Hi, I am a newbie here and hence still getting my head around...

Hi, I am a newbie here and hence still getting my head around some of the science. It would appear that IMU are getting the paper work ready for a breakthrough designation application for bile duct cancer. This is only me reading between the lines. Also they dont have any translational data research yet as said by Dr Woodard. Also and remember im a rookie here so go lightly, i have not been able to see any data from IMU about potency assays and batch to batch consistencies, has this been ticked of by the FDA. You may sense from my question another stock i am invested in also.
From my limited research if the trials keep progressing as they have been this could be a once in a lifetime treatment and stock choice? Lets see