1. ANA380 for HBV: a) The period during which NVS had the exclusive right to license ANA380 has expired. NVS could conceivably still license the drug, but it’s less likely because they no longer have any special standing relative to other bidders. b) The design of phase-3 will be determined by observing six-month data from the not yet started phase-2b trial. The most likely design of phase-3 is to test the 90mg and 150mg doses in Lamivudine-refractory patients.
2. ANA975 for HBV: Due to the animal tox issues disclosed in late June, there will be no IND in 2006 for the HBV indication as was previously planned. (The FDA has placed a hold on the ANA975 program in HCV.)
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