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Re: grandma_of_jbraika post# 41083

Wednesday, 12/11/2013 11:50:51 AM

Wednesday, December 11, 2013 11:50:51 AM

Post# of 80490

"Actually with stupid comments like that, no one is going to take it seriously. FDA didn't change AE definition," posted jq1234.

No one? Dr. Michael Mauro, who is more than no one, does take it seriously as he said,

There shouldn’t be different ways of interpreting the risks or different ways of categorizing them.”

"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.

"Why was the change in the FDA methodology? Where did that come from?", asked Michael J. Yee, RBC Capital Markets.

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