I wonder if Z is frustrated since he hasn’t been involved in bringing a single drug to market.
Response criteria can be adjusted and stratifications made, etc., but a randomized trial—where patients are randomly assigned to a group—is unbiased. You see, those adjustments affect all groups.
As I said, abandoning OS (Overall Survival) is bad for two reasons: A) no survival benefit can be demonstrated (what’s the use of a cancer drug if it doesn’t extend life?)
B) If bex truly worked as a bridge to transplant, it would significantly increase the OS of the bex group.
The FDA’s job isn’t to be some godfather helping biotechs get drugs to market and making investors rich. The FDA is a regulatory authority, and their primary interest is ensuring that drugs are definitely A) effective and B) safe. I have personal experience with this as an investor; I’ve repeatedly taken hits from FDA decisions.