Yes marzan I agree. Indeed the company should have enough money for at least next several months with the money already raised and the money from warrant exercising.

It seems there have been algorithm machines working to bring share price down slowly every days, absent of news, but people may not realize there will be algorithm machines kicking into action start buying shares. All these machines have their set own points for actions.

Anyhow I don't think the share price will go down any more further.

Thank you marzan for all you and your minions have done, and GL.

From one lesson the company has learned that when the company didn't meet its deadline, mostly assumed by retail investors or probably by the short, there came tens of thousands of angry emails/phone calls, let alone full page upon full page of grievance in ihub, etc.

They (the company) would never PR something they are intended to do or are currently doing, without knowing for certainly they will get it from FDA, etc., such as seeking approval of rGBM, not only nGBM.

Imagine, a PR will be released, we get FDA approval of nGBM -- share price ultimately goes to $10-$20

Imagine, taking a longer time and get more detail analyses and you have to wait for FDA comments, etc, a later PR will be released, we get FDA approvals of both nGBM and rGBM -- share price will eventually go to $30-$40.

In the meantime, some retails have been squeegeed out of the market while some get more shares of the company by adding;and yes a little more dilution may come in effect.

What outcome do you choose?

The above is just some educated speculation, the company is still within its deadline to announce TLD later this month or early Dec.

The point, one has to exercise patience and trust Linda Powers. She will do things correct and do it on behalf of herself and all other investors to the maximal interests of us all.

BTW, she is the largest share holder, isn't she?

Until it doesn't [but nothing wrong with it].

I am with you brother. My share counts only increase with days passing by, peaking each passing week.

For a usual small development stage biotech company with a binary event coming, I would normally sell enough so that I could play with house money. I have done that before, but not this time with this stock.

The reason, as I said repeatedly, is we are actually not faced with a binary event anymore since the adaptation of the endpoints were revealed in EU clinicaltrial registry, specifically UK and Germany.

Then based on the blinded, blended data and the subsequent uptrend updated data, it's obvious the primary endpoint is met;

With the knowledge we have known about this disease and its standard of care treatment and outcomes, as well as various numerous failed Phase 3 clinical trials and the FDA approved Optune device, it would be highly likely at least one key second endpoint out of the five second endpoints will be met, which will be a support enough for FDA approval based on both safety and efficacy.

Because the endpoints the statisticians and the company and its experts are analyzing are numerous and complex compared to that of a usual trial, and because Linda Powers is ambitious, capable who is not a normal CEO who would just take anything which can normally be given, we may see a big surprise when everything is settle.

It's tough to hold all the shares but selling some at around $1-$2 is just out of the question.

I noticed Jane Street Capital LLC has served as a MM recently. It used to swarm the ETFs in the past, wondering why it suddenly is interested in an OTC traded stock.

It seems it has quietly manipulate in order to collect shares when the stock has been experiencing a "quiet period."

Below is an interesting article of 2016 about Jane Street:

https://www.nytimes.com/2016/02/23/business/dealbook/a-new-breed-of-trader-on-wall-street-coders-with-a-phd.html

A New Breed of Trader on Wall Street: Coders With a Ph.D.
By Landon Thomas Jr.

Feb. 22, 2016

HOLLYWOOD, Fla. — The mood in the markets may be getting grimmer, but in the booming world of exchange-traded funds, people just want to party.

And so it was last month at the $2.8 trillion industry’s annual jamboree in South Florida, where 2,200 investment advisers and fund salesmen came together for three days of hard drinking and product pitching. Against a backdrop of New Orleans jazz bands and poolside schmooze-fests — some call it spring break for the E.T.F. crowd — one event stood out, though.

It was an invitation-only party (crabs, cocktails and a D.J. on a moonlit dock) thrown by Jane Street, a secretive E.T.F. trading firm that, after years of minting money in the shadows of Wall Street, is now pitching itself to some of the largest institutional investors in the world.

And the message was clear: Jane Street, which barely existed 15 years ago and now trades more than $1 trillion a year, was ready to take on the big boys.

Much of what Jane Street, which occupies two floors of an office building at the southern tip of Manhattan, does is not known. That is by design, as the firm deploys specialized trading strategies to capture arbitrage profits by buying and selling (using its own capital) large amounts of E.T.F. shares.

It’s a risky business.

As the popularity of E.T.F.s has soared — exchange-traded funds now account for a third of all publicly traded equities — the spreads, or margins, have narrowed substantially, making it harder to profit from the difference.

