NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

It’s evident you are working very hard to make a case that NWBO is not worth anything but the $6 price your July puts are currently at… and as you’ve indicated here… and elsewhere… you want to buy back in at. -Sent

I don't recall ever writing I wanted to buy NWBO back at any price. And I'm not holding any options or shares at the moment, and certainly not $6 July puts. Actually, I've never purchased a $6 strike put in NWBO. My prediction was, and in a way still is, that NWBO's share price will be below $7 by the time those puts expire. $6.99 is below $7, and would make the $6 puts worthless, so I don't even know where you're getting your hypothesis from.

My statement that I suspect NWBO will be below $7 by then is based on a few things. One, I believe the expectation of DCVax-Direct data, especially at ASCO, was high, and that investors were anticipating a number of partial responses (PR), or at least a high % of stable disease. There is neither. Therefore the hot money (retail) that has come in hoping for a big move will probably exit. Two, Woodford has ceased buying, and there is no evidence he has or ever will at these high levels. His cost basis is around $6.60, and there is no reason for him to buy $7-$8 shares on the open market. Three, the massive interest in puts in July indicates some sort of colluded effort, and four, no strong catalysts are on the horizon. Assuming a drift lower is therefore logical.

Before I examine at what you’ve said in your recent “contrarian” post… let’s not forget your own pertinent i-hub tagline…

Quote:I'd offer you advice, but I just don't care about your money, unless you give me money to care about your money. I might even be tricking you with the above post…

and elsewhere…

Quote:I admit to taking advantage of them. Every small cap biotech company does the same, although more directly; I pick up some of the loose change these companies leave in their wake while running off with whatever they can stuff in their pockets. It might be shameful or not, I don’t know—but if I don’t, another will come and do it anyway. Perhaps I am doing nothing to ‘fix’ the world by my behavior, but I’m certain flipper isn’t either. -Sent

The first one is obviously my signature but the second one I didn't write. But in reading the ivil posts recently I see you have come to the erroneous conclusion I am jmlogan and slappdaddy, is that right? Sounds fun.

My signature is a sarcastic way of me telling people reading my posts not to rely on what I'm writing but rather themselves and their own DD. Too many remoras on these boards.

So anyone reading your posts may also want to keep those nuggets in mind. -Sent

Mhmm, I'm sure.

Now… first you state that…

Quote:NWBO had likely submitted a standard abstract for admittance of DCVax-Direct data to the ASCO poster presentations but were rejected… They either did not submit an abstract (less likely) or did and it was rejected (more likely). The only way they could present was to pay their way in.


As you very well know, had they submitted an abstract to ASCO, they would have had to have done so by Feb 3. According to the rules of ASCO, they then could NOT have presented anything about the trial before the embargo for ASCO had lifted (around May 15?). From the same ASCO guidelines...

Quote:Furthermore, the contents and conclusions of the abstract must not be presented at any scientific, medical or educational meeting of 500 registrants or more or be published in a scientific, medical or educational publication (in any medium), in whole or in part, before the ASCO Meeting. -Sent

I know the ASCO guidelines very well, and have been following companies for years that have presented data there. It looks like you have not. You seem to have even forgotten that NWBO did this when they reported a recent case study the morning after the embargo lifted, and then two more PRs on up to date DCVax-Direct data all before the actual meeting last year.

Once the embargo lifts companies are free to present all data both in the abstract and up to date data. There is no more hindrance upon them. I quoted you this but you seem to have ignored it:

Once an abstract has been publicly released by ASCO and the embargo has lifted, you may widely distribute a press release containing the full data, including any additional data that will be presented at the meeting even if not included in the abstract itself. -ASCO Guidelines

Of course, the embargo is lifted weeks before the meeting.

You continue:

Yet we also all know they had similarly booked an “Exhibitor Spotlight Presentation” for Monday, April 20, at AACR. They booked that presentation (similar to what they just did at ASCO), despite the fact that they actually did have an abstract accepted at AACR. Now why would they have booked a big presentation like that at AACR? -Sent

Why do you think? Publicity!

Let’s consider this… if they had wanted to present what they just presented at ASCO, at the April 20 AACR meeting, they couldn’t have, could they, if they had submitted an abstract to ASCO. The rules would have prohibited that. -Sent

No. They did not present the same data at both conferences. It's quite different, obviously (or not, I guess). And as long as it is unpublished it can be accepted at ASCO.

