Replies to post #431087 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

JRIII,

All the things you're saying can't be done can be. They can be done as long as they're done properly. It's clear that NWBO changed the judgement criteria before they locked the trial. We know what the changes are because the European authorities put them in their version of Clinical Trials, it surprised NWBO because they forgot that in Europe the regulators do that, not the trial sponsor, but it's there, anyone can check it out.

It was the regulators who after halting the trial agreed that all should get the vaccine, no further control group. As I understand it the German's insisted on this change as they saw the benefit and wanted no further patients not to receive it, finally the other regulators agreed. Frankly, the regulators should have halted the trial right then and approved the vaccine, but they just aren't that dynamic.

You and others can fault the company all you wish, but I don't believe that you can cite anything that's truly illegal, the rules permit what they've done and sadly the regulators often don't care how much time and money can be spent while they're reviewing a requested change, but at the end of the day, they agreed.

Frankly it saddens me that a company can't change the goals after they've seen the results when the results are telling them there was a better way to judge it. In our case Overall Survival is the most convincing case, why not allow it to become the primary goal. It wasn't hard to see that that should be the case when so many people were living so long, but if they had ignored it, why not permit them to ask the regulators to change the goal even after it's unblinded. They didn't do that, they did it by the book, but what would be the harm in the book being re-written permitting it.

Gary

[X Master]

We don’t need the FDA. We want the FDA but.

[10baggerz]

Happy New Year JRIII. I’ll admit that you and others were right when you predicted no TLD in 2021 and I was 100% wrong.

I’m not gonna argue about how the FDA will view the SAP changes, although I agree with Gary.

I’m not sure if you’ve ever experienced first hand what it is like to watch someone you care about suffer and die from GBM. It is an understatement to call it a horrible disease.

Everything about GBM is torture, from the lack of any treatment that works, to the brain trauma and rapid decline, to the horrible side effects of the current SOC, to the hopelessness and helplessness of patients and their families - mothers and fathers, sons and daughters, husbands and wives, brothers and sisters.

I can tell you first hand that my friend who got DCVAX at UCLA is still alive and enjoying life 9 years later, while my stepfather lasted 6 horrific months that I can’t even begin to describe. I’ll just say that we had to lock his doors and hide all the knives in the house because the man we knew was long gone and replaced by an emaciated memoryless wreck with traumatic brain injury who didn’t even recognize his own daughter.

So I respectfully ask that you consider the effects of GBM on millions of lives and the FACT that DCVAX safely extends many peoples lives (OS) far beyond any approved treatment and without any of the horrible side effects.

For the sake of those suffering from this devastating and heartbreaking disease, let’s all hope DCVAX gets approval and quickly.

If it doesn’t based on the use of historical controls due to compassionate crossover of the trial’s original control arm and a reordering of endpoints to address a newly discovered issue of pseudo progression, then it will be be one of the biggest travesties in the history of medicine. The suffering of us investors will pale in comparison to the millions of patients and families that will be destroyed.

[hoffmann6383]

skeptics is one way to put it. misleading and data falsifying is another

[biosectinvestor]

I don’t have time to reply to this ridiculously long post that you made on New Year’s Eve. That you spent the day writing this is amazing that you have so much time on a holiday to do it when this is not a stock you like. Time must be irrelevant in your sector of the galaxy.

I actually never believed that the company required a change in law to likely ultimately get approval. But changes in law will make accelerating all further trials and getting DCVax to patients for all cancers much easier I think, and I often say I could be wrong on speculating about the future, because it is all IMHO and we can’t know the future anyway, but the coming reforms should accelerate everything and often the bad move is to be impatient and go under an old rule when waiting a little longer, you could come under another rule, get something much clearer, and then everything falls into place more quickly in subsequent changes that are already law, just not yet final regulation and policy.

It is easy to twist anyone’s words to suggest they mean something they do not mean.

I never said the only way they can get approval was legal reform. They did update their SAP pursuant to that reform though, because it looks like a much cleaner and rapid way to get unambiguous approval, likely even, if final results validate blinded results, accelerated approval and maybe opportunities to be advanced into pending and new ways that the FDA will accelerate treatments to patients for other cancers.

Patience is not necessarily about a fear that they’d not have been approved previously. I honestly think the regulator would have squared it, if the results justified it, regardless of the noise skeptics make on stock trading bulletin boards. Give me a break. The FDA does not read stock trading bulletin boards to figure out what it will or won’t approve. And ultimately if eminent doctors in oncology and neuroscience agree this treatment is incredibly encouraging and promising and will benefit patients, if non-profit patient advocacy groups likewise agree and patients advocate for it, and if research hospitals also have their weight in for it as well as potentially big pharma, then what gets written on bulletin boards or even a ridiculous commentary from a devolving biotech commentator probably won’t have much impact on the decision. All of that is in the works, and then there are the stock trading skeptics here, in Yahoo bulletin boards and Twitter… and the commentator whose claim to fame is a dated analysis based on a failed theory of intelligent markets who claims he can predict biotech success, is NOT a scientist and has a perverse obsession. I do not see any of that as a compelling counterweight to the science. I am sorry, it just is not. But good luck.

[ilovetech]

JRIII, relax, take a load off. Your claims are completely misplaced. There's a lot of head in the sand going on, it's time to see where darkness emanates:
https://www.bitchute.com/video/4NqNErmGj4yj/

ILT