Brilacidin has already completed it's safety trials. A single possible drug related SAE out of this trial won't have any impact on moving forward into a Phase III. This trial is just looking at optimizing the dosing of a drug already known to work. One SAE is nothing to worry about out of 215 people. It really doesn't matter which arm it's in.
In Reply to 'oddone33320' 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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