Replies to post #528572 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Well, the FDA and regulators are not as arbitrary as you and they apparently disagree. PFS is a surrogate measure of OS that can be derived, under the proper conditions, as a surrogate measure of OS. In this case, it was clearly not possible as PFS was, as measured at that time, not fit for this kind of trial and did not serve as surrogate measure of OS nor was it apparently correlated with OS. That suggests that it was problematic and that inflammation was confused for PFS, so PFS was not diagnosed properly.

The regulators, unlike you, understand this issue far, far better and so do the clinicians, who are the top of their field and concluded otherwise. The change was made previous to unblinding, following regulations and OS is a much better measure and really the aim of the original measure of PFS.

So you're really just giving reasons for why you HOPE that they decide otherwise. You're not giving the facts as they were, and you're simply stating your own conclusions over and over again as if that is what will be found and was found. We have to wait for the regulators to decide, so your posting this over and over and over again is not productive.

[Dr Bala]

Totally nonsensical post.

[SkyLimit2022]

The global clinical P3 study provided the scientific data, but the “testimonials” are simply beautiful to look at—that is the purpose of “testimonials.”

Many of the survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …

https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/

https://virtualtrials.org/dcvax.cfm

[Roman516]

So, what is the PFS statistical estimated data was thrown out, it is the OS data that is the key, and the gold standard were many doctors, scientist and professionals all agree and are impressed with the data. Testimonials do count for any approvals when the right people are able to agree with the truth.

[Doc logic]

HyGro,

An approval in the UK does not require that much time (months to prepare then 2 months plus 10 months) when an MIA is already submitted. A statement like “will take months to prepare” writes off likely rolling type submissions to both FDA and also MHRA, which is waiting on commercial scale manufacturing certification, and ignores circumstances whereby FDA and MHRA can keep things under wraps so that otherwise publicly known dates are kept quiet. Start researching all the exceptions and it doesn’t take long to figure out that false claims while multitudinous are sorely lacking the clarity available in the regulator guidance. Sadly, this reminds me of what was written in Deep Capture about repeating the same things over and over to create a desired effect. Best wishes.