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oc631

09/14/11 9:22 AM

#126534 RE: genisi #126527

they might think PSI-7977 mono isn't enough in GT1





Since PSI-938 was designed to work with PSI-7977 I would say it's the obvious choice for pairing in the difficult to treat GT1 subgroup. Results from testing should bring Peg/Riba one step closer to the grave.



Interferon sparing trials (if necessary) will become increasingly more difficult to enroll if all goes well in all oral. This will be an even bigger issue for early stage HCV companies doing all their testing with Peg/Riba. Conversely VRUS should see brisk enrollment going into phase 3 for the oral platform.



I agree that PSI-7977 mono could work well in GT2/GT3 patients. When I proposed the idea of early approval for PSI-7977/PegRiba in these subgroups it was based on the FDA's comfort level with SOC usage as opposed to the limits in efficacy and/or the drugs resistance profile.