Replies to post #373836 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The problem is that you can not define "indicative of a failed trial" here.

NWBO (it looks like) is arguing that they can compare the OS of treatment arms to historical controls. That will almost certainly "work".

The FDA will not provide a definitive answer on a change to the endpoints such as this, I would assume the FDA is saying it might not be acceptable, but they will have to see the BLA to answer.

So what exactly does NWBO have to define as "failed"?

EDIT: I also disagree any 4 day rule applies regardless, but that is more complicated question.

[biosectinvestor]

Hi Gary,

If there was no question in anyone's mind on THEIR SIDE, as managers of the business that they would not proceed with an FDA approval, based on all information, including their updated SAP, meaning, if they had failed on OS... and in fact everyone died earlier than 16 months and all their research partners were just pulling their legs on all those patients surviving... sure, they'd want to let us all know in 4 days. That would be as good as having been rejected by the FDA, but they'd have made the determination themselves that they'd get rejected, without going for a rejection officially.

This has ALWAYS been a false measure and meaningless debate because we already know what we know just from the unblinded data and that approximately 90% received the drug.

And it does not work as an axiom for determining if they will receive approval. It's a fake measure.

Are you asking me, generically, if you have a really simple trial, and it is futile, but they continue anyway only to find out, yes, it was always futile, everyone died as expected, with no difference or a difference that was not significant, with no further measures to suggest possibly otherwise, sub-cateogories, etc.? Yes, in those cases, it is wise for them to announce it asap. Basically, it as as good as an FDA rejection, just without the expense of the application process.