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Re: rkrw post# 3774

Tuesday, 09/28/2004 11:06:06 AM

Tuesday, September 28, 2004 11:06:06 AM

Post# of 257295
Re 10mg dose:

>> Sounds like genr is trying to find the absolute minimum effective dose. Possibly all the more important because of the systemic delivery as well as something no doubt the fda would want to see. <<

We know that the FDA recommended last spring that GENR try lower doses (and also replace the prior size-dependent doses with fixed doses). Moreover, the amount of attention devoted to systemic safety at the Macugen panel meeting in August surprised me, considering that Macugen is administered locally and only one-thousandth of the dose escapes from the vitreal chamber.

GENR presumably paid close attention to the activities at the Macugen panel and, if they were on the fence about trying a 10mg dose in the phase-2 combo study, the panel meeting may have given them the nudge they needed.

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