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Thanks, emsem, for posting lots of useful information.The passage: " ... Also, a 72-week control arm might be required, which could extend the filing date. We see some risk to the clinical timeline..."brought us down here from 37 area.A 72-week control arm is irrational if control arm is the IFN+RBVN standard of care. How many patients can withstand such a long torture!From the front part of the SP passage, see that FDA thinking is that a short trial is OK if the efficacy is good.If 24-wk SVR is 75%, don't see who would dare demand 2 year IFN.I predict that SVR for patient with genotype 1 would be better than 83% with 950. This figure comes from the rate of hard-to-treat mutant occurance.
What would you think would be the 24 week SVR lowest threshold beyond which FDA would demand a 2 yr IFN ?
They won't demand a 72-wk IFN control arm ... but will a 48-wk one. Expect a very good number for SVR.