CRL issued for ongoing ITM-11 NDA citing CMC and third-party commercial facility inspection-related items
“Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” said Dr. Andrew Cavey, chief executive officer of ITM. “Our pivotal COMPETE trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living with advanced GEP-NETs.”
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