"FDA believes that when adequate evidence of safety and efficacy...

"FDA believes that when adequate evidence of safety and efficacy exists for the use of combination therapy with individually approved HIV drugs, the path to regulatory approval of an FDC or co-packaged configuration of those drugs is straightforward. FDA
is prepared to move swiftly to evaluate such products when applications are submitted for approval.

FDA strongly
recommends that any company interested in pursuing the approval of FDC or copackaged products consult with FDA as early as possible to ensure that applications are complete. FDA also recommends that sponsors submit available information regarding
their products in advance of an official application to enhance the efficiency of the review process."
"A priority review designation provides for the review of an application in 6 months or less. We expect, however, that the applications described in this
guidance could be reviewed within shorter time frames."
http://www.fda.gov/cder/guidance/6360fnl.pdf

Someone is desperate to complete their portfolio swapping of shares before the inevitable tsunami occurs in the sp, imho. You can see it happening with the use of the algo computer programme working in both directions.