The CEO of Biogen Idec faces a set of difficult decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series, focuses on operational decisions triggered by the drive for early approval. Sparks discussion about a leader's economic, legal, and ethical responsibilities to multiple constituencies, and how a leader can guide a company to execute effectively, fulfilling those responsibilities, in a complex situation. Decisions facing the company include how to sustain credible research on the drug's efficacy and safety, how to increase manufacturing capacity to meet expected demand, and how to secure insurer reimbursement. All of these challenges arise against the backdrop of the accelerated approval process, uncertainty about what the FDA will ultimately decide, and whether the company should indeed pursue early approval.