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Wednesday, October 28, 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.
@AsifSuria 1 click

Asif Suria on X

Now that the Bumble $BMBL deal is confirmed, the key question is: when will this deal close? Usually we get an indication of that in the press release announcing the deal but that was not the case here. There is also something called the "outside date" that is specified in the merger agreement filed with the SEC and this is the drop dead date by which both parties expect to close the deal. Like most things in life, there are exceptions and outside dates often have extensions. In the case of Bumble, the outside date is July 12, 2027. Ithaca has also indicated that they don't plan to close before November 26, 2026. So we land somewhere between November 26, 2026 and July 12, 2027. The average time it takes deals to close based on about 15 years of our internal data tracking M&A is 120 days. Biotech deals generally tend to close much faster and the average there is closer to 90 days. Considering there doesn't appear to be shareholder, financing or antitrust risk here, I would not be surprised if this one closed in less than 90 days. Personally I would prefer that it close in 2027, so I don't have to think about short-term gains this year. Another situation I was involved in last year (the narcolepsy drug company Avadel), ended up closing just days before it would have turned into a long-term position for me and we ended up paying short-term capital gains on it. This is one of the issues with all cash deals that force a tax event for long-term shareholders.

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Terawulf INC

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