Unverified record. The outcome below was inferred from the share-price reaction around this date. Nobody has confirmed it against an FDA, SEC or company document, and it may be wrong: we have published at least one inferred outcome that turned out to be impossible (see corrections). Treat it as a price observation, not as a regulatory fact. Verified decisions on this site always link a primary source.
Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Daily close, T-120 (6/23/25) through T+5. Run-up high $18.09 on 12/5/25, low $8.24 on 9/24/25 (T-120 to T-1). FDA decision 12/8/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-12-08
OutcomeUnconfirmed · price consistent with a CRL~ price-only (validating)
Decision-day move+18.7%
T-120 run-up (low→high)+105.0% ($8.24→$21.47)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMicro
Cohort decision-day move (history)4.7% median (n=312)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.