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Failed Phase III For NeoCart May Still Fly With US FDA, Histogenics Argues

 
• By Emily Hayes

Agency guidance does not require coprimary, dual responder endpoint for drugs developed for knee cartilage repair, so in Histogenics' view, door is still open for approval.

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Histogenics Corp. believes that the US FDA will accept data from a Phase III study of its knee cartilage cell therapy NeoCart for review, even though the study failed the primary endpoint, because the firm believes the data meet a lower bar for approval now accepted by the agency.

The company will be requesting a "Type A" informational meeting with the FDA after reporting results from a Phase III...

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