What is the expected timeline for clinical trial milestones and potential FDA approval for the expanded indication?

Timeline for Clinical‑trial Milestones & FDA Decision

• Fast‑Track designation (announced May 2024) means NRX‑100 will now be developed on an accelerated path. The company has indicated that it will initiate a pivotal Phase 2/3 trial in the first half of 2024 that will enroll the newly‑eligible 13 million‑person suicidal‑ideation cohort.
  
• Phase 2 read‑out is expected by Q4 2024 (≈ 12 months after the first patient in). Assuming the data are positive, the Phase 3 confirmatory study will be launched in early 2025 with a mid‑year 2025‑mid‑2026 enrollment window.
  
• Because the Fast‑Track program allows for a rolling‑submission of the NDA, the company can file the primary NDA as early as Q4 2025 (once Phase 3 data are available) and request priority review. If the agency accepts the filing, the FDA’s target review clock is 6 months, putting a potential approval window in early‑mid 2026.

Trading Implications

• The next catalyst is the Phase 2 read‑out (Q4 2024) – a clear driver of short‑term volatility. A positive read‑out could push the stock into a $1.30‑$1.45 range (≈ 30‑40 % upside from current levels). A miss would likely trigger a 20‑30 % pull‑back.
  
• The mid‑2025 Phase 3 initiation and the potential Q4 2025 NDA filing are the two “big‑move” events that will shape the longer‑term price trajectory. Assuming the trial proceeds on schedule, the market will price in a mid‑2026 approval well before the actual decision, creating a run‑up phase from now through 2025.
  
• From a risk‑management perspective, a stop‑loss around 10‑12 % below the current price can protect against early‑stage trial setbacks, while a trailing‑stop at 20‑25 % can lock in gains if the drug stays on its accelerated path toward a 2026 approval.
  

In short, the clinical‑trial calendar is compressed: Phase 2 Q4 2024, Phase 3 2025‑2026, NDA filing Q4 2025, and FDA approval likely by early‑mid 2026. The stock should trade ahead of these milestones, with the most immediate price‑action centered on the Q4 2024 Phase 2 data release.