Sepracor-Looks very promising Message Board

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Biotech / Medical : Sepracor-Looks very promising

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To: Ed Ajootian who wrote (912)	6/20/1998 2:56:00 PM
From: RCMac	Read Replies (1) of 10280

Tom and Ed, Re FDA action on levalbuterol, this is from SEPR's 1997 10-K, dated 3/31/98: "In July 1997, two years after initiating clinical trials, Sepracor submitted a new drug application ("NDA") to the FDA for the nebulized form of levalbuterol. The FDA formally accepted the Company's NDA filing in early September 1997. Subject to FDA approval, the Company plans to introduce levalbuterol in late 1998." I believe FDA has to act within one year after its formal acceptance of the NDA; accordingly, in the normal course the FDA decision must be released by early September 1998. The 10-K is available at: edgar-online.com -- RCM

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