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Friday, November 13, 2026

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@kevin__mak

Kevin Mak on X

$CMPS Some questions about the CNPV program being shelved and how it will affect Compass' application. The honest answer is "nobody knows", though FDA has said on the record that career staff are still reviewing applications that already hold a voucher (a bit vague!). My hope is that they continue the existing process. CMPS (and Usona) have been on a rolling submission, so there is an established workflow to "keep the ball moving". See the transcript below for a sense of the relationship they've built with the FDA over the past months. Also, my guess is that 30-70% (yes, wide range) of the review is already "done", so FDA isn't starting from scratch as of the Nov 9th submission date. Even if they reallocate resources and "slow things down", I could see a plausible slowdown case where it takes 3-4 months (instead of 1-2 months on a full CNPV program, but not the 8-12 months of the regular non-CNPV track). Disclosure: Creek Drive and its affiliated funds holds a long position in CMPS. 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. -- Related/unrelated, the "race" between Usona and Compass is actually kind of moot. The actual "approval effective date" will likely be the DEA rescheduling date. Once the FDA gives the nod to EITHER drug, that starts the process on DEA rescheduling (which people are guessing will take around 90 days).
@ActAccordingly

PAA Research on X

@LizAnnSonders has been talking about this for a while, but as we get closer to 2027, perhaps one of the biggest issues for the market at large is earnings growth deceleration. Companies start to beat by thinner margins and investors begin to wonder if earnings growth estimates are too high. The opposite dynamic has been the case for the past 2-3 years in the tech sector where earnings momentum has been spectacular. If you're looking for a playbook for tech stocks, I'll point you to this investing bible from Dan Benton on tech stocks. It's as good a rubric as you will ever find. He provided an update to his "rules" for the 2026 landscape. Value investing in tech rarely works. Pointing to the low P/E in $NVDA currently is a fool's errand. If you want to be long, you better have a strong view on FY28 estimates. PERIOD. The multiple reflects that people think estimates for FY28 could be too high. There is no margin for error in the valuation of $NVDA currently because the variance of outcomes as it relates to estimates is incredibly high. Is it cheap in that context? Rules 1 and 2: 1) Sell technology stocks when estimates are being reduced 2) Buy technology stocks only for positive earnings surprises What we're seeing right now in tech is a heightened level of concern about risks to 2H27 estimates and 2028. Even if the $ANT IPO prices well, how do these earnings concerns get resolved?

Investor Letters

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PYPD · long

Polypid LTD

PolyPid, an $80 million Israeli biotech, fell nearly 30% despite solving a clinical problem.

PYPD $130M
Value Investors Club

Do You Trust Apple?

Apple’s HomeView strategy ties Siri, privacy and smart-home control to consumer trust in its vision for the home.

AAPL $5.2T
Stratechery by Ben Thompson – On the business, strategy, and impact of technology. 3 clicks

Semtech Analyst Day Review

Semtech raised Q3 guidance and targets $3.2 billion of fiscal 2030 revenue, excluding upside from its AI data-center optical and copper…

SMTC $11B
CV's Substack 14 clicks

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