The pre-clinical is certainly not needed to consider advancement to a phase 3 trial, however it may be a very cheap way to VERY CLEARLY affirm efficacy pitted against other agents now used in order to generate partnerships or licensing deals, and it may be used to clarify other aspects of the treatment landscape that are important both from a trial and clinical standpoint. I am recalling Dr. Jay’s comment in the midst of the COVID19 drama: “I think in the future we won’t be questioning that it works, but why it doesn’t work for some people.”

I think we can agree this strategy paid large dividends for MASH.