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ChikiTiny

01/10/17 12:50 PM

#207839 RE: DewDiligence #207785

Dew, was the Certain-1 Study results released earlier than expected? Or am i confusing something? Thanks
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CERTAIN-1—245 Japanese patients with any genotype; 8-week and 12-week arms (including an arm for renally-impaired patients); expected completion May 2017:
https://www.clinicaltrials.gov/ct2/show/NCT02707952
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vinmantoo

01/10/17 2:26 PM

#207846 RE: DewDiligence #207785

ENTA reports near-perfect G/P data from portion of CERTAIN-1 study in Japanese patients:

http://finance.yahoo.com/news/enanta-announces-high-svr12-rates-120500217.html

Treatment-naïve GT1 patients without cirrhosis were given 8 weeks of G/P and were analyzed in two subgroups: a) patients without the Y93H variant; and b) patients with the Y93H variant.

Among patients in a), the SVR12 rate was 99% (105/106); the only non-SVR12 patient was one who was lost to follow-up.

Among patients in b), the SVR12 rate was 100% (23/23).

CERTAIN-1 data from non-GT1 patients and various hard-to-treat subgroups will be presented later (at an undetermined medical conference). The ct.g listing for CERTAIN-1 is at https://www.clinicaltrials.gov/ct2/show/NCT02707952 .



Dew, I am a bit surprised this news didn't give at least a little boost to ENTA given only two drugs are used so ENTA's royalties will be higher if approved. Am I missing something?