Fred - having waded through all 204 pages with a fine tooth comb I can now confidently predict that HyQ will be approved 15-0 by the ADCOM. It appears that the FDA are not in the slightest bit concerned about titers causing strokes. Baxter however will have to conduct numerous post approval studies - some right through to patients' deaths. It seems like the FDA are prepared to concede the point but the onus is still on Baxter to eventually prove it. This if course might put off other potential partners as presumably the same rules will apply to them too. So this is partially good news but not great news.
"It appears that the FDA are not in the slightest bit concerned about titers causing strokes". Yeah, I've been telling you that on here for weeks (FDA has been concerned with non-neutralizing antibodies with HyQ - not clotting). We'll see what the FDA actually says, but welcome to the current HyQ conversation, pentech (It's good to have you here). We'll see how burdensome some or any post approval studies will be.