Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

FDA didn't change AE definition? Let's replay Ariad 2013-3Q CC:

"You went through a lot of the differences in how the thrombotic events are counted. I guess, why was the change in the FDA methodology? Where did that come from?", asked Michael J. Yee - from RBC Capital Markets.

"I think that's not anything that we can comment on or know. So we're just not really in a position to comment on that.", answered Timothy P. Clackson.

"The drug safety communication and these analyses were not shared with us in advance. The communication stated that approximately 24% of patients in the Phase II PACE trial with a median treatment duration of 1.3 years and 48% in the Phase I trial with a median treatment duration of 2.7 years have experienced serious adverse vascular events.", said Timothy P. Clackson.

"I really appreciate all the information on the event rates for Iclusig, but there just seems to be a pattern where FDA says one thing and then you guys come on the call publicly and say something else. So I'm just wondering, what's the logic of having this debate in a public forum? It just seems like every time you guys do that, they come down hard on you at the next possible opportunity. So I'm just wondering why you think this should be prosecuted in public rather than just in meetings with FDA?", asked Jason Kantor from Crédit Suisse AG.

jq1234, how do you know the FDA didn't change AE definition? Are you an FDA employee? Or are you an Araid employee? Or are you a Novartis employee? Or ... ??????????