NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

Dmb2:

I largely agree with the view that PFS is a surrogate and that it may not be a significant factor wrt RA approvals provided that other end points are met and that the tail is long and robust.

Having said that, even though PFS endpoints may not have been achieved/ may not be statistically significant, this does not mean that circumstances surrounding PFS analysis may not yield important information.

For example, it has been stated by Dr. Liau that patients appear to be living longer than expected. Accordingly, an important consideration to evaluate is the interval between PFS eventing and OS eventing.

In addition, it may be that even though patients progress, DCVAX L effectively slows the rate of progression as the vaccine’s effects become manifest as time unfolds. Immunological approaches require a longer time-frame within which to become more fully efficacious and manifest positive results.

Thus, while the endpoints, in and of themselves may not have been achieved or are otherwise not SS, the above described factors may provide strong support and dovetail with the indication that patients are indeed living longer due to the effects of DCVAX L when considering overall factors. All IMO.