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Re: indiasoutheast post# 24027

Wednesday, 02/15/2006 8:17:09 PM

Wednesday, February 15, 2006 8:17:09 PM

Post# of 257307
Re: CONR

>What implication does the protocol change (reducing the proportion of patients with multi-vessel disease from 50% to 25%) have on its ability to get a multi-vessel label? Specifically, is the ability to get a multi-vessel label significantly reduced?<

Common sense says, yes, the protocol change makes it less likely (but not impossible) that they will get a multi-vessel label. However, the first priority is clearly getting the CoStar-2 trial enrolled so it can be completed in a reasonable amount of time. CONR can work on the label expansion later if need be.

Incidentally, multi-vessel and multi-lesion are two different things. CONR thinks interventional cardiologists are reporting an erroneously high number of multi-vessel procedures as a proportion of total procedures because: 1) they are lumping in multi-lesion procedures; 2) they have selective memories; and 3) they like to boast about the most difficult cases.

p.s. Do you still own MATK?

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