I have pointed out before that Regeneron stayed flat after its first approval. But the increasing revenue was undeniable. Within a year it started to climb. But before that, the validation should get this to a more level range of valuation.

I know there are people who do not want this, whatever their reasons. And I can’t predict price anymore than the can. But I can counter opinions that give price predictions as a given. No one saw that price pop to $2.51. NO ONE. So don’t tell me the wise guys around here know at all what they are talking about.

It’s not “academic”. They already have production. Approval means revenue. Nature means broader validation.

Where did that post say anything about LP or geniuses? I missed it.

I understand some have certain expectations and I recognize that this indeed does happen. But no one can really say. It depends on a lot of factors. Predictions either way have mostly been wrong. When it hit $2.51 and stayed about $1.50 and $1.25, whiffs were sure it must go down immediately. Of course, what has hurt is the non-stop silence, and the normal context where a lot of people pile out pre-approval, just in case. It’s a common thing to see price go down in the run-up to an approval and then to take off.

As I said, you have potentially incredible results to publish in a journal like Nature. That will transform narratives. What does that mean? It means a lot more speculation on deals and buyouts. That transforms the hunger for the stock, especially one so undervalued.

But yeah, could pop and then go back down. Just about anything can happen in microcap land. If they literally had hens who laid golden eggs, probably there would be piles of skeptics trying to short and talk down the process, first saying no such thing existed, then claiming that they would upset the market price for gold and therefore it’s very bad thing.

The shorts in each of those companies took the opportunity to mess with those innovative companies and spread false information because the opportunity to profit was believed to be easy. It's technical, and retail, shorts believe, is stupid.

It works better for small, not yet validated biotechs.

Shorts are a menace to the world. A person can legitimately short a portfolio holding. That's a reasonable way to manage the downside risk if they anticipate something they own was bought at too high a price or if there are macro events that will drive that value down.

But the shorts that manipulate markets and sentiment and spread false light narratives are criminals who leverage our constitutional protections to do harm to society and other investors for profit, spits and giggles.

Oh nonsense. They are all over the place as the microcap level. They are constantly being shorted and attacked by opportunists who think they can take them over like Martin Shkreli. And some have garbage and stay valued highly for years before they crash, because they are being milked by investment funds and their friends taking investor money and playing with them.

Your insight is really not very insightful.

And yeah, there was not an ecosystem developing the CDMO space for this exact product, and so she invested in other people creating it, and they sold, and she bought the retained expertise as part of her spinoff rights so that she could maintain the SAME company effectively, for manufacturing through approval.

But the company owns Flaskworks, and that is the obvious future. They also have the full economic control of Sawston except for those parts that will be used to meet their requirements for local regional development financing, which was low cost, but requires that they provide CDMO services to other, local researchers and companies at Cambridge and in that region.

But yeah, according to shorts it's all criminal even though they are top lawyers who had extremely responsible positions in government and could be making way more money doing other things, with no cares.

Such fricking idiocy. But yeah, it's in your economic interest to spread this nonsense. And of course, UCLA, doctors at top research institutions in immunotherapy including University of Pennsylvania and Brown University, don't agree with you. But you're the anonymous expert online telling people how it really is. Pffft! nonsense! Get lost.

They are likely to be approved. Assuming approval, they have done an immense job keeping their expenses low, their manufacturing scale-up costs low. They are not "dendreon" though the idiot shorts made that bet 10 years ago and they won't let go... but it's a bad bet. This technology is way better at every level, and is breakthrough. Companies do go bankrupt, with fantastic technology as well, and as I said, that is ALWAYS the risk in these small biotechs. ALWAYS. But the opportunity is that IF they succeed, they have the potential to become extremely valuable. Unlike others, I won't predict the market gets it on any event. But someone will, and that will likely transform the conversation. All IMHO.

Any small biotech can fail. They can also go from zero to billions. That is the whole point. But your scaremongering is empty. Expected and empty.

Nature publication…. Could be just ahead.

That will likely change perception in the marketplace. I can’t say it will bring in institutions, but it could substantially change the narrative, overnight.

Actually, you exaggerate the number of years since completion by 2. What’s new?

And yes, the trial was completed. It started before most immunotherapy trials, but they ran out of cash in 2008, and restarted. They also learned a lot and across the industry, standards have changed since that time for the evaluating things like PFS from the knowledge that was gained not just by this trial but all the others.

