ISIS trials for Kynamro have been ongoing, why would FDA not halt them ?
Agree with you in this regards. The lawyers want to push the envelop in the hopes of winning the lotto. If there was legislation intact that would ensure that there was risk on the other side instead of just pushing a lawsuit through a lot of this BS would dry up. t
PSLRA did heighten Sanctions for strike complaints. It would be interesting to see ISIS, upon receipt of FDA approval, go for counter claims of say 200 billion. Why so high? They have hundreds of diseases to tackle. They cannot afford 200,000 class action complaints slanted at and gambled upon each (potential) rejection for a license. All the FDA panel did was to suggest measures in the ongoing license, if granted, to be sure heart attacks, liver failure and cancer are not caused by Kynamro because there is no way to rule it out at this time, with 130 patients under study. That was the panel's opinion and I am not sure if its certain individuals or the whole panel's authority and opinion. Readers need to remember, severe FH patients die at the rate of 50% by age 50. The panel could just as well concluded ISIS saved some 20 people from certain death, only, as with the negative outcomes, the positive are also too soon to tell with so little statistical data.