NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The drug was of course sipuleucel-T, trade name of Provenge.

They tried to get approved based on a P2 that failed the primary endpoint of PFS but was stat sig on the secondary endpoint of OS. The FDA said that is no good and they needed a real P3 trial that properly defined the prospective OS endpoint in advance.

The P3 completed and the results led to a relatively quick approval. The Improve P3 had a data cutoff Jan 18. 2009. FDA approval was April 29, 2010.