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Replies to post #41216 on Ariad Pharmaceuticals Inc fka ARIA
grandma_of_jbraika
12/13/13 7:34 AM
#41217 RE: grandma_of_jbraika #41216
It was the FDA that did not follow the SAE-reporting standard criteria.
12/13/13 7:57 AM
#41218 RE: grandma_of_jbraika #41216
"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
"Ponatinib was pulled by the FDA under VERY suspicious circumstances. They changed the definition of what constitutes an adverse event, then attributed every event to the drug, despite the fact that these patients were heavily pretreated and in BLAST phase. They came to the study at deaths door after failing all other options," commented Richard Parkinson.