Dendreon Corp fka DNDNQ

[rancherho]

A big issue will be whether TTP is measured pursuant to "A Clinical Development Paradigm for Cancer Vaccines and Related Biologics" which was developed by the FDA, NCI and various experts and reported at the February FDA / NCI Workshop on cancer vaccines. http://sabin.org/files/PDF/CVCTWG.clinical.development.paradigm.JIT.2007.pdf

This allows an immunotherapy ramp up period to occur before measuring TTP, giving a three month example. If this approach had been used in 9901 retrospectively, it would have been statistically significant, though 9902a probably would not have been.