Key Milestones (all achieved to date)

• Clinical Batch Manufactured November 2025
• IMPD ethics submission approved February 2026
• Clinical study completed May 2027
• Clinical Study title: “Evaluation of the bioavailability of two products containing naloxone hydrochloride, our test IMP vs. the comparator Naloxone HCl 4mg nasal spray. A monocentric, open, randomized, single dose, two period, crossover trial in healthy volunteers.”
• Full suite of product & quality records available (including COAs, BMR and Batch Uniformity).
• Stability trials
• Gold-standard device validated for powder delivery, fit for commercial use.
• Blend uniformity exceeded required specifications.
• Clinical trial and IMP registered in EUDAMED database.
• Initial commercial interest strong, with multiple discussions ongoing.