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genisi

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genisi

Re: oc631 post# 153004

Tuesday, 11/27/2012 6:38:39 AM

Tuesday, November 27, 2012 6:38:39 AM

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PBTH

Do you think the rumored pivotal study design would be sufficiently powered for the FDA to accept a BLA filing without a SPA?

Yes, I think so. Also heard Mr. Novik a while ago. Seems the comp believes so. Said they got orphan designation and therefore needs only one pivotal phase III for approval. They are going to start the phase III trial of hGH-CTP in adult early next year. Design is: 150 patients, 2 arms (vs placebo), 6 months treatment with 6-12 extension for safety, primary endpoint will be change in truncal fat, cost ~ $15M, NDA filing in 2015.
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