Vivesto AB announced that the company had a successful and encouraging pre-submission conference (PSC) with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) regarding development of Paccal Vet. Vivesto requested the meeting to get the FDA's feedback on the planned clinical development program for the company's veterinary oncology drug candidate Paccal Vet (paclitaxel micellar) with the intention to pursue full approval in the US. On a high level, the FDA agreed to Vivesto's development strategies.

The strategy is to perform a pilot study, to evaluate Paccal Vet in dogs with hemangiosarcoma and malignant melanoma, which is to be followed by a pivotal study. Vivesto plans to start the pilot study in the second half of 2023. The company received advice on major technical sections Chemistry Manufacturing and Controls (CMC), Target Animal Safety (TAS), Environmental Impact (EI) and Effectiveness.

Vivesto also received advice regarding MUMS (Minor Use/Minor Species) application and designation.