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mcbio

08/12/13 7:41 PM

#165251 RE: DewDiligence #165247

JNJ/Medivir - potential rejected BTD

I don’t know; was mainly jerking mcbio’s chain, although I do think the rejected application might be Simeprevir. The FDA has granted so many BT designations for HCV, JNJ may have figured there was nothing to lose by trying.

I'm not so sure it's simeprevir myself. The first potential approval for simeprevir, and the one we have the most data on, is basically a better interferon-based regimen. I'm not so sure what's so "breakthrough" about that. I don't think the potentially better interferon-based regimen that simeprevir may have soon for a short while before the all-oral HCV combos start to eventually take over the market is the reason to be long Medivir. Rather, I'm long Medivir because I think simeprevir is a potential best-in-class PI, not a "so-so" one (#msg-90536586 ) that requires several other components to pick up the slack. Also, I like the potential for simeprevir to participate in one or more 2 or 3-drug QD combos rather than be mired in 4 or 5-drug BID combos like certain other competing regimens. I think the former is more likely to compete effectively against GILD in due time. ; )