BC probably has more relevant experience, but I don't think this finding would cause the FDA to do anything. Monkey cells in a dish have the barest relation to activity in human patients. Some researchers may take this up though and do follow up studies.
The FDA black box warnings and recalls I am familiar with have all been based on experience from human patients, not in vitro experiments.
The FDA black box warnings and recalls I am familiar with have all been based on experience from human patients, not in vitro experiments.