NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

Very interesting points...gotta love an erudite, intensive takedown of my ideas without being able to spell my pen name right. I imagine Richard Drury would be very interested in these allegations, as well.

This Seeking Alpha article looks to be a purposely written hit piece coordinated with market manipulators to drive the share price down.

So well coordinated that the stock price was already falling before it published. And has continued to fall for a month since.

DCVax-L is a threat to numerous business models of pharmaceutical companies who are the sellers of chemo and radiation therapies.

If anyone thought DCVax-L was a credible threat to any treatment approach, then they would have taken NWBO out by now.

The potential success of NWBO will also hurt those who short the stock, naked or otherwise, and those who have spent years attacking the company.

On this point I fully agree. Shorting NWBO is a recipe for disaster for all of us who have no access to useful insider information. Good way to get wiped out.

In its first sentence, the article underplays the size of the rally by indicating it was 40%, which pales in comparison to the actual rally of 182%.

Almost as if it was written when the stock price was only up 40%. Huh.

progression of the cancer tumor

Small tells you have no idea what you're talking about.

Consequently, to have a credible endpoint the trial had to be changed to measure overall survival (OS) from PFS to have a far more reliable endpoint.

This isn't really true. You can report the trial as originally designed, including a full readout of the negative PFS endpoint, while pointing to the positive signals observed with overall survival. This would be the "intention to treat" analysis, and they would have been perfectly within bounds to then pivot to their secondary endpoint of overall survival, noting the comparisons with contemporary external controls.

It should be noted that OS is the “gold standard” primary endpoint for any oncology clinical trial.

This was also true when the phase 3 trial was initiated.

PFS was intended to serve as a surrogate endpoint for an Accelerated Approval from the FDA that would later be confirmed by the trial’s OS endpoint.

No. While PFS is a surrogate endpoint, its use has been the basis for full drug approvals that stood even if OS was not positive in the end. Osimertinib was one example where PFS enabled FULL approval years ahead of an OS readout.

Accelerated approval is typically granted with shakier surrogates, like objective response rate, with evidence for improvement in other outcomes.

Northwest simply did away with the PFS primary endpoint and instead made the confirmatory OS the primary endpoint.

I mean, I know it's a dead horse on the board, and that you guys don't believe me, but this is a pretty weird thing to do in a clinical trial. DCVax-L phase 3 is about the only time I've seen a big trial do this endpoint switch that is handwaved away. Yes they went through a lot of hoops to switch things in a way that gave it some backing, but that doesn't change the fact that other trials don't do things this way, even when their primary endpoint does not succeed.

Indeed, the Pediatric Investigation Plan (PIP) ...

...is not a confirmatory, phase 3 trial. It's a test of the drug in pediatric patient populations. The fact that it uses contemporaneous controls by design is consistent with the tiny size of the studies (~24 patients). These are not likely to be studies you could do a randomized trial in. It does not support the endpoint switching.

Roswell...Glazus overlooks...

Didn't overlook shit. I don't view it as actionable to the investment thesis until the results come out. It's why I'm also a doubter of JANX until they show us bigger datasets. Every single biotech in the world has the cure for cancer in these early trials.

But I accept that others disagree here. The fact that I don't agree with the magnitude of this collaboration is not me "overlooking."

Other omissions...phase 1 trial...

Wonder why Bamboo Lounge doesn't run down all the phase 1 trials from the last 25 years in dendritic cell therapy to espouse the promise from n of 8 clinical trials. See my point about JANX.

NWBO is a late-stage, almost commercial biotech. Phase 1 trials aren't what are going to move the needle. You can look to them with hope. I'm not denying that the results are interesting. But they're signals, and they need to be confirmed in more robust trials. This particular phase 1 trial hasn't even had a data readout yet. So what am I supposed to analyze from this?

Additionally, there is no recognition that the dilution has been significantly increased by the illegal actions of the Defendants as alleged in the lawsuit

These sure are definitive statements couched in the same sentence as the word "alleged."

There is no mention of the possibility that DCVax-L approval could trigger events such as investments by institutional investors, the announcement of the acquisition flagged in the latest 10-K, the possibility that the stock uplists or other events that significantly increase the value of the company.

NWBO could be acquired now. Could have been in the last 5 years. Could uplist right now. They could go up on the announcement of approval.

They may go down on the approval news. This is a fact largely ignored by this guy/girl. As if approval means success.

I don't know. Look again at how cell therapy companies have done after their approvals. You get a sense of how things are viewed right now. If NWBO goes up and stays up on the news, excellent. But if a reader is reading that article thinking "approval is a sure bet (which it is), so I will buy at the 11th hour and 10x my investment," then they should be warned about that.

For the rest of you guys, I hope you all make tons of money on this.

vicious...bombshell...panic...

Bamboo's colorful language neglects the salient observations that the article offered very little in the way of something that anyone paying attention for the last 2 years wouldn't know. They have never read a real hit piece, and it shows.

The manipulators and bashers both gain in reputation and wealth, while the basically clueless investors and companies get taken to the cleaners

Ah yes, the profound gains I've made in reputation. I'm savoring how much you guys love me on here.

This Glazus Research report has all the hallmarks of such a similar scam.

I would invite similar analysis of any of my other 250+ articles. Do you think NWBO is special to me?