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Re: DewDiligence post# 31907

Thursday, 07/27/2006 4:10:25 PM

Thursday, July 27, 2006 4:10:25 PM

Post# of 257262
Re : VRTX CC

I'm surprised that VRTX rarely mentions their strategy for the HIV-coinfected cohort and also that the analysts don't seem to be interested. It sounds like any label mention will be as an add-on later rather than on the first go.

I suppose they want to see the results of ritonavir addition before they initiate trials in coinfected patients. This delay by VRTX may be why IDIX has made the coinfected cohort a priority for NM283. A good move , IMO , since coinfected patients are such a large chunk of the market.

A couple of the questions were aimed at getting the VRTX folks to admit they were angling for approval based on P2 results , but they didn't get too far except for an acknowledgement that it was a possibility. Assuming the product stability data is done by early '08 , they could file at that time based on P2 , or wait for P3 data and file in late '08.

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