The list of drugs that received accelerated approval had a number of breast cancer drugs. One of the breast cancer drugs proved to extend the life of a patient by nearly 50%. That trial had 160+ patients combined for both arms and the trial took at least 24 months to complete. In that trial, the patients on the placebo died sooner than those on the drug. Additionally, other women died during that trial who didn’t have access to the drug. The argument that women are dying doesn't seem to matter to the FDA. I hope that the FDA has since changed their approach, especially considering CTC and tumor shrinkage is easier to measure over a short period of time, but I’m not holding my breath.