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Biotech / Medical : Biotech - Technical Analysis

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To: JEB who wrote (129)3/7/2002 9:27:27 AM
From: Jibacoa  Read Replies (1) of 544
 
SEPR found resistance yesterday at its previous support level of 47 and today it tanked on pre-market after news from the FDA's intention of a "not approval letter" on Soltara:

Sepracor receives non-approvable letter from FDA

(SEPR) 47.27: Co informed by the FDA that it intends to issue a "not approvable" letter for the New Drug Application for Soltara brand tecastemizole 15 mg and 30 mg capsules.

The FDA identified three issues that are not adequately addressed in light of certain aspects of the drug's pharmacokinetics and potential for accumulation in tissue.

Two of the issues pertained to observations from safety studies in animals that were not observed in humans.

Company has requested a meeting with the FDA to discuss the requirements for resolution of identified issues concerning the NDA

It is trading on pre-market below its May 2001 L of 23.45, Will see if it can find support at this level before trying for a come-back.

siliconinvestor.com

Bernard
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