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
As the 2017 Holiday Season [1] is upon us, here some concepts to ponder while in the mood. Certainly not strategic imperatives, just musings and thoughts for discussion: #1: Consider developing your inhaled antibiotic in CF first. Pursuing a new indication is high risk, akin to playing Russian roulette but with Continue reading Aerosolized Antibiotics (Part 3) – How To Avoid Hitting A Wall
INSMED – NTM The company that is developing Arikayce, a preparation of liposomal amikacin inhalation (LAI), for the treatment of NTM had to withdraw its MAA in Europe earlier this year [1] because data was not convincing enough for regulators to approve the application. Insmed now has to wait until more Continue reading Aerosolized Antibiotics (Part 2) – Mixed News on Two Fronts