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Biotech / Medical : CEPH -- Ignore unavailable to you. Want to Upgrade?

To: KurtVedder who wrote (517)11/29/1997 12:28:00 PM
From: Brad Brubaker  Respond to of 998
 
What does not having an advisory panel meeting mean for Provigil? Is it also true the FDA only has to comment on Provigil, not make a decision, w/in one year of Cephalon's filing of the NDA?

Thanks for your comments in advance,

Brad



To: KurtVedder who wrote (517)11/29/1997 5:07:00 PM
From: NeuroInvestment  Read Replies (1) | Respond to of 998
 
In theory they have a year, but the definition of what they must do in that timeframe is open to (their) definition. They have a year to take some action...which could be approval, disapproval (highly unlikely), referral to an AC, request for more info. If they decide an AC is not needed, that would be a major plus for Provigil. NeuroInvestment


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