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Lumosa has received the FDA’s feedback from the Type C consultation
Corporate
2025.11.28
Lumosa has received the FDA’s feedback from the Type C consultation
The Company submitted a Type C meeting request to the U.S. Food and Drug Administration (FDA) for LT3001, its investigational therapy for acute ischemic stroke, based on the existing nonclinical data and clinical trial results.
The consultation covered topics including the completeness of nonclinical safety data, the Phase 3 clinical trial design (such as efficacy endpoints, sample size, patient eligibility criteria, and interim analysis considerations), as well as regulatory expectations for a future marketing application in the United States.
The FDA has provided specific and highly informative guidance on the above topics. The Company will refine and optimize the Phase 3 clinical trial design in accordance with the FDA’s recommendations and will prepare the Phase 3 clinical trial protocol as a key reference for future regulatory submissions.
The consultation covered topics including the completeness of nonclinical safety data, the Phase 3 clinical trial design (such as efficacy endpoints, sample size, patient eligibility criteria, and interim analysis considerations), as well as regulatory expectations for a future marketing application in the United States.
The FDA has provided specific and highly informative guidance on the above topics. The Company will refine and optimize the Phase 3 clinical trial design in accordance with the FDA’s recommendations and will prepare the Phase 3 clinical trial protocol as a key reference for future regulatory submissions.
