NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

As a result, the updated FDA guidance regarding RWD and RWE is not relevant to the DCVax-L Phase III trial.

If the RDW/RWE evidence is not relevant then what guidance is? If we are still waiting for the FDA guidance regarding the use of ECAs is the one we are waiting for then NWBO can not submit a BLA to the FDA until its finished. How long will that take, another year, 2 years?

NWBO had its endpoints bought in during their Special Protocol Assessment which permitted ECA's.. NWBO did not pull ECAs to then hope on a hail marry on FDA guidance regarding the use of ECAs.