NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Let me give you just one reasoned (but slightly dramatized) hypothetical to prove why OS should only be used against the historical OS group if PFS is the primary endpoint.


Let's say HISTORICAL standard of care is globally:

6.9 months PFS and 15 months OS. Again, Standard of Care.

Now let's say DCVAX-L = 18 months PFS, and OS = 24 months in the treatment group.
BUT ....Crossover = 6.9 months PFS, but OS = 25 months.

Under the foolish OLD FDA (not the new and improved one) they would say, "sorry, no significant difference in OS between the cross-over treatment group and the treatment group, therefore no approval."

Patients would understandably scream at the FDA, "you idiots!!! The cross-over treatment group and the treatment group OS trounced the historical standard of care OS by 9-10 months!!!"

The FDA can only reach such an absurd result if they primarily compare the treatment group with the cross-over treatment group.