Replies to post #162928 on Biotech Values

[genisi]

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.