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Biotech / Medical : CEPH
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To: Jonathan Rothschild who wrote (392)6/8/1997 1:25:00 PM
From: NeuroInvestment   of 998
 
While your point regarding risk to others is not incorrect, it does not fit the definition of a life threatening illness as viewed by the FDA, and thus is irrelevant to the issue of how fast Modafinil will be reviewed. Since the Advisory Committee has ignored the ALS patient lobby, I see no reason to think that they will respond to this concern; there is hardly a lobbying group like MADD arguing for sanctions against narcoleptic drivers.You are also correct that things will eventually improve with a new commissioner, but a selection has not been made, and even once installed, it takes a while for someone to learn the 'culture' of a bureaucracy and to plan a strategy for altering it. This will not be in time to hasten Modafinil's review.
NeuroInvestment
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