Avita Medical discloses FDA request for additional information on RECELL GO

In a regulatory filing earlier this morning, the company stated: “As previously disclosed, on June 30, 2023, AVITA Medical submitted a premarket approval supplement application to the FDA for its latest device, RECELL GO. The submission initiated a prioritized, interactive review of the PMA under the FDA’s Breakthrough Device program, which follows a 180-day review cycle. At the halfway point of the process, the Company received notice from the FDA that additional information regarding the PMA is required for the continuation of a substantive review. This request, which is not unique to the Breakthrough Device Program, places the application file on hold for approximately 4 to 6 months while the Company addresses the FDA’s questions. Upon the Company’s submission of a complete response to the FDA’s request, the application will reenter the 180-day cycle, with 90 days remaining in the review period. This timing would imply a product launch between May 1 and July 1, 2024.” Shares of Avita Medical ended the day down 26% at $10.80.