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.
I already showed this to you but you kept pointing to some drugs.com narrative. They failed on pfs just like nwbo did. And they got a CRL and had to run another OS primary trial. Hmm it is taking years since data lock and nwbo still haven't even submitted?
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