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Re: jq1234 post# 54868

Friday, 10/10/2014 10:04:17 AM

Friday, October 10, 2014 10:04:17 AM

Post# of 80490
PRAC's decision clearly puts what was wrong with FDA's action. FDA should have done exactly what PRAC did - do their due diligence appropriately and as the decision clearly puts it, the risk-reward is heavily biased towards the reward. I remember the comment by Pazdur which clearly put the motivation behind FDA's or his move... which was not certainly what PRAC followed.

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