NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

JR111,

I have a question for you. Why didn't the Germans finish enrolling their placebo patients into the trial and why might this be related to NWBO's still in force voluntary hold on the trial portion in Germany when the screening hold was lifted by FDA? I always love to see what the bears try to come up with. Best wishes.

Submission of applications to the Coordinating Ethics Committee in accordance with the German Medicines Act (AMG)

Temporary halt of trial / recruitment stop and restart


A temporary halt of the trial or a recruitment stop have to be notified.
The restart of the clinical trial is an amendment which requires approval.Notification of the temporary halt of a trial or the recruitment stop should be made using the Annex 2 form “Substantial Amendment Form”.

The sponsor need not wait for approval, but can interrupt the clinical trial or stop recruitment immediately.Only after approval of this notification can the clinical trial be restarted.

The application to restart the study has to be made on the Substantial Amendment Notification Form just as the notification of the temporary halt, but with different statements.

https://www.uniklinik-freiburg.de/ethics-commission/submission-of-applications/submission-of-applications-in-accordance-with-the-german-medicines-act-amg/as-coordinating-ethics-committee.html