Based on the existing Phase 2 data in patients with OPC treated with Validive, Monopar is planning an adaptive design Phase 3 development program that will evaluate Validive compared to placebo in OPC patients stratified for HPV status. This design will allow us to prospectively confirm the observation made from the Phase 2 trial, that Validive will be effective in preventing radiation-induced SOM in patients with OPC. The Phase 3 program will also evaluate if Validive performs better in the HPV+ OPC cohort. Monopar is currently working with the U.S. and EU regulatory agencies to design a development plan to move Validive toward registration in both a time- and cost- efficient manner.