Rose Conway Walsh (Sinn Fein) | Oireachtas source

On Translarna, I want to take it in three parts. First, I want to take it in relation to the FDA and what has been said so far. Then I want to take it on the cost specifically and on the data issue.

In terms of the FDA and the witnesses' reference to non-approval in the US, is it true that most orphan drugs that are put before the FDA are not approved in the first instance? Is it the case that almost all drugs fail in the first instance and then additional information is requested at that point? Could the witness tell us, and I am sure he will know these figures, in the last year how many drugs were approved by the FDA and how many were refused on the first submission? I refer to orphan drugs.