To see vertex estimate that it expects a loss in the area of $750 mil this fiscal year alone is astonishing. I think they might surpass HGSI's as having one of the largest carry forward loss's.
I do not know who is advising Vertex on the data they are gathering but two of the simplest painful approval delay mistakes a company can make is to give the FDA too little data or too much data.Of course if you give too little data they will ask for more but you can give them too much data initially and they have come back to companies and said " Thats interesting give us more data on that " They are at a disadvantage with the current management team IMO Off to my day job