I had the same sadistic hold myself; would we have been better off with a complete hold in place, then to apply anew a few month's ago. Don't forget, Stoll alluded to this very point in a past conference call, noting that all of their FDA consultants felt that the worse thing that could have been done, for Cortex, would have been to have left the hold in place. I'll take Cortex' experts at their word on this. Getting the dosages loosened is a more informal process.
I'm a small government kind of guy(except when it helps me of course!), but I'm now in favor of doubling the FDA staff CNS toxicology(and other divisions)and upping their pay as well. But, a metaphor, perhaps, could be made with the post 9-11 cry for more grade VI Arabic language speakers in the NSA/CIA. Yea, sounds good, but you don't get to be an expert Arabic speaker over night, and I strongly doubt you can mass produce toxicologists overnight. What biotech and pharma is facing requires change; perhaps a stronger FDA, bolstered by user fees, is the answer.