NorthWest Biotherapeutics Inc (NWBO)

[Nemesis18]

Current Status
Appraisal is Suspended: NICE is currently unable to proceed because NWBO has informed them that it cannot provide the evidence submission required for the appraisal at this time.
Awaiting MHRA Approval: The primary reason for the delay in the NICE process is that NWBO is still fully occupied and engaged in the separate Marketing Authorisation Application (MAA) process with the Medicines and Healthcare products Regulatory Agency (MHRA).
Regulatory Sequence: UK regulatory procedure requires MHRA approval and the final Summary of Product Characteristics (SmPC) label to be confirmed before NICE can conduct its full assessment, including cost-effectiveness analysis.
Future Steps: NICE is continuing to liaise with the company and monitor timelines, but a full appraisal, including the specific costing/reimbursement status for the NHS, will follow only after the MHRA process is complete and NWBO submits its evidence.
In short, there is no official costing status yet because the appraisal process is on hold, pending the necessary documentation from NWBO following the MHRA's licensing decision.