- Company completed Late-Cycle review meeting with FDA
- FDA no longer intends to hold Advisory Committee meeting
- FDA Review of NDA continues to proceed as planned with PDUFA target action date of November 28, 2024
https://www.globenewswire.com/news-release/2024/09/18/2948089/0/en/Applied-Therapeutics-Provides-Regulatory-Update-on-Govorestat-for-the-Treatment-of-Classic-Galactosemia.html
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