Comment from NEXI Biotech Inc.

Summary: Case Lorance, CEO of NEXI Biotech, supports the draft guidance but argues it must be expanded to include efficacy-oriented New Approach Methodologies (NAMs) rather than just safety. The commenter proposes a structured industry-sponsored validation pathway, a dedicated efficacy track within ISTAND, and a Priority Review Voucher-equivalent to incentivize biopharma companies to invest in and qualify these technologies.