Monday, November 23, 2015 10:16:33 PM
It's a pretty rough translation at times, but read and enjoy; (this was from the page 5 Q and A)
http://seekingalpha.com/article/3708036-enanta-pharmaceuticals-enta-ceo-jay-luly-on-q4-2015-results-earnings-call-transcript?page=5&p=qanda&l=last
Q and A
colin from Robert W. Baird & Co.
Luly's answer was that the G-1 8 week had essentially 100% cure rate, except for the cancer patient that died and didn't complete.
You will also notice that the 8 week SVR rates were very close to the 12 week trials.
I interpret that when greater numbers roll in that the 8 week trials for Geno 1's will look quite good
One of the disadvantages of Viekira has been twice a day, and that should switch to once a day dosing. (in 2016 if FDA approved?)
Europe and Japan are solid G1b populations where riba is not needed for Viekira.
In G1b cirrhotics, I think they are seeing that even riba added doesn't add much to the cure rates.
Point is.... Merck may not be such a shoo in for 2nd place, particularity on how the program gets labeled w/ regard to RAVs.
FWIW, Gild took 7977 through phase 3 trials in just 2 years to approval, but with several 24 week trial cohorts.
I would guess that since the trial cohorts will be 12 weeks, but who knows; there may be some conservative ones for treating cirrhotics, or contrasting 12 to 24 weeks (or 18?)
I expect approval in late 2017
I'm expecting better cure rates for the 3rd phase 2nd gen program than we are currently seeing, due to the higher (300 mg ABT-493) dose formula, and based upon the smaller data reported and a few flukes that skewed the SVR rates. I continue to believe that there were some later 2nd gen data that is wrapping up but has not/ was not reported at AASLD.
Nothing to do with the CC, but the Viekira prescriptions have been slowly raising, and the Harvoni, slowly decreasing.
I'm still kinda wondering, what this drug combo would do if combined with Sovaldi? Would it be better than the GILD triple DAA? (efficacy, duration, or curing certain genotypes/subgroups?)
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