The FDA will always let a company know if early approval is likely. The company has to prepare for launch and for a drug like Kalydeko the last thing you want is for an approval to be handed down and then the patients have to wait 2 months while the company reacts to the early approval. The hard part is keeping it quiet which Vertex seemed to do very well as nobody on wall st had any idea. It's a good model, works for the patients.
since it is so critical to investors' decision making, I've always wondered why companies can't find it useful to release actual fact/data based information on sales as they happen....weekly, monthly....why in this day of instant and verifiable data do we need to wait 90 days to know what those on wall street can see if they subscribe to certain outlets or have the COO or CFO cell number?