Replies to post #181544 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

JR111,

I think you have me confused with another poster. I don't recall ever saying the price is irrelevant. The price is always relevant to someone for some reason. For some the price represents too much risk. For others the price might be viewed as a buying opportunity. For some it is a current inconvenience to tolerate while complaining about it. For others it is at a point that they just need to wait a while longer to see the price correct. So no, I do not view the price as irrelevant.

As for what I seem to be saying, to you, vs what I am saying, there is a difference. I am saying that Linda made it her mission to make sure DCVax-L gets across the finish line and she has shown that this is exactly what she plans to do. She was obviously willing to accept help under the right conditions, ie Mr. Neil Woodford. Those conditions certainly included not surrendering control of the company or it's trial progress to that end. Linda has kept this trial moving forward and now as we approach the end, a sudden influx of investor angst magically appears. Save the angst for after November or if you think this is going to tank, even temporarily, you can always sell your shares and get back in later if you want and then you can at least say you acted on your angst and were rewarded for it.

Now as far as you saying "They blew the trial..." you must joking. You can't tell me why the last patients were apparently all treatment arm patients and yet I have been saying it was due to a finding of efficacy for one reason or another for quite a while now and well before anyone saw the actual numbers of enrollees in treatment vs placebo. A blown trial? Hardly. Clinicians like Dr. Ashkan like what they are seeing. Hard to understand? Sure, and that's how they were able to continue the trial because some would claim futility and try to tank the price while others would claim efficacy.

If someone leaked non adjudicated PFS eventing to outside parties and those parties acted on that information they might be in for a big surprise at the end of the trial when adjudication takes place and whoops, treatment effect might turn out to be a factor. Bummer for those so sure of themselves if this turns out to be the case and surveilance indicates they had their hands in the cookie jar right? Best wishes.

[LessIsMore]

This is a great post. It should be a sticky.


All posters need to realize 1 thing. This is a message board for investors, it's called Investors Hub. The object of investing is to MAKE MONEY. Losing 99% of investors money while being lauded for advancing a Phase 3 trial is a disaster of biblical proportion. Let's be sure on this, this Company is a disaster.

Linda Powers has been a disaster as a CEO.

She estimated a total cost of 10-15M for this trial, the numbers I've been hearing are 10X that amount. For this epic blunder she should've been fired.

She was the owner back in 2005 when the split adjusted high for the year was $2,520. Now we sit at 23 cents. She should be fired many times over for the investors lives she's ruined while she personally became rich many times over.

Both the Primary and Secondary endpoints of this trial have long been surpassed. This trial has failed, period. At no point did Linda Powers give advance notice that primary and secondary endpoints would not give way to an unblinding. She should be fired for misleading her investors many times over on trial duration and cost.

Back when the share price was $12 what would've happened if Linda Powers used her CEO skills to estimate how much money she needed for completion of the trial. She could've sold 10 million shares at $10 each. They would still have money left for completion of the trial. Outstanding shares would be around 90 million as opposed to 1 Billion. Share price would be AT LEAST 10 to 30 times the 23 cents it sits at today. Just think what could've happened if she was a smart CEO.

Keep those honest posts coming. If you haven't noticed many of the longs have stopped supporting the Company via posting, they still hope for trial success (which we all do). There are still some delusional longs who are unable to utter a negative word on management, but those numbers have dwindled significantly.

GLTY

[Al4door]

This post should be stickied for this board to be fair and balanced, please have a cheerleader refute anything that is written here with evidence.
This is the best and most important post of the year, but like usual it will be quietly swept under the rug by the usual suspects who when this company goes bust will disappear.
Just my opinion.

[flipper44]

I agree that they should data lock by August, but I also think it is the thinking of many the refreshes are poorly named and are more accurately called data collections. It appears at some point, hopefully the current data collection, it will be used/converted toward final data lock. Other than indirectly via the NICE timeline (which points to August 2018), since giving guidance to unblind at 233 OS back in the summer of 2017, NWBO has thereafter been intentionally noncommittal regarding their parameters for unblinding. Dr. Bosch now states (after previously committing to 233) it has to do with event rate, but he won't share that rate. LP now apparently has a less scientific view that she wants to enter the Guinness Book of World Records for fat tails, even though the km tail will be drawn by the end of this latest data collection. Management have presently gone missing in their guidance.

Here is the history.

