How many biologic drugs are as complicated as Lovenox or Copaxone? The fda can do whatever they think is best. Just because technically Lovenox falls under small molecule regulations doesn't mean the fda can't require clinical trials for final approval. Alternatively they could just point out where mnta isn't exact and not approve. It's going to be interesting to see what happens. I'm assuming $35 on approval or $4-5 on another setback.
On ports, another benefit is that with frequent Cinryze dosing, say 1-3 times per week many patients will eventually blow out their veins. A port is much more convenient, less painful and easier to administer. The additional benefit of home, self administration is in treating for acute attacks. I think the label expansion was something of a settlement or make up call to vphm for the bogus denial of the acute indication.
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