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Re: DewDiligence post# 103585

Tuesday, 09/07/2010 11:34:02 AM

Tuesday, September 07, 2010 11:34:02 AM

Post# of 257262
Dew,

As I understand it, none of the adverse events showed up until at least five days after the participants left the clinic. In other words, there were NO adverse events during the clinical part of the trial, but only showed up some days after the participants left the clinic and, furthermore, only after the second evaluation after the patients left the clinic. The first evaluation after the participants left the clinic showed no adverse effects. What do you make of this? Could there be some exogenous event (e.g., people taking recreational drugs and/or using excessive alcohol--many young people enter these trials with a friend--that might account for the AE's?

Assuming the FDA lifts the clinical holds on both drugs individually, how do you think this will affect partnership discussions?

J.P. mentioned that there will probably be two new drugs entering the clinic before the end of the year. One is the NS5A inhibitor. What is the other?

Do you think there is much value in the IDX375 program, where IDIX said studies are continuing in the 4th quater?


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