You post somewhere else you’re “buying today”. You’re just a swing trader with multiple accounts.

Nonsense. It is already doing all the things intended, you’re just unaware. NWBO is not yet in a position to benefit from the clauses I was referencing that address directly and clearly the comment. Additionally, the regulator has already implemented those provisions. It’s not just the law but the implementation.

Just because some people here have misrepresented what it is, out of perhaps enthusiasm and a bit of unsophistication, your comment much the same, it doesn’t annul the law.

As for Car-T, myself have posted at length on the subject of Car-T and NICE… I don’t recall your posts on the subject. DCVax-L does not reflect the issues that caused Car-T to be limited in application.

By the way, 1) the cures act is about more than RMAT; 2) I have owned and then got out of RMAT designated trials just in time before they failed; and 3) RMAT was not what I was referring to and since you did not reply on topic given your previous post and my response with 21st Century Cures Act, you do not seem fully cognizant of what it provides.

Nice try.

I am not here to advocate your investment in anything nor to explain how markets work to you. A decline in market price can be due to many things. Stocks go up and down, often not for any particular reason at that company. If you haven’t noticed, a lot of good companies declined quite a bit over the last few days. Macro and micro economic events can be the cause.

You clearly are not paying attention to the 21st Century Cures Act or what that means for new labels and insurance coverage yes, for data only gotten through real world examples.

You have no idea what you’re talking about.

If that were true, and this were nothing 1) I’d expect you to show much more professionalism and to be much more competent; and 2) I would not expect you to be wasting your time here trying to annoy investors in a small company. You should have better things occupying your time if you were vaguely competent at your job that complaining on this board and wasting everyone’s time with your nonsense.

It’s not up to the company. It’s UCLA’s trial. Hopefully they will be fast.

I suppose the NIH support and research with millions of dollars is nothing. But yeah, no support.

Successful administration. The sleepy guy in court is scharting himself awake periodically.

He doesn’t have a “fear”. He just posts for the obvious purpose of constantly dissuading anyone from investing.

Name calling is for the people who actually have nothing to say. You pervert the truth in some instances. But generally speaking, you tell lies daily.

Of course this is a false description, but that never stops you. PFS is only for early approval. It is a surrogate measure for survival. But with immunotherapies, especially brain tumors, early on the methods for determining recurrence did not take into account the actual response to an immunotherapy, which, duh, causes inflammation, which looks like a flair on a scan, but is actually the drug working. They can’t take back those designations, but when everyone is living longer, a lot longer in certain instances, that is a survival benefit and that would make PFS in this instance, the old way of measuring it, not a valid surrogate for survival and therefore not a valid measure of failure or success in any way.

Subsequently, PFS has been adjusted, PFS+6, for instance, but this trial was already started and far along.You can’t adopt a newer PFS plus that may be flawed as well. Hence, better measures have evolved and NO, they couldn’t just throw in some ORR, at that point. That’s ridiculous and stupid and shows you have no idea of what you post.

They got permission to make OS primary, and to use a very thoroughly vetted, externally proposed, expertized, blinded placebo based on concurrent trials that has the same placebo standard of care.

You can invent all you want. You can look to doctors with competitive treatments to make the argument based often on ignoring key parts of the trial, and details.

But the reality is, virtually all the other drugs that have been approved have in fact actually failed, at one point or another and still been approved based on other data. This trial does not have those problems.

People post those screen shots regularly. Yours doesn’t show your ID. No way to know if that is true. And we know the rest of what you wrote is flatly false.

I don’t believe they have it in that form, that it is available to personnel who would be doing such work or that it is available generally in the way the suit suggests. For their broad claims, depending on the judge, and they likely brought it somewhere in a favorable forum, they might even be successful in undermining regulation, and market surveillance. But the unfortunate likelihood is that they are just making the SEC more blind, and that is the purpose of the suit. And the SEC is definitely not going to suddenly start doing anything remotely as you suggest particularly but not likely because of the suit you point to…

I think your description of the game is a far more accurate one Beartrap, and a more likely unfortunate outcome. I agree that it is in the day-to-day manufacturing of a market and settlement back and forth, that that “naked short” market exists. They fill orders without the shares, back and forth to each other, they roll the FTD’s forward filling the ones at the end or later in the process first, and they ultimately settle up, likely regularly, for unaccounted shares that were not going to any real retail accounts in the end anyway. In the overall process, their big clients get “favorable pricing”…

It’s a BS suit and surveillance data like that is not used for prosecution. It’s used for broad market surveillance. Assuming that what is in one category can be used to other categories when likely the law is written very distinctly, to ensure compliance with the Cinstitution just because some anti-regulation, not pro-regulation toady fake third-party says so, is not the way to get real information or understand what is really likely going on.

