Replies to post #592395 on NorthWest Biotherapeutics Inc (NWBO)

[iclight]

From the links provided:

An external control arm data source should be temporally and clinically relevant to the investigational arm to minimize bias, and necessitates sufficient individual patient-level data to ensure a well-powered comparison.

Hardly sufficient patient level data.

The same data may have disadvantages, however,

such as being temporally irrelevant with respect to patient selection,

prognostic biomarkers,

Patient selection total different especially by including low life expectancy of biopsy only patients when the trial required GTR.

I could go on and on but this literally took me a minute from one of the supplied links.

None matter as using an ECA needs to be specified in the design process, not the cover ones ass from the crappy data process.

[HyGro]

All the evidence you have does nothing to change FDA requirements. It's not going to change their guidelines that ECA MUST be designed and approved BEFORE the trial begins, not 16 years later when the trial is virtually complete.