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Re: gofishmarko post# 41811

Friday, 02/09/2007 5:25:31 PM

Friday, February 09, 2007 5:25:31 PM

Post# of 257262
wrt HCV combos, gofish I can't argue that your scenario 2 is a lower risk option as it obviously is. You make excellent points wrt to potential regulatory impact. There are 3 points I would like to make though: 1) there is a huge difference in combining inherently toxic oncologic drugs and highly specific HCV inhibitors which are designed to have minimal AE's, and therefore this in itself is a lower risk scenario; 2) Death is not a likely scenarios for these classes of compounds, and the risk of serious AE's is minimal, assuming no drug-drug interaction. Even if there was a drug-drug interaction this would most likely be caught in early PhI trials so that risk could be mitigated before starting more advanced trials. Keep in mind if NM283 was selected, a GI AE in a combo trial would not expected to impact the other monotherapy at all as this was already known with that class. 3) the timing of the combo trials could be staged such that the lead monotherapy could be approved PRIOR to starting any Ph3 trials, again mitigating risk for the montherapy. For all these reasons I still see Scenario 1 as a low risk/high reward option with a potential annuouncement to start planning clinical trials in 2007. The emphasis is on high reward.

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