Comment from Ocugen, Inc.

Summary: Ocugen, Inc., a biotechnology company, supports the FDA's Expedited Investigational New Drug Pilot Program but argues it should be further streamlined by adopting a notification-based approach modeled after Australia's Therapeutic Goods Administration (TGA) framework. They recommend specific modifications including permitting single-species toxicology data, allowing GMP-like material for Phase 1 studies, and prioritizing US-based sponsors and innovation.