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Unmet Need Can Trump Anything At US FDA Panels, Even An Ill-Prepared Sponsor

 
• By Michael Cipriano

Emmaus was unable to answer several questions about its product and was also missing several pieces of data, but FDA's Oncologic Drugs Advisory Committee didn't criticize the sponsor, and instead praised it for paying attention to the largely neglected sickle cell disease.

The largely unmet medical need for a sickle cell disease treatment seemingly allowed the US FDA's Oncologic Drugs Advisory Committee to look the other way on a sponsor that appeared to be unprepared to defend its drug under panel review.

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