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Omeros Receives FDA's Interim Response On Formal Dispute Resolution Request For Narsoplimab

Omeros Corp. (OMER) announced FDA provided an interim response to the company's formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. According to FDA's interim response, the deciding official is collecting additional information, and a response to the appeal will be provided within 30 days from the date that the additional information is collected and any required follow-up is conducted.

Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the agency, in this case the
Office of New Drugs.

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