NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Fact: Germany (defacto EMEA) and UK have approved the new enpoints
Fact: EU plus accounts for 35-45% global revenue for most globalized products
Fact: NWBO submitted finalized SAP to all 4 RAs
Fact: NWBO has built manufacturing capacity through partnerships in US, UK and Germany
Fact: FDA has opened regulatory pathways for the current endpoints
Fact: FDA has proven responsive to patient demand, especially where safety is reasonable
Fact: FDA generally listens to expert advisory opinion (individuals w/o industry conflicts)

We dont even need FDA to justify current prices as a 40-80% discount to inherent value. But I have a lot of confidence FDA does not want wealthy US citizens traveling to private Canadian hospitals for too long, ethically questionable.