Oct. 24 at 7:36 PM
$ACHV I'm going to be posting a lot of data, really an end to end analysis of this as I see it under this post. For further sections see the comments to this:
1) Clinical & Regulatory Posture (Smoking + Vaping)
Smoking: two positive, biochem‑verified P3s; NDA accepted; long‑exposure safety (≥300 @ 6 mo; ≥100 @ 12 mo) being delivered; PDUFA Jun‑20‑2026. Vaping: positive P2 (same MOA), FDA Breakthrough and National Priority 1–2‑month review voucher once sNDA is filed; plan: start P3 ORCA‑V2 in 2H‑2026, file sNDA on readout, Q1‑2027 approval plausible.
2) Approval Probabilities (Not AI Generic, but based on extensive review of data points, comments, and mitigations to risk in place)
Smoking PoA: 93–95% (replicated efficacy + clean safety + NDA accepted + long‑exposure safety in hand).
Vaping PoA (today): ~95% overall given (a) same API/CMC as smoking label, (b) positive P2, (c) P3 designed to confirm, (d) 1–2‑month review lane; residual risk is execution/labeling, not CMC.
