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Monday, November 9, 2026

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@kevin__mak 4 clicks

Kevin Mak on X

I believe there's a high % chance $QURE gets its approval. Stuff like this from the FDA, in my eyes, further strengthens that belief. They want to generally make the review criteria more clear, more patient (advocacy) focused, and more flexible about what evidence is reasonably attainable. Not lenient for the sake of being reckless, but because there are situations that warrant different criteria. I think it would be quite incongruent to be vocally advocating for these new policies (which are suspiciously similar to the QURE debacle), while simultaneously crushing a high-profile drug approval like AMT-130. Incongruent doesn't mean it can't happen, just that it seems like the tail outcome. "The new framework is intended to enable patient input at earlier stages and at milestones throughout the development and review process. It also aims to provide greater clarity and consistency to drug developers on regulatory decision making. The agency said in a statement that it should take into account what evidence is reasonably attainable, given the nature of rare diseases." To be clear, FDA officials denied that the initiative was motivated by the earlier controversies. The connection to AMT-130, and the positive read-through, is my interpretation. "In an interview, senior officials at the agency denied that the initiative had anything to do with the earlier controversies" --- Disclosure: Creek Drive and its affiliated funds holds positions in QURE. Views expressed are current opinions for information only, subject to change and are not investment advice or a recommendation to buy or sell any security. Investing involves the risk of loss and past performance is not indicative of future performance. See the disclosures link in my bio for more important information.

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