Replies to post #469468 on Anavex Life Sciences Corp (AVXL)

[Hosai]

"Dr. Jin is a statistician. He is not an AD or PD or MS trial expert."

He actually is an AD trial expert - look at this bio:

"Dr. Jin will draw on his extensive experience, including recently as the Statistical Team Leader at the U.S. Food and Drug Administration (FDA). Dr. Jin provided statistical review coverage and expertise for neurological drug products for the Center for Drug Evaluation and Research (CDER), and performed timely and quality reviews of marketing applications, including New Drug Applications (NDA), Biologic License Applications (BLA), and Investigational New Drug (IND) applications. Under the leadership of Dr. Jin, the neuropharmacological statistical team has completed several hundred statistical reviews of NDAs, BLAs, and efficacy supplements.

Prior to joining Anavex, Dr. Jin had a distinguished career of more than 27 years at the FDA. During his tenure at the agency, Dr. Jin has contributed extensively to statistical review issues and trial designs surrounding the regulatory approval of drugs for the treatment of neurological diseases including Alzheimer’s disease, Parkinson’s disease, migraine, epilepsy, and multiple sclerosis, as well as rare diseases, such as ALS and DMD. Dr. Jin was the lead author in top theoretical statistics, biostatistics, and molecular genetics journals. He was also a winner in a worldwide innovation competition on clinical cardiology data processing (Predicting Acute Hypotensive Episodes).

Dr. Jin has extensive research experience in Alzheimer’s clinical trials. He has been an invited speaker and has authored publications on topics in Alzheimer’s disease endpoints and trial designs. He conducted FDA/CDER The Oak Ridge Institute for Science and Education (ORISE) Summer Fellowship projects, built the Integrative Alzheimer’s Trial Database, FDA/CDER Regulatory Science and Review (RSR) Project and the results have been communicated at Accelerate Cures/Treatments for All Dementias (ACT-AD), Drug Information Association (DIA), and Joint Statistical Meetings (JSM). Before joining the FDA, Dr. Jin was Assistant Professor at the Division of Biostatistics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Dr. Jin received his Ph.D. in Statistics from the University of California at Berkeley, California."

[Doc328]

I agree for the most part - Dr. Jin will have invaluable input into the study design - especially endpoints, power calculations to decide N, and the statistical hierarchy and how the endpoints will be evaluated but will not actually design the trial. Power calculations are done without much budget consideration. N and cost of the trial are related and the final decision will be up to Missling. However, though I would not consider Dr. Jin to be an AD or PD or Rett expert, I would consider him to be an expert in neurologic clinical trial design and their analysis. He has personally seen many dozen neurology trials and their associated strengths and weaknesses. He will be in charge of the SAP . If Anavex had not hired Dr. Jin they would be spending just as much on consultants (as they likely did with Dr. Ette)