NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

You cannot make a survival benefit claim from a single-arm study, i.e., a study without a comparator arm! This is an iron-clad rule. No exceptions.--AF

Lol, wow! What have we been debating all this time about Keytruda over, eh? Looks like according to AF the FDA will have to retract their approval. I suppose they should have run it by him first. Their bad.

A number of accelerated approvals have been granted on single-arm studies alone: http://jnci.oxfordjournals.org/content/96/20/1500.full

Anyway, maybe he's learned a little since the date of this mailbag: 06/17/11