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DewDiligence

09/07/10 6:51 PM

#103678 RE: mcbio #103674

I think I misunderstood the 184/320 DDI trial design.

No problem—I think oc631 did also, judging from his posts. To be clear: all patients in the DDI study who received either IDX184 or IDX320 received both drugs together for one of the two study weeks.

…it's probably not a great stretch to think that a safety issue could crop up when moving from 3 days to 14 days. All told, if IDIX can pin down 320 as being the culprit behind the SAEs, I feel pretty good about the chances of ultimately rebounding from today's fall.

Agreed that IDX184 is less likely to be culpable than IDX320, but I think it’s too soon to say that IDX184 is in the clear. There have been several HCV cases from various drug classes that turned up safety problems when well into phase-2; ITMN-191 is one such instance.
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oc631

09/07/10 8:47 PM

#103691 RE: mcbio #103674

All told, if IDIX can pin down 320 as being the culprit behind the SAEs, I feel pretty good about the chances of ultimately rebounding from today's fall.




The way I see it there are three outcomes and these are from best to worst for IDIX

1-The SAE's are a result of a drug interaction problem. The proposed combo is dropped.

2-The SAE's are from IDX320 and the PI is dropped along with the combo with IDX184.

3-The SAE's are from IDX184 (least likely by the way) and the nuke is dropped along with the combo with IDX320. Being that IDX184 is their most advanced HCV candidate it would be the biggest loss. I find greater value in the nuke class going forward to which I'm sure you disagree.