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Re: A_Good_Day_2 post# 120290

Friday, 09/15/2017 8:07:23 AM

Friday, September 15, 2017 8:07:23 AM

Post# of 459912

If data is released before new regs they could not be considered in light of the new regs.



Good observation. IMO, any previously done trials of consequence would need some kind of retrospective validation to the new rules, if they plan to use that data. They can avoid a scramble of cross talk but it is better now for everyone to calm down and be ready to have a value added discussion. Anyone who has ever done a retrospective validation will testify that requires intensive subject matter expert (SME) attention. My observation is whenever you get a room full of SME's nothing (very little) positive happens, Which is proly why we will not see much of it. A connect the dot exercise between previous rules and new rules will typically serve to slow everything down until everyone is RETRAINED.
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