> Second, you're ignoring the possibility of other treatment options. It isn't always the binary life-or-death you're making it, so SAEs do matter.

A common reason for a drug (especially a cancer drug) going to trial is because other options have already failed. For example CAR-T therapies are commonly trialed on patients with R/R (relapsed/refractory) cohorts.

https://www.fda.gov/regulatory-information/search-fda-guidan...

> "In subjects who have early-stage disease and available therapies, the unknown benefits of first-in-human (FIH) CAR T cells may not justify the risks associated with the therapy."