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Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment. This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary endpoint was a non-standard composite efficacy and safety endpoint that Continue reading Gepotidacin ABSSSI – How to Fail Adaptively,
Whatever has become of investigative journalism? All we read after the Stifel conference call (11/17/2015) is descriptive rehash of information provided by Tetraphase at the conference. No probing questions that we thought investors would ask who just lost 80% of their money. No signs of analytical or strategic readjustment at Continue reading Eravacycline Conference Call: Unrevealing and Disappointing
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