If ISIS falsified the efficacy, then the suits would make sense.
Because the incidence of cancer, heart failure and liver failure was reasonably consistent with the specific population under study, the FDA did not recommend anything except ALLOWING THE LICENSE and then making sure when the patient population gets large, these data, heart failure, liver failure and neoplasms, do not track to the therapeutic in use here. The panel did not say there was a connection. The panel noted due to the small population, when the population expanded to larger more statistically relevant numbers, then these data would become more important to watch for a possible but unlikely connection.
To my eye, this looks like one cancer incident in the placebo group and 2 or 3 in the treated group of 150 +- patients studied for more than 1 year. And ISIS has data from other studies using the same delivery vehicle, different antisense payload.
With its partnerships, Sanofi, Genzyme and now Biogen, I am sorry to say, these outsiders and law firms are making up their grist and rolling the dice. Maybe, one day, the dice will come up snake eyes and a smart Judge will whack them with a couple hundred million in sanctions. After all, if you look at Kynamro and even look at the patients who used it in conjunction with the drugs (from others), Kynamro saved a significant number of lives. (Based on survival rates for severe FH patients)
Law suits are part of a capitalist society. I just see the lack of merit and the very, very curious timing, to break down longs and get stock available for the shorts. That is the more obvious ploy to this.