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Tuesday, September 20, 2016 12:25:11 PM
Totally in agreement but it also takes an environment, in this case 2 key opinions, to make this a reality. I see AVII77's view as one painted by the reality of the old guard revealed in discovery of recent bias and influence. This has been partially rooted out at FDA now. I see your view as prioritizing the influence on decisions by intent of guidelines and law. While the minimum scientific proof must be used as the basis for any decision, justifying the use of a minimum will always lead to controversy. This is why the 2 decision makers in this case had to be people with the fortitude to take the heat and AVII77 and I would both agree that this is rare. This decision is perhaps one of the first in a new wave of culture change at FDA. As you have pointed out, this should not be ignored either. Best wishes.
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