Biotech Values

[biomaven0]

Does the FDA accept RDTs as a pivotal trial?

To my knowledge it's only ever been used in a Phase II and I can't imagine the FDA accepting one as a pivotal trial.

The poster boy for success of this design is Nexavar. It makes most sense for agents where it's quite unclear what cancers will respond and also for drugs that are likely to produce stable disease rather than an objective response.

Peter