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Replies to #76700 on Biotech Values
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DewDiligence

07/21/09 8:35 AM

#81149 RE: DewDiligence #76700

IDIX 2009-2010 Clinical Goals

[Updated for disclosures on 2Q09 CC. Some of the dates
shown below are explicit guidance from IDIX and some are
my interpretations based on implicit guidance from IDIX.]



HCV

3Q09: Submit IDX184 monotherapy data to NVS, which triggers the 90-day negotiation period for NVS to decide whether to license the drug.

Oct 30-Nov3, 2009: Present full data set of IDX184 monotherapy study at AASLD conference.

4Q09: Start IDX184 14-day phase-2a combination study (SoC ± IDX184). The study will have ascending-dose cohorts and will include at least one cohort dosed at greater than 100mg/day.

4Q09: Decision by NVS on whether to license IDX184 (assuming IDIX submits monotherapy data to NVS during 3Q09 as planned).

4Q09: File IND for IDX375 non-nucleoside polymerase inhibitor.

4Q09/1Q10: File IND for IDX136 or IDX316 protease inhibitors.

Mid 2010: Report results of IDX184 phase-2a combination study.

2010-2011: File IND for newly disclosed NS5A program.


HIV

Timing unknown (it’s up to the GSK-PFE JV): Start IDX899 phase-2 head-to-head trial vs Sustiva.