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And in many cases, some of the most popular E.T.F.s track hard-to-trade securities like junk bonds, emerging-market stocks and a variety of derivative products, adding an extra layer of risk.

These dangers were brought home last August, when markets were rattled by China’s decision to devalue its currency; some of the largest E.T.F.s sank by 50 percent or more.

While traders at large investment banks watched their screens in horror, at Jane Street, a bunch of Harvard Ph.D.s wearing flip-flops, shorts and hoodies, swung into action with a wave of buy orders. By the end of the day, the E.T.F. shares had retraced their sharp falls.
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“It’s remarkable what they can do,” said Blair Hull, a founder of an electronic trading firm who relies on Jane Street to make a market for his recently started E.T.F. “If you look at who provides this kind of liquidity these days, it’s fewer and fewer firms.”

It is not only Jane Street, of course. Cantor Fitzgerald, the Knight Capital Group and the Susquehanna International Group have all capitalized on the E.T.F. explosion.

And as these firms have grown, so has the demand for a new breed of Wall Street trader — one who can build financial models and write computer code but who also has the guts to spot a market anomaly and bet big with the firm’s capital.

In a word, these are not your suit-and-tie bond and stock traders of yore, riding the commuter train into Manhattan. They are, instead, the pick of the global brain crop.
The Morning: Make sense of the day’s news and ideas. David Leonhardt and Times journalists guide you through what’s happening — and why it matters.

Here is a small sample of Jane Street’s main traders: Tao Wang (doctorate in philosophy and finance from the National University of Singapore), Min Zhu (master’s in chemistry, Columbia), Brett Harrison (master’s in computer science with a focus in artificial intelligence, Harvard) and Srihari Seshadri (bachelor’s in computer science, Carnegie Mellon).

For large asset management firms like BlackRock, Vanguard and Invesco, the business of rolling out one E.T.F. after another has become a major profit center. But in many ways, the real money is being made by the trading firms that specialize in making a market in these securities.

For example, Jane Street, which is privately held, has increased its shareholder’s equity, or net worth, to more than $1 billion today from $228 million in 2007.

That cash cushion handily surpasses what such established investment banks as Evercore, Moelis and Greenhill have (as of 2014) as well as that at money management firms like Eaton Vance.

Moreover, it supports just 450 people in offices in New York, London and Hong Kong.

Jane Street was founded at the beginning of the previous decade, when a couple of option traders and a computer expert left Susquehanna to start their own business.

Harnessing Ph.D.-toting mathematicians to the most powerful computers money can buy has become the accepted way for hedge funds and banks to get a trading edge these days, but Jane Street takes this marriage of high tech and high intellect to a new level.

Writing computer code, or at the least being conversant in the firm’s program of choice, OCaml, is a requisite for all traders. Indeed, new traders must complete a monthlong OCaml boot camp before they start trading.

And to the degree that the super-shy Jane Street does have a public face, it belongs to its chief technology officer, Yaron Minsky, who gives frequent lectures at Harvard, M.I.T. and Carnegie Mellon, promoting the firm’s ability to manage risk by developing the best software around.
Caml TradingCredit...CreditVideo by Yaron Minsky

If Mr. Minsky is the spirit guide for Jane Street’s techies, Sandor Lehoczky, a past math Olympian and co-author of a book on problem-solving strategies for number whizzes, stands guard over the firm’s brain.

A star trader for the company, he also oversees its hiring process.

Jane Street has acquired a reputation for being perhaps the toughest interview in Silicon Valley and on Wall Street.

This is in part because the firm hires only a handful of new employees each year. To survive, candidates have to ace brain-twisting math riddles and game theory tests.
ImageMonish Shah of Mizuho at his desk, which has four computer screens. Exchange-traded funds now account for a third of all publicly traded equities.
Monish Shah of Mizuho at his desk, which has four computer screens. Exchange-traded funds now account for a third of all publicly traded equities.Credit...Cole Wilson for The New York Times

But as Mr. Lehoczky has said when asked what he is looking for in an E.T.F. trader, the ideal candidate possesses what he calls second-order knowledge — a form of intellectual humility in which really smart people can accept being wrong and own up to mistakes.

In that vein, a prospect might be fed a math problem that cannot be answered, just to gauge reaction to failure.

