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genisi

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genisi

Re: ghmm post# 162928

Sunday, 06/23/2013 2:09:47 PM

Sunday, June 23, 2013 2:09:47 PM

Post# of 251889
PLX / KMDA

I thought being a recombinant product would convey some safety benefits but perhaps that wouldn't enough to break orphan exclusivity?

I think you're right in theory but PLX has to convince the FDA and CHMP that their product is indeed safer and since I don't recall safety problem with any plasma derived AAT, I don't think this argument is strong enough to break orphan exclusivity.
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