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Re: willyw post# 597

Saturday, 09/13/2014 11:09:01 AM

Saturday, September 13, 2014 11:09:01 AM

Post# of 2954

if the comparator trials were required, might (hypothetical) 2nd/3rd generation trials)Abbvie trials be able to use their own product, since they may also be considered the SOC (standard of care)?





Yes that's a possibility. The funding burden on these larger companies is nominal due to their scale. The threat here is to the small developers that are behind in the clinic. I suggested the active comparator may be determined on a class combo specific basis but the final objective is the same so this is unclear. Another advantage the incumbents had running open-label studies is patient screening (cherry-picking) lead to higher SVR rates. Patients in a non-inferiority study will be randomized and blinded to investigators. Enrollment may be slower due to the availability of existing oral treatment options and reduced warehousing.






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