This brings up again the sorry state of medicine being "default banned". Should this treatment be banned for patients? Absolutely not. Is it a small, underpowered study that needs to be replicated? Absolutely. Could it warrant banning in the future? Sure. Should it be covered by insurance? Complicated. We need to unbundle these things.
Here are some interesting case studies of drugs graduating from Phase 2 trials only to fail Phase 3 trials on efficacy and safety grounds: https://www.fda.gov/media/102332/download
[1] https://www.parexel.com/application/files_previous/5014/7274...