Because Jane Street finds itself competing more with Facebook and Google for talent than with, say, Goldman Sachs, the firm lays on the perks. These include a catered breakfast and lunch, a substantial gym right off the trading floor, generous child care benefits and an in-house speaker series that has featured the likes of Salman Rushdie, Christopher Hitchens and Garry Kasparov.

As for compensation, how much Jane Street’s rocket scientists get paid is as closely guarded a secret as its trading formulas. Still, it is apparently quite a bit.

“As a trader, if you do well, you will retire before you turn 30,” said one employee on an industry message board.

A number of larger banks, Goldman in particular, have been involved in exchange-traded funds for some time now, but the rest of the Wall Street banks are seeking to recruit their own E.T.F. hotshots.

One such trader is Monish Shah, a 31-year-old native of Mumbai, who was hired by the Japanese bank Mizuho to build a trading desk in its New York office.

Mr. Shah fits the profile of the up-and-coming E.T.F. trader: He is young, has a master’s degree in quantitative finance at Georgia Tech and is as much a writer of code as he is a trader.

On an old-school trading desk of mostly white men in their 50s buying and selling common stock, Mr. Shah stands out.

Ensconced at the far end of the firm’s equity desk, his four computer screens flash an array of color-coded execution cues, and he is a frequent target of good-natured trading-room banter, sending up his supersize console, his youth and even his Indian accent.

As stocks tumbled yet again on a Friday this month, curses rang out up and down the desk. An E.T.F. that Mr. Shah had been eyeing was down more than 3 percent, and now his color-coded signals were flashing green for buy — which is what he did, just as the market bell rang at 4 p.m.

Within a half-hour, the desk was empty as his colleagues rushed to catch the early train home. But Mr. Shah was not going anywhere; he had a business to build.

“There are so many moving parts; if just one thing goes wrong, you get killed,” Mr. Shah said, letting out a slow sigh. “So yes, it is stressful — but it is also my passion.”

Sub, I do think that's the case. For the SAP contains six endpoints, I think it's logic to conclude it's a compromise between the company and RAs because not company would like to have that numbers of endpoints.

So definitely I think the way we have six endpoints shows buying in of all RAs.

And because of that, it does need to take longer time than usual.

This stock will fly just with a little publicity from the company, which I think it's coming.

Nobody calls anybody full professor. It's really strange you called your self full professor the other day.

But at least you have a better understanding as to why TLD has been delayed buy not sure what you suggested is in your post.

Anyone should realize the trial now have one primary endpoint and five other secondary endpoints which unlike a usual trial which would normally have around three endpoints including primary endpoint.

So it should be understood DCVax-L trial should take longer time to analyze than a usual phase 3 trial.

Nothing abnormal is going on at this time, not definitely withholding data as you asserts.

Investors also don't understand if DCVax-L is truly very effective, then not all endpoints should be med. For instance, if patients reacts very positively to DCVax-L injection, then pseudo-progression would most likely occurs, then the second endpoint compares PFS between the treatment arm and the placebo arm would definitely not be met.

There is added complexity so it would take longer time than usual for statisticians, the company and experts to analyze the data.

For that reason, I don't see any delay at all, but it's about time if anything goes smoothly the TLD should be announced any day now.

Bio, I counted on a physical calendar using my index finger (it was due 14 Nov, and this Thursday 19 Nov with five day extension) . The point is we are not due yet for this Q report with extension, but why everybody said it was over due.

For such a simple fact easy to be verified by a simple google search, why people just said it was over due, which puzzle me!

As the general rule of thumb, "Companies must file their 10-Qs 40 or 45 days after the end of their quarters depending on the size of their public float." from https://www.investopedia.com/terms/1/10q.asp

Since NWBO's quarter ends on 30 September, its quarterly will be due on 14 Nov 2020, which is the day 45-day from 30 September.

So the company has time to release the Q later this week since it filed NT-10Q for five days of extension.

Too much FUDs from long today, and it seems most short takes a break. What a coincident?

For God's sake, if holding a few tens of thousand shares or a few hundreds of thousands of shares make you sleepless, sell enough before TLD if that makes you sleep better;

And the thinking of "but what are the chances our placebo group did better than expected," from a long, please give me a break!

