NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

I'd heard it initially from someone close to but not part of the company literally several years ago - that it had never been done. At the time, I thought no way, surely there was one. The SAP is mentioned in the leaked protocol, although it was never been leaked, while the protocol itself was accidentally leaked twice since the trial became a P3. And I recall hearing this same thing again much more recently, although I can't remember which source of a couple that I'd heard it from.

And for these reasons, I referenced this topic as a rumor.

The protocol actually references the SAP like this:

Additional details of the interim analyses will be provided in the DMC Charter and the statistical analysis plan (SAP).

The use of the "will be" seems to imply a future tense. This phrasing was in both the 2013 and 2014 leaked versions of the protocol.

Although the same two protocols also stated the following, implying that they already existed:

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