Question · FY 2024
Joe Phillips and Jeff from Biovantage asked for updates on the timing and commercialization path for REC-994 in CCM, questioning the efficacy signals and the rationale for continued development.
Answer
CEO Christopher Gibson pushed back on the characterization of the trial being 'negative on efficacy.' He explained it was a 'signal-finding' study not powered for statistical significance, which successfully identified encouraging trends in lesion reduction via MRI and functional improvement via the modified Rankin score. He stated these signals warrant further exploration in a larger trial and that the company will provide clearer plans after discussions with the FDA and analysis of long-term extension data.
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