NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Hi Fosco,

You may find this recent guidance from the FDA helpful if you are concerned about possible pathways forward should the need to use historical comparisons arise.

https://www.fda.gov/media/133660/download

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry

While we won't know until the data is unblinded how the treatment arm compared with the control arm for both PFS and OS, a pathway towards approval is still stronger than you might think, especially if you are basing your assumptions on older, more dated (IMO) paradigms.

Your concerns have been discussed on almost a daily basis here on this board for the past 5 years. Many of us have a lot riding on this, and so our DD has been pretty thorough on this topic. And here we all are, still.

There is a post of mine at the top in the sticky section where I offer up some possible pathways that you may (or may not) find helpful. It's worth reading, whether you agree or disagree with my assessments as it will give you further insights.