Biotech Values

[mcbio]

IDIX @ Stifel (9/16/10)

1. Management believes it has strong evidence that IDX184 is not the culprit behind the side effects seen in the DDI study involving IDX184 and IDX320 (believe this was in reference to all of the studies conducted to date of 184 that have been clean). Management believes the culprit is either 320, the 184/320 combo, or the safety signal was just a fluke.

2. IDIX hopes to get written feedback from the FDA within 30 days (presumably formalizing the clinical hold in writing and not a lifting of the hold as the company still has a 28 day combo tox study to run).

3. IDIX hopes to be back in the clinic with 184 by the end of this year or early next year and hopes to "gently" move 320 forward in the clinic one more time at some point.

4. Regarding the three patients who experienced SAEs in the DDI study, there has been no evidence of drugs or alcohol and it's believed that these patients properly followed protocol. The patients with the grade 2 and grade 3 liver enzyme elevations are now back to baseline.

5. IDIX anticipates initiating additional HCV combo trials in 2011. There were no additional details provided, but I think we can safely assume that these trials won't involve the 184/320 combo.