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Strategies & Market Trends : Point and Figure Charting

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To: Judy who wrote (9230)11/2/1998 5:33:00 PM
From: Nancy  Read Replies (1) of 34811
 
Next FDA play - PFE/MTC's Celebrex

Subject: Celebrex Review Milestones
Date: 11/1/98 8:56 PM Central Standard Time
From: BigKNY3
Message-id: <19981101215626.18366.00002535@ng-fa1.aol.com>

LSarmie: <<BigKNY, is there a time frame when celebra will be reviewed for approval?>>

Here's an estimate of the Celebrex review milestones

The FDA announced expedited review for Celebrex on August 24, 1998 (as per the handy Peabody Daily Log).

An FDA Advisory Panel should be convened to review Celebrex in December, 1998 or January, 1999.

According to their guidelines, the FDA must report the status of the Celebrex NDA by February 24, 1999.

One final point: to date every NDA that has been given an FDA expedited review has been approved for marketing.

Have PFun!

BigKNY3
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