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Biotech / Medical : Theravance - THRX
THRX 9.810+0.4%Jan 8 4:00 PM EST
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To: rkrw who wrote (56)10/26/2007 1:23:09 PM
From: kenhott   of 74
 
Thanks rkrw. I'd just listened to the CC on the approvable letter this morning. Still have to listen to the quarterly call. Couple of points that I picked up. It is not the QTc issue. I would guess it is not a safety issue but an efficacy issue. I have to go and read the draft non-inferiority guideline for antibacterial drugs that the FDA published in Oct 07. I don't know why mgt is being so tight on info but they are using the FDA as the excuse. It is pretty obvious to most people they have a label claim problem. But the head dude basically stated that they will not run extra trial and they will try to convince the FDA with existing data. If that doesn't work, they will accept the lesser label.
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