RE:RE:Decision time frame....here an article mate, but there's not example in it. i found it to be hard to find something specific, but i guess it's because generally the FDA maybe announces it only few days earlier, not months. so it's not worth a real news to say "it was too early!" but rather to just say a decision has been made.
so with telesta we're talking about some days now too, not 2 months earlier. main point IMO is: PDUFA = target date.
"Below are some upcoming important PDUFA dates in the rare disease community. The FDA must approve or deny a new drug application (NDA) by the PDUFA date. It should be noted, that the FDA may make a decision before the PDUFA date – in fact, that tends to be the norm lately. In addition, they can also extend the date."
https://www.raredr.com/news/pdufa-dates-in-early-2016