You bring up a very good point that I liked hearing. The FDA is not raising safety concerns at all. Does that mean as you stated in no# 3 that the population in general explains the imbalance. Could this also be some of the data "patients condition" the FDA requested in June along with the 80 day data numbers. It is a known fact that Dr. Pazdur is very big on survival.
I don't believe there is any safety issue with orbec or that the combined 10 day use caused more treatment failures (if there was any difference I'd expect the opposite, as seen in Ph II).
What I'm suggesting is a win-win scenario that allows the drug to be approved despite primary endpoint failure while satisfying to some degree those who are obsessed with precedent. The additional testing corroborates the basis for approval due to design flaw (patient imbalance that heavily weighed against orbec at the outset). It bridges the gap between a binary choice set of approval or approvable w/ another long P3 trial.
News 
Market Data 
Discover 
AI
