Replies to post #690691 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Please correct me if I am wrong, but I believe that Sawston was inspected and approved for commercial production some time ago. I don't think further inspections are required unless modifications require additional inspections.

They absolutely are required.

Inspections for GMP (which Advent has passed) say that they follow proper Quality Assurance standards. They do not say anything about the manufacturing process of the specific product.

The inspection as part of the MAA will insure that the process as used by Advent to make the commercial product is the same as the process as defined in the MAA. The process defined in the MAA is that which was used in the P3 trial unless NWBO can establish they are equivalent.

When Advent was certified for GMP it did not ,matter what the process was, as long as Advent properly executed it.

[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.