NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Basparks, That is a very good question for which I can only speculate. Obviously, the database was locked in October 2020 and thus the study as we understand it today is complete already. Companies can and do continue to follow patients and given that survival in the 4 participating countries can be tracked by public records of death with investigative accounting for gaps, perhaps the FDA is allowing for an additional analysis of the 7 year survival tail which concludes with all patients in Nov 22. While this is historically considered a post approval commitment or phase 4 design, perhaps it was prespecified in the approved SAP and may be helpful in demonstrating efficacy in the originally randomized cohorts. Cross-overs did well which confounds the original analysis of OS but not that well that you wouldn’t see separation over the long term.

Or perhaps, it is wiggle room or smoke screen to continue to provide the other side to criticize and question.