NorthWest Biotherapeutics Inc (NWBO)

[beachhyena]

I occasionally peruse the board to see what mud is being thrown at NWBO and find it amusing that much of the conversation has centered around the SAP.
Let's be clear about the SAP process during a trial and in this case a blinded trial.

1) Statistical analysis plan for a clinical study – describes the planned statistical analysis of a study
2) Interim statistical analysis plan – describes the planned statistical analysis of an interim analysis for a study and therefore needs to address handling of partial unblinding issues in case of blinded studies. It also describes possible impact on the conduct and the complete final analysis like the possible adjustment of significance levels.
3) Data Monitoring Committee (DMC) statistical analysis plan – modification of interim analysis used for DMCs and describes regular (e.g. monthly) data monitoring procedures for safety or efficacy questions. The DMC SAP also contains the DMC charter which clarifies exactly the names and responsibilities of the involved parties.
4) Integrated statistical analysis plan – describes the planned analysis for an integrated analysis which is used for example in submissions. It defines the details of programming output for an ISS and ISE usually in one document.

So NWBO is in the process of submitting their final Integrated Statistical Analysis Plan that no doubt has taken longer than expected considering they have employed the services of 3 world renowned statisticians. The confidence I gain is that they have these renowned statisticians in their employ working closely with the experts to produce a finalized SAP that will pave the way not only for this trial but for all future DCVAX trials.
I believe that once they have DCVAX-L approved under the new SAP protocol they will have a powerful new weapon under their belt that will bring worldwide attention to their pipeline. If BP is not taking this little company seriously at this point believe me this will end once we reach topline under the new Integrated SAP guidelines.

Here is an example of an SAP being changed multiple times by Bayer so yes this is common and an expected part of final SAP submission by a company especially those involved in a blinded trial.
[url][/url][tag]https://clinicaltrials.gov/ProvidedDocs/24/NCT01776424/SAP_001.pdf[/tag]