Scott Gotlieb's FDA initiative update should be read or reread(Thanks Roygbiv).....it certainly reinforces our pertinent points Xena. It would cease a lot of "gnashing of teeth" and negative posts this morning. For you surfers its like looking over your shoulder and seeing that swell building causing you to turn and paddle like mad to catch and ride the wave of you life!
Commissioner Gottlieb has outlined a very aggressive and forward looking agenda for the FDA and one aligned with his stated priorities before Congress (post 104555).
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"We need to make sure that our regulatory principles are efficient and informed by the most up to date science. We don’t want to present regulatory barriers to beneficial new medical innovations that add to the time, cost, and uncertainty of bringing these technologies forward if they don’t add to our understanding of the product’s safety and benefits."
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His and the FDA's initiatives that have a direct and future benefit for our drug development:
1. Under the 21st Century Cures Act, taking a "risk-based approach to reduce the time and cost of bringing new drugs and devices to market.
2. FDA's Center for Drug Evaluation and Research(CDER) development of "in silico" clinical trials to use computer models and simulation to develop and evaluate devices and drugs. VP Fadiran had a leadership role in this area of CDER when he worked for the FDA.
3 Right now, FDA is collaborating with scientists to develop natural history models in Parkinson's, Huntington's and Alzheimer's diseases.to help model placebo arms and simulations in rare diseases.
4. More money for computing capabilities and a Cures Steering Committee to help implement the 21 CCA
5. FDA's Center for Biologics Evaluation and Research(CBER) establishing the Regenerative Medicine Advanced Therapy (RMAT) designation for drugs. This is a big initiative for our Sigma 1 platform. There are currently 21 submissions under this category with 4 approvals to date. Very likely 2-73 is has been submitted and is awaiting approval currently. This would be a game changer IMHO.
6. There is a newly established Oncology Center of Excellence and Gottlieb has stated he wanted to elevate CNS Diseases and Cardiovascular disease efforts to mirror the success in the cancer arena.
7. CDER and CBER issued a plan for the development and issuance of patient focused drug guidance to inform FDA's regulatory decision making.
So much happening at the FDA that is positive for ANAVEX and bodes well for us in the last half of 2017.
Let's catch that wave!
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