NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Leaving alone the semantics and jargon ..... basic premise of using PFS is based on an assumption that it is a surrogate marker for OS and can cut short the trial time . If the trial can show statistically significant OS , then who cares about the surrogate marker ( you don’t need surrogate marker if you have actual event that surrogate marker was supposed to predict . You don’t need prediction when you have actual facts that primary endpoint was supposed to predict ) . If FDA can’t understand that then there is something seriously wrong with the drug approval process .