What is the expected timeline for trial readout and potential FDA submission?

Timeline outlook

• Phase‑2 read‑out: The ADDRESS‑LC trial is only now opening enrollment in U.S. sites. Assuming a 12‑month enrollment window (typical for a Long‑COVID fatigue/cognition study) and a 6‑month treatment‑plus‑follow‑up period, the first topline data are likely to appear mid‑2025 (≈ Q2‑Q3 2025).
  
• Potential FDA submission: If the Phase‑2 results are positive, BioVie would need to complete a Phase‑3 confirmatory program (often 12–18 months) before filing a New‑Drug Application. In the most aggressive scenario—leveraging the Phase‑2 data as a “breakthrough‑therapy” filing and fast‑track the Phase‑3— an BLA could be submitted in late 2026 (around Q4 2026). A more conventional path would push the filing into 2027.

Trading implications

• Short‑term: The stock is likely to trade in a tight range until the first patient data emerge, as the market digests the enrollment news (current sentiment is modestly positive at 45). Technicals show limited upside‑bias; the price is near its 200‑day moving average with low volume, so a catalyst‑driven move is needed to break out.
  
• Mid‑term: If the trial meets its enrollment targets and early safety signals are encouraging, the market could price in a “read‑out in 2025” rally, especially on any interim data releases. A positive read‑out would set up a high‑multiple, growth‑oriented run‑up toward the anticipated 2026‑2027 FDA filing window. Conversely, a delayed enrollment or safety concerns would keep the stock depressed and may trigger a sell‑off.
  

Actionable take‑away: Keep a tight stop‑loss around the current support level (≈ 2%‑3% below the market price) while the trial is still in the enrollment phase. Position a long‑biased entry once the first interim data are released (expected Q2‑Q3 2025) to capture the upside toward a potential 2026‑2027 FDA submission, where the catalyst‑driven upside could be substantial if the data are robust.