NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Ok clear

Well I'm glad you know that you can't do an IA without an SAP. I didn't, and still don't know that. What I do know is that there was not a previous SAP for this trial, and that the protocol for this trial states that the interim analysis is done WITH using the SAP.

Perhaps I should have changed my wording into follows from logic. Like I told exwannebe, if there is not an SAP in place that has been approved by the FDA then the risk is front and center, after analyzing the data for IA for efficiency, for the FDA to disavow the way the data has been analyzed which would throw the whole throw in the bine unnecessary. Of course any biotech can unblind or have the DMC IA anytime without any regulation prohibiting it, so that's not what I meant.