Keep the biotech stage-gate cheat sheet
Recall the stage-specific question, evidence, and common overclaim across the biotech development path.
Stage question What does discovery evidence mainly answer? Think target and mechanism Whether the biology, target, modality, assay, and disease rationale are plausible enough for deeper development. Trap: treating mechanism plausibility as clinical proof. Compare IND opened vs. drug approved: what changes? Human testing permission is not market authorization. Objection But Phase 1 was positive, so the therapy works, right? Use when someone overreads early clinical data. Your line Phase 1 can support safety, dose, exposure, or target-engagement confidence. It usually does not prove clinical benefit in the label population. Do not let positive become a universal evidence word. It…
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