Biotech Values

[biomund]

As a relative newbie to analysis of clinical results, the fact that 6.3.4 of briefing documents states that the interim analysis on OS failed to show a significance difference between treatment arms and that final analysis of Overal Survival not performed pending pre-specified number of deaths occuring, how can drug receive approval at this time? Would appreciate comments on the briefing documents suggestion that overal survival appears to be tending toward final significance