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Biotech / Medical : Biotech Valuation
CRSP 54.59-0.9%3:59 PM EST
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To: Henry Niman who wrote (13223)9/30/2004 11:22:51 AM
From: bio_kruncher  Read Replies (1) of 52153
 
Actually, FDA has been "requiring" these large long term safety studies for many years already. This is why Novartis did their big TARGET study and probably why Merck withdrew its ARCOXIA NDA. I would speculate that given the build up of evidence in the last few months there were already some discussions from FDA about this.
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