in his staggered timelines.
The initial validation generally happens though, as I said previously, during the pre-submission process using the MHRA’s systems. It is basically presumed valid unless they find something glaring and that Phase 1 period is when most questions are going to come up, so I expect anything reasonable would come during that part of the process in reality.
Here are some further relevant sources:
“Guidance:
150-day assessment for national applications for medicines
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.”
“Guidance for new Marketing Authorisation assessment routes in the UK following Brexit: 150-day National Procedure”
No, they do not mean the same thing. Off label means not approved, but prescribed by a doctor. Extended label means an official decision by the regulator to add additional indications for a drug.
You’re revealing a profound lack of knowledge, maybe this is not a good investment for you. You really can’t evaluate an investment if basic concepts sound like “word salad” and you are too impatient to do careful due diligence.
As for the investment thesis, my point to you was that under newer laws, regulations and guidance IN the U.S., and other countries, access to new treatments and drugs earlier in the past has been a focus of change. Therefore looking back over 20 years, isn’t going to be fully informative.
But if you prefer to only look backward, that’s a perfectly good way to make decisions. I am not here to tell you to invest here or anywhere else and given your responses, I really don’t think this is for you. You really have to be able to do basic confirmation of basic ideas and facts yourself. You clearly can’t do that. Neither can the other young lady here earlier. These kinds of investments are not really ideal for most people. Try an index. Get a financial advisor. They would not put you in anything like this anyway, just to avoid liability. Investments should be understandable for you or you won’t be able to manage the ups and downs and if you can’t manage those and decide rationally what to do (buy low, sell high, which seems easy, but most people do the opposite even in blue chips), then highly volatile, early stage and risky companies like this are definitely not right.
We are discussing basic recent regulatory efforts and reforms widely discussed in this sector. But you seem unaware and dismissive. So really, try another option.
My meeting got canceled but I am not in a position to post more than snappy posts. I hate doing serious posts by phone. No, there is a good basis. I believe it gets referenced here regularly.
You are definitely not believable. You can’t even look up and prove basic details.
That’s all you know huh? Not surprised.
Untrue. But All of that to get back to the standard false argument? Sounds like you’ve been here under another name.
Feel free to give that list of patents by Dr. Liau, as inventor, and we can unconfuse you.
Since you can’t seem to look up patents, it’s pretty much a waste of time with you.
I don’t have time for you at the moment. The term “vaccine” is useful here but also not, it is a therapeutic treatment like any other, not preventative.
Yes, doctors can give you “off-label” prescriptions. I did not say “off-label” in said extend label. Big difference.
You have to use the right terminology. Extend label, meaning you get to utilize it and get insurance and Medicare coverage and whatever other insurance coverage you want.
But I am not here to debate with you and don’t have time to give you the full info, so I will leave you wanting more… or someone else can answer if they feel like it.
You don’t patent a trial. Dr. Liau would not be on NWBO’s SAB. NWBO is not a sponsor, but the drug used in that trial is DCVax-L.
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
“A vaccine to treat glioblastoma
Glioblastoma is the most aggressive primary brain tumor in adults, with more than 10,000 new cases diagnosed in the United States each year. Standard treatment involves surgery, radiation, and chemotherapy; and the median overall survival rate is only 15 to 17 months from diagnosis.
A vaccine to treat glioblastoma called DCVax-L has been in development for several years. Linda Liau, MD, PhD, MBA, and a team of UCLA researchers were the first to investigate whether a patient’s own dendritic cells (a specialized type of immune cell) could be used to create a personalized treatment for the deadly cancer.
“We tested the method with a single patient in 1997, and then moved to a phase 1 safety trial in the early 2000s,” says Dr. Liau, professor and chair of Neurosurgery at UCLA.
A series of phase 2 early efficacy and optimization trials followed, and then an international, multi-site study led by Dr. Liau began in 2007.
The vaccine consists of two components: a patient’s dendritic cells, which are special types of immune cells, and proteins prepared from a patient’s tumor.
To create the vaccine, which is individualized for each patient, medical staff first perform a procedure called leukapheresis, in which a patient’s blood is drawn and their white blood cells are collected. Then, the patient’s tumor is removed and sent to a lab where researchers obtain proteins from the specimen, called tumor lysate. The white blood cells are cultured to differentiate into dendritic cells, and then combined with the tumor lysate to make the vaccine.
Dendritic cells are “antigen-presenting” cells, which means that they are able to process all kinds of foreign invaders in the body and alert the immune system’s T cells to mobilize a broad immune response against those invaders. Glioblastoma is a highly heterogenous disease, meaning there are many different types of cancer cells within a single tumor. Therefore, the dendritic cells — loaded with a patient’s own tumor lysate — allow a patient’s immune system to recognize a wide variety of tumor targets and spur the immune system to respond, according to Dr. Liau.
The phase 3 trial led by Dr. Liau involved 331 study participants at 80 sites around the world from August 2007 to November 2015. During the study, 232 people received standard care and DCVax-L at new diagnosis, while 64 out of 99 people received standard care and a placebo. (Patients in the placebo group received the DCVax-L at recurrence.)
The trial results, published in JAMA Oncology in November 2022, showed that newly diagnosed glioblastoma patients receiving the vaccine had an overall survival of 19.3 months on average, compared to 16.5 months on average among the contemporaneous, matched external control group.
“There is a significant subgroup of patients who lived more than five years, but the challenge is trying to determine which patients it may work for, and for which patients it doesn’t,” Dr. Liau says.
