Replies to post #112357 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

Thanks, on the benefits of RMAT designation:

Section 3033. Accelerated Approval for Regenerative Advanced Therapies

This section allows FDA to build on existing expedited programs available to regenerative medicine
products by establishing a new program to foster their development and approval through the new
Regenerative Medicine Advanced Therapy (RMAT) Designation. Upon RMAT designation, sponsors
of such products are eligible for increased and earlier interactions with FDA to help facilitate an efficient
development program, including discussion of which approval pathways would be appropriate and the
size of clinical trials. In order to support effective development and review of these products, the Center
for Biologics Evaluation and Research (CBER) will provide continual regenerative medicine advanced
therapies training for all Center staff who may work on these products. Robust training is crucial to
ensure that FDA reviewers are well versed in the latest practices in this rapidly evolving field of
medicine.

https://google2.fda.gov/search?q=cache:eFLciHsSgQYJ:www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration/ucm556618.pdf+rmat+benefits&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&ie=UTF-8&access=p&oe=UTF-8