Although I haven't finished listening to the cc one of the factoids mentioned is that they intend to start a large randomized ph ii non-inferiority (vs peg ifn alpha) trial for genotype 1 in mid 2009.
Question is - how many randomized trials is the FDA requiring in this indication. Any chance that one trial would be adequate or is the FDA likely to require a large safety database? (it was surprising that they referred to as a large non-inferiority as a ph ii instead of ph iii)
My caveat is that of course this treatment regimen is more similar to extant treatment regimens than the newer antivirals - so the FDA will probably be somewhat more lenient than with the antivirals, but require more than with different formulations of ifn-alpha.
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