Biotech Values

[mcbio]

Re: IDX184/320 clinical hold

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.

I probably should have just included reference to the 184/320 combo going forward in my prior post. Clearly, the only possible option for the combo to move forward, as unlikely as it is, is for the FDA to allow lower doses of one or both drugs together. We'll see what data the animal tox combo studies bring in the unlikely event that this remains an option. For 184 especially, and hopefully 320 as well, I remain optimistic that we'll get a full lift of the clinical holds on the drugs individually. I agree that just a partial lifting of the holds on these drugs individually (especially 184 given how much more advanced it is) would be bearish. Even if we do get a full lift of the holds on individual testing of 184 and 320, there still remains the question of to what extent a prospective partner would view each drug as damaged goods when they are individually combined with any other HCV DAA. I.e., is the 184/320 combo tox issue just specific to the 184/320 combo alone or is it an issue that could occur when each drug is combined with another HCV DAA? But, I like to think that this question and the related risk are sufficiently priced into what is now a ~$200M market cap.