Replies to post #183580 on NorthWest Biotherapeutics Inc (NWBO)

[Ultraz2]

Well, that speaks for itself...

[exwannabe]

Some lessons we can take from the study below:

It was an open label trial. So no unblinding.

The issue would be that they spent all the alpha on the first look that failed.

Can P value get lower if one waits? Yes. How likely to actually cross .05? And does it really even matter formally once the primary has failed?

To be clear:

. The ABBV trial failed because the primary outcome failed, despite a subsequent analysis showing OS with P<.05

. Would DCVax-L not have the same issue if the pre-defined analysis failed yet a susbsequent analysis of OS is PP<.05 ?

[sentiment_stocks]

So true Lykiri -

They looked at the study's data, found it wasn't stat sig.

Then they look a few months later and guess what? The data is better. But they can't use that additional data for approval because they unblinded already.

Which is exactly what a number of us have been saying for some time now. If they unblind too soon, they risk not being stat sig.

And you've just offered up a perfect example of this.

Thank you. :)