Usability/Clinical CRL — Human-factors deficiencies (pouch opening, film placement) plus a requested PK study on packaging changes; no CMC or efficacy issues cited.
Historical price action; green = local high, red = low/sell-off.
FDA decision date2026-02-02
Outcome✗ CRL✓ source-verified
Decision-day move+39.0%
T-120 run-up (low→high)+27.0% ($2.95→$7.49)
CRL reasonUsability/Clinical — Human-factors deficiencies (pouch opening, film placement) plus a requested PK study on packaging changes; no CMC or efficacy issues cited.
ValidationOutcome consistent with price; primary-source verification in progress.