If it (IVIG) works what would other immunoglobulin makers need to do to get approved. Would they need full efficacy studies in the patient population? That would still give Baxter a pretty big head start (though capacity will be an issue).
Being long HALO I am biased but I thought this would be a great HyQ (sub-q) indication (which as a bonus would have IP too).
The U-shaped dose-response curve doesn’t bother me as much in this instance as it normally would because the MoA of Gammagard in AD is very poorly understood
Two comments:
a) I think the base rate of drugs with u-shaped dose response vs more traditional monotonic dose response is that u-shaped is pretty rare.
b) That said, my impression is that the immune system is more likely to have odd dose response curves. But it is only an 'impression'.