Further it is doubtful not just that it cannot legally be used, but also that it is actually detailed enough to be useful for the purpose you speculate it is useful for. Extremely unlikely.

It is doubtful that anyone who has shares and has held them for any amount of time, does not have shares or won’t have shares. It doesn’t really work as simply some who speculate on this topic believe. At the end of the day, if literally they were short shares, there would be an increase in volume and price until the relevant accounts are covered and anything else is covered by normal market processes, at their brokerage.

No retail shareholder will be left holding the bag and it is doubtful there are enough such shareholders that that would be the case, which is why they can manipulate the market so completely.

Most likely it’s just general market data and is not intended to be used as alleged, and the lawsuit itself, the group behind it is likely funded by hedge fund founders and similar people who do not like any possibility of prosecution for market distortion.

But I doubt that is what this data was being used for. I doubt anyone’s personal data, wrong doers or ordinary citizens, is available through this surveillance for individual prosecution. The lawsuit will likely make any use of it, even if they had the relevant data and could use it, impossible until and unless it is dismissed completely.

It’s doubtful the data is for surveilling individual trades, likely hasn’t the right detail for this kind of case either. As I said, probably more for observing the market broadly. The’ve never heard of anyone being charged with such data not directly from their financial institution, and I doubt we would ever hear of such a thing. Though banks/broker-dealers and hedge funds likely do not want any kind of market surveillance if they can stop it in any way. Fox is reporting such suits as if they are protecting ordinary investors investors, but that is definitely not the intention. It is to reduce regulatory compliance burdens for larger intermediary players and reduce the risks that data will show they maybe manipulate markets in unfair ways, though doubtful that would easily be shown for any individual company or shares.

Shorts love to squeeze these stocks before news hard to squeeze out the longs and manufacture panic.

No, I do not say that, I appreciate anyone as they actually are, but I am amused by the effort to hide by inquirig so vociferously being upset at me early on because I did not realize the Inquirig ID was a lady… making a clear effort to make people take note that a lady had joined the bashers… must be someone “new”…not.

In this case someone attempted 2 identities by saying they were two completely different people not just by ID name, but also gender. That was purely for the purpose of hiding their sock puppetry.

Ahh, but Nemesis is a man boy and Inquirig insists to be a lady. Yet the same person, same mean tone? This site never ceases to amaze me. Who needs to travel to see the wonders of the world? Two ID’s, one person… Incredible.

If the issue is naked shorts, the problem would be that the trades are not properly documented by definition. Access to falsified records from brokerages at the DTCC would not reveal anything.

BS…

Which literally has absolutely NOTHING to do with this company or DCVax-L. You’re just here because we are a captive audience.

If you can read like everyone else, why exactly are you presenting patently false information? You can’t read apparently or you lied.

The company clearly reported their result and the difference and the fact that it is a significant benefit for virtually all patients generally and there are specific groups of patients who did incredibly better than the median. By a lot. And subsequent studies are showing that with combinations to address secondary immune responses that typically happen because the body misidentifies an immune response as an autoimmune response, or because the immune response is not as vigorous though the right targets are identified. These methods of action are cumulative and are being addressed with the relevant drugs that are already approved that will enable what looks like it could be an incredibly strong and broad immune response from the pending paper with possibly Nature.

In fact, in a key arm, as you know. 100% of the patients are still living, all over 9 years of 4, and 3 of those over 10 years, all still alive, last we heard. Not GBM, but serious brain tumors for which shorter terms of survival are typical.

As multiple survey papers have suggested as well as the JAMA paper, there is no reasonable alternative suggestion for the increased survival though our resident shorts like to argue that larger tumors that can require surgery are “better”…

No, the 3.1 months was subtracted. Is says so clearly in the JAMA article explaining the results. If you include that time, patients had an additional 3.1 months behind the current survival benefit.

It discusses the 3.1 gap multiple places including in the visual you linked to, and in the results multiple times it explains the gap.

