There's that pesky word "should" again which makes it not a requirement. Most importantly, none of the efficacy good or bad would affect an IND application nor is it even expected to be included in an IND application since it is not a requirement.
Face it -- NNVC's 11 year of delays is the result of bullshit excuses because it's a biowreck scam. No, dude, this failing ridiculous joke isn't sitting on top of the greatest medical breakthrough of the century. Sorry pal.