Kun Jin joined the company around the time that the decision would have been made.
I would have to think such a critical decision would have been discussed when he was interviewed for the position and certainly in great depth after joining. Perhaps he’s not nearly as smart as some people on this board?
Kun Jin, Ph.D Dr. Jin Vice President Head of Biostatistics 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.
While a second, confirming trial may be the rule, it is not an EMA requirement. Historically, in fact, there have been plenty of single trial EMA approvals -- 45 percent of new, active substances during one period studied:
While this statistic does not extend to CNS diseases during that period, I think the "not a requirement" point still applies.
I am less convinced than some others here that the Anavex version of CNS trial data is, for purposes of regulatory acceptance, representative of the class of prior CNS drug trials as a whole -- particularly given its unusually safe profile and relatively high efficacy.
There should be a distinction made between what has been customary and what has been required by the EMA. They aren't the same.
But I don’t understand what new unique data could be obtained beyond having more participants and for trials with marginal expectation for success even minor benefits for a small subset could be gleaned from a large participant count. MABs did just that.
Our 2b/3 trial was conducted at 52 sites in a number of different countries with equally high standards. Confirmed in a peer reviewed article in JPAD.
Why should we think another trial would suddenly produce different data?
You may not have noticed but regulatory agencies are changing how they do things. The FDA ,UK, and EMA have issued statements about how they are changing to address the long and expensive development of new drugs.
CNVP is a good example of how the FDA is changing.
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