Anavex Life Sciences Corp (AVXL)

[nidan7500]

Yup....it won't be long now....more robust over time...Virtual trials modeling...IMO:Thx investor2014

Complex innovative trial designs (CID) – including the use of adaptive, Bayesian, and other novel statistical approaches – may help streamline and advance drug development and inform regulatory decision-making. Both the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and the 21st Century Cures Act contain provisions to make the use of CID in drug development and regulatory decision-making easier.
As part of a new initiative to advance the use of CID, FDA launched a pilot program in August 2018 for sponsors planning to use innovative trial designs that would provide substantial evidence of effectiveness. The CID pilot program is a joint initiative between CDER and FDA’s Center for Biologics Evaluation and Research, with CDER’s Office of Biostatistics leading the program for CDER. Sponsors participating in the CID pilot will have additional opportunities to meet with FDA staff through two focused meetings. To encourage expanded use of CID across therapeutic areas, acceptance into the pilot requires the sponsor to agree that FDA can publicly disclose certain study design and analysis elements of the CID even before the product is approved.
Dionne Price, Ph.D., who is the Director of the Division of Biometrics IV in CDER’s Office of Biostatistics, describes the latest developments in this rapidly advancing area.