NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

"Once DCVax-L is approved for GBM, future use for that indication will shift under the marketing authorization. However, SI 87 will remain fully valid for all other cancer types, allowing physicians to prescribe it for off-label use without waiting for new clinical trials or formal extensions of the label"

Could this imply perhaps that if sufficient data is gathered that the efficacy of DCVax-L
treatment of a large enough number of patients suffering from various cancers
(e.g. pancreatic or breast cancer) is impressive, then even in the absence of
trials, DCVax-L could be approved for those indications. Alternatively, some
follow up trials may be required but those could be much smaller confirmatory
trials with substantially fewer patients than would have been enrolled prior to SI 87.