Reata Pharmaceuticals Good News
Reata Pharmaceuticals (RETA) announced it received a communication from the Division of Neurology Products of the U.S. FDA stating, that after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-NDA meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich’s ataxia
The Division suggested that the Company withdraw the current meeting request for a Type C meeting and instead request a pre-NDA meeting that the Division will grant upon receipt. The Division asked the Company to focus the new briefing package on questions, issues and needs applicable to a pre-NDA meeting. As requested by the FDA the Company currently plans to withdraw the current request for a Type C meeting and submit a request for a pre-NDA meeting as soon as practicable.