Replies to post #427275 on NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

I know you are being sarcastic Bob, but I do want to add here just for the record and those listening from home.

Progression is a surrogate endpoint meaning it can stand in for the true endpoint because it represents it very well. You see if you progressed with GBM before DCVax, one could be reasonably certain death would be knocking soon.

You can no longer assume this because the new STANDARD OF CARE can cause pseudoprogression. Anything tested on top of that SOC will have to be suspect of a progression. Now, the FDA has very standard ways to deal withthis type of confounding of variables. The first step is to look again at a later date like 3 or 6 months depending on the condition. The next is to have blinded reviewers adjudicate cases so that borderline calls can be made. That is usually a committee of 3 experts not otherwise involved in the trial.

Sound familiar….

[sentiment_stocks]

Yes, well, I do believe overall survival is still considered the "gold standard" as an outcome in cancer trials. PFS is merely a surrogate, and perhaps not such a good one when it comes to the highly personalized DCVax-L.

[biosectinvestor]

Yes, I think changing to the more difficult gold standard of endpoints being controversial or causing a problem at FDA seems unlikely to me as well. They just did a review if early access and approved treatments conditionally based on PFS that ultimately had no OS benefit. That is because they wanted to see an OS benefit, they ended up not canceling a lot of approvals because they thought the PFS standard still allowed for improvement in quality of life, but that was not the FDA’s preferred outcome. The preferred outcome would have been extended OS or survival.