NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

As LP stated, NWBO would ultimately need to submit comparability for Flaskworks.

1. The GMP compliant design and post approval comparability plan were needed for the MAA.

2. The actual comparability testing is accomplished post approval.

The latter, again, was needed to support the anticipated post-approval major change (down the road) in manufacturing

To submit comparability data after approval, NWBO had to provide the final, GMP compliant design of the Flaskworks system before approval. My guess is they completed this by November 20, because they began c level clean room construction, and as lp stated, they could order the commercial versions (once GMP compliant) be manufactured after they began construction on the suites, because the unit manufacturing would take less time. See the 10k.

You cannot confirm product comparability (i.e., that the final DCVax-L is the same) until you confirm the new manufacturing equipment (Flaskworks) meets Good Manufacturing Practice standards.

The entire dispute with Fikst centered on their failure to deliver a GMP-compliant, final design (i.e., one that could pass regulatory inspection). NWBO had to submit the corrected design to the MHRA for acceptance as part of the CMC section of the MAA.