But in the end, the AACR presentation was not provided to us in a webcast. Why? Well because as you are prone to stating your presumptions as if they are fact, I will too. My “guess” is that they when they had booked that AACR event, they had hoped to have the information available on Direct at that time. And my guess is, they didn’t. So instead, they elected to move it to the back-up time… ASCO… because the timing of the independent data analyses coincided with the May 30 time slot… and it didn’t come in time to make the AACR presentation booked. So they had Dr. Bosch give an update there for any interested parties at AACR (since we already knew is was booked) … but they didn’t webcast it for us because there wasn’t anything new to tell shareholders. Capesh? -Sent

That's quite tangled, and honestly makes no sense to me.

On you go:

Regarding Direct…

On Slide 7… you state:

Quote:Shows a compelling-looking survival graph of the 39 evaluable Ph I patients. What is missing from any of these slides are a comparator group. The only way to know how well DCVax-Direct is or isn't working, in the absence of obvious extensive tumor shrinkage, would be to enroll a concurrent control group with identical inclusion/ exclusion criteria, give them placebo or no treatment at all and compare survival times between groups.

Well then, you should surely be pleased that you actually do have somewhat of a comparator group. Because as Dr. Bosch points out at the ASCO presentation (I don’t have to use disclaimers) :) …

Quote:I mentioned already two different activation regimens and we found that there were two and that survival and stable disease were observed very frequently with one method, but not with the other method. So one method in fact becomes a control for the other method, demonstrating that the effects that we are seeing are truly related to the treatment….

and

Quote:…in this way, the trial becomes it’s own internal control. It’s almost like we tested two products… one which is potentially inactive or less active, and one which then compared to this one, shows a great level of activity in keeping patients alive.

-Sent

Let me get this straight--you think his statement about the two groups given different activation methods is the same as a control group vs experimental tx group? No way. You are given no further information about these patients. They changed the criteria part way through the trial. Those who received Method A activated DC therapy were likely those enrolled with worse criteria early on before they made it more strict and switched to testing Method B. There is evidence that occurred.

And if you need a further comparator… how about this? Anyone that had exhausted all their options… and with only an approximate 3 month life expectancy (don’t worry, I’ll cover that later on) is told to go home and call hospice. With such a small life expectancy… like Beach Life says… they’re told to go home and simply “make sure your house was in order.” -Sent

Sorry, no again. You don't know any patient's life expectancy because it hasn't been revealed. If we were told this, we would have a better understanding of how DCVax-Direct did or didn't work. Do you know if Allan Butler had 2 years to live? 5? 1? 6 months? Nope. You haven't a clue. So how can you be impressed with his current OS? You also don't know how many of these patients are progressive disease (PD). It could easily be 80% or more of them. They won't tell you PFS/SD rates. Why not? Well probably because they aren't flattering. Management is only telling you what they want you to hear, and framing data in any way they can to seek to make it look good. Most small cap bios do the same. It's because they are constantly in jeopardy of failing to remain as a going concern. Paycheck to paycheck is how they live, and if they can't pump up the data, nobody will write them one.

Gnawkz covers your comment pretty thoroughly about “Kris Carr” when he tells you it’s “highly improbable that the clinical trial would’ve recruited a number of “Kris Carr”s.

investorshub.advfn.com/boards/read_msg.aspx?message_id=114163984

As you yourself point out, she’s actually moderately famous BECAUSE she’s a “IV cancer patient with multiple lung and liver metastases that has been alive for over 10 years since her stage IV diagnosis.” So if there be 27 Kris Carrs out of 39 patients, well this DCVax Direct P1 trial ought to become hugely famous, right? -Sent

Sorry, I must have missed the part where gnawkz rebutted my point. Kris Carr is in the 10% minority for her indication. With hundreds of cancer patients from most of the indications present in the Direct trial to choose from via MDA and Orlando Health's acclaim, finding a handful with 2 years+ life expectancy is not very hard to do. The math doesn't lie.

Now let’s examine another of your “presumptions.” You contend that Method B is different from Method A because the patients for each Method really just had their criteria changed… despite the fact that Dr. Bosch specifically tells us it’s the activation regimen that is different. Surely you’re not “saying” that it’s the criteria that is the activating regimen? Or are you just suggesting that Dr. Bosch is lying to us? Or maybe he suffers hugely from confirmation bias. -Sent

Um, I don't think anyone would argue Method A and B aren't "different" as you write. I certainly wasn't. I question whether or not Method B is truly better than Method A, and whether or not with these limited data one could claim Method A patients as a control group. Method A was of course tested first (hence the 'A') and during the time when the criteria was weaker. They then strengthened it to increase life expect from > 3 months to > 6 months, and very importantly added the requisite "minimum 500 mm3 total lymphocyte count," which is strongly correlated with improved survival. Certainly more patients selected later were given DCs activated with Method B than patients enrolled earlier. The two groups had literally different criteria. They are not equal.

