That is the exact situation. The fact that the FDA can offer no rational for the lower dosage, leaves Dr. Jay and the patients in the trial dumbfounded.
pretty simple solution if the FDA doesn't want to allow us to run our trials as we see fit....and it aint just doing crappy small trials.
go to another country. sad part is it's taken them years to figure it out because NO ONE leading the company had any clinical trial experience until recently.