A snippet of Dr Paul Ambrose's bio, it sounds like they got the perfect lead and expert team to evaluate all the prior PK/PD data to help ensure a truly optimized dosing regimen that would be successful in the imminent 2B trial. Really a shame for PYMX shareholders because scientifically, it really does seem like they did everything in a top notch way, its just the finances that were grossly mismanaged and killed Brilacidin while it was at Polymedix. PYMX's loss is now CTIX's very big gain.
Here is the snippet:
"Our team’s expertise ranges from the microbiology laboratory, with in vitro PK-PD infection models, to the animal laboratory for PK-PD studies, through the Phase 1 Unit for healthy-volunteer and patient studies, into Phase 2 through 4 clinical trial design, to pharmacokinetic and PK-PD mathematical analyses to support regulatory and commercial efforts.
More specifically, our team’s mathematical expertise includes pharmacokinetic and population pharmacokinetic modeling, PK-PD analyses, Monte Carlo simulation, and epidemiological analyses of drug use and antimicrobial resistance.
We are interested in novel PK-PD-based clinical trial design, which serve to better describe the time-course of drug effect. The use of PK-PD-based clinical trial endpoints can have a significant impact on sample size power calculations and thereby hold the promise of reducing the total number of patients required to demonstrate therapeutic efficacy.
Dr. Ambrose is the author of over 60 peer-reviewed scientific publications and approximately 100 scientific abstracts. Dr. Ambrose has served as an Editor for four textbooks, most notable the 1st and 2nd Editions of Antimicrobial Pharmacodynamics in Theory and Clinical Practice."