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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).
@aleabitoreddit

Serenity on X

My personal opinion is that Kress leadership is negative for $NVDA centric ecosystems and its financing. Companies like $COHR that supply everyone, with long term visibility are more isolated. As for some of the commentary: Kress reportedly “challenged some of Huang’s proposed investments in customers, including deals involving Lambda (Neocloud)” Jensen later called her “A deer in the headlights”. And said she was “A reporting CFO”, not someone who is able to make strategic decisions… In regards to decisions made where Nvidia could build a moat against hyperscaler diversification. Reports have also said CSP executives have now considered $AMD and $GOOGL TPUs following Jensen’s departure. But didn’t do so earlier in fears of retaliation from Jensen Huang.

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