the best summarys are here
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124040.htm
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124454.htm
but to summarise about 400 pts on isentress or prezista
currently, atc has phiib about 35 and phiii about 150 = 185, for a much safer drug class...
the others got accelerated approval on cd4 and viral load decline, have posted cd4s, and in terms of viral load reductions (not %s but absolute numbers used for accellerated approval, which depend somewhat on initial load..., but anyway)
-1.85 log10 copies/mL for isentress
-1.9 for prezista
Note this measure has not been reported by AVX for ATC in Phiii yet, coming soon i suspect, and the significantly different clinical measures suggest it will be good for ATC
so, i dont think this phiii alone will be enough based on number of pts, hence my comments that maybe start another smaller phiii (say 300) to show non-inferior with significantly better secondary measures, and file once full recruitment to allow NDA and then approval 24 wks after... this year? or @ market early next...
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