In other trials with other indications, this had indeed happened repeatedly. To the knowledge of the SOC treatment for GBM and its outcomes, and the outcomes of numerous of clinical trials of various agents for GBM, none has indicated placebo (SOC) has had better outcome than the treatment, only exception I saw is with the result of CLDX Phase 3 trial. Nonetheless, in the trial, its placebo is not actually placebo and instead a proven active agent called KLH. In the case of NWBO, the placebo used is autologous PBMC which is known to be inactive substance compared to KLH.

Now what matters is that nwbo has run a lengthy trial and had five years of trial data for all patients, and as of 5 Oct, the trial has been locked for analyses.

What we have known are 1) its primary endpoint will be met, and it's highly likely at least some of its five other secondary endpoints will be met as well, which is enough for FDA approval.

Nobody in FDA in his/her right mind would not agree the above, particularly if more than triple or quadruple of patients in the trial can live five years than SOC patients!

EU approval is guaranteed with approved adapted endpoints, which at least warrants a price of $2-3 now; USA will follow. Even if FDA has not yet bought in with the adapted endpoints, it will be forced to approve with the convincing data.

We are all living in the public eye. FDA's own ADCOM if called upon will deal a huge blow to FDA, and FDA will have a convenient excuse to compromise -- agree to approve (this is of course a speculated worst case. I personally believe FDA like its EU counterpart has bought in the adapted endpoints. No reason why not.

Before the huge running up beginning a month ago, I said buying anything below $1 was no brainier; now I say buying anything below $2 is no brainier.

Facing TLD any day now, manipulation can only have a very short span of life.

Have to run for some errant. No time to spell check, or edit. Sorry for any inconvenience

Great, Good for you. I think investors being withholding now not buying more shares is because most want to see what is in the Q which should be out today or tomorrow. Normally, quarterly report of a developing stage biotech company is not beautiful, which is expected.

That's maybe we have not seen significant trading volumes in recent days, and people are "scared" to get in or add more.

When most investors think they are smart to wait after "not beautiful looking Q," it often surprises.

I don't care that much. Only thing I know is the share price will be substantially higher within a month time, if not tomorrow or within the next week.

This is my last post for today. GL

From the reading, it should be in parallel; otherwise I would use a then, or after. But it could be in serial as well. Even that, it should be very soon since the preparation alone would not take a long time versus submission, acceptance and publication. [If it's later in serial, then the results to be reported would be not only TLD, maybe much comprehensive and detail since the preparation of the publication has been done]

The company may report TLD any day now while it is still preparing the publication!

Regardless, share price at around 1.4 is very low considering what we have known about the trial, and its potential market values.

Important: Support for TLD any day now:

Click the link of Harry1969's post below:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159521482

Then click on Northwest Biotherapeutics, then you get a short explanation about Northwest Biotherapeutics in which the last sentence reads:

"After statisticians' analyses are completed and reviewed by the company with its Scientific Advisory Board, Steering Committee of the trial, and a panel of independent experts, the company anticipates preparing a peer reviewed publication and publicly reporting the results."

anticipates PREPARING a peer reviewed publication and publicly REPORTING the results

Namely, preparing (note only preparing, not submitting or publishing) and publicly reporting the results can happen at the same time, which is any day now.

[Bought about 20k more shares below $1.41]

The whole theory (FUD) of that poster (I withhold myself to not response to that poster most times. He/she is not worthy of my valuable time) is that Linda has to show up like him/her in a message board posting 24/7 each and every day for years in order to make a living if Linda doesn't have a fall back plan like the previous Cognate, and now Advant if the trial were a failure. The fudster must have thought Linda were living in a ghetto like him, the never learning curve,

These fudsters will always exist no matter what. They do seem increasingly desperate!

Gap up Monday and steady increase ever since.

Dave, the key is publicity. Linda has kept a very low profile for years and even today. Besides the reason we are all familiar that had turned any good news to "bad" news, today the company still keeps a low profile. I think there is a good reason for that.

we know with just some publicity, the stock price would be well above $3 now.

But I trust Linda in what she has been working hard for.

When we have the publicity we will have much better publicity. And it is coming very soon.

Gap up Monday!

Last post. Have a good weekend!

In effect, any sane persons would adapt the endpoints to fit the reality, any science-based persons would do so, and actually any human being with heart would do so.

Only the short-sighted, the short hearted, and in general the naked short wolfpack would think otherwise.

The safety and efficacy of DCVax-L ought to be measured scientifically and accurately. The adapted endpoints are the correct target measures.

Gap up Monday!

