Allphase Pharma Consulting, LLC
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It is interesting to see how often a discussion of study results moves from microbiology to clinical significance to statistical analysis details. When an antibiotic is not evaluated on the basis of its antimicrobial activity but on its ability to change a clinically relevant measure (the “feel, function, survive” mantra Continue reading Aradigm Lost in ORBIT – Hayward, We Have a Problem
Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions about regulatory requirements, have contributed to this trend in a Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria
Roche’s current Phase 2 program is strangely ambiguous. RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed. An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” is enrolling. Well, good luck finding those patients! At best, Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 2)