HALO - Around the 16.30 mark the first analyst asks about the EU application status for Herceptin and Mabthera.
It's not clear from the call what the relationship is between a plasma derived product and elevated non-neutralizing antibodies. It appears that the FDA is concerned that the combination of the plasma derived products and rhuph20 causes the elevation but it's not clear why. Is it likely that the treatment duration with rhuph20 is the reason for the elevated levels of the antibodies? Both HyQ and Cinryze probably have longer treatment durations. I think it was mentioned during the call that the % of antibodies increased for the other products as well but the % was smaller compared to HyQ and Cinryze.
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