Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things about the drug. It also highlighted how strategic missteps can Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin
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