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Re: pcrutch post# 146353

Tuesday, 07/31/2012 8:57:06 PM

Tuesday, July 31, 2012 8:57:06 PM

Post# of 257389

They said QTc was within FDA thresholds for this issue. You left this bit out

"To further explore the safety and tolerability of ARRY-797, Array is currently conducting a multiple ascending dose trial in healthy volunteers at doses up to 2.5-fold higher than those evaluated in the osteoarthritis pain trial. ARRY-797 has been well-tolerated in this trial to date, and greater QTc prolongations were observed at these higher dose levels. No subject in either trial exhibited an absolute QTc interval >500 msec or a change from baseline >60 msec, two values cited by regulatory authorities, including the FDA, as thresholds of particular concern for cardiac arrhythmia. These QTc observations warrant further evaluation."

So what should we make of the final sentence? They kind of seem to quell the safety questions in the preceding part of the paragraph but that final sentence kind of opens it back up to interpretation.

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