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Re: genisi post# 122973

Thursday, 07/07/2011 6:18:04 PM

Thursday, July 07, 2011 6:18:04 PM

Post# of 252444

Perhaps I should have emphasized the word cure in #msg-61679544 :) I really cannot guess what will be the FDA' position regarding early filing, but I do expect good 24-week SVR data from that trial and even see a reasonable chance for monotherapy to work in GT2/3 patients.





VRUS added a 8-week GT2/GT3 treatment arm to the ELECTRON study using the 400mg dose. If all treatable patients in this study achieve an RVR at 4 weeks, which was previously demonstrated in PROTON, and an SVR at 8 weeks this would reduce the time patients need to be on interferon by 16 weeks (current SOC for GT2/GT3 patients is 24 weeks of Peg/Riba). An advancement of this magnitude deserves to be brought to market early if PSI-7977 continues to prove safe and tolerable across all studies come November.


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