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Re: rstor1 post# 1120

Saturday, 02/07/2004 9:30:25 PM

Saturday, February 07, 2004 9:30:25 PM

Post# of 257295
>> This is a valid point. I would like to look at the pIII size of drugs that have systemic action, but are administered for a localized condition. I am having trouble thinking of any. Do you have any leads? <<

Many dermatological conditions, such as acne and toenail fungus, have approved oral treatments. But, again, the comparison to Squalamine treatment in AMD is not very precise because the pills for these dermatological conditions are given every day (or multiple times a day) for several months.

>> Aside from that point, how much do you think that the PIII would run? <<

If GENR were to proceed directly to phase 3, I think the program cost would run in the several tens of millions of dollars. By running additional phase-2 trials, GENR (with or without a partner) could reduce the number of arms in the phase-3 trials and thereby whittle the cost down by a factor of two or more. The question is whether the reduced cost is adequate compensation for the longer time to market.


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