1. Efficacy interim supposed to occur early 2014.
Excuse: The trial was resized August 2014.

2. "Topline" (trial completion) was supposed to be reached early 2016.
Excuse: Screening halt in August 2015 prevented last 17 patients from being enrolled.

3. Trial completion was suppose to occur November 2016.
Excuse: By December 2016, they suddenly wanted to unblind OS simultaneously with PFS.

4. Unblinding was suppose to occur July 2017 at 233 OS events.
Excuse: They really didn't mean it -- according to comments in January 2018.

5. Indirectly, NWBO's guidance to NICE points timeline regarding data deadline for appraisal by August 2018).
Preexcuse? Unblinding occurs when tails are the proper secret thickness and the event rate hits an undisclosed secret number.

[meirluc]

JR, I believe the current Spring Refresh and adjudication of PFS while the trial is still blinded precede the unblinding and are an integral part of presentation of top line results. They will not have to go through another spring refresh etc. etc. next year.

[Ultraz2]

Perhaps, they aren’t doing the spring refresh.

[IkeEsq]

For Al4door and JRIII, a response to JR’s stickied nonsense. That this drivel is stickied at all is a joke. Being fair and balanced is fine if you are presenting arguments from both sides that are supported by actual evidence. However, JRIII provides no evidence anywhere in his post.

You seem to be suggesting that just because the company isn't bankrupt she's done a good job. I disagree. Technically it is bankrupt,

No. Bankruptcy is a legal process a company or individual goes through which must be approved by a court. NWBO has not filed for bankruptcy. NWBO is not technically bankrupt, nor is there any evidence to suggest that it has even begun the process for filing for bankruptcy.

and her management has been a disaster of epic proportions. The evidence overwhelmingly supports my point of view, while your point of view depends entirely on a confluence of highly unlikely occurrences.

A conclusory statement without any evidentiary support. If there is overwhelming evidence, then why can it not be posted? Argument invalid.

They blew the trial and they know it, and now they are trying to cover their mess by manufacturing some backdoor approval that is a total shot in the dark. That's what all the evidence is pointing to, and though you try to pretend otherwise you know it, too.

Another conclusory statement without any evidence to support it. In fact, the evidence presented in the published article suggests that DC-VAX works and does not have serious side-effects. More to the point, Linda did not design the trial so if the trial itself fails, it could hardly be her fault.

The stock has free-fallen from $12 to penny status, destroying all shareholder value while the insiders have gotten rich. Do you deny that? Are you OK with that?

Although I am not an expert in this, I am under the impression that this is not an uncommon state of things with small bio-tech startups. The evidence suggests that the stock was manipulated by short sellers. See Smith on Stocks and Washington Post articles or this article on how manipulation is done. Nor is there any explanation for how they could possibly have prevented this from happening or how they were complicit in causing it. Also, there is still shareholder value as long as the stock is trading.

You have stated that the stock price is irrelevant until they unblind, which is just incomprehensible to me. How can it be irrelevant?

No, I said that the stock price is largely irrelevant [from now] until unblinding. It is relevant to financing but for the most part, it is likely to continue to trade somewhere in the .20s until unblinding. It is unlikely to go much lower because there are a lot of people who seem willing to buy when it drops lower and who feel that the trial will be a success. It is unlikely to go much higher because shorts can manipulate any rally for their own advantage. Until a larger pool of investors becomes interested, the stock is not likely to go anywhere. Whether it is at $0.27 or $0.22 is largely irrelevant.

If it had held even half of its peak value imagine where it would be if all of your unlikely occurrences were to occur. But no, we are at 23 cents and sinking fast, so where will it be if all of your unlikely occurrences were to occur now? The stock price is not irrelevant – ever!

But it didn’t and as I explained earlier, maintaining that price was never likely to happen. This is a company with no approved products, no revenue, and when it was at $6 a long path ahead to approval. There is no way it can maintain that kind of price when there are lots of people out there who can make a LOT of money manipulating it. The value of this company upon approval is not going to be based on its stock price now. That is why the current price is largely irrelevant. The price after approval is going to be based on the potential market for their products. Also, the price is not sinking fast. Your post from 2 weeks ago at $.23 and now it is selling at $0.223. Not exactly sinking fast.

It is the only reason we are here, as investors. Maybe you are here for a different reason, being a doctor and all, but if that is the case then why are you posting on a board for investors?

