Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

"Per standard criteria, SAE = AE reported as serious by the investigator" - http://t.co/MP4P3hn3FM

The clinical trial doctors report SAEs per standard criteria.

But are there such standard criteria? If so, shouldn't everybody follow the standard criteria?

Dr. Michael Mauro said that the different interpretation and calculation of rates of toxicity as reported by the manufacturer versus the FDA was concerning, given that everyone was looking at the same raw data. This is an example of the need for common parameters for calculating such risks, he said. “One can render different opinions on their impact and their weight, but there shouldn’t be different ways of interpreting the risks or different ways of categorizing them. ”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902

Whom was Dr. Mauro blaming? Who didn't follow the standard criteria, Ariad or the FDA?

"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, 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.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93998347

What's the purpose of the change in the FDA methodology? Where did that come from?