Hallal described a series of events since a Type A meeting with the FDA in November that included Novo Nordisk and Cure SMA. A week after that meeting, the FDA issued a warning letter to the Catalent Indiana facility; Novo responded to the FDA by mid-December. The FDA then scheduled an early first-quarter meeting with Novo, and according to Hallal, the agency had “no additional requests” to Novo’s remediation plan at that meeting. Hallal also said the FDA sent a field team to Catalent Indiana after the meet ...