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Biotech / Medical : Biotech Valuation
CRSP 55.84+1.8%3:59 PM EST

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To: Icebrg who wrote (9204)9/25/2003 2:24:40 PM
From: Icebrg  Read Replies (1) of 52153
 
>>>>But fundamental news was good>>>>

Alertness Drug Backed for Some New Uses
Thursday September 25, 2:04 pm ET

BETHESDA, Md. (Reuters) - A U.S. advisory panel on Thursday backed Cephalon Inc.'s (NasdaqNM:CEPH - News) drug Provigil to combat excessive sleepiness due to shift work or severe snoring that causes individuals to wake frequently.

But the Food and Drug Administration (News - Websites) advisers split 4-4 on whether Cephalon should be allowed to market Provigil more broadly for excessive sleepiness from other sleep disorders.

The FDA usually follows the advice of its advisory panels.

Provigil already is approved for treating narcolepsy, a rare condition that causes uncontrollable sleeping during waking hours.


It seems (to me) that they will get what they want. Perhaps not the very broad label incorporating everything, but enough to make it worthwhile (and legal) to start visiting general practitioners. The idea is of course that once these MDs are getting more comfortable prescribing the drug they will start doing it off-label. In exactly the same way that they managed to expand from the narcolepsy base.

Erik
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