Replies to post #58466 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Would it be possible for the FDA to give AA for use in the mesenchymal subgroup?

The level of proof required for an AA is the same as for a full approval. The difference is that the endpoint is one that can be seen earlier, such as PFS, and presumably (but not known for sure) implies the full endpoint, such as OS.

So an AA on PFS requires the same quality of data, but only the PFS endpoint would be needed.

Subgroup? These can not establish efficacy unless they have a predefined alpha spend. Trials can have dozens of pre-planed subgroups, and one could be p<.05 by pure luck.