NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

NWBO did that. NWBO did submit its trial design before initiating the externally controlled trial. NWBO submitted an IND with a trial design SPA and SAP.

The trial was started in 2007. The IND did not include an ECA. The SAP with the ECA was created in 2020. The FDA states clearly the ECA control arm should be defined prior to initiating the trial.

Per the FDA:

Sponsors should finalize a study protocol before initiating the externally controlled trial including selection of the external control arm

You say:

You still have not quoted where the DMC will tip the sponsor off, on the progress of the locked data

Uhm, yes I did provide a quote and link stating how the DMC provides recommendations to the sponsor, and how those include efficacy and futility termination recommendations. Have you never heard of a trial being halted early for efficacy/futility> How do you think this happens?