Question · Q4 2025
Mike asked about the gating factors to get the ATTR studies back up and running, and what has been heard from regulators regarding the path forward for ATTR-CM.
Answer
President and CEO John Leonard explained that gating factors for PN are local operational issues at sites (IRB submissions, local regulatory considerations), with active accrual expected soon and full accrual by year-end. For CM, the gating factor is receiving an FDA letter lifting the hold. He reiterated active engagement with the FDA and significant progress, but the hold is not lifted until the letter is received.
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