NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

You realize that the SAP they submitted to regulators in 2020 ws the first one, right? There was hands down, NO SAP existing for the trial prior to that time. Yet in order to perform an efficacy analysis required an SAP. It's not that it just wasn't mistakenly leaked (by outsiders)... there wasn't one to leak.

I'm curious as to how they could have conducted an efficacy analysis without having a statistical analysis plan (SAP) when the protocol clearly states that in order to do any analyses, they need one?


From the DCVax-L trial protocol v.6:

Additional details of the interim analyses will be provided in the DMC Charter and the statistical analysis plan (SAP). If significance is between 0.01 one-sided and 0.05 two-sided, this will be considered as very strong evidence of benefit conferred by DCVax-L.

“Additional details for ALL ANALYSES will be provided in the SAP.
*emphasis mine”

“Hypotheses and analytic methods for these endpoints are specified in the Statistical Analysis Plan (SAP).”

I know you also grabbed that leaked version back in 2018 (from Cleveland Clinic) so you can check confirm that for yourself.

If proving the endpoints change was post-hoc is what you're counting on to prove your bear case, that fact kinda buries it.