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Item 8.01 Other Events. Clearside Biomedical, Inc. (the “Company”) provided an update regarding the Company’s New Drug Application (“NDA”) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular edema associated with uveitis. As previously disclosed, the U.S. Food and Drug Administration (“FDA”) requested additional data on clinical use of the final to-be-marketed SCS Microinjector\u2122 delivery system in at least 30 patients. In response to that request, the Company proposed the submission of clinical use information in 160 subjects from its TOPAZ study for the treatment of macular edema associated with retinal vein occlusion. In recent meeting correspondence, the FDA agreed that it would be acceptable for the Company to submit such data in lieu of the requested clinical use assessment. As a result, the Company no longer plans to conduct an additional clinical use assessment with the SCS Microinjector. As previously disclosed, the Company plans to re-submit the XIPERE NDA in the second quarter of 2020 |
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| aus der Diskussion: | CLSD (Mkap $39 M) (Cash $65 M) NDA bei der FDA eingereicht =200%+ Chance |
| Autor (Datum des Eintrages): | Chancen1904 (17.12.19 15:20:12) |
| Beitrag: | 882 von 1,108 (ID:62179803) |
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