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Despite Latest Oral Remodulin Phase III Flop, UTHR Says It Still Has Enough Data For FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

The company tells skeptical analysts it will pursue a limited monotherapy label based on a single positive Phase III study in the wake of a second combination trial failure.

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A “complete response” letter from FDA to United’s December NDA for solo therapy of PAH with oral treprostinil certainly will delay and may endanger the Maryland firm’s best near-term growth driver.

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