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DewDiligence

12/17/08 8:16 AM

#5842 RE: markjohn62 #5841

>I wondered also if a FOB pathway could be found without major legislation, maybe some current rule tweaking.<

It already has been found—e.g. Omnitrope from NVS (#msg-11358021). But this kind of FoB approval (via the 505b2 pathway) will work only for the simplest kinds of protein drugs. Regards, Dew