b'A key question the FDA considers is:Has the sponsor conducted necessary modeling and simulation to support the discussion of questions related to the development of the drug?Because CNS-active drugs can have unintended effects in the critical neuralsystemthataffectssomanyaspectsofhumanhealth,the requiredmodelingandsimulationaretypicallymoredetailedand rigorous than for other types of drugs. In addition, the results of the modeling will have a material impact on your development program going forward, both in terms of timelines and budget, so you will want the answers for yourself as much as for the regulatory bodies.Some significant questions related to CNS agents are:Does the drug have potential for abuse?The decision to undertake additional preclinical and clinical testing to evaluate abuse potential will largely depend on the preclinical/clinical data already collected and reviewed at the time of the EOP2A meeting. Relevant adverse events, target receptors, and other signals of abuse potentiality are carefully examined by regulators to determine if there may be a need for further data and consideration of scheduling status. Understandingthisearlyindevelopmentassurespreparednessfor budget and timeline in your program. Our experts can assist in creating a comprehensive analysis in the eight-factor format used by the FDA for NDA submissions, and can help you set a strategy for your complete program during the critical early development milestones.'