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Biotech / Medical : CVTX - CV Therapeutics, Inc.

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To: keokalani'nui who wrote (80)5/30/2003 7:03:33 PM
From: Miljenko Zuanic   of 411
 
Thanks WE, (LLC)

<<The =2.9 msec mean increase in QT interval…>>

So, why was there concern in first place? What is QTc interval and confidence level for alfuzosin?

“To date, drugs that prolong the mean QT/QTc interval by 5-10 msec under conditions of maximum effect have also not been clearly associated with risk. Drugs causing a mean 10-20 msec increase under conditions of maximum effect are of concern, but have been approved if they appear to have important therapeutic roles. Drugs that prolong the mean QT/QTc interval by >20 msec have a substantially increased likelihood of being proarrhythmic, and may have clinical arrhythmic events captured during drug development.””

As I did mentioned early QTc for Ran is not concern, interval is 3-10 msec. Only very few have >500 msec, no difference from placebo.

Obviously, market like very much this news. However, and for record, my concern (also mentioned early) was and is not Ran QTc. It is TTS small exercise duration difference from placebo and possibility that pFOX may influence weight gain in diabetic population?

Miljenko
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