NorthWest Biotherapeutics Inc (NWBO)

[CogDiss 1188X]

Ex - more on the shipping record theory.

As I mentioned in my original response to your post asserting the shipping record theory of the trial blind being broken:

Isn’t it more likely that whatever entity shipped the placebo/treatment vials simply kept a running total of “number of patients who received placebo”, “number of patients who received treatment,” and reported that number at some point?

Evaluate linked to an actual SAP document for a recent BC trial for my enlightenment and diversion yesterday.

On page 30 of the SAP, page 31 of the pdf, we read:

Data sets will be created for the purpose of aggregate data review by the sponsor in which treatment assignment is scrambled so that personnel involved in the day-to-day conduct of the trial and development and validation of analysis programs will be blinded to patient treatment assignment.

https://clinicaltrials.gov/ProvidedDocs/03/NCT02107703/SAP_005.pdf

The above procedure is entirely consistent with Cognate keeping an aggregate total of the number of patients for which it shipped DCVax-L, while still maintaining the blind for the sponsor, clinicians and patients. It is data that the sponsor would be interested in, and could potentially act as a value to check against for data intregrity.

It would be most accurate for Cognate to call this the “number of patients for which DCVax-L was shipped.” It would be entirely natural that LL would use the same term in the JTM article, even though it might be slightly less accurate, given the remote possibility that DCVax-L was shipped for a patient who for some reason never received the treatment. Hit by a bus crossing the street to the clinic jumps to mind.

No need to rifle through shipping records is necessary. No breaking of the blind. Certainly no admission that either ever happened.