October 9, 2012 – Results of Type C Guidance Meeting with Food & Drug Administration (FDA) of ZYDIS™ ODT Fluoxetine in the Treatment of Repetitive Behaviors in Autism

Posted by on Oct 9, 2012 in Press Release | 0 comments

Autism Therapeutics announced today that the Type C Guidance Meeting with FDA to discuss the ZYDIS® ODT Fluoxetine / Autism program has taken place. The FDA and Autism Therapeutics discussed the completion of the Phase III development of the program including the use of differentiated doses and strategies to control placebo response. Autism Therapeutics will now be discussing final details of the upcoming pivotal Phase III trial design with FDA under Special Protocol Assessment (SPA).

AT Press Release October 9 2012 (FDA Type C Guidance Meeting)