OMER - Omeros appeal of FDA Complete Response Letter on narsoplimab denied; shares down 7%

• The US FDA has denied an appeal of a Complete Response Letter issued to Omeros ( NASDAQ: OMER ) over its Biologics License Application for narsoplimab.
• Shares are down 7% in premarket trading.
• The company's dispute resolution request had asked the agency to accept resubmission of the existing BLA and begin labeling discussions.
• Omeros ( OMER ) noted that the FDA's decision still allows a path forward for narsoplimab. The agency proposed resubmitting the BLA with a comparison of the existing response data to a threshold derived from an independent literature analysis as well as evidence of increased survival from patients in the pivotal trial compared to a historical control group.
• The BLA for narsoplimab is for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
• Read why Seeking Alpha contributor Terry Chrisomalis recently argued that Omeros ( OMER ) is a strong buy.

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