NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

And for ATLs education , here is AI summary, as he has been repeatedly posting same excerpt from FDA guidance which is not relevant to DcVax trial

“ No, Northwest Biotherapeutics’ DCVax-L phase 3 trial would not be considered a non-interventional study under the FDA’s definitions in the August 2023 guidance you linked (Considerations for the Use of Real-World Data and Real-World Evidence).

Here’s why:
• The guidance defines interventional studies (clinical trials) as those in which participants are assigned to one or more interventions according to a study protocol to evaluate effects on health outcomes (e.g., randomized controlled trials, single-arm trials) ?.
• In contrast, non-interventional (observational) studies analyze data on patients who receive a marketed drug during routine medical practice and are not assigned to an intervention by a study protocol ?.
• The DCVax-L phase 3 trial was a randomized, placebo-controlled clinical trial where patients with glioblastoma were actively assigned to receive either DCVax-L or a placebo, following a predefined protocol—not observed passively in routine care.

Because assignment to treatment or placebo was determined by the study protocol, the trial is firmly classified as interventional, not observational (non-interventional).”