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Re: Watsonturtle post# 717

Friday, 01/24/2020 11:00:47 AM

Friday, January 24, 2020 11:00:47 AM

Post# of 1121
Thanks for the repost! There was obviously a flaw. The question will be what to do about it. Will the FDA require the entire trial to be redone or will only the data from the 5 sites be tossed. Those individuals represented 35-40% of the trial participants. The total trial took 22 months to complete so 40% of that is 8.8 months. Because recruitment takes time to ramp up in a new study (and this not being a new study) I dont anticipate it taking as long to complete. My guess is somewhere below 8 months. The big question is if the entire trial has to be tossed or not.
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