• Our client’s investigation drug candidate was being reviewed by the FDA for approval
  • As a new compound entity, the FDA required a public Advisory Committee to debate the drug candidate’s benefits versus risks


  • The investigational drug demonstrated similar, but not superior, efficacy to incumbent product that was already on the market for 20 years
  • Safety evaluation trended towards inferiority to the market standard in critical patient populations although overall safety was noninferior
  • The public has a live in-person opportunity to express opinions for the Committee to consider


The Xelay Approach

  • Xelay Acumen developed and implemented a strategic grass roots campaign to develop patient, provider, and professional society advocacy which would be able to participate in the oral public hearing during the Advisory Committee
  • Client enjoyed a monopoly of all speaker slots in support of the drug candidate, the turning point in a 15-1 vote in favor for the client and eventual drug approval by the FDA