Confirmatory trials, page-17

It's hard to believe that FDA have expressed the view that the data submitted is inadequate to justify approval without also indicating in what respects it was thought to be deficient. Assuming FDA provided that information, why wasn't it included in the announcement? I agree with @CaptainBarnacles re lack of transparency. Here we are left wondering whether what is required is some further analysis of existing data or another Phase 3 trial (either of which may or may not give a "confirmatory" result).

Also, Europe would have been a useful source of additional (post marketing) data if SPL had got the product to market upon approval. Instead they have fluffed around for years without ever properly explaining why such a substantial market was put on ice. Share price says it all. Massive loss of confidence in management.  All IMO.