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Tuesday, September 20, 2011

United Therapeutics faces bleak future for oral Remodulin approval with disappointing PAH results, lack of physician enthusiasm

United Therapeutics' (NASDAQ:UTHR) oral Remodulin (treprostinil) faces a bleak future, experts said. The company still plans to file for FDA approval for the pulmonary arterial hypertension (PAH) treatment indication, despite its recent failure in the pivotal Phase III Freedom-C2 study. The failed combination therapy study (oral Remodulin combined with other first line PAH therapies) was described by physicians as the pivotal study which would likely mirror its realistic treatment setting.

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