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gburgin

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gburgin

Re: anders2211 post# 114672

Wednesday, 08/09/2017 1:10:23 PM

Wednesday, August 09, 2017 1:10:23 PM

Post# of 461226
What they're required to report are material events that are not a matter of opinion or interpretation. If the FDA had halted the trial due to unexpected deaths, the halt would be a material event not a matter of opinion . This trial is not even powered for efficacy so what might be considered "bad" efficacy related data showing up since the last update would not have to be reported. The only requirement is that they can't selectively disclose it if they decide to disclose it.
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