"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.
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