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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: Cal Gary who wrote (8085)	11/22/2001 12:28:20 PM
From: Greg Spendjian	Read Replies (2) \| Respond to of 14101

To all, A question to anyone who knows about the way the FDA works: Does the fact that an inspection visit to a drug manufacturing site is scheduled mean that the FDA is satisfied with the "safety and efficacy" requirements of the drug submitted for review? If so, then the planned site inspection is very good news indeed. With the site having passed HC's inspection it is more than likely that it would pass the FDA's inspection. Even if there were any hitches, it would be easier to deal with bringing a manufacturing site up to a proper standard than resolving concerns about safety or efficacy.