All 35 patients treated with drisapersen completed the study, with the majority of side effects related to injection site reactions and proteinuria, where excessive protein is observed in urine, according to the abstract.
Yes very stupid.
You are right the FDA never requires more than 6 patients to assess the safety of a product because bjackstat says it is enough. You would be a product liability lawyer dream come true.
When do you become FDA Commissioner?