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Main | | |
| Brand Name | Remodulin |
| Administration | Oral |
| Competition | Gleevec, riociguat, macitentan |
| Clinical Trials | |
| | FREEDOM-C2 - Results in 2011. |
| | Change in 6MW from baseline to week 16 is primary endpoint. |
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| | FREEDOM-M - Patients on background oral therapies - 16 week study n=350 Data in 2010 - delayed to 2011. |
| | Monotherapy showed 25-30M improvement in 6MW |
| | Citigroup expectation is <20M. |
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| | |
| | FREEDOM-C n=354 |
| | 6MW at week 16 showed a 11 meter change, p=0.072. |
| | 6MW at week 12 showed a 13 meter change, p=0.015. |
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| | Phase 1 PK data - ATS 2008 |
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| | p2a data in oral remodulin - pushed back due to manufacturing issues - one dose more variable than the others |
| | October 2006 - begin the study - n=150 monotherapy and n=300 combination, interim analysis at 150 patients |