NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Dan88, I would like to mention of a few facts / points:

(1) There is only 1 DCVax-L clinical trial.

(2) The 1 clinical trial is being conducted in 4 different countries (US, UK, Germany & Canada)

(3) There is only 1 SAP for this clinical trial.

(4) The SAP is the same in all 4 countries, with all 4 regulatory authorities (RAs).

(5) NWBio said that they would not unblind the data & let the statisticians start the process of reviewing & analyzing the data until they got buy-in on the SAP from all 4 RAs.

(6) In the UK & Germany, the RAs (MHRA & PEI) are responsible for updating the revised endpoints in the clinical trial register. In the US, NWBio is responsible for updating the revised endpoints in clinical trial register.

This tells me that NWBio already has SAP buy-in from the FDA & all the other 3 RAs.