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genisi

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genisi

Re: ghmm post# 125595

Thursday, 08/25/2011 6:54:32 AM

Thursday, August 25, 2011 6:54:32 AM

Post# of 252254
UTHR/oral remodulin

In orphan indications with one positive trial and < .01 significance there are numerous precedence for approval.

Sorry for the nitpick but FREEDOM-M had p = 0.0125 plus it didn't do well with most secondary endpoints. As you said, even if approved based on FREEDOM-M alone, I don't see much use as monotherapy.
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