NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

Hi CapHillGuy, I don't think this draft guideline has any immediate meaningful bearing on NWBO to release TLD. NWBio will release TLD/publication whenever it is possible. But by a quick look at it, it seems it puts focus on various uncertainties in drug/biological product developments and approvals, such as flexibility weighing on high safety risks over efficacy. In that sense, not really a concern for NWBIo's DCVax-L, since it has been proven very safe.

Nonetheless the recent regulatory developments including this draft and the one called "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry," etc, seem to be very favorable regulatory developments for drug/biological product approvals in the future. That is good for NWBio and I believe it also good for CVM as well.

GL