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Re: mskatiescarletohara post# 4382

Friday, 10/29/2004 1:27:48 AM

Friday, October 29, 2004 1:27:48 AM

Post# of 257262
The 10mg data:

I am still piecing together my observations about the new 10mg dose and will post again later today (Friday). Following is a copy of slide #12 from the R&R webcast, which shows data for the 6 patients treated at the 10mg dose in the “207” pharmacokinetic study:



At only two months from baseline (one month from the end of treatment), the mean vision change from baseline for the six patients on the 10mg dose is already a slight loss of 0.3 lines (1.5 letters). By comparison, in the phase-1/2 trial in Mexico, there was a mean gain of 1.2 lines (6 letters) as late as four months from baseline (three months from the end of treatment) at doses equivalent to 40mg and 80mg.

Evidently, 10mg is too low a dose for any lasting efficacy, which leads me to question why it is being tested and, further, why Dr, Levitt is talking about it as much as he is. More on this later.

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