NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Skitahoe,my main point is that the DCVax-L Phase III study data and analysis, which were peer-reviewed and published in JAMA, did not use RWD or RWE.

However, I do agree that RWD may be used in the future for some of the DCVax-L and DCVax-Direct combination trials, or for approval of new cancer indications, or for label expansions.

Also, RWD and RWE could be used for approval of new formulations of DCVax-L and DCVax Direct, which will include immune boosting agents, like TLR agonists, danger signals, biological response modifiers, and activators of antiviral pathways.

These immune boosting agents, added to the new DCVax formulations, will hyperactivate and maturate the dendritic cells in vivo.

These immune boosting agents will be treated like new additive ingredients in the new formulations of DCVax-L and DCVax-Direct. So, when the new revised DCVax formulations are approved, all of the ingredients (including all the immune boosting agents) used to make the new versions of DCVax-L and DCVax Direct are automatically approved.

These immune boosting agents WILL NOT NEED THEIR OWN INDEPENDENT AND STAND-ALONE REGULATORY APPROVALS.