XML 36 R31.htm IDEA: XBRL DOCUMENT v2.4.0.6
DESCRIPTION OF BUSINESS (Details)
1 Months Ended 12 Months Ended
Sep. 30, 2012
item
Dec. 31, 2012
item
DESCRIPTION OF BUSINESS    
Number of phase III LibiGel efficacy trials   2
Number of adjudicated cardiovascular events at the time of DMC review 53  
Adjudicated cardiovascular event rate (as a percent) 0.72%  
Number of breast cancers reported 27  
Rate of breast cancers reported (as a percent) 0.37%  
Period of average exposure in the safety study prior to submitting a LibiGel NDA and prior to a potential FDA approval of LibiGel 12 months  
Average time for which the subjects had been in the study 24 months 15 days  
Number of unblinded reviews by Data Monitoring Committee 9  
Minimum
   
DESCRIPTION OF BUSINESS    
Number of subjects under study for more than one year 3,200  
Period for which more than 3,200 subjects had been in study 1 year  
Number of subjects enrolled in study for more than two years 1,700  
Period for which more than 1,700 subjects had been in study 2 years  
Number of women-years of exposure obtained to arrive at adequate safety data of LibiGel 7,400