Sunday, April 09, 2017 12:17:31 AM
While there was general improvement over standard of care sufficient that the same results in a larger P2/3 would result in approval, there may be certain characteristics that enabled seven of those people to respond in an unexpected and unprecedented way.
If the P2/3 enrolls patients with those characteristics the trial will be shorter, less expensive, and possibly terminated early because of a high response rate. This is the data that is being studied post-trial.
The news released was not "fluff". Missling has appeared as participant on recent panels and upcoming panels. His perspective on trial design is respected in the industry.
Personally, I believe that they are stalling Alzheimer's a bit so Rett's can give a head start, giving orphan drug IP protection which is longer, then Alzheimer's and Parkinsons each would give an additional three years of IP protection...
Missling is a highly qualified biotech professional.
Christopher U. Missling, MS, PhD, MBA
Dr. Missling, President and CEO of Anavex™, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
http://www.anavex.com/about-us/management_directors/
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