Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Statements that have the words ‘FDA’ and ‘flexibility’ in a single sentence need to be approached with some skepticism. Especially if made by the Agency. ‘Flexibility’ always sounds better than ‘less rigidity’. Regulators are tasked with providing a certain sense of consistency or stability in the drug development jungle where Continue reading The New Default: 1 (One) Single Pivotal Trial
Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty penmanship it is, if you haven’t noticed. Just as a Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug
SIRS, sepsis, severe sepsis, septic shock is a continuum, a crescendo of signs and symptoms associated with an infection uncontrolled by host responses. An avalanche or cascade of seemingly unstoppable events occurs often in a matter of hours which has defied causal intervention but for which symptomatic treatment has improved Continue reading Recent Sepsis Literature