For a company whose pipeline is based on antisense technology, the mention of adverse effects, particularly cancer, is troublesome for them as a whole.
Is this sour grapes? Are there studies showing these concerns, (animals)? Wouldn't there be some other support for this claim?
That concern is independent of the drug type whether it’s molecule antibody protein, antisense small molecules or what.And they have quite a number of concerns. I think many of them are, it’s hard to justify some of them, but they have also indicated that they are going to require, certainly requested in a strangerous way, a very substantial addition of studies. Some of these studies are going to be very difficult to do because they want them done in combination with statin.
They have also indicated that they want (Inaudible) studies done very early because they are very worried about potential malignancies and our read of it is that even for FH it’s not going to be possible to get approval even for FH without outcome studies. There is plenty of room for interpretation there, but that’s our interpretation.