Allphase Pharma Consulting, LLC
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Gepotidacin Study 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 Continue reading Gepotidacin ABSSSI – How to Fail Adaptively
WHO compiles a list of antibacterials in clinical development on a regular basis, the last in mid-2024 [1]. The information is up-to-date and detailed: it provides MoA and antibacterial spectrum, coverage of problem pathogens, the development phase, and whether it Continue reading A Critical Review of WHO’s List of Antibacterials in Clinical Development
First and upfront, let’s call this virus WARS*, which stands for Wuhan Associated Respiratory Syndrome. President Xi Jingping called for a war against the new virus, and a war it is. Therefore our acronym makes intuitive sense. The naming of Continue reading Some Thoughts about the New Coronavirus Syndrome and its Transmission
The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All Continue reading FDA Needs Radical Reform
Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to Continue reading The Letermovir Top-Line Results are Out – Or Are They?