Has that issue been resolved with regard to the hepatotoxicity study?
Not yet to the best of my knowledge. It’s an area of considerable discussion amongst the participants. Part of the timeline for the liver submission has been a focus on this issue. There are certain participants, including some FDA participants that felt very strongly that the first pathology readings should be blinded, which means that controls and the treated groups should be randomized and then you would perform pathology readings blinded in this way. When you look to the STP and leadership among members of the pathology community, their guidelines recommend controls be read separately and then treatment groups are randomized, to better determine a baseline control. Because we use different strains, different ages, and different sexes in our preclinical models your baseline could vary and some pathologists prefer to have that baseline before they can really say definitively that there’s a treatment related effect. Now, in terms of severity rating, this approach still blinds the next