The pattern is very familiar when the price was manipulated down from above $2 to about $1, and since a few days ago when the price has been "manipulated" up from around $1.

Note because I think the rightful price for nwbo now should be well above $3 just before TLD, so I used " " for the second manipulated.

So it seems it's the same group that has done both, first manipulated down (done) and now "manipulated" up (ongoing).

The speculation comes with the very think trading volumes for both, and both have been done under the context of no new news.

The lady's following up newspaper article may just be a coincident or else.

This trend up will not be stopped, now in a very cautious stage without substantial news. It calls for those shares bought during the down period to sell to the market (the manipulator), plus shares sold by those impatient investors and/or those investors who looked at the history and hoped the future will repeat the history.

So-called the hindsight is always 20/20.

Mistake is daily occurrence, and there will always be lessons to learn.

With such think volume really nothing to think about it. We wait for solid news.

Nobody in his/her right mind would expect the company to say top line data would not be announced in the near future or on any day now as it is still within the guidelines of company's latest news release (5 October news release), which indicates

Statisticians would be first unblinded to analyze raw data and prepare report for the reviews and analyses of the company, experts of the steering committee and the scientific advisory board, and some independent experts. The statisticians would be then continually working with the company and these experts for the preparation for public announcement and scientific publications;

And nobody in his/her right mind would expect the company to say the already extended warrants would not be extended again if necessary, leaving absolutely no wiggle room in case and if necessary.

Retail investors are a fussy bunch. While some are genuine, some are just utter pathetic, but Karma is a bitch.

It's in your own perils to not base your own DDs on the latest news release/SEC filing, which in this case is the 5 Oct PR, but some historical news/filing or hearsays.

It's always top line data first, followed by publications/conference. After that the flood gate will be fully open, and that when we will see Linda on national TV.

[I have used up my three posts a day quota recently, unbelievable]

IkeEsq, the emphasis is and below:

Quoted from 5 Oct data lock PR:

"... who will analyze the data with the statisticians in preparation for public announcement and scientific publication...."

public announcement AND scientific publication

As it is usually the case for most companies in such circumstances:

Public announcement of top line data, followed by journal/conference publications

Does that mean we will expect 20% less complaining or 20% more complaining from you

Citing 20% more company history and you have a long way to go all back to 1996 when this company was founded.

Things have changed, more in the positive side. Don't need to agree with me. The market has said so.

You are very good fella, I really hate to see you grudging.

BTW, the company is still in line with their latest PR (5 October) regarding top line;

The data have been analyzed in accordance with adapted SAP with new reordered additional endpoints in which we are pretty much assured that its primary endpoint will be met with statistically significant p;

we still have the blinded paper to review if we are by any means shaking, and the trending better update to the blinded paper;

[I would say even "the Night King of Biotech" (aka AF, or grapefruit juice marketer) has recently covertly acknowledge the success of DCVax-L trial by only nitpicking evidenced by his various tweets;]

Let the company do it right, which takes time.

Karlchen, I think we can only think those statements in future tense with rationality and reasonability, ie, common sense.

I don't believe the company was intended to deceive. As as timeline is concerned and based on the company's guideline of 5 October news, I think by now the statisticians have been working on the data for at least two to three weeks (preceding with one to two weeks assigned to the job, preparation if any)

Today, I expect both the company (LP, and LG), along with key experts mentioned in the 5 Otc PR must have been unblinded

The statisticians, the company and key experts are working towards a PR, and journal publication, etc.

If "the company is 'mostly' unblinded," and Linda Liau has not yet been unblinded as of today, then there must be something going on between the statisticians and RAs like FDA, perhaps on behalf of the company or with the instruction of the company via its steering committee. Or as I said in the previous post, there may be a substantial financial injection on our way, etc, so a quiet period is warranted.

This is my last post allowed so I am sorry for having no chance to reply to any other posts. GLTA!

Quite period -- If this board really wants to talk something interesting it should note for multiple times, claimed by multiple people that the company said/indicated it is currently in a quite period.

I don't want to get into whether the company should say it's in a quite period or not, or whether such quite period really exists, or whether there is or not law governing it, etc.

The fact is from my lengthy biotech investing experience, tons of companies did say they were in a quite period. For a small biotech company on the cusp of a binary event, such a quite period usually indicates the underlying company is in hold of unblinded trial data, and top line or a PR related to trial result is imminent.

