Data discussion is not relevant to us investors....it is revenant to the FDA in the process of Anavex negotiating a series of trials for 2-73. We need to assess the playing field as we enter September. New Administration, new FDA Commissioner, new drug development guidance and competing priorities. We see things from our shareholder perspective but not from the Federal Regulatory perspective. Here a a couple of points that may help us see what is going on in Washington and determine our probability of moving forward:
1. Janet Woodcock is a very powerful and important individual in the process. She has been at the FDA since 1994 and will have served with Scott Gottlieb earlier when he was Asst Commissioner. He has confidence in her championing some of the FDA key goals: reducing drug costs, bring to market game changing drug innovation and getting on top of the "opioid addiction epidemic". She holds two key powerful positions as CDER Director and the Head of Office of New Drugs (OND). This allows her direct control over cost, innovation and the "opioids". Our fortunes go directly thru her as the Office of Drug Evaluation I has the Division of Neurology Products. One of our chief competitors for attention is ODEII which has the Opioid Div. While there is much change going on in OND and many competing priorities, I believe Tayo Fadiran who worked along side of many of personnel in CDER/OND will keep our interests moving and off the rocks.
2. Much of the new adaptive trials ideas are Janet Woodock's and where presented before Congress in her "21st Century Cures - Moderizing Clinical Trials" testimony (post 113359) which include:
- Accepting flexible clinical development design
- Collaborative FDA and industry development of drug trials
- Creation of clinical trial "network" and " master protocols" (which could tie several 2-73 CNS applications to to a master trial plan)
- Surrogate endpoints for rare disease approvals
- Patient inputs on perceived benefits, risks and unmet needs
- Adaptive trial design that allows design modification as information about drug response accumulates
- Enrichment strategies to enroll patients more likely to respond to drugs under study
- Wide range of study designs to include single arm studies where the patient populations are extremely small
- Collaborating with industry and academia on biomarker development
If Dr Woodcock gets these implemented it will be of great benefit to our cause. Be patient with the process it will be worth the wait.
