Replies to post #534455 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Anyone can put forth one's pontifications.

[biosectinvestor]

By your standard, no paper tells people anything meaningful about approval, because none will ever say, "because we achieved this result we WILL be approved". Of course no paper would say that.

But your argument is nonetheless, ridiculous at this stage.

[hoffmann6383]

Nothing in that paper says the trial met the level of evidence expected by the RAs

Bullshit. This is not information you will find in a Journal article such as this. This is simply an irrelevant distraction narrative.

Have a good one ex. by.

[dennisdave]

Why do you keep fighting FDA regulation? The fact is the FDA permits endpoints to be changed prior to data lock and even after data lock. That's just reality why is that so difficult for you to grasp? I really dont get it. I can disagree with many regs and laws but what will that bring me nothing. I disagree with capital gain tax ok now so what, will that now somehow remove that rule for me?

A blinded IA does NOT legally prevent a biotech to change endpoints /to amend SAP. Where do you come up with this stuff?

[survivor1x]

LOL what about all the drugs approved based on open label PH II and 3 trials. Meaning they were not blinded at all patients or caregivers. FDA has approved drugs with a worse side effect profiles on unblinded trials.

You can't honestly tell me that you know DCVAX doesn't work.

[HappyLibrarian]

The science of NWBO has always been solid and it is very good that we got published in a journal and a top-tier journal.

It was mildly surprising to get the article today and not after more months I’ll take it.

Now as to your points:

First, the changing of the endpoints would be of concern to both the authors and peer reviewers if it impacted the scientific integrity of the trial. . But as we can see, neither the authors or reviewers had that concern.

Second, unless you can show how other JAMA articles explicitly spoke to regulatory approval then I do not think that the authors failing to weigh in on that issue (either way) is noteworthy.

[Doc logic]

exwannabe,

We hold these truths to be self evident, that all actual heartbeats, having been sustained over time by DCVax-L treatment intervention, matter to patients, their loved ones, clinicians and regulators even when the status quo objects due to financial ramifications they can not avoid. Best wishes.

[Judge Smails 40]

Haha hahaha Pride is the Devils favorite sin for a reason