There are two interpretations of that poorly written article. Which had the company and the FDA agreed upon — before or after? Read the quote again, you can make a case for either interpretation.

The article that I read elsewhere said that the FDA had moved the goalposts and had changed their requirements. I don’t care enough to research it to find out what the situation actually is.

However, we’ve seen plenty of drugs and medical devices get the go-ahead on sketchy data - as long as they were Big Pharma products.