The approval is good news, and now it all depends on the labeling. But it seems that only a precaution would be indicated in the subset of patients not well responding to it.
The FDA noted that the disease can impact people of all races, but African American Women have a three times higher incidence than Caucasian women. The studies did show that the patient of African American heritage did not appear to respond to Benlysta.
"To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients," the FDA said.
Hopefully, this will allow the stock to trade in the 40's, unless management does something stupid again, and they are totally capable of doing so.