FDA Plays

[DewDiligence]

Anyone have any clue as to why Spectrum (SPPI) could not show that Fusilev was non-inferior to leucovorin back in 2009.

SPPI submitted to the FDA an old study that was not designed to show non-inferiority; rather, the study was designed to show superiority and failed to do so.

A finding of statsig non-inferiority requires a prior agreement between the sponsor and the FDA about the size of the non-inferiority delta, which is something that SPPI did not have for the study in question.