NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

meirluc, the Flaskworks’ comparability study cannot be initiated in one manufacturing facility (London) and then completed in another facility (Sawston). The entire study (start to finish) will be conducted in one facility (Sawston). There are a multitude of variations between labs (personnel, equipment, media, etc.) which can have an effect on a product, so any change in a manufacturing site is considered a change in manufacturing, and will require its own comparability study. The level of a comparability exercise that needs to be conducted should be commensurate with the degree and timing of the change.