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At around this time (July 2015), Cellceutix is expected to hammer out a Phase 3 program for brilacidin, its defensin-mimetic and host-defense protein (HDP) mimic structurally similar to magainin, with FDA. Brilacidin is certainly an interesting novel compound, coming from a new class, with a unique mode of action. It has Continue reading Brilacidin – QIDP Drug At a Critical Juncture
For GC antibiotics, the development path looks like a trip down the road less traveled, leading into some uncharted territory. Let’s take Melinta’s statement [1] at face value according to which the single 900 mg dose of delafloxacin failed because of “insufficient efficacy”. So, what then determines efficacy? Delafloxacin’s MIC90 was Continue reading Treating GC in the Face of Dwindling Antibiotic Options – (2)
..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…