Anavex Life Sciences Corp (AVXL)

[sokol]

Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex, said yesterday, July 29, 2016, in the press release that: "Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies."

I suppose the analysis of PD determines the oprimal dose of the drug most likely to obtain the desired effect in the body, and that determination key to arriving at the number of trial participants and the length of the trial the FDA may accept for p3.

This artice provided by bsparks: http://www.dddmag.com/article/2007/09/modeling-success-pkpd-testing says:

"PK/PD modeling can greatly compress timelines by enabling companies to utilize PK/PD data collected in phase I trials," says Graham. "Instead of a sequential approach, modeling enables a parallel approach, helping jump-start phase II and phase III trial designs. This can significantly reduce the development time at every phase. Added benefits of PK/PD modeling are optimized dose regimens resulting in smarter phase II and phase III trials with a decreased risk of drug failure at the final stage." He cites the example of a company that benefited from PK/PD modeling at the phase IIb stage by eliminating the need for an additional dose group, thereby reducing the sample size by approximately 60 patients, something that saved six months and more than $1 million.

Thus, it saves time and money. The question is: How much time and money for this AVXL p3 trial?