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Re: nidan7500 post# 145403

Saturday, 03/24/2018 8:52:20 AM

Saturday, March 24, 2018 8:52:20 AM

Post# of 462572

Finally, some kind of common sense or real world (call it reality) stepped in. Maybe Dr.M. was one of those who wanted to go a different path. Dr. G. saw an opportunity to reset the trials process. "I Know let's call it Precision Medicine". Anyone who has been around these parts for a while will tell you that BUT, such changes do not happen at the speed of light. THAT, IMO is the issue they/we face. Now, it's gonna be ALL ABOUT TIME. Is it OK to start/stop a trial? Apply what you just learned and RESTART? How do you do that when the herd has been trained to run in a straight line until they go over the cliff? (SEE RWE)



IMO, the new guidance from FDA (previously posted) will allow "Clinical Hold" to be used and then ...restarting. Very cleverly done, IMO.
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