Cortex did run 3 month tox studies on CX-717 already, though I think they were in dogs and rats (I'll check my notes). From today's press release, the new 3 month studies the FDA wants to see (and that will be finished by year end) are in primates and rats.
It's possible that the 800 mg BID dose used in the ADHD trial is beyond the dose that the FDA is currently allowing for CX-717. That would be a problem if 800 mg BID is the upper dose being planned for a Phase 2b. We'll find out more specifics on the FDA's dosing limitations in the upcoming conf call.
A big question is how far BP negotiations can proceed if the 800 mg BID dosing level is beyond what is currently allowed for CX-717. Even without this factor however, I figure we're probably looking at a financing before year end, unless we get some significant warrant excercising.