Countervail’s first targeted drug indication for the use of galantamine is as a pre-treatment against nerve agent toxicity. It is important to obtain regulatory guidance in the development of medical countermeasures for these types of indications. To do so, Countervail held a Type B – Pre-IND meeting with the Neurology Division of the FDA. As an outcome of the meeting, two key guidance components were obtained. With this targeted indication, both the “Animal Rule” and a 505(b)(2) regulatory path were considered the appropriate approach by the Agency.