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Re: randychub post# 4496

Tuesday, 11/02/2004 11:32:37 AM

Tuesday, November 02, 2004 11:32:37 AM

Post# of 257266
>> I understand and agree with the safety concerns but this is a topic that has been talked about alot here and you have always strongly supported the execution and results of these mexican trials. <<

Yes, the Mexican results were the best I have ever seen. That’s why the 10mg data revealed last week were a bolt from the blue.

Until recently, I had assumed that GENR would not be testing at 10mg unless they were confident the drug would be efficacious at such a low dose. In thinking things through, however, I’ve reached the conclusion that GENR’s hand is being forced by the FDA’s newfound cautiousness.

If GENR cannot find a Squalamine dose that is both effective and safe –according to the FDA’s revised thinking about safety-- the company has a problem.

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