For the specific case of NWBO however, if Linda Liau was still anxiously waiting for results as of last Friday, and assume "the company is 'mostly' blinded" statement did come from Les' big mouth as of yesterday which means the company may not have possessed the unblinded data yet as of yesterday, then what that quite period is really related to, considering the company said it is currently in a quite period at least two weeks ago?

If above is true, then the quite period must have related to other thing. What could it be?

Could it be a major substantial regulatory decision? or

A substantial financial injection, which differs with those diluted deals we have been all very familiar with and disliking?

What could it be then if not?

This is the most recent PR from the company which I base for my DD, not who claim what he/her said in social media/bb/mb or via phone or email.

here is the link: https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/

Quote "The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication."

So 5 October -- data lock, after that

Statisticians would be unblinded and analyze the raw data and prepare summaries of the Trial results for review by xxxxxxxx

Then, the statisticians would continue working, ie, analyzing the data with xxxxxxx in preparation for public announcement and scientific publication

So of course I believe at the time being the statisticians are still working with expert and the company to prepare PR AND scientific publication.

So according to the most recent company PR on any day we may expect a PR, most likely top line data PR, and a publication at much later time. [the PR on top line would be prepared in a way which would not compromise scientific publication. There are tons of precedents and it would not be difficult to do that!]

To summarize, PR on top line any day, journal publication on much later day! and each of these step, the statisticians would be engaged.

Don't know and understand why so many people are so confused, unless you trade the stock, in and out like changing baby diapers, flip flop,...

This is one of a few times I have actually replied to you; most time I simply ignore you for obvious reason.

The reason for the last publication to take considerate long time is because the content of that publication is blended, blinded trial data. As you said at the time, no Journals would publish such a crabshoot;

Now the content of the to be published trial data is unblinded data of an unprecedented 14 years long, data rich pivotal phase 3 DCVax-L for one of the deadest cancers. I can tell you there will be fierce competition for the right to publish such data, and time is short.

There are a couple of prestigious Journals now regrets to the core for refusing to publish the blinded data last time, only seeing it was published in Journal of Translational Medicine with huge success, with many tens of thousands of accesses, and significant numbers of citation.

They will not hesitate this time.

I know you know all the above, and I am just waste my time for you, but once in a while I just cannot help...

yes you just answered your own question! Down significantly and it has always come with pathetic volume, and on an up day it comes with much larger volume.

Me. It's manipulation!

Cheered by small potatoes as usual. Those who are holding or were holding probably shares from a few thousands to a few hundreds of thousands, and who usually get out and come back in like changing baby diapers with mood shifting daily.

Non issue, and I am ready to buy despite holding too many shares I have lost counts for years, particularly this year, adding in any downtrend!

I need to hire somebody to count my shares!

[flip flopper is very dangerous at this point as we have been derisked first by publication of blinded data, followed by adapted endpoints which guarantee primary endpoint med with statistically significant p; manufacturing has been ramped up; top line any day -- what else you still need to see the forest!!!]

Thank you very much BioInvestor4 for sharing your conversation with DI which took place a couple of weeks ago. It contains rich information. On that my thoughts are as follows:

1) Yes, it's now a fact that EU, specifically UK and Germany have approved our SAP which contains the adapted endpoints;

2) Maybe partly because of 1), DI expects the same from "the other countries," presumably US and Canada for buying in shortly; and

3) Since he mentioned he could not say much because the company was in the quiet period at the time, this suggests what we can wait for from the company as a result of its quiet period is not the US and Canada's buy in for adapted endpoints, but something else.

So what could that something else be? Of course, top line data could be one. Besides that, maybe the company was waiting for some kind of important regulatory decision, or maybe by that time (a couple of weeks ago), only Linda Powers and Les Goldman were unblinded who were then in negotiation with Merck representatives who were also unblinded and signed NDA for a deal, either partnership or buyout.
Maybe the partnership or buyout deal was reached after both parties had reviewed preliminary unblinded data, and now maybe pending official US' buy in.

So as of recently, even Linda Liau had been kept out of the loop, not yet be unblinded, and the withdrawal of conferences are also the result of the above.

So maybe when we have top line news we will also have the news of a deal with Merck and/or some substantial regulatory decision on our favor. We will be instantly on a rock solid base with share price in double digits reflecting the deal.

The bottom line is we pretty much have EU in the bag for approval (an anchored share price of at least $2 if the price reflects reality for EU alone), and it seems US and Canada will soon follow suit, by first buying in for adapted endpoints. In the meantime, all others may just be wild or entertaining speculations.

