Nov. 14 at 8:42 PM
$QURE – Continuing to Hold Position Ahead of FDA Response
I’m continuing to hold my position in QURE as we move toward the anticipated Complete Response Letter (CRL) from the FDA. Despite the filing challenges, the unmet need in Huntington’s disease is extraordinarily high and remains one of the most urgent in neurology.
There are tens of thousands of patients in the U.S. living with mid- to late-stage Huntington’s disease, a population that experiences relentless neurological decline, severe functional impairment, and a dramatically shortened life expectancy. Once patients reach advanced disease, progression accelerates and options become extremely limited.
Importantly, the recent leadership and policy shifts at the FDA this week may shift the view of the prior meeting acknowledging both the severity of Huntington’s disease and the lack of meaningful disease-modifying therapies. I believe these developments meaningfully increase the likelihood that regulators may support an accelerated or modified approval pathway for QURE’s HD program.
Given the profound medical need, shifting regulatory tone, and the absence of effective alternatives, I continue to believe QURE has a viable path forward despite the CRL process. Any constructive update from the FDA could unlock substantial upside in the stock.
Still holding. Good luck to all patient long-term shareholders.
