Theravance Trims Loss, CEO “Optimistic” About FDA Panel Ahead
This article was originally published in The Pink Sheet Daily
Feb. 27 brings first test of noninferiority’s importance to regulators, analyst tells “The Pink Sheet” DAILY.
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Non-inferiority margins in anti-infectives trials, product development topics on schedule for April meeting.
Johnson & Johnson’s ceftobiprole and Theravance’s telavancin will be discussed Feb. 27-28.
Broad range of issues - from trial design to manufacturing - must be addressed before firm can add product to its antibiotic portfolio.