OMER - Omeros receives response from FDA on formal dispute resolution request

• Omeros ( NASDAQ: OMER ) said on Wednesday that the United States Food and Drug Administration had given an interim response to the its formal dispute resolution request that it had submitted in June, appealing the decision by the agency review division to issue a complete response letter for the marketing application for narsoplimab to treat hematopoietic stem cell transplant associated thrombotic microangiopathy.
• The FDA in its interim response said the deciding official is collecting additional information, and a response to Omeros’ appeal will be provided within 30 days from the date that the additional information is collected and any required follow-up is conducted by the deciding official.
• Narsoplimab has Breakthrough Therapy and Orphan-Drug designations.

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