CannPal Animal Therapeutics Limited announced that it has been granted its second US FDA Sponsor Fee Waiver for its lead drug candidate CPAT-01. The waiver was granted under the significant barrier to innovation provision of the FDA's Animal Drug User Fee Act (ADUFA) of 2003, as codified at section 750(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for Fiscal Year 2018. The waiver covers the current USD $75,150 Fiscal 2018 ADUFA sponsor fee which can be renewed each US fiscal year. CannPal may also be eligible for reductions in other fees such as the drug application fee which can cost in excess of USD $300,000. The company was initially granted a fee waiver for an osteosarcoma pain treatment under the Minor Use/Minor Species (MUMS) pathway in 2017 which is a pathway that applies to diseases that affect a minor number of patients every year. This new waiver under the barrier to innovation pathway is applicable to much broader indications, which allows CannPal to apply the waiver to CPAT-01D, which is being developed as a pain control in dogs. CannPal plans to take the results from the recently commenced Phase1A and B studies to file an INAD application with the FDA prior to the AU fiscal 2019 financial year, at which point the Sponsor fee would be required to be paid.