NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Skitahoe, IMO, the inspections that are referenced in the 10-Q, are specifically in connection with the DCVax-L Phase 3 trial. Here is the exact language from the 10-Q:

It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.

That leads me to believe that everything that is being inspected was part of the DCVax-L Phase 3 trial, including: the trial master file (TMF), the trial sites, the CDMOs that manufactured the DCVax-L for the Phase III trial (Cognate / Charles River Laboratories & the London Lab & Fraunhofer), the CRO (Synteract), & all documents & records related to the DCVax-L Phase 3 trial.

Advent / the Sawston facility was not involved in the DCVax-L Phase 3 trial as a CDMO. The Sawston facility did not get its MHRA license to manufacture DCVax-L for investigative or clinical trial purposes, and for Compassionate Use purposes until after the DCVax-L Phase 3 clinical trial was completed.

Now, the Sawston facility has already been inspected by the MHRA, and has received its license to commercially manufacture DCVax-L after MHRA approval. The Sawston facility was inspected by the MHRA and has already been approved to commercially produce DCVax-L. This was 1 of the completed milestones listed in the 10-Q table below. See footnote 1:



Now, the Sawston facility will continue to be inspected periodically by the MHRA in order to retain its commercial manufacturing license. But, IMO those inspections will occur from time to time, in the future, after DCVax-L approval.

IMO. the current inspections referenced in the 10-K & the 10-Q, are all about the DCVax-L Phase 3 trial & all parties involved & all related documentation & records.