ETON PHARMACEUTIC WKN: A2N38G ISIN: US29772L1089 Forum: Aktien Thema: Hauptdiskussion

Provides Update on EM-100 Program DEER PARK, Ill., July 12, 2019 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc(Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that the U.S Food and Drug Administration (FDA) provided Eton’s partner with a Complete Response Letter relating to the application for EM-100. No concerns were raised about the clinical data in the application, so it is not anticipated that any additional clinical work will be required. A response to this letter is expected shortly, and the Company remains confident in the approvability of the product. “We believe the issues cited in the CRL can be addressed in the coming months, and we remain confident that EM-100 will be available to patients as quickly as possible,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-provides-update-em-100-program