NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

If NWBio is unblinded, then that reinforces my belief that NWBio indicated that they would not unblind the DCVax-L Phase 3 trial data until the Statistical Analysis Plan (SAP) was completed & submitted to all 4 of the regulatory agencies in the 4 countries (US, UK, Germany & Canada) for their comment & buy-in.

NWBio comments also indicate the following:

1. There is only 1 SAP. This 1 SAP was submitted to all 4 of the RAs.

2. NWBio received comments & buy-in from all 4 of the RAs.

3. The trial would not be unblinded, and the TLD will not be analyzed until the SAP process is completed with all 4 of the RAs.

4. There is not a different SAP in each of the 4 countries. There is only 1 SAP. NWBio refers to the SAP as “the SAP” singular not plural.

Please note these quotes from the NWBio PR about the SAP and the TLD analysis.

As soon as the SAP process is completed with the 4 regulatory agencies, and the simultaneous data checking is finished, the trial will be unblinded and the data analysis stage will take place and result in top line data

As soon as the SAP is finished (including review by advisers), it will be submitted to the regulatory agencies for each of the 4 countries where the trial was conducted, for their comment and buy-in.

Here is the link with these quotes again:

https://www.prnewswire.com/news-releases/highlights-of-nw-bios-program-update-in-the-industry-expert-theater-presentation-at-asco-300861654.html