RE:RE:RE:FDA moving along....Wyndewest,
That FDA backlog was concerning requests for orphan drug designation. Nothing to do with approving drugs. PLI already has orphan drug status for Pg. FDA clearing that backlog in 90 days may mean we here of an IAIP ODD soon.
https://www.raps.org/Regulatory-Focus/News/2017/06/20/27941/FDA-Commissioner-Vows-to-Eliminate-Backlog-of-Orphan-Drug-Designation-Requests/