And yet they have the data and the ECA to validate the effect… Regulators do not like to unnecessarily ignore good data and patient and company sacrifice where life extension is proven for a rare disease: it will be about the proof and data, not your formalistic nonsense. The trial was revised prior to unblinding because of the ethical and practical issues around ensuring that patients got access to the drug… their rare disease being literally a death sentence prior to DCVax-L.