What makes you think that is the only reason all of us investors are here? I am certainly not here in the hopes that the interim pre-unblinding price goes up or down a few cents. I could not possibly care less about that. I am here because of where I believe that price will be after unblinding and approval. Other people may be here at least in part because they want to support a company that can help people with the most dire cancer to live longer.

Here is the most important question: Why haven't they unblinded the trial? Why is this trial still going more than two years past primary endpoint?

Sentiment_stocks already addressed this here so I won’t bother. The real question is why you think that you, with no knowledge in the field and little information about the study, have a better idea about when to conclude the study than do a group of doctors who practice in this field and have been getting all available data for the last 10 years? My personal take is that this company is likely to live or die as a result of this Phase III trial and they want to be sure that they have what they need to get approval. If they need to wait an extra 6-12 months to get from 85% to 95% or whatever, then that is what they will do.

And that question leads to this one: Why are they doing a spring refresh if they are going to unblind right after? Why not just unblind? What's the point of a spring refresh and the expense that goes with it when they could just stop the trial and take the blinders off?

They have discussed this, multiple times. The Spring Refresh provides them with data on how the trial is going. Specifically, it is showing them the existence and properties of the long tail. They NEVER committed to unblinding after the refresh, quite to the contrary, in fact. Once they stop the trial and take the blinders off they can’t restart if they determine that they do not have the data they need to get approval. I am far more concerned about them ending the trial before they secure the data needed for approval than I am with the possibility that they allow it to run a bit longer. Imagine the uproar if they stop the trial prematurely after 10 years and fail to get approval that they could have secured if they had waited a few more months.

If they are waiting for 36 months past enrollment to unblind then why are they doing a spring refresh right before that all-important threshold? Has anyone else asked this simple question? Why not just unblind at 36 months, right? What's the point of a spring refresh? If 36 months past final enrollment doesn't occur until August, then why would they spend money to do a spring refresh so close to this critical date, a date that only became critical when somebody threw it out a couple of months ago as a possible explanation for the company's inaction and total silence? None of it adds up

The company never said that they were waiting for 36 months. However, assuming that is the goal, then it seems logical that they would want to know what the data looks like prior to unblinding. Why would they pick an arbitrary number of months and unblind without knowing if the data was likely to show what they needed for approval?

The people on this board who claim to know so much about the protocols medical trials are supposed to follow in order to attain FDA approval should know that this one doesn't fit the protocols in the least.

You base this on what? Instead of accepting that the people who know what they are talking about actually know what they are talking about you claim without evidence that you know more about their specialty than do they.

But instead they just ignore the evidence in front of their faces and in delusion blame every possible outside factor for this company's failings. I hate to break it to you but management doesn't have any intention of unblinding this trial. Why? Because It is way off the tracks, and it all falls entirely on Good Job Linda.

And finish with more conclusory statements supported by nothing.

You also forgot to mention your contradictory claim that they are giving themselves bonuses . . . in stock that you claim is worthless.

Let me finish with something written by someone who you should be willing to listen to . . .

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136842794

What they wrote in those press releases was accurate, but if everything mentioned in those releases occurred as described, then what it means is that right now there is a lot of work going on behind the scenes to bring this product to market. The best way to ensure that happens successfully and without compromise is to operate in quiet mode. Everything that we have staked our hopes for a better world on, and our hard-earned money on, is now at the end game. That end game involves a very careful, deliberate process of review, analysis, review, analysis, and then more review and analysis until conclusions are drawn and papers are written and published. It takes a lot of time – perhaps many months – and any misstep along the way can jeopardize the whole thing. That's why silence is golden right now. When companies make meaningless statements like "the process is ongoing" just to appease a restless audience, it can do serious damage and end up exacerbating the perceived problem. Do you think anyone on this board would be satisfied with that kind of statement? Ha, not likely. And saying anything more than that could be perceived as manipulation. At this stage of the product trial and review, I can assure you that the SEC will be taking a close look at any public communications this company makes. In my experience, company press releases are often "Exhibit A" of shareholder lawsuits. Sure, they can also do good things – inform shareholders and boost share prices – but even the most innocuous-sounding press release carries an inherent risk of backlash, misinterpretation, and/or just plain dissatisfaction from shareholders. I have seen companies send out seemingly mundane and/or routine press releases and have it come back on them in ways they never imagined. Regardless of intent, PR can be very, very dangerous, and right now dangerous is not what NWBO needs. With so much at stake, it's just not worth the risk to be sending out press releases until there is something final and significant to say. I think they are close, but not quite there yet.