IDIX has finally reached agreement with the FDA on the design of the NM283-ribavirin drug-interaction study. It will contain three arms of 30 patients each: NM283+ifn+riba, NM283+ifn, and ifn+riba. PK/PD will be evaluated at 36 days and safety will be evaluated at the end of dosing at 12 weeks.
This is a welcome piece of news because this trial—a prerequisite for proceeding to phase-3 with NM283—had been held up all summer while IDIX and the FDA worked on the design. The trial will now begin as soon as clearance is obtained from the trial-center IRBs.
JP Sommadossi said IDIX has hired 30-40 sales reps to sell Telbivudine in the U.S. and 75% of these reps are experienced in the HBV market, specifically.
I infer that IDIX has hired away some reps from GILD and BMY because there are few other places where sales reps experienced in HBV can be found.
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