NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Yes, I think it’s all related to the process in the U.K. As we know, the U.K. appears to be on track to approve DCVax-L first. That would explain why they have gone ahead and updated their (GB) clinical trial register with the revised endpoints before Germany, the rest of the EU, the US & Canada.

Once NWBio releases the TLD, they can go ahead and provide NICE with the efficacy, safety & cost evidence submission. NWBio can also submit an application for approval of DCVax-L through the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K.

The next step in the U.K. approval process for DCVax-L is for the NICE to appraise the clinical and cost effectiveness of DCVax-L for newly diagnosed GBM. Once NWBio gets a favorable appraisal from NICE, DCVax-L will be automatically approved for insurance coverage for all U.K. citizens through its National Health Service (NHS). This national insurance covers all citizens of the U.K.