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Tanne

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Alias Born 09/24/2009

Tanne

Re: None

Monday, 08/02/2010 8:40:37 AM

Monday, August 02, 2010 8:40:37 AM

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On June 29, 2010, the Company was notified that its request for an End of Phase 2 meeting with the Food and Drug Administration (the “FDA”) was denied. The FDA in its letter recommended that the Company continue to conduct Phase 2 investigations. The Company plans to conduct Phase IIb studies for its URG101. The Company believes that successful phase IIb studies may provide sufficient evidence of safety and efficacy to form the clinical basis of an NDA submission and that this plan will not delay its ultimate NDA filing.
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