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oc631

09/07/10 12:23 PM

#103613 RE: DewDiligence #103600

No—the DDI study (in healthy volunteers) is the one that encountered the problem.



The completed DDI study showed no drug-drug interaction between IDX184 and IDX320 in terms of PK and plasma concentrations.




Perhaps clean wasn't the right choice of words. Your quote above is what I was referring to. The DDI study does not conclusively indicate the cause of the three SAE's is through combination. Idenix hasn't even delivered the POC study results for IDX320 to the FDA. Would you like to comment on the AE discussed in the c.c.?



There were no safety signals of undue consequence when IDX184 was given as monotherapy or in combination with SoC.




We discussed this topic in detail a couple months back. McBio raised the subject if you recall.