You don't wait 5 years from data lock (let me stress this, 5 f*cking years since data lock) to submit a BLA if you actually think your product is a success.
As I said, because they are not ABLE to, They just cant, because of the lack of IPD. So getting mad at them for THIS (as you did/are) is pointless, as I said. Getting angred for a thousand screwed up thing they did and didnt sure but not that one.
Is a Citation Mustang unsuccessful because its not able to fly non stop from NY to Sydney?