close to earnings - can you smell it, page-39

I don't know what the average is, but some NDA's seem to push through quite quickly. I could be wrong. If I was Mr FDA, I'd be more urgent with new drugs and new indications than generics, particularly where one showed improved efficacy. The point is that you can't really compare the 2 because FDA are looking at some different issues (eg efficacy and safety rather than similarity) and would have differing priorities.

If you look at the approval letter for Pradaxa, there were many, many amendments submitted in the time, so the process seemed quite intense.

With oral.... there is certainly a lot of space in there. $10-20B is 2 orders of magnitude bigger than the fonda generic market share bandied around on HC.