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Home » FDA Frets Data Shortfalls on GSK’s COPD Candidate, But Analysts Predict Approval
FDA Frets Data Shortfalls on GSK’s COPD Candidate, But Analysts Predict Approval
September 6, 2013
The FDA has called for a panel of advisers to review GlaxoSmithKline’s chronic obstructive pulmonary disease (COPD) treatment Anoro Ellipta, expressing concern about “substantial missing data” in the drugmaker’s primary efficacy studies.