A long time ago I dug deep into pre-approval manufacturing gearing up to commercialization. It was my conclusion back then that regulators make a special effort before approval to make the new technologies companies understandably implement prior to approval, gearing up for approval, easier to get approved. Further, having the ability to potentially meet demand and create a treatment that is validly not just efficacious but deliverable, is a consideration for the regulators.

So at that time it was my conclusion that they would likely delay until they had gotten their commercialization and specifically their manufacturing technologies to a certain point in the regulatory process before applying to any regulator.

I am sure they would have loved to have had more availability for patients sooner. But there is only so much that can be done at any given time. The obvious solution has always been to have many more resources but the objective of all of the shorting has always been to keep them short on resources and maximize dilution. In that context, the shorts have been successful. But shorts cannot change the technology.

At this stage, it’s moot and regardless of bulletin board chatter about old ideas, all the facts literally are out and it’s quite obvious in my view. There would be no point in putting out such a PR or further details about that. It is not currently material nor has it really ever been likely to be material for approval beyond the details we already know and those are: 1) the placebo arm was not fit for purpose; 2) but they did ultimately repurpose those patients for recurrent GBM; 3) they extended the length of the trial to get OS data because PFS data was also not fit for purpose in that it was not correlating, clearly, with survival data, and that is the entire purpose of PFS data; 4) they were given permission to and hired an outside firm to create a blindly created, external placebo arm, for comparison of OS date; 5) all kinds of additional statistical work was done to ensure that that arm was very accurate and likely to be true and fit for purpose; and 5) end results were published and validated DCVax-L as statistically efficacious and valuable as a new potential treatment for GBM and possibly other cancers given it’s mode of action.

I do not think there is any other reason to say more except to feed trolls and people affected by trolls. It definitely would not help either the regulatory processes of approvals, nor likely really lead to investors being “more informed”, given what we know shorts do with such information and even undeniably positive information.

It would serve no one’s interest but the shorts.

We will likely hear the full story once this is fully approved and in hospitals giving encouraging or even miraculous results. Then it won’t matter what shorts say. And they will likely be on to new companies and new skulduggery.

I believe it’s quite obvious. The placebo arm had too many crossovers. It was not fit for purpose. At that moment the FDA had not formulated a strategy to address an ethical problem that they created. Also, telling the company “why” or that the regulator had stopped randomizing, which appears to be what happened, would technically spoil the trial by effectively “unblinding” them, even if it wasn’t a true “unblinding” once you have an external placebo arm.

But technically, I believe the regulator made a lot of calculations to avoid spoiling the trial for a large number of ethical and other reasons as well. So transparency was really up to the regulator. But the regulator couldn’t be transparent for a slew of reasons including potential liability and spoiling scientific research that literally could lead to a cure for this disease. There was more to lose than to gain.

Except that is the mean. We know for some patients, they appear to be virtually cured. There is no sign of recurrence or disease after 5, 10, and even over 20 years now. The object will be to find the lock and add the additional keys to make that a more common or most common result.

Both false. It was a partial halt, not for safety, and apparently it was the placebo arm that was halted because too many patients had crossed over and randomizing patients to a placebo arm that was no longer valid, would be unethical. You can’t tell the company or the patients to avoid spoiling the results.

And the fact is no, the placebo arm MOSTLY crossed over as recurrent patients and we know recurrent patients had an incredibly great survival response as well as newly diagnosed patients.

The measure you claim it failed on is invalid. It is not a valid measure correlated to the survival of patients. PFS is ONLY valid as an early predictor for survival, and then you have a Phase 4 to confirm it. Most of the other, already approved, early, based on PFS alone, immunotherapies actually failed to prove survival in many cases. Yet the FDA allowed most to stay approved for other benefits.

In this case you have even more quality of life benefits, you have a clearly applicable idea of how this will likely work, method of action, with other immunotherapy drugs and not least of which, you actually have the first substantial improvement in OS for many patients, some seemingly cured, for a systemic treatment in many, years, probably actually ever.

Your claims are part of the formalist rejection of progress because it will endanger their profits in treating very ill people. There are no doubt massive profits that will be lost for the ameliorative products if drugs like DCVax-L come to market and in combination do prove to ultimately cure a substantial number of patients without the horrors of treatment that cost so much and bankrupt families.