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Re: None

Monday, 10/06/2014 12:56:10 PM

Monday, October 06, 2014 12:56:10 PM

Post# of 403090
With regard to the single, possible SAE in the Brilacidin trial what are the implications if it was in one of the B arms? Specifically, with regard to FDA and moving forward into Phase 3? Does it take more than 1 SAE to be considered a cause for concern by the FDA when planning additional trials?
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