NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

The SAP we know about was on the table by mid 2019. But a SAP after the last patient was treated is a big no no for the FDA. I'd bet the FDA had a SAP prior to 2015 and your 2020 submission was for a subgroup. ??


3.9 Analysis method
For each study objective, explicitly describe the statistical method or model, and the assumptions required by the method. Levels of statistical significance (eg, confidence interval and P-value) should also be defined in this section. Secondary or subgroup analyses should also be defined, to avoid post hoc “fishing” for associations should the primary analysis prove not to be statistically significant.