NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

According to NICE Submission Manual PMG24 (page 53), companies are not allowed to submit until the final Summary of Product Characteristics (SmPC) has been issued by the MHRA.

But the actual document states:

Appendix A: Summary of product characteristics (SmPC) and UK public assessment report
1.1 SmPC
Include the (draft) SmPC for pharmaceuticals or information for use (IFU) for devices in
appendix A.
1.2 UK public assessment report
Provide the (draft) UK public assessment report for pharmaceuticals, or a (draft) technical
manual for devices in appendix A.

The reason they allow a draft version is so the NICE process doe not have to wait for the MHRA decision to start the review.