NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

They likely will not need to. First, there is off label use in the United States. Secondly, if you simply reject off-label use is an option before more DCVAX-L studies are completed on different cancer types, let me suggest that the Direct platform will beat any such post-approval label extension studies to the finish line. While safety is the primary endpoint in the phase I/II trial in Direct, Tumor regression and/or lack of progression is the secondary outcome measure. In any IIB/III pivotal trial for Direct, tumor regression would be the primary endpoint/outcome. This is the fastest route to approval there is in cancer trials. The events happen at lightening speed, and unlike the first phase of the Direct trial, there will be no first-in-human bottleneck protocol to slow it down -- and remember, direct is for all solid tumors.