NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Sometimes regulators might expand approved indications without requiring a separate marketing application. This expansion can occur through a process known as "label expansion," where additional indications are added to the drug's label based on new data or studies showing efficacy and safety in treating different conditions within the same therapeutic area. If the regulatory body deems the new evidence compelling and consistent with safety standards, they might approve these label extensions without the need for a separate application.

The assertion that one or more regulators would do this for indications beyond CNS now seems premature, because, while DCVax undoubtably, imho, treats mesenchymal cancers (for instance) originating anywhere in the body, there would need to be sufficient evidence for regulators to expand the label requested beyond GBM (and possibly other brain cancers).

That said, there is likely sufficient evidence to cover most brain cancers, and NWBO probably has more potential IP protection based upon this being a new biologic (ten year protection), then relying upon orphan status. Imo.