DR. DIXON: May I ask for a point of
clarification? Is it too late? With reference to the
need for longer-term outcome studies, is it the
conclusion that such studies are needed for all
members of the class of NSAIDs or are we singling out
this particular product for demanding those kind of
studies?
DR. O'NEIL: I don't believe the discussion
that and I was just trying to summarize. So I'm going
to buck that answer.
But unfortunately for the sponsor, they started
these studies before the rofecoxib debacle, and we are
in a new world with more data every day.
Dr. Hertz, you have a comment for that?
DR. HERTZ: So we've already mentioned that
for something that was truly novel, that they would
need to come in with outcome studies to look at , they started cardiovascular effects.
buona settimana a tutti.