"The Company expects to have further toxicological information available toward the end of this year, after completion of three-month toxicology trials in both monkeys and rats. "
So, they have completed 3 month tox studies and have more tox results to come.
The FDA dosing restriction was not a surprise to Stoll and it shouldn't be a surprise to us. The FDA is just trying to be as conservative as possible, which is the same reason the hold was introduced in the first place.