Remedy Pharmaceuticals announced that a Type C meeting held with the FDA on October 16, 2024, provided valuable feedback on the design of a Phase 3 trial of its investigational drug, CIRARA, for large hemispheric infarction (LHI), a severe and life-threatening form of ischemic stroke.
A Type C meeting is a formal discussion between the FDA and a sponsor to review product development plans. Remedy sought feedback on the proposed Phase 3 study, and the meeting, along with meeting minutes, clarified key aspects of the trial's design.
"The FDA's feedback reinforces our confidence in our planned Phase 3 trial design and CIRARA's potential to address the urgent unmet needs of patients with LHI," said Sven Jacobson, CEO of Remedy Pharmaceuticals. "We are committed to advancing CIRARA and to redefining the standard of care for this devastating condition characterized by high mortality and severe long-term disability."
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