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whirlybird

09/13/12 8:42 PM

#2768 RE: oddone33320 #2767

Thanks for the interesting references. Yes, the time for 510K approval should be comparatively quick versus that for drug approval. I would also add that in the EXPECT study the criteria for effectiveness reported that "the two most recent hepatitis c (HCV) infected patients to receive Hemopurifier® therapy in combination with peginterferon+ribavirin (PR) drug therapy achieved undetectable viral load at day-7, which represents a significant clinical milestone in HCV care." Wow, seven days to prove effectiveness possibly is truly a short time. No doubt the FDA would want studies of viral loads at later dates, e.g. six months or even longer, before agreeing the HemoPurifier as an adjunct treatment is effective. Still the time periods could be very short in comparison to studies P1-3 for drugs as treatment for any condition.