Note that JNJ started two phase-3 trials of Sovaldi + Olysio in GT1 patients: one for pts with cirrhosis and one for pts without cirrhosis.
As I mentioned early, GILD does not have meaningful statistical data for HCV pts with cirrhosis based only on one dozen pts. GILD cannot claim that its drug combo works for NCV pts with cirrhosis with efficacy above 70-80% even if all pts responded. GILD clinical trials were poorly designed.
Just imaging a cancer ~100-pts clinical trial were 85 pts without metastasis and 15 pts with metastasis. Even if the trials meets its PFS and OS primary goals, it is absolutely unacceptable to state that a drug is effective for both metastasis and non-metastasis pts. Note that even if the drug worked for 8 pts out of 10 its efficacy can be well below 30-40% based on such limited statistical data base.
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