HCV . 191 Phase 2B starting in Summer (20 million milestone). No specific reason just time frame based on expected FDA communications. RVR data Q4 '09 or Q1 '10. . INFORM top line results at EASL full results Q4 AASLD . Working to name a 2nd generation PI (no time table or profile given) intended as life-cycle mgm.
Pirfenidone/IPF . File in US summer '09, MAA late '09 . Partnership discussions expected to go several months (said because of large number of companies evaluating). . Analog announced ITMN-520, target IND mid '10. Would be dosed daily (pirfenidone 3x day) and potential for better tolerability. Other indication would pursued using this compound (as opposed to Pirfenidone) . Not commenting on any planned dialog with FDA.
Financial . 155 million End of '08 (+ 65 million from financing 2/09 financing) . Roche due 11 million for ITMN's share of 191 development. . Targanta sale should net 6 million . Marnac payment (expensed) 13.5 million. . DOJ settlement 11.4 million [13.2 million would be remaining] . '09 Revenue guidance 40-50 million (half Actimmune) . R&D 90-100, G&A 35-40 . 60% of R&D Pirfenidone related, 35% 191 related
Some Thoughts . No up-front for 2nd generation PI in return Roche paying all costs through Phase 1. . Dropping of early stage programs could mean the Helicase program is dead or at least on the shelf (they reportedly had other targets in pulmonology being pursued that could be shelved too).
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