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Omeros Confirms Submission of Briefing Package to FDA Following Narsoplimab Concerns

4:05AM ET 1/20/2022 MT Newswires
Omeros (OMER) said late Wednesday it has submitted a briefing package to the US Food and Drug Administration after the agency raised concerns about narsoplimab in a complete response letter.

The company is seeking approval for narsoplimab as a potential treatment for a fatal disease called hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Omeros said it has also requested for a type A meeting with the FDA to resolve any outstanding items.

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