Replies to post #103650 on Biotech Values

[mcbio]

Re: IDIX DDI study design/SAEs

The two SAE’s that are not explainable by the gallstone event were in the arm that had two weeks of IDX320 and one concurrent week of IDX184. The gallstone patient was in the arm that had two weeks of IDX184 and one week of concurrent IDX320.

I think I misunderstood the 184/320 DDI trial design. I thought it was 1 week on 1 drug and then the second week on the other drug solely. If in fact each arm had one drug that was used both weeks then that obviously would lead to differences in total dosage of a given drug received in each arm. Given that the two SAEs of focus occurred in the arm where 320 was received both weeks, this strengthens my inkling that 320 may be to blame for the SAEs. I don't think this is much of a stretch given that 184 has been tested much more extensively in the clinic and without any issues. Although the 3-day monotherapy trial may have looked clean for 320 (still haven't listened to the CC to better understand what issues oc631 is referring to), 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.