Comment from Ferring Pharmaceuticals Inc.

Summary: Ferring Pharmaceuticals supports the Commissioner’s National Priority Voucher (CNPV) Pilot Program, provided that the FDA maintains its rigorous "gold standard" scientific and evidentiary requirements for all approved products. The company specifically argues against the approval of Pergoveris® under this program, citing insufficient clinical data, lack of US-specific testing, and a history of failed confirmatory studies.