Biotech Values

[DewDiligence]

…do you see any chance that IDIX can convince the FDA of allowing it to move forward in testing 320, either alone or even with 184, at a much smaller dose like 100mg QD?

I think the answer is probably no. At this point, IDIX’s contention that the two SAE’s were probably caused by an intracellular drug-drug interaction is the only explanation I would elevate to the status of a bona fide hypothesis. However, the FDA is not going to accept IDIX’s explanation by default just because a more plausible hypothesis is not available. Rather, I presume that IDIX will have to demonstrate the validity of the intracellular DDI hypothesis with hard data from the new animal-tox study in order to get the clinical hold lifted.

From a practical standpoint, I’m not sure a partial lifting of the clinical hold on IDX320 along the lines you suggested would be a great outcome for investors. As long as there’s a partial clinical hold, investors—and prospective partners—are apt to treat the drug in question as damaged goods. All told, I think it’s probably better for investors if the company aims for a full release of the clinical hold before pouring more money into the program.