Lastly, I thank you all from the bottom of my heart for reading and responding to my posts. My apology for not responding to each of your posts, either because I don't know how to appropriately respond, or because I personally want to limited my exposure in ihub which has "generously granted" my wish and given three posts a day for me.

Very exciting journey ahead of us, wishing we all a good luck!

[In concept, the name of Merck can be replaced by any other big P; it's just like more likely Merck is the one coming first, maybe because Duffy's short employment with NWBO and/or reported Merck sVP's handshake with Ms Powers at ASCO. If Merck is indeed the one, it only means that it has the first right, other big P can also come into competition afterwards]

ATLnsider, and Gary I actually agree with what you both have stated in principle regarding all four RAs' buy in for the adapted endpoints as per company's previous communications and the fact the data was locked on 5 October.

But if that is a certainty. It would have been useful and meaningful for the company to release a PR saying so. So it feels there seems to be something ongoing between the company and FDA. My intuition is it must have been something more than making ascertain of buying in for adapted endpoints, like Gary suggested. It always strike me that the first second endpoint is regarding recurrent GBM. I wonder if this endpoint is met, should the company request FDA to approval DCVax-L to treat recurrent GBM as well, at least conditionally.

All in all I believe the company should issue a PR regarding adapted endpoints and RAs acceptance if all are onboard, if such PR would not poke the eye of any of the four RAs.

And I also believe there may be something more on the stake and the more we wait the better the outcome will be.

At this stage I think the primary and at least some secondary endpoints will be met in a statistically significant way, and UK and German's approvals will be in the bag in due time. As far as the FDA is concerned, I believe it will be ultimately onboard and approve DCVAx-L for nGBM, and even more for rGBM as well as long as data is good enough.

The fast-changing, seemingly genuine mood swings in this board really point to too many small potatoes who are holding sharees probably from a few thousands to less than a few hundreds of thousand shares at one time, and constantly trade in and out of the market. For me these are just white noises.

For some others who are genuinely on the mood swing syndrome maybe they just can't see the forest for the trees.

This is exactly anyone should have paid attention to: endpoint changes which I would prefer endpoint adaptions.

It has been a tedious process back and forth between the company and the four RAs, and this process has now bore fruit: UK and Germany have bee onboard with company's request for endpoint adaptation.

Nonetheless, we have not seen FDA doing the same; otherwise I have seen no reason that the company has not PR or updated US clinicaltrial register.

I guess if that's the case, it is still better the company should work hard to persuade the FDA to onboard now -- this is the goal the company should aim with the utmost priority, to have some trouble now and guarantee smoother success later!

In a logic thought, the company should PR endpoint changes/adaptations first before announcing top line data.

So on possibility is that the company may elect to be still blinded and let FDA access or instruct statisticians to report directly to FDA and let FDA more informed before it can make a decision.

However, by no means FDA's nod or not is not required by the law, the company can still be unblinded and report top line data, and later submit BLA to FDA for approval, and let data to speak for itself, but obviously this will not be the best way forward.

So it may be that the company initially anticipate FDA's nod/buying in would come shortly after 5 October so that all the conference presentations could go forward as planned, but for whatever reason, this process still needs more time.

Besides waiting for FDA's buy-in for the adapted endpoints, there may be other regulatory process on going which could include early approval if FDA gets unblinded data, etc.

To sum it up, the best scenario is that the company can get FDA's buyin for adapted endpoints soon so that all four RAs involved will have been onboard, and based on what we have known about the blinded data, at least the primary endpoint will be med with statistically significant p value, in addition to some if not all of the five secondary endpoints.

The worst scenario would be that the company cannot get positive response from FDA regarding its endpoint adaptation, and will elect (after a while the company has to move ahead without FDA's buyin)to move forward to be unblinded and announce top line data, and come up with a best way forward, including journal publication, conference, etc., and later submit BLA to FDA for approval.

What FDA can do when it receives BLA, even it is not happy, it has to review the BLA, and may convene an Adcom to evaluate the data. If the data is good enough, I don't see why adcom would not recommend to FDA to approve, and FDA has no reason to decide against its own Adcom's recommendation.

All in all, if you are seeing the forest for the tree, instead of not seeing the forest for the trees, take easy and let the process play it out.

In the meantime, make the stock price up and down into own advantage.

