Everyone in the pharma and regulatory world has known this stuff is worthless for years. I feel like the pharma industry should be severely fined for knowingly perpetrating a fraud on the public. Sadly, they would likely be able to defend themselves on the grounds that the FDA allowed it.
A faculty member clued me in when I worked for a college of pharmacy 20 years ago! FDA should be embarrassed. This shouldn't even have been hard. How many drugs have been p-hacked into efficacy and would need expensive trials to disprove? Oral PE is metabolized too quickly make it to the bloodstream and can't be more than a placebo.