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Potent and bactericidal
Plasma concentrations
Mechanism of action
Efficacy
Microbiology results
Comparative potency
Rapid
Cessation of spread
Primary efficacy endpoint
End of Treatment (EMA)
Simple dosing
Xydalba dosing regimens
Streamlined dosing administration
Single vs two dose regimens
Reconstitution
Dilution
Safety and tolerability
Adverse reactions
Drug interactions
Phases 2 and 3 clinical trials (Time to onset)
Phases 2 and 3 clinical trials (Duration)
Summary
Xydalba
Single dose trial
DISCOVER 1 & 2 trials
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Time to absence of fever or cessation of spread
7
A single 30 minute infusion of Xydalba delivers rapid (36 to 72 hours) results in 90% of patients
Pooled analysis of DISCOVER 1 and DISCOVER 2
7
7 FDA Briefing Presentation. Anti-infective Drugs Advisory Committee Meeting. March 31, 2014. NDA 21-883.
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