NorthWest Biotherapeutics Inc (NWBO)

[Nick119]

I know you didn't ask me, but I do believe we will see certification in the next two weeks. If you look at the GMP site, https://cms.mhra.gov.uk/mhra/gmp , the frequency of certifications issued has been increasing and I believe that the MHRA has moved to remote-based certifications and has not halted the certification process due to COVID increase, as seen in their most recent certifications with the content of:

"The certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. A risk-based site inspection programme remains in force."

We know from the press release issued on the subject of HTA certification, that the physical site inspection was already conducted:

"The original inspection timing was delayed by MHRA due to their caseload; however, the week-long onsite review by two MHRA inspectors was recently completed. The final phase of the process involves receiving an official MHRA inspection report and taking any responsive actions that may be required. The Company currently anticipates that this process will be completed before year-end."

Based on the likelihood of gaps being procedural & documentation based, I believe they will still meet the anticipated timeline.