H2 2025: Request meeting with FDA to discuss 505(b)(2) pathway. H2 2025: Target submission of New Drug Application (NDA). Sublingual ED medication H1 2026: Finalize formulation and manufacture test ...
H1 2026: Finalize formulation and manufacture test product. H1 2026 Initial Phase 1 pharmacokinetic clinical cross-over study. "Our pipeline is focused on research in therapeutic areas where we can ...
Prioritizes High-Value Approved Drugs in Multi-Billion-Dollar Markets to Accelerate Commercialization Future Platform Expansion into CNS, Men's Health, and Anti-Nausea ESTERO, FL / ACCESS Newswire / ...