AMAG Open To Another Makena Trial, But Also Appears Ready To Challenge Any Withdrawal Request

CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.

4 Four brown pieces of puzzle stand on wooden table isolated on gray or white background. empty copy space for inscription or objects. idea, sign, symbol, concept of connecting - Image
How to design studies that will provide confirmatory evidence of Makena's clinical benefit is a puzzle that AMAG and the FDA will have to solve. • Source: Shutterstock

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