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Well, as I said, some things go over people's heads because they lack the comprehension to really understand things. Is that simple enough? I did not use "big words" like connote.
Stick with Big Pharma investments. These tiny companies and new technologies are not for you. We are just investors talking amongst ourselves. No one wants you to invest or put your money here. Feel free to focus your attention on investments that you think will prosper you.
You don't understand the context of the overall contractual arrangement. You gave a narrow view. People were already aware of the basics, so providing the link to a contract and simplistically making the assumptions you made is not factual, it's a perfect demonstration of the Dunning-Kreuger effect. You think you know things you don't know. You don't appear to have the competence to know the things you don't know. And you're extremely certain that you know everything you need to know, even when you state things in your messages that clearly show you have large pieces of information missing from your understanding.
But the reality is that no one wants you to invest. We discuss our investment amongst ourselves here. This is an obscure board for investors. You've invested in Merck and are interested in MRNA vaccines. This is not the place for you. So now there is no explanation for why you are expending so much energy and time harassing NWBO investors about their investment decision. Usually there is a real motive behind such behavior. Typically, when one has shorted and is insecure about the short position, one might spend a lot of time harassing investors because that is the only way to try to make one's bet go the way one might want it to go, perhaps. And look, I'm not saying that harassment doesn't work. I think it does. But it's crooked. And in a case like this, it's disgusting, unethical and immoral. But that typically doesnt' discourage shorts. They can pretend to be moral and it seems to allow them to do immoral thins and feel OK about it because their pretensions feel very compelling to them. But as we know also, some of them have engaged in illegal activity.
Good for you. Those are already established companies and technologies. Not a hugely adventurous investment, but then you have no reason to be ghosting around here trying to harass NWBO investors now do you?
You definitely don't post factually. You post partial facts, partial stories in some very few cases. Mostly it's all opinion.
If you don't know what happened, how can you claim you post factually?
It was lifted, Bride of Hygro. Regulators have to be careful disclosing too much and spoiling a trial inadvertently, twice in a situation like this one. So, you can presume whatever you want. But that seems to me to be the most likely answer given all the details. You're not a big detail person. So it's doubtful you could get to any kind of rational determination beyond your own initial and immediate opinion.
You think "connote" is a big word? OK.
You know, it's only 7 letters...
It was not a "Halt", it was a partial halt, and not for safety. Likely for the fact that crossover was so broad, likely owing to the fact that patients saw the treatment as very successful for their peers, that there was no longer a placebo arm and enrolling new placebo patients would be unethical. That would not prevent a trial from proceeding on to approval from any regulator, and especially not when a regular wanted the crossover to address risks that turned out to be non-existent.
You know that giggles don't somehow connote that you actually know what you're talking about. More likely the opposite.
Dunning-Kreuger syndrome is a profound thing.
Yeah, it's a pretty hard and fast rule. Even if you're not one, they often won't say the name of a company related to a breakthrough drug. You'll see stories about the trial and doctors and they might slip in the name, very circuitiously somewhere in the article at best. It might not appear at all. The journalists see it all as pure science, not commerce and when it comes to tiny penny stocks, their entire mindset has been filtered by old news not contemporary news, which is why hedge funds have such an advantage in knocking companies down, putting them on the OTC and then messing with them. It's a very imperfect market.
Too much ignorant BS in your posts.
Approval is likely, the cost and benefit are very favorable at that rate.
The company will be well positioned to advance the treatment and reduce their costs as well. They are well positioned. The discussions I have had with AI, based on the most recent results with combinations, suggests that they would qualify yes, for premium pricing even in the UK. So their current pricing fits well within that range, but I know that they may want to make it less expensive. My suggestion is that they maintain a reasonable comparative price to where they are now or above, for patients who are covered, so that they can provide lower prices to patients who need treatment and do not have coverage. They need to ensure that the company is on solid financial grounds before they can pursue their best impulses.
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:
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
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.