Abstract can be one or two paragraphs in length or one to a few full sentences per each paragraph.

A poster is usually at least one page in length.

At this point before top line data is released, I guess the best way to do it at this conference is to just have an abstract published, which will not compromise the release of top line data later, let alone journal publication. [At this time Sentiment already confirmed there would be not abstract nor poster. Nothing changes. top line data can still be any day!]

[Thank you Sentiment for your post #327174. This is my last post allowed for today so I could not reply to your said post]

You are absolutely right on this one sentiment_stocks. And I will add it will be not easy to come out a top line announcement as there are one primary and five secondary endpoints. they need time to think and write that one in accommodation with other priorities, such as journal publication, etc

He does move his fingers quick googling

Even quicker for a few pennies of hoped for profit

most often lost in the forest for staring at the tree

All these chatters on conferences, journal publications, when and how, etc are useless as the company is position itself for the best way forward. There are and will be definitely some changes, revision, etc.

In the end, nothing fundamentals have changed. Top line data still can come out any day.

We all shall have a basic trust that Linda has been acting on behalf of the best interests of both the company and its shareholders.

flipper44, flip flopped again? How many thousands of shares?

buy, buy and buy as many as you can afford.

Let Biden declare victory this afternoon/evening, then tomorrow or Monday we get top line news.

[this is my last post allowed. GLTA!]

Jammyjames, as you know it's a virtual presentation/poster. I guess doing in this way allows the poster content to be published in journals and/or conference proceedings later as the poster may not be regarded as publication since it will not be published in print form by the conference.

On the other hand, at this point I guess the most important thing is to get message out -- top line data, and then focus on publication.

Think about it, three world-class world-known experts converge in a conference (virtual of course) to present a poster in a usually /Master"s/PhD student swarmed session. What that suggests?

The only reason and implication is that there must be something very significant to present, which in my opinion it's indeed something related to top line data, and the data must be very positive, less you don't shame yourselves in such a humble way, waste the time of three world-class experts...

Gap up or I will add!

Not after top line data are announced. I would recommend the conference organizers get a big hall ready to accommodate a lot of people who will come to see the poster and participate in Q&A from three known world-class experts!

Gap up tomorrow! Not much time left to cover for naked short wolfpack!

Yes there are always two opposing forces in play, particularly on NWBO. But I should say, the bad guys are more nervous than the good, so any downward attempt should be corrected in a short time, although I pretty much prefer to see a straight up movement!

All the negative talking about the withdrawal of Linda's 10-min plenary presentation is pure pathetic, and lacking of common sense!

If Linda Liau still wanted to talk it at SNO plenary session, she can do it, even with results of a "failed trial," because there will always be something worthy academically.

So what it happens really is that because data/results will be discussed earlier at SITC in a manner of much more content richness (one hour instead of merely 10 minutes previously scheduled at SNO plenary), it will simply go against the rule of SNO. As a result, she has to withdraw. In other words, if nobody presents at SITC, then she doesn't have to withdraw.

On the other hand, it is more meaningful and considerate to have the presentation presented by all three experts who have contributed significantly to bringing this 13-year long trial into successful completion, not only either of the three.

It's exactly that fact that the three most important experts of the trial will jointly present at SITC that signifies that top line data will be released just before that presentation happens!

Gap up tomorrow, or I will buy to [contribute to] make it up!

I am now convinced there are about 200 million naked short shares still trapped and Linda Powers want to burn them, so do all long!

I interpret Today's 8-k as such, besides Linda really cares about us retail investors.

Burn naked short wolfpack before Christmas!

yes in thin volume trading day like this, they can do this with almost no loss/small loss at best.

It's all pointing to a fact that this stock is supported mostly by retail investors

Linda's so-called friendies hedge funds are too small, too selfish, too short-sighted, or simply put lack of resource to even protect own interest.

As pity as it sounds, it also means that when the time is right we can run much higher the price than most would expected when the market is finally waken.

I can see that and I am actually happy about the current situation. More short pain (days) but much more long-term (month or months) gain really.

The algo machine is running this morning as some expected. In the loop,if no resistance it will run the price as low as possible to its predetermined target; if there is some resistance, it will pause and wait, then it will be running again trying to reach the target

And if the resistance is strong enough or there are buying pressure coming in strong, the algo machine then will reverse course. Ditch its own working, and instead run an alternative program or may change course in 180° reverse.

Funny and inexperience teenager