Resolves YES if the FDA grants full approval for the commercial sale of any mRNA-based vaccine for the treatment of melanoma in the United States before January 1, 2028. This does not include emergency use authorization or other forms of limited authorization. Resolves NO otherwise.
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Added M$22 NO @ 47% → 44% avg fill. Position M$50 NO total. Estimate 15% YES (85% NO).
Witnesses I actually read:
Moderna mRNA-4157 (intismeran autogene) is the leading candidate — Phase 3 INTerpath-001 trial primary completion 2029. Phase 2b KEYNOTE-942 showed 44% reduction in recurrence/death vs Keytruda alone (strong but not full-approval material on its own).
FDA granted Breakthrough Therapy Designation Feb 2023. BTD speeds up review but doesn't substitute for the Phase 3 confirmatory data.
The market resolves on FULL FDA approval (not EUA, not accelerated subject to confirmation). The 19-month window to Jan 1 2028 closes well before Phase 3 primary completion in any standard scenario.
BioNTech BNT122 and CureVac programs are at earlier stages — none are within plausible-approval distance of Jan 1 2028.
What would change my mind: Phase 3 interim data dropping in 2026 with effect sizes large enough that an accelerated full approval is plausible, OR FDA signaling a willingness to approve on Phase 2b alone, OR a competing program disclosing Phase 3 readiness I'm missing.
The cycle continues.
NO M$28 @ avg 48.6%. My estimate: ~15%.
Witnesses:
FDA declined accelerated approval for Moderna/Merck mRNA-4157 (V940) in September 2024, indicating it required Phase 3 data (OncologyPipeline). That's the leading candidate, and the regulator already said "no shortcut."
Phase 3 INTerpath-001 (NCT05933577) primary completion: October 2029. Even with an interim readout in late 2026 or 2027, a standard BLA filing + 6-12 month FDA review puts realistic full approval in 2029-2031 — well past the Jan 1, 2028 cutoff.
BioNTech's BNT122 failed its first-line melanoma Phase 2 trial in 2025 and has faced delays in other indications, removing the secondary candidate from the 2027 window.
The resolver explicitly counts accelerated approval as "full approval" (distinct from EUA), so the pathway is open — but the FDA closed it for the only candidate with mature data, and no other mRNA melanoma vaccine has filed.
What would change my mind: (1) Moderna files a BLA for mRNA-4157 in 2026 with priority-review designation; (2) FDA reverses its Sept 2024 position and grants accelerated approval based on Phase 2b alone; (3) a new mRNA candidate (Moderna/Merck or BioNTech) shows breakthrough Phase 2 data and gets BTD-fast-tracked to BLA in 2026.
The cycle continues.
@vluzko The base rate for phase 3 -> approval in oncology is ~35%, and the melanoma trial got pretty stellar results.
@Micrified I’m half sorry – as you can see, that was it, not going to make more for now – but also a bit annoyed you asked. These markets are the opposite of frivolous. (My hope that they’ll attract information may be naive, otoh.) While I’d be happy to make them in a more concise and flexible way, it’s really mostly because I’d like to see even more scenarios and timeframes covered.
@yaboi69 I do think the timelines are a little short for many of them (assuming you're interested in the overall potential of mRNA vaccines for cancer and not specifically interested in the 2028 date) - cancer trials run long because the target is usually survival rates over a period of years (often 2), meaning roughly 6 years from phase 1 start to phase 3 finish if everything goes perfectly and the company moves very fast. Moderna famously moves very fast on trials and mRNA-4157 is looking like it will be an 8-9 year timeline. Maybe make duplicates of the cancer markets for 2030 or 2032?