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

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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