But let’s look at that criteria anyway. I’m sure you are aware that the clinical trials site still states that the criteria for the P1 trial is greater than 3 months (not 6). It is only MD Anderson’s website that shows the inclusion criteria to now be greater than 6 months.

And I “suggest” that this is because the criteria now found on the MD Anderson is for the Phase 2 trial… and not the Phase 1,-Sent

No. They will be changing the dosing schedule completely in the Ph IIs. > 6 months won't be required to get through the 4th injection in the Ph IIs. Probably only 2 months will be needed. It was also a change made some time ago.

As for suggesting that the scientists provide you (us) with a life expectancy for each patient… compared to a current survival time for each patient, etc., etc….you have to know how impractical and almost impossible that would be… -Sent

Absolutely not. It is a requirement they show exactly what their life expectancy is to get into the trial. It would be incredibly easy for NWBO management to reveal it. They won't, likely because it would make the mOS far less impressive. Btw estimating life expectancy is a very basic and important part of treating a late stage cancer patient. After treating hundreds of these patients oncologists get quite proficient at it.

I had looked under both cancer.org and cancerresearch uk.org to find there currently is no available survival time for a stage 4 soft tissue sarcoma patient.

www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-survival-rates

Quote:Stage
5-year observed survival rate
I
90%
II
81%
III
56%
IV
Not available

-Sent

Not sure why you are looking at 5-year survival rates. No one in the study is anywhere near that. What are the 1 and 2 year survival rates? Now we're getting somewhere.

You can also try to find soft tissue met sarcoma studies that require (in this example) patients have > 6 months life expectancy and min 500 mm3 lymphocyte counts to enroll and find out their mOS. Good luck. I have found studies with less strict criteria with 18 months mOS for control for this indication.

So what would you suggest MDA and Dr. Bosch and the gang do then? Would you suggest that they provide 10 or so abstract links for each of the 13 cancer indications demonstrating the possible median OS for each of the 39 patients? Really? -Sent

Nope, I've already said very clearly what they should do if they want to be fully honest with the public. Tell us each patient's life expectancy and the rate of their progression before and after receiving DCVax-Direct. That's all. Easy. Oh, and tell us PFS and SD while they're at it (will never happen).

Then you briefly look at Pancreatic Cancer in your post.

Quote:Seven patients with metastatic pancreatic cancer were enrolled. The median overall survival (mOS) for these is only 3.9 months.

Yes… but if you gave a median OS for those pancreatic cancer patients that were treated under the Method B activation regimen, what would it be then? -Sent

I only needed to be brief. And who knows, maybe all 6 were given Method B. All except Allan. But I see now, the goal posts have shifted to "Method B is what works." Okay, if you want to adhere to that notion. But there really is no proof. It could very well have primarily been due to a mid-stream shift in criteria.

Sure, management will paint the slides any way they can to get you to stay long. But you're responsible for your own money, ultimately, and failing to consider how these data have been skewed will only be to your own hurt.

So as far as Direct is concerned, you can try to convince us that

-perhaps they had an abstract rejected for ASCO;

Yep, pretty much certain of that one.

-or the Method B activation regimen was just a lie and that it was really just the inclusion/exclusion criteria that changed;

Well, I never said it was "a lie," but an unreliable indicator of treatment effect, being confounded by the change in criteria mid way through the trial.

-or if only they’d had a comparator group, this data could be validated;

Or telling us life expectancy and rate of progression of each.

or better yet, if only they’d provided us with all the individual life expectancy versus current survival times, and rates of progression before and after therapy for each patient;

Uh, yes!

-or that the pancreatic cancer patients had a 3.9 median OS when you discount the important fact that those still alive most likely fall under the Method 2 regimen - and would be subject to another median OS;

You're completely guessing. The fact remains pancreatic cancer patients in this trial have a mOS of 3.9 months, and they will not be testing DCVax-Direct in this indication going forward (obviously due to the terrible outcome).

In another post, you accuse NWBO of having

Quote:a vested interested in painting the best possible picture of their therapy, whether that picture is very accurate or not isn't their primary concern. -Sent

Yes, this can be validated in a number of ways. Just read my last 40 posts or so.

It would seem that your vested interested is in painting the worst possible picture… in a vain effort to drive the price down to $6. Sent

I know you and others would really like to put me into a neat category of "short/basher," or someone with some kind of vested interest in seeing the pps tumble. I have no such interest. At all. If you don't believe me, that's really not my problem.