$ICPT A NISS is categorized into a i) potential risk, ii) an important potential risk, or iii) an emergency. The potential risk i) implies a "yet-to-be-established" suspicion of a direct link between the drug and the potential safety issue. This has been going on for almost half a year now and they have not found a link thus far. The amount of jumps and hoops this company is put under is staggering to me. Oh well I still believe the company will overcome the hurdles that are put in the end.