NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Hopeforthefuture3, if you go back to the Musella Foundation interview, of the CEO of MimiVax as he talks about the SurVaxM clinical trial control group that they proposed to use with the FDA, you will see why the FDA would not approve the ECA MimiVax wanted to use.

You can start around the 33:30 minute mark at the link below. The CEO said that they proposed to the FDA, to use an external control arm (ECA) that was comprised of real world data (RWD) from a patient health registry database, but the owner of the RWD database did not have patient-level data.

Again, NWBio did not use any RWD from a patient health registry database. Instead, NWBio used pooled control group data from other contemporaneous external randomized controlled trials (RCTs).

The FDA approved NWBio’s statistical analysis plan (SAP), including its ECA in advance, prior to data unblinding and analysis.

But, now all of this is a moot point anyway, because the FDA recently changed their guidance, and they are not requiring ECAs that have RWD, to have patient-level data.