Anavex Life Sciences Corp (AVXL)

[sokol]

This 3 year extension is an extension of "FDA exclusivity" irrespective of any patent:

"Other" Exclusivity - 3 years for a "change" if criteria are met: • Granted to drug when application or supplement contains reports of new clinical investigations (not bioavailability studies) conducted or sponsored by applicant and essential for approval • Runs from time of NDA approval • Bars FDA from approving, for a three year period, any ANDA or 505(b)(2) application that relies on the information supporting the approval of the drug or the change to the drug for which the information was submitted and the exclusivity granted • Described in 21 CFR 314.108