NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

So there are other ways for DCVax-L to go to market. What is the chance of that happening?

There are a few cases when drugs get dissed by the FDA but approved by EU or Japan. Both of those have similar processes to the FDA though.

I am not aware of a single case where the "alternative" pathways such as German HE, US RTT / compassionate access, UK PIMS, etc. lead to commercial value.

The AMRN board was arguing this for years following 2013(?) when the FDA spit on AMRN;s SPA. Yet, the FDA is still the only approval they have, and likely the first expanded label. Zero commercial revenue ex-US, and an Irish company.

The FDA is "IT" when it comes to valuating baby biotechs for very good reason.