At UCLA, Dr. Liau and other researchers are now testing whether the vaccine would be more effective in combination with a PD-1 checkpoint inhibitor. Checkpoint inhibitors are a type of immunotherapy that work by blocking proteins that stop the immune system from attacking cancer cells. While the vaccine allows T-cells to get inside of the tumor, the checkpoint inhibitors may allow T-cells to be more functional and better attack the tumor cells.
“Because of the heterogeneity of glioblastoma, I don’t think there is going to be one drug or one treatment that is going to be effective for all patients. The future of glioblastoma treatments is going to be these combination approaches,” Dr. Liau says.”
You are a big? Don’t be so hard on yourself.
No one cares with or without you. Zero is what you apparently know.
That’s what you know. I agree, you know zero.
You appear not to understand what happens on a university page, a bio page for a researcher, or how to look up patents.
So you say.
No, you can’t explain why because you’re too poorly informed to know what you’re talking about.
This is an irrelevant page. I do not have to.
As I said, you make claims and do not know where to look. Basic due diligence is beyond you.
No, it is being brought to market and converting from a development stage company to a commercial venture that will be sold, partnered or earn its way to better valuations upon validation by the regulator.
Your job is apparently to try to stop that, but you won’t succeed. The process is too far along.
for MM’s every stock worth any dollar amount represents opportunity to transfer wealth, and a potential risk to reputation and business.
They are all the same, and some can be manipulated more easily than others by their real clients, which are firms that require more services and generate more income.
Now you realize I was right and try to change the subject… As I said, you are terrible at this…
Is this your first time trying to sink a stock, because you’re not very good at this… that has nothing to do with ownership of the technology. You appear deeply misinformed and unable to manage this debate.
I’d post more but the thing I learned a long time ago was not to teach shorts. I am not here to educate you.
You know who you remind me of? HyGro.
Please post the patent. You can’t. Because it is not the relevant patent and it is not the patent for DCVax-L or any DCVax product. They are process patents. NWBO has the patents outright.
I asked you to do the basic to prove your point. You’ve proven you can’t.
You seem not to understand what a CDMO is either. You’re embarrassing yourself.
You realize this is a bio. Not a proof of patent ownership.
The Dunning-Kreuger effect is a debilitating disease for some, unfortunately.
Please go ahead and post your evidence. You have none. Your posts are false and increasingly desperate.
The fact is, NWBO owns the patents, for DCVax-L and DCVwx Direct outright. Not licensed.
The fact is, you can’t produce what is basic and what I requested and you know it. Hence your desperate claims.
That’s false information. Post the patent and the agreement. You lie and make claims for which you have no information.
The fact is, NWBO has the patent. As for professors and patents, they do not “relinquish” them and get them first. Research patents typically belong to Universities and then are licensed out. But the DCVax patents belong to NWBO and are all process patents. You can’t patent a cell type. You patent the process by which you make a treatment.
As for the combination patent, that falls under the collaborative contract with NWBO.
Why don’t you do this. Post the patents for which Dr. Liau is the inventor. Can you do that? Or is that too difficult for you?
Well, that’s you. I have no worries and I don’t say things just to say them. I told people when it was way down to average down, take losses against gains and manage their portfolios. I do like concentration, but I am not a big believer in single stock investing as a general rule. Sometimes my portfolio gets concentrated for various reasons, but I think best practice is to be in a few stocks you can carefully manage and take losses against gains and reinvest the gains where they will give the biggest gain, and where the most value lies in that portfolio.
Ahh, really. Thanks for the advice.
At least you’re no longer pretending. Now everyone knows what you’re here for…
I can’t tell you what to do. I understand the frustration. The markets are high and we are low. That is the nature of being in stocks that are not following the larger cycles always, but often their own cycles. No one can really tell you to hold, and there is no certainty one way or the other about what exactly the future holds. It’s all up to you.
I totally get it. We all have our internal timelines, financial imperatives, and other drivers of our circumstances. You can only do your best. Wishing you good luck!
Sure. You know the future. You know better than Dr. Liau, and all of the other experts out there who signed onto this research and Dr. Musella, and all the other longs as well as my own judgment because your one month here makes you an expert.
I think rather, the believability challenge is on your side. And quite honestly, I do not care. I am not here to convince anyone to invest or stay invested. I do enjoy challenging the short narratives however. It gives me pleasure to make shorty squirm.
If you check many of these tiny bios, you’ll see that they tend to get squeezed hard when they are being validated. It can last well after even approval, with the justification that commercialization requires cash. But deals with BP can completely shift the circumstances, and those can come at any time.
Certain interests love to squeeze longs out and discourage them just before the end of the race. Just before the summit, when you are on to your third false summit…meanwhile they drained your pockets by squeezing it and shorting it down over years, when it was necessarily being diluted. They have a longer time horizon, they have seen it all a thousand times, and retail are just mice to herd around in their maze to the larger players, especially the hedge funds.
Great minds. I was just looking at that. 122 negative posts, all since the day after Christmas, basically 1 month old.
Yet claiming to be an expert here and denouncing people who have been invested here and discussing the ins and outs here for literally years.
Why the urgent need to undermine this stock only since this one month…? Obviously we will likely never know for sure, but given the patterns, it seems quite obvious.
Everything you just said was false. But hey, I get it. You’re frustrated that your game is not going as planned and you’re striking out. Failing is frustrating. Try some other occupation, because this one is not working for you.
Oh, that makes me “awful”, knowing to accumulate when shorts squeeze the price maximally?
I think you’re just unhappy that your efforts to spread fud are unsuccessful today. Understandable.
I feel sorry for anyone whose purpose is to be crease suffering in the world under false pretenses. No amount of compensation can justify such behavior.