CannPal Animal Therapeutics Limited announced that the Food and Drug Administration, Centre for Veterinary Medicine (FDA-CVM) Office of New Animal Drug Evaluation (ONADE) has established an Investigational New Animal Drug (INAD) file for CannPal's lead cannabinoid-derived drug candidate, CPAT-01. CPAT-01 is a highly purified pharmaceutical product derived from natural THC and CBD extracts which is being developed as a veterinary medicine for the reduction in symptoms associated with osteoarthritis, with an initial focus on pain and inflammation. A summary of the scientific rationale for the development of CPAT-01, which included data generated from the pre-clinical and Phase 1 research program, was provided to the FDA with an INAD request on 14th January 2020. Sponsors of new animal drugs typically submit a request to open an INAD file when they have enough pilot data to start discussing the development process with the FDA and/or they want to begin shipping drug for use in investigational studies in the US. The INAD file contains correspondence and submissions that may be used to support a new animal drug application (NADA) for CPAT-01 and allows CannPal the ability to request a Pre-Submission Conference (PSC) with the FDA-CVM. In the PSC, CannPal will propose its detailed development plan for CPAT-01 and discuss the overall regulatory pathway for the drug candidate. This meeting is expected to take place in Q2/Q3 2020. The establishment of an INAD file also allows CannPal to submit a Notice of Claimed Investigational Exemption (NCIE) which allows the shipping of investigational drug product to study investigators in the US for future animal studies, including but not limited to, further pilot studies and pivotal studies for effectiveness and safety.