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Saturday, October 06, 2007 11:04:35 AM
Agree with you on that. I'm not experienced enough with the FDA's dealings to comment on the politics. What i'm most concerned about is the statement made by one of the panelists which was regarding lowering the bar. Is there substantial evidence that the 50-day endpoint was flawed? If there is then orbec has a high chance of approval. If not I just don't see the FDA lowering the bar just to appear compassionate. Other companies could claim that future trials would not be ethical and use Orbec approval as a precedent. What i've seen of the FDA, which is very limited, leads me to believe that they are an extremely rigid agency with ice in their veins.
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