NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Updating the clinical trial register with the revised endpoints in the revised SAP in the EU, is done by each regulatory authority in that country. In the UK it was updated by the Medicines and Healthcare products Regulatory Agency (MHRA), and in Germany it was updated by The Paul-Ehrlich-Institut (PEI).

In the US, the clinical trial register is updated with the revised endpoints by the sponsor, NWBio. As you know, they have not updated the DCVax-L Phase 3 clinical trial registry in the US since October 2016.

I do not believe that updating the clinical trial register right now is a top priority for NWBio. I think their primary focus now is TLD. But, I do believe NWBio will update the clinical trial register just before or just